tag:blogger.com,1999:blog-34711151258872168362024-03-18T19:27:07.274-07:00Penn State Food Safety BlogProviding news and commentary on important food safety issuesmwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.comBlogger3374125tag:blogger.com,1999:blog-3471115125887216836.post-37529046640914303792024-03-18T19:26:00.000-07:002024-03-18T19:26:13.111-07:00Trader Joe's Recalls Imported Cashews After FDA Testing Finds SalmonellaWenders LLC of Dublin, CA is recalling specific production lots of Trader Joes Nuts – 50% Less Sodium Roasted & Salted Whole Cashews – (SKU Number – 37884) Lot# T12139, T12140, T12141, and T12142 because they have the potential to be contaminated with Salmonella. The issue was identified through routine testing by FDA during import, which indicated that at least one of the recalled lots tested positive for the presence of Salmonella.<br /><br />As part of the importers FSVP, the hazard analysis would identify pathogens as a significant hazard. The company would need verification activities that would include a facility audit. Along with that, product testing and records verification should be considered. From the label, it looks as though the importer is buying from a few different countries, thus a few different suppliers. <div><br /></div><div>In these situations, it may be better to import the raw nut and have them roasted by a domestic processor where you have better control of the roasting process.<br /><div><br /></div><div><br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wenders-llc-recalls-trader-joes-nuts-50-less-sodium-roasted-salted-whole-cashews-because-possible<br /><b>Wenders LLC Recalls Trader Joes Nuts – 50% Less Sodium Roasted & Salted Whole Cashews Because of Possible Health Risk</b><br />Summary<br />Company Announcement Date: March 17, 2024<br />FDA Publish Date: March 18, 2024<br />Product Type: Food & Beverages<br />Reason for Announcement: Potential to be contaminated with Salmonella.<br />Company Name: Wenders LLC<br />Brand Name: Trader Joe’s<br />Product Description: 50% Less Salt Roasted & Salted Whole Cashews</div><span><a name='more'></a></span><div><br />Company Announcement<br /><br />Wenders LLC of Dublin, CA is recalling specific production lots of Trader Joes Nuts – 50% Less Sodium Roasted & Salted Whole Cashews – (SKU Number – 37884) Lot# T12139, T12140, T12141, and T12142 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.<br /><br />Product was sold in the states of AL, AR, AZ, CA, CO, ID, KS, LA, NM, NV, OK, OR, TN, TX, UT, and WA at Trader Joe’s locations.<br /><br />The product can be identified by the country of origin, India or Vietnam and the “Lot No:” printed on the back panel of the plastic pouches Trader Joes Nuts – 50% Less Sodium Roasted & Salted Whole Cashews (SKU Number – 37884) No other Lot No:s or products are affected by this recall.<br /><br />Lot No# Best Before Date<br />T12139 Feb 21, 2025<br />T12140 Mar 01, 2025<br />T12141 Mar 08, 2025<br />T12142 Mar 10, 2025<br />No illnesses have been reported to date.<br /><br />The issue was identified through routine testing by FDA during import, which indicated that at least one of the recalled lots tested positive for the presence of Salmonella.<br /><br />Consumers should not eat any products covered by this recall. Consumers who have purchased a recalled product are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at foodsafety@wendersllc.com<br /> </div></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-84973686484392766482024-03-18T18:59:00.000-07:002024-03-18T18:59:59.098-07:00Wisconsin Firm Recalls Dark Chocolate Cherry Granola for Undeclared AlmondsKick Ash Products of Ellison Bay, WI is recalling Door County Love Dark Chocolate Cherry Granola with Lot #061241, because it may contain undeclared ALMONDS. The recall was initiated after Kick Ash discovered that the Dark Chocolate Cherry Granola containing almonds was distributed in packaging that did not reveal the presence of almonds. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production processes.<br /><br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kick-ash-products-issues-allergy-alert-undeclared-almonds-product<br /><b>Kick Ash Products Issues Allergy Alert on Undeclared Almonds in Product</b><br />Summary<br />Company Announcement Date: March 14, 2024<br />FDA Publish Date: March 18, 2024<br />Product Type: Food & Beverages<br />Reason for Announcement: May contain undeclared almonds<br />Company Name: Kick Ash Products, LLC<br />Brand Name: Door Country Love<br />Product Description: Dark Chocolate Cherry Granola<span><a name='more'></a></span><div>Company Announcement<br /><br />Kick Ash Products of Ellison Bay, WI is recalling Door County Love Dark Chocolate Cherry Granola with Lot #061241, because it may contain undeclared ALMONDS. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.<br /><br />The Door County Love Dark Chocolate Cherry was distributed in Ellison Bay, Wisconsin and may have reached through consumers via our retail store in Ellison Bay or online orders placed at kickashproducts.com between the dates of 02/26/24 to 03/11/24.<br /><br />The Dark Chocolate Cherry Granola is sold in a brown plastic bags, with clear viewing window and a red label. The affected Dark Chocolate Cherry Granola will have Lot # 061241 and Best By date of 08/31/24 . Both the Lot number and Best By Date can be found imprinted at the top of the bag.<br /><br />No illnesses have been reported to date.<br /><br />The recall was initiated after Kick Ash discovered that the Dark Chocolate Cherry Granola containing almonds was distributed in packaging that did not reveal the presence of almonds. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production processes.<br /><br />Consumers who have purchased Kick Ash Door County Love Dark Chocolate Cherry Granola with a Lot # 061241 and Best by Date of 08/31/24 are urged to return it to Kick Ash Products for a full refund. Consumers with questions may contact the company Tuesday through Saturday from 8am to 3pm Central Time at 1-920- 854-9400.</div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-83435159638970618702024-03-15T12:43:00.000-07:002024-03-15T12:43:16.478-07:00News on Food - 3/15/24 editionWhen perusing through news sources, one comes across interesting (to me, and perhaps you) news items on food that are not food-safety related. Here are very brief summaries and the reference links at the bottom. <br /><br /><ul style="text-align: left;"><li>Is cabbage the next vegetable to make it big in restaurants? It seems to be turning up as a favorite for many innovative chefs, similar to what occurred with Brussel sprouts. Just a matter of time before I have my Steak au Poivre with a side of <a href="https://www.food.com/recipe/halushki-cabbage-and-noodles-251055">halushki</a> at the newly renovated <a href="https://thenittanylioninn.com/" target="_blank">Nitany Lion Inn.</a>- opening Fall of 2024.</li></ul><ul style="text-align: left;"><li>Is gravy the next ketchup? The folks at KraftHeinz are promoting their gravy as a ketchup type of condiment. There are many who add gravy to their fries, but to your hot dogs?</li></ul><ul style="text-align: left;"><li>Are you chewing gum? It seems that pandemic was not only a death nail for many restaurants, but also dealt a sever blow to chewing gum. Many stopped chewing because of wearing masks and then never went back, or so the story goes.</li></ul><ul style="text-align: left;"><li>Microplastics have been reported to be everywhere. But how much? Hard to know when there is so much inconsistency of microplastic measurements. "There are notable disparities in the reported numbers of MPs in foods and beverages, warranting a thorough investigation into the factors contributing to these discrepancies".</li></ul><ul style="text-align: left;"><li>The standard of identity was removed for frozen cherry pie. Being the only frozen pie with a standard of identity, there was push to get rid of it. However, we already see pies with little fruit in it. Currently, "The standard of quality for frozen cherry pie is as follows: (i) The fruit content of the pie is such that the weight of the washed and drained cherry content is not less than 25 percent of the weight of the pie when determined by the procedure.</li></ul><blockquote style="border: none; margin: 0px 0px 0px 40px; padding: 0px; text-align: left;">Quite frankly, there should be Standard Identity for all fruit pies with the amount of measurable fruit. Have you purchased a blueberry pie and wondered where the blueberries are at?<br />Goes into effect April 15, 2024. You need to buy some frozen cherry pies now, and then wait a good while and then buy some produced after this date and then do a comparison.</blockquote><div style="text-align: left;"><ul style="text-align: left;"><li>A news story on pizza trends that was total crap. It comes via a software company called Otter - "In celebration of Pi Day, the team at Otter dug into the 1 billion+ orders they’ve processed to discover pizzeria and pizza chain trends" Anyhow, they ranked Pennsylvania as having one of the lowest rated pizza.. Their rating: "The states with the top rated pizzerias are: New Hampshire, Maine, Wisconsin, Kentucky, and Oklahoma" Are you kidding me? What a joke.</li></ul><div><ul style="text-align: left;"><li>Impossible foods, the maker of artificial meat products is changing their packaging to dark red color to give the impression of blood in an attempt to attract more meat lovers.</li></ul><ul style="text-align: left;"><li>Pizza-flavored beer? "The Nestlé-owned brand is teaming up with IPA brewer, Voodoo Ranger, on a pizza-flavored beer called I(Pizza)A. The brew is described as “the ultimate blend of a Tombstone crispy crust, tangy tomato sauce, and savory herbs and spices.” It also reportedly features a finishing pepperoni kick of heat." I like my beer beer-flavored.</li></ul></div><div><br /></div><div style="text-align: left;"><b>CABBAGE</b></div>Robb Report<br />https://robbreport.com/food-drink/dining/cabbage-restaurant-trend-1235541546/<br /><b>How Humble Cabbage Became a Culinary Darling at Fancy Restaurants</b><br />The cruciferous vegetable is being upgraded from its humble beginnings.<br />March 11, 2024<br />By <a href="https://robbreport.com/author/tori-latham/">TORI LATHAM</a><br /><br />If you follow the Chinese zodiac, 2024 is the year of the dragon. According to Pantone, it’s the year of peach fuzz. And in the restaurant industry, it’s looking like 2024 will belong to the humble cabbage.</div><span><a name='more'></a></span><div style="text-align: left;"><br />The cruciferous vegetable is popping up on restaurant menus from coast to coast, The New York Times <a href="https://www.nytimes.com/2024/03/10/dining/cabbage-popularity.html">reported</a> on Sunday. And while it’s long been a workhorse of many cuisines—think Korean kimchi or Irish corned beef—chefs are getting creative with cabbage.<br /><br />“I think 2024 is going to be a really exciting year in cabbage,” the celeb farmer Lee Jones told the Times.<br /><br />The rise of cabbage is in line with that of other hearty vegetables that chefs turn to in the cooler months, when fresh produce is less abundant. Greens like kale and Brussels sprouts have had a similar time in the spotlight, for example. Cabbage, though, has the added benefits of being cheap, long-lasting, and particularly bountiful.<br /><br /><b>GRAVY</b><br />MarketingDive<br />https://www.marketingdive.com/news/heinz-gravy-new-ketchup-hot-take-cpg-campaign/710067/<br /><b>Heinz serves up gravy ‘hot takes’ to boost condiment beyond the holidays</b><br /><br />Part of the “It Has to be Heinz” creative platform, the effort leverages the brand’s icon status to encourage consumers to use gravy how they use ketchup.<br />Published March 12, 2024<br />Chris Kelly<br /><br />Dive Brief:<br />Heinz is launching a new campaign backing its gravy offerings, the company’s largest marketing investment in the product category outside of the holiday season, per details shared with Marketing Dive. “Gravy Is The New Ketchup” is part of a larger “It Has to be Heinz” creative platform.<br /><br />The campaign features short online videos, creator content and a “Gravy Hot Takes” series on TikTok and Instagram. Paid media support is running across Meta, TikTok and Pinterest, as well as through out-of-home (OOH) ads at retail points of sale. In addition, Heinz is introducing three new vegetarian-based gravies.<br /><br />Created with agency Wieden + Kennedy, “Gravy Is The New Ketchup” aims to expand the use of gravy beyond traditional, holiday-based occasions to more everyday use as a condiment on everything from fries to unusual picks like brownies.<br /><br /><b>CHEWING GUM</b><br />https://fortune.com/2024/03/07/chewing-gum-sales-decline-gen-z-likes-sour-gummy-mondelez-wrigley<br /><b>Big candy befuddled by Gen Z’s love for sour gummies, scrambles for plan to get Americans chewing gum again</b><br /><br />BYDEE-ANN DURBIN AND THE ASSOCIATED PRESS<br /><br />March 7, 2024 at 7:51 AM EST<br />Gum’s bubble burst during the COVID-19 pandemic, when masks and social distancing made bad breath less of a worry and fewer people spent on impulse buys. The number of packages of gum sold dropped by nearly a third in the United States in 2020, according to Circana, a market research firm.<br /><br /><div>Consumer demand has picked up only slightly since then. Last year, U.S. chewing gum sales rose less than 1% to 1.2 billion units, which was still 32% fewer than in 2018. Although sales in dollars are back to pre-pandemic levels, that’s mostly due to inflation; the average pack of gum cost $2.71 last year, $1.01 more than it did in 2018, Circana said.<br /><br />It’s a similar story globally. Worldwide gum sales rose 5% last year to more than $16 billion, according to market researcher Euromonitor. That still was 10% below the 2018 sales figure.<br /><b><br />MICROPLASTICS</b><br /><b>COMPREHENSIVE REVIEW in Food Science and Food safety</b><br /><a href="https://ift.onlinelibrary.wiley.com/doi/10.1111/1541-4337.13315?af=R&utm_medium=email&utm_source=rasa_io&utm_campaign=newsletter">https://ift.onlinelibrary.wiley.com/doi/10.1111/1541-4337.13315</a><br /><b>Assessing the inconsistency of microplastic measurements in foods and beverages</b><br /><br />Emine Merve Canga, Aoife Gowen, Jun-Li Xu<br /><br />Abstract<br /><br />The widespread occurrence of microplastics (MPs) in the food chain has gained substantial recognition as a pressing concern, highlighting the inevitability of human exposure through ingestion of foodborne MPs, coupled with the release of MPs from plastic packaging. However, there are notable disparities in the reported numbers of MPs in foods and beverages, warranting a thorough investigation into the factors contributing to these discrepancies. Table salt is one of the major sources of MPs, and there was an approximately hundred-fold difference between the reviewed studies that reported the highest and lowest number of MPs. In addition, more noticeable discrepancies were discovered between studies on MPs released from teabags. One study reported that approximately 15 billion MPs were released into a cup of tea from a single teabag, whereas another research paper found only approximately 106.3 ± 14.6 MP/teabag after brewing. This comprehensive review focuses on the inconsistencies observed across studies examining MPs, shedding light on the plausible factors underlying these variations. Furthermore, the review outlines areas in analytical procedures that require enhancement and offers recommendations to promote accuracy and standardization in future research efforts, such as employing analytical methods capable of confirming the presence of MPs, using appropriate filter sizes, considering representative sample sizes when extrapolation is involved, and so on. By pinpointing the detection processes leading to the inconsistent results observed in MP studies, this comparative analysis will contribute to the development of reliable analytic methods for understanding the extent of microplastic contamination in the human food chain.<br /><br /><b>CHERRY PIE</b><br />https://www.fda.gov/food/cfsan-constituent-updates/fda-revokes-standards-identity-and-quality-frozen-cherry-pie<br />FDA Revokes Standards of Identity and Quality for Frozen Cherry Pie</div><div><div>Constituent Update</div><div>March 14, 2024</div><div>The U.S. Food and Drug Administration is revoking the standards of identity and quality for frozen cherry pie. The standards are no longer necessary to ensure that these products meet consumer expectations, and revoking the standards will provide greater flexibility and the opportunity for product innovation. The action supports FDA’s goal to modernize standards of identity.</div><div>Standards of identity establish requirements related to the content and production of certain food products. Foods for which standards of identity have been established include bread, fruit jams, certain vegetable and fruit juices, and certain types of chocolate. No standards of identity and quality exist for any other types of frozen fruit pies, or for any non-frozen fruit pies, including non-frozen cherry pie. We conclude that the standards of identity and quality for frozen cherry pie are no longer necessary to promote honesty and fair dealing in the interest of consumers.</div><div>The action responds in part to a citizen petition from the American Bakers Association.</div><div>The rule is effective on April 15, 2024.</div></div><div><br />From the Standards of Identity for Frozen Cherry Pie 21CFR152.126 </div><div>https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-152</div><div><div>(b) Quality. </div><div>(1) The standard of quality for frozen cherry pie is as follows: </div><div>(i) The fruit content of the pie is such that the weight of the washed and drained cherry content is not less than 25 percent of the weight of the pie when determined by the procedure prescribed by paragraph (b)(2) of this section. </div><div>(ii) Not more than 15 percent by count of the cherries in the pie are blemished with scab, hail injury, discoloration, scar tissue, or other abnormality. A cherry showing skin discoloration (other than scald) having an aggregate area exceeding that of a circle nine thirty-seconds of an inch in diameter is considered to be blemished. A cherry showing discoloration of any area but extending into the fruit tissue is also considered to be blemished.</div><br />The response to the quantity of cherry in the docket</div><div>https://public-inspection.federalregister.gov/2024-04598.pdf</div><div><div>"Manufacturers also must comply with identity labeling requirements, which require that a </div><div>food in package form be labeled with its common or usual name, or in the absence thereof, a </div><div>statement of identity that accurately describes the food on the principal display panel (§ 101.3). </div><div>If a product is offered for sale under the name of another food (e.g., a frozen cherry pie that does </div><div>not contain cherries), it would be misbranded under 21 U.S.C. 343(b0"</div><br /><b>PIZZA</b><br />Otter Celebrates Pi Day With Report on Pizzeria and Pizza Chain Trends<br /><a href="https://www.businesswire.com/news/home/20240313085207/en/Otter-Celebrates-Pi-Day-With-Report-on-Pizzeria-and-Pizza-Chain-Trends/?feedref=JjAwJuNHiystnCoBq_hl-R-HrziBh-2TFM2GMuUU7RcPFX-aV_QoYAKqdUX1TA5LrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3k8sXd0xy82dHvVAQyb6kaYOoOnRBQBKcY2buBEMh6FZQ%3D%3D&utm_medium=email&utm_source=rasa_io&utm_campaign=newsletter">https://www.businesswire.com/news/home/20240313085207/en/Otter-Celebrates-Pi-Day-With-Report-on-Pizzeria-and-Pizza-Chain-Trends</a><br /><br /><b>ARTIFICAL MEAT</b><br /><div><b>Impossible Foods has always claimed to bleed red, now its label will</b></div><div>The plant-based pioneer announced new packaging at Natural Products Expo West to attract more meat lovers to its burgers, sausages and chicken.</div>https://www.fooddive.com/news/impossible-foods-gets-meatier-makeover/710149/<br /><br /><b>BEER WITH PIZZA FLAVOR</b><br />The Weekly Sip: Pizza and beer in a can? | Kylie Jenner debuts canned cocktails<br />https://www.fooddive.com/news/nestle-tombstone-pizza-ipa-voodoo-ranger-kylie-jenner-sprinter-vodka-soda-boston-beer-sun-cruiser/710279/<br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /></div></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-46438912545040516412024-03-15T10:05:00.000-07:002024-03-15T10:05:28.213-07:00MMWR - 2023 Foodborne Illness Outbreak in Montana Associated with Morel Mushrooms<div>In this week's MMWR, the investigation report on an foodborne illness outbreak associated with morel mushrooms.</div><div><ul style="text-align: left;"><li>During March–April 2023, a total of 51 persons reported mild to severe gastrointestinal illness after eating at restaurant A in Bozeman, Montana. The outbreak resulted in multiple severe outcomes, including three hospitalizations and two deaths. </li><li>The findings from this investigation suggest that uncooked or undercooked morel mushrooms were the likely source of the outbreak. The epidemiologic study demonstrated a clear association between consumption of the special sushi roll with morels and gastrointestinal illness, including a dose-response relationship, and an apparent stronger association among persons who ate the morels on a day when the morels served by restaurant A were reportedly uncooked. </li><li>The investigation highlights the importance of prompt cross-agency communication and collaboration, the utility of epidemiologic studies in foodborne disease outbreak investigations, and the need for additional research about the impact of morel mushroom consumption on human health. Although the toxins in morel mushrooms that might cause illness are not fully understood, proper preparation procedures, including thorough cooking, might help to limit adverse health effects.</li></ul></div><div><br /></div><div>https://www.cdc.gov/mmwr/volumes/73/wr/mm7310a1.htm</div><b>Outbreak Linked to Morel Mushroom Exposure — Montana, 2023</b><br />Weekly / March 14, 2024 / 73(10);219–224<br />Heather Demorest, MPH1; Rachel Hinnenkamp, MPH2; Maggie Cook-Shimanek, MD2; Alyssa N. Troeschel, PhD3; Michael Yeh, MD3; Thao-Phuong Christy Hallett, MD3; David Kuai, MD3; Johnni Daniel, DHSc3; Andrea Winquist, MD, PhD3 (VIEW AUTHOR AFFILIATIONS)<br /><br />Summary<br />What is already known about this topic?<br />Although morel mushrooms are generally considered edible, rare cases of illness have been reported after consumption; little is known about the human health effects of morels. During March–April 2023, a total of 51 persons reported gastrointestinal illness after dining at a Montana restaurant; two patients died.<br /><br />What is added by this report?<br />A case-control study identified morel mushrooms as the likely outbreak source. Consumption of raw morels was more strongly associated with illness than was consumption of cooked or partially cooked morels.<br /><br />What are the implications for public health practice?<br />This outbreak investigation highlights the importance of prompt cross-agency communication, collaboration, and the use of epidemiologic studies to guide outbreak investigations. Morel mushrooms should be cooked before eating to mitigate potential toxic effects.<span><a name='more'></a></span><div><br />Abstract<br /><br />During March–April 2023, a total of 51 persons reported mild to severe gastrointestinal illness after eating at restaurant A in Bozeman, Montana. The outbreak resulted in multiple severe outcomes, including three hospitalizations and two deaths. After an inspection and temporary restaurant closure, the Montana Department of Public Health and Human Services and Montana’s Gallatin City-County Health Department collaborated with CDC to conduct a matched case-control study among restaurant patrons to help identify the source of the outbreak. Consumption of morel mushrooms, which are generally considered edible, was strongly associated with gastrointestinal illness. A dose-response relationship was identified, and consumption of raw morel mushrooms was more strongly associated with illness than was consumption of those that were at least partially cooked. In response to the outbreak, educational public messaging regarding morel mushroom preparation and safety was shared through multiple media sources. The investigation highlights the importance of prompt cross-agency communication and collaboration, the utility of epidemiologic studies in foodborne disease outbreak investigations, and the need for additional research about the impact of morel mushroom consumption on human health. Although the toxins in morel mushrooms that might cause illness are not fully understood, proper preparation procedures, including thorough cooking, might help to limit adverse health effects.<br /><br />Introduction<br /><br />On April 18, 2023, the Montana Department of Public Health and Human Services (MTDPHHS) and health departments in Gallatin and Broadwater counties were notified of two persons who experienced severe nausea, vomiting, and diarrhea after separately dining at restaurant A in Bozeman, Montana on April 17. One restaurant patron was hospitalized and later died; the second died hours after being discharged from a hospital emergency department. Both persons experienced symptom onset within 60 minutes of their meal. These reports prompted an immediate restaurant inspection on April 18 by the Gallatin City-County Health Department (GCCHD) and a temporary closure of restaurant A. On the basis of the rapid onset of symptoms in the hospitalized patient, the provider suspected a foodborne toxin as the source of illness and sought clinical consultation from Rocky Mountain Poison and Drug Safety (https://www.rmpds.org/) for testing and treatment recommendations. On April 19, MTDPHHS requested assistance from CDC and the Food and Drug Administration (FDA).<br /><br />Investigation and Findings<br /><br />Identification of Index Patients and Implicated Foods<br /><br />Investigation of the two index patients revealed that both persons had consumed a special sushi roll containing salmon and morel mushrooms. Morels were a new menu ingredient and were the only ingredient unique to the special sushi roll, making it an early suspected source of the outbreak. The morels were prepared in various ways during March 27–April 17. On April 8, morels were served partially cooked: a hot boiled sauce was poured over the raw morels, after which they were marinated for 75 minutes. On April 17, the morels were uncooked and cold-marinated before serving. During an inspection of restaurant A on April 18, food samples were collected, including salmon and morel pieces remaining from the original packaging. Multiple violations were identified at the time of inspection, including temperature control issues, improper time control and sanitization procedures, and improper storage of personal items. On the basis of the thorough environmental inspection and collection of food samples, clinical presentation of index patients, and early evidence implicating a specific food item, investigators determined that environmental sample collection was not necessary. On April 19, restaurant A informed GCCHD that it had received four additional telephone calls from patrons reporting illness after consumption of the special sushi roll. Other patrons reported illness directly to GCCHD throughout the investigation.<br /><br />Clinical Characteristics of Ill Persons<br /><br />After a May 3 press release providing an update on the outbreak and soliciting additional cases, GCCHD continued to receive reports of gastrointestinal illness related to eating at restaurant A between March 28 and April 17. In total, the investigation identified 51 cases of illness* (including five cases among employees and 46 among restaurant patrons); of these cases, four ill persons visited a hospital emergency department, three were hospitalized, and the two index patients died (including one who sought emergency care but was not hospitalized). Among the 51 ill persons, 45 (88%) reported consumption of morels at restaurant A. Review of medical records for the three persons who were hospitalized and one person who sought emergency medical care without hospitalization revealed that the onset of gastrointestinal symptoms was rapid, with a median symptom onset of 1 hour after the restaurant meal. Vomiting and diarrhea were reportedly profuse, and hospitalized patients had clinical evidence of dehydration. The two patients who died had chronic underlying medical conditions that might have affected their ability to tolerate massive fluid loss.<br /><br />Testing of Clinical and Food Specimens<br /><br />MTDPHHS and GCCHD coordinated with FDA for food specimen testing and with CDC’s toxicology and enteric diseases groups for clinical specimen testing.† Food specimens were tested for multiple substances, including volatile and nonvolatile organic compounds and enteric pathogens.§ Neither clinical testing nor food testing identified a causative agent.<br /><br />Traceback of Implicated Food Items<br /><br />Health department sanitarians traced the morels to a single importer, and a separate distributor that supplied mushrooms to multiple states. The morel mushrooms were cultivated and imported fresh from China. FDA and the California Department of Public Health contacted 12 California facilities that received morels from the same importer during January 1–May 17, 2023, six of which responded to the inquiries and reported receiving no illness complaints from patrons who ate morels prepared and served by those facilities. All six facilities reported cooking or otherwise thoroughly heating the morels before they were served. A CDC Epidemic Information Exchange (Epi-X) multistate call for cases did not result in additional case reports.<br /><br />Matched Case-Control Study<br /><br />To identify foods associated with illness and assess a possible dose-response relationship, MTDPHHS and GCCHD, with support from CDC, conducted a matched case-control study. A questionnaire solicited demographic and symptom information and food items consumed.¶ A case was defined as the occurrence of diarrhea, nausea, vomiting, or abdominal pain in a person any time after eating at restaurant A during March 27–April 18, 2023. Cases were identified through reports received by restaurant A, public health departments, and case-patient interviews. Control participants were identified during case-patient interviews as dining partners who did not report illness after eating at restaurant A. Case-patients (or a proxy) and control participants were interviewed during May 4–12, 2023.<br /><br />State and county health department staff members collected questionnaire data using Jotform software (version 4.0; Jotform Inc.). Deidentified data were sent to CDC for analysis. CDC personnel conducted matched and unmatched logistic regression analyses using SAS software (version 9.4; SAS Institute). This activity was reviewed by CDC, deemed not research, and was conducted consistent with applicable federal law and CDC policy.**<br /><br />A total of 41 case-patients†† and 22 control participants responded to the questionnaire and were included in analyses, representing 29 unique dining parties. Overall, 27 (36.9%) case-patients were female and 31 (75.6%) were aged 20–49 years. A majority reported diarrhea (37; 90.2%), nausea (34; 82.9%), abdominal pain (28; 68.3%), loss of appetite (25; 61.0%), fatigue (24; 58.5%), vomiting (22; 53.7%), and abdominal distension (22; 53.7%) (Table 1).<br /><br />In logistic regression analyses matched on dining party, the odds of eating the special sushi roll with morels among case-patients were 15.78 times higher than the corresponding odds among control participants (Table 2). In addition, the odds of eating any morels among case-patients were 10.77 times higher than the corresponding odds among control participants. Other foods did not appear to be associated with case status.<br /><br />When the amount of the special sushi roll consumed was modeled continuously, the association was positive between a one-piece increase in consumption of the special sushi roll and case status in all analyses (Table 2). When the special sushi roll was modeled as a three-level categorical variable (none, one–three pieces of a roll, and four pieces of a roll or more), associations in the unmatched models also suggested a dose-response relationship.§§<br /><br />In models stratified by meal date, odds ratios comparing the odds of eating the special sushi roll (yes versus no) among 27 case-patients and 18 control participants were higher among those who ate at the restaurant on April 17, when uncooked morels were served, relative to April 8, when the morels reportedly underwent a partial cooking process (Table 3).<br /><br />Public Health Response<br /><br />In response to this outbreak, FDA published information on morels and other mushrooms that are traditionally wild and foraged but can also be cultivated (1). MTDPHHS and GCCHD published a press release summarizing the investigation’s findings and provided recommendations on how to properly store and prepare morels to reduce the risk for illness (2). Restaurant A reopened to the public on May 25 once it was determined that public health risk had been mitigated by addressing health code violations. Restaurant A elected to stop serving morels.<br /><br />Discussion<br /><br />The findings from this investigation suggest that uncooked or undercooked morel mushrooms were the likely source of the outbreak. The epidemiologic study demonstrated a clear association between consumption of the special sushi roll with morels and gastrointestinal illness, including a dose-response relationship, and an apparent stronger association among persons who ate the morels on a day when the morels served by restaurant A were reportedly uncooked. The California Department of Public Health and FDA investigation also supported the potential impact of preparation method on health outcomes, because no gastrointestinal illnesses were reported among patrons who ate morels at facilities where they were cooked before serving.<br /><br />The signs and symptoms reported by ill persons and documented in medical records, including gastrointestinal illness and dizziness, are consistent with those reported in association with consumption of improperly handled, prepared, or cooked morels. Previous reports have described gastrointestinal illness after consumption of morels, which were consumed raw or cooked to varying degrees, as well as neurologic symptoms, including cerebellar effects, and, in some cases, death (3–6).<br /><br />Morels should be refrigerated at a temperature of ≤40°F (≤4.4°C), in breathable type packaging, such as a paper bag. Morels should be cooked thoroughly before consumption because cooking is likely to reduce toxin levels present in the mushrooms (1).<br /><br />Limitations<br /><br />The findings in this report are subject to at least five limitations. First, this investigation could not determine the specific characteristic of the morels that caused the outbreak. Morel storage and preparation methods, in addition to the differences in cooking methods described, that were not identified during the outbreak investigation might have differed between April 8 and 17, and might have played a role in causing illness. Second, morel mushroom toxins are not well characterized; therefore, the presence of a specific toxin could not be confirmed through laboratory testing (1). Third, limitations inherent to the epidemiologic studies included the small sample size and the possibility of unidentified confounding by something closely associated with the morels. Fourth, the study could have been affected by differential exposure misclassification (e.g., if case-patients had better recall of what they ate compared with control participants). Finally, responses could have been biased by public knowledge that morels were the suspected cause of illness.¶¶<br /><br />Implications for Public Health Practice<br /><br />The investigation of this outbreak demonstrated how a coordinated collaborative public health response including local, state, and federal agencies can preserve and promote public safety. These findings also highlight gaps in knowledge regarding morels that need further research to better understand how they affect human health, and to identify effective treatment for morel toxicity beyond supportive care. Morel mushrooms should be cooked before human consumption to mitigate their potential toxicity.<br /><br />Acknowledgments<br /><br />Whitney Bermes, Lori Christenson, Hannah Crooks, Joanna Fink, Travis Horton, Shane Lewis, Lauren Parri, Jera Samuelson, Anna Snyder, Chandler Spilo, Mary Valenzuela, Holly Whaley, Gallatin City-County Health Department; Staci Evangeline, Jenna Fisher, Deborah Gibson, Todd Harwell, Beth Hopkins, Jessica Lopeman, Michelle Mozer, Sadie Overlie, Samantha Saycich, Magdalena Scott, Laura Williamson, Montana Department of Public Health and Human Services; Ruby Taylor, Broadwater County Health Department; Brandon Harris, Broadwater County Sheriff’s Department; Christopher Hoyte, Sabrina Kaplan, Karen Muschler, Rocky Mountain Poison and Drug Safety; Brandon Adcock, Amber Barnes, Christian Bond, Omar Hummadi, Ken Zamora, California Department of Public Health; Arthur Chang, Laura Cooley, Laura Gieraltowski, Haley McKeel, Thai-An Nguyen, Jerry Thomas, Laura Whitlock, Luke Yip, CDC; Karen Blickenstaff, Brittany Carpenter, Bria Graham Glover, Stranjae Ivory, Lauren Singleton, Adiam Tesfai, Kelsey Volkman, Food and Drug Administration; Walter Kemp, Kendra O’Neal, Tonya Shaffer, U.S. Department of Justice, Forensic Science Division; community members and service providers who participated in qualitative interviews.<br /><br />Corresponding author: Heather Demorest, heather.demorest@gallatin.mt.gov.<br />1Gallatin City-County Health Department, Bozeman, Montana; 2Montana Department of Public Health and Human Services; 3Division of Environmental Health Science and Practice, National Center for Environmental Health, CDC.<br />All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.<br />* Initially, a case was defined as the occurrence of gastrointestinal illness or neurologic symptoms in a person after eating at restaurant A during March 27–April 18, 2023, and the interval between these dates was considered the potential exposure period. However, follow-up indicated that all ill persons ate at the restaurant during March 28–April 17, 2023.<br />† Clinical testing for persons with specimens available included urine amatoxin testing, random total urine arsenic level, stool gastrointestinal panel and culture, and standard clinical laboratory tests used for medical management. Results of laboratory testing did not identify a causative agent.<br />§ Salmon and morel mushroom specimens tested negative for various known toxins, heavy metals, pesticides, volatile and nonvolatile organic substances, and pathogens, including Clostridium perfringens, Bacillus cereus, Staphylococcal enterotoxin, and other common enteric pathogens. DNA sequencing identified the mushroom specimen as Morchella sextelata, a species of true morel.<br />¶ The questionnaire included details related to dining (e.g., date and foods and beverages consumed), new or worsened symptoms after dining, receipt of medical care for those symptoms, underlying medical conditions, and dining partners. The survey accounted for the amount of each food eaten, menu modifications, unlisted food items (e.g., daily specials, chef’s choice, and “secret menu” items) and whether morel mushrooms were included in any food items. A proxy dining partner was interviewed to obtain information on one of the case-patients who was deceased.<br />** 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. Sect. 241(d); 5 U.S.C. Sect. 552a; 44 U.S.C. Sect. 3501 et seq.<br />†† Among the 42 case-patients eligible for the case-control study, two were lost to follow-up, and one was deceased with no available proxy to interview. Two control participants were later found to have met the case definition and were reclassified as case-patients.<br />§§ An employee cohort study was also completed but had a small sample size. Eleven employees were interviewed, four of whom reported illness that met the case definition. Employees were not included in the case-control study. Employees who reported eating more pieces of the special sushi roll were more likely to report illness (Cochran-Armitage trend test two-sided exact p-value = 0.033). Using exact logistic regression, the odds ratio per one piece of special sushi roll increase was 1.92 (95% CI = 0.97–6.77; p-value = 0.067).<br />¶¶ Early in the investigation, morel mushrooms were publicly discussed as being a suspected cause of the outbreak, through media and social media channels. GCCHD and MTDPHHS mentioned morels as being a suspected cause of the outbreak in a press release on May 3, which was before most of the interviews were conducted.<br /><br />References<br /><br />Food and Drug Administration. Investigation of illnesses: morel mushrooms (May 2023). Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2023. https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-illnesses-morel-mushrooms-may-2023<br /><br />Montana Department of Public Health and Human Services; Gallatin City-County Health Department. DPHHS and GCCHD provide final summary on foodborne outbreak linked to morel mushrooms. Helena, MT: Montana Department of Public Health and Human Services; 2023. https://dphhs.mt.gov/News/2023/July/FinalSummaryonMorelMushroomsFoodbourneOutbreak<br /><br />Beug M, Shaw M, Cochran KW. Thirty-plus years of mushroom poisoning: summary of the approximately 2,000 reports in the NAMA case registry. McIlvainea 2006;16:47–68. https://fungimag.com/archives/Poisonings.pdf<br /><br />Pfab R, Haberl B, Kleber J, Zilker T. Cerebellar effects after consumption of edible morels (Morchella conica, Morchella esculenta). Clin Toxicol (Phila) 2008;46:259–60. https://doi.org/10.1080/15563650701206715 PMID:18344109<br /><br />Saviuc P, Harry P, Pulce C, Garnier R, Cochet A. Can morels (Morchella sp.) induce a toxic neurological syndrome? Clin Toxicol (Phila) 2010;48:365–72. https://doi.org/10.3109/15563651003698034 PMID:20507248<br /><br />Piqueras J. Morel mushroom toxicity: an update. Fungi 2021;14:42–52. https://www.fungimag.com/spring-2021-articles/Morel%20Toxicity%20Update.pdf<div><br /></div></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-40006792101259657912024-03-14T08:50:00.000-07:002024-03-14T08:50:30.404-07:00CA Establishment Recalls Salad Bowl Products Due to Undeclared WheatTaylor Farms Pacific, a Tracy, Calif. establishment, is recalling approximately 19,976 pounds of ready-to-eat (RTE) apple walnut with chicken salad bowl products due to misbranding and undeclared wheat allergen. The problem was discovered by the establishment during a routine quality assurance check of ingredient labels. The establishment then notified FSIS that the product may contain wheat, which is not declared on the label.<br /><br />https://www.fsis.usda.gov/recalls-alerts/taylor-farms-pacific-recalls-kroger-brand-ready-eat-apple-walnut-chicken-salad-bowl<br /><b>Taylor Farms Pacific Recalls Kroger Brand Ready-To-Eat Apple Walnut With Chicken Salad Bowl Products Due to Misbranding and Undeclared Allergen</b><br /><br />WASHINGTON, March 13, 2024 – Taylor Farms Pacific, a Tracy, Calif. establishment, is recalling approximately 19,976 pounds of ready-to-eat (RTE) apple walnut with chicken salad bowl products due to misbranding and undeclared wheat allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product may contain wheat, a known allergen, which is not declared on the product label.<div><span><a name='more'></a></span>The RTE apple walnut with chicken salad bowl products were produced from Feb. 28, 2024, through March 9, 2024. The following products are subject to recall [view labels]:<br />5.5-oz. clear plastic bowl containers with “kroger APPLE WALNUT WITH CHICKEN SALAD KIT FOR ONE” with use by dates of 03/12/24 through 03/22/24, lot codes TFPM059B41, TFPM060B41, TFPM061A41, TFPM062A41, TFPM063B41, TFPM064A41, TFPM064B41, TFPM065A41, TFPM066A41, TFPM067A41, TFPM068A41, TFPM069B42, and TFPM071A41.<br /><br />The products subject to recall bear establishment number “P-34013” below the use by date and lot code. These items were shipped to retail locations in Alaska, Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington and Wyoming.<br /><br />The problem was discovered by the establishment during a routine quality assurance check of ingredient labels. The establishment then notified FSIS that the product may contain wheat, which is not declared on the label.<br /><br />There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider.<br /><br />FSIS is concerned that some product may be in consumers’ refrigerators. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.<br /><br />FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution lists will be posted on the FSIS website at www.fsis.usda.gov/recalls.<br /><br />Consumers with questions about the recall can contact Taylor Farms’ Consumer Line at 855-455-0098. Members of the media with questions about the recall can contact press@taylorfarms.com.<br /><br />Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.<br /><br /></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-89007327738317483232024-03-13T18:28:00.000-07:002024-03-13T18:28:34.641-07:00Great Value Honey Roasted Cashews Recalled After Consumer Finds Coconut CashewsJohn B. Sanfilippo & Son, Inc (JBSS), Elgin, IL, announced today it is voluntarily recalling a limited amount of 8.25 oz Great Value Honey Roasted Cashews, because it may contain undeclared coconut and milk. The recall was initiated after a consumer report of finding coconut cashews within a container labeled as honey roasted cashews. An investigation identified that a limited number of incorrect honey roasted cashew labels were applied to the plastic cans of coconut cashews during the manufacturing process.<br /><br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/john-b-sanfilippo-son-inc-issues-allergy-alert-undeclared-coconut-and-milk-great-value-honey-roasted<br /><b>John B. Sanfilippo & Son, Inc Issues Allergy Alert on Undeclared Coconut and Milk in Great Value Honey Roasted Cashews 8.25 Oz</b><br />Summary<br />Company Announcement Date: March 12, 2024<br />FDA Publish Date: March 13, 2024<br />Product Type: Food & Beverages<br />Reason for Announcement: Undeclared milk and coconut allergens<br />Company Name: John B Sanfilippo & Son, Inc.<br />Brand Name: Great Value<br />Product Description: Honey Roasted Cashews<span><a name='more'></a></span><div><br />Company Announcement<br /><br />FOR IMMEDIATE RELEASE – ELGIN, IL - MARCH 12, 2024 - John B. Sanfilippo & Son, Inc (JBSS) announced today it is voluntarily recalling a limited amount of 8.25 oz Great Value Honey Roasted Cashews, because it may contain undeclared coconut and milk. People who have an allergy or severe sensitivity to coconut or milk run the risk of serious or life-threatening allergic reactions if they consume this product from the impacted best if used by date listed below.<br /><br />Potential affected products include the following details:<br />Description: Great Value Honey Roasted Cashews<br />Best if used by Jul 08 2025 GH2 (located on the bottom of the plastic can)<br />8.25 oz plastic can with a blue wrap around label<br />UPC: 078742133348<br />No adverse reactions have been reported to date.<br /><br />Product was distributed in select Walmart stores within the following states:<br />(AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VT, WV) and via Walmart.com.<br /><br />The recall was initiated after a consumer report of finding coconut cashews within a container labeled as honey roasted cashews. An investigation identified that a limited number of incorrect honey roasted cashew labels were applied to the plastic cans of coconut cashews during the manufacturing process.<br /><br />If this product is still in your possession, do not consume it. Please discard the product or return the product to a Walmart store for a full refund.<br /><br />Consumers with questions may contact John B. Sanfilippo & Son, Inc. at 1-800-874-8734 Monday – Friday, 8:00am – 5:00pm CDT, or via email at info@jbssinc.com.<br /><br /></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-58227085935716277162024-03-13T07:32:00.000-07:002024-03-13T07:32:02.615-07:00Parasitic Worms in Man's Brain, Undercooked Pork Blamed<p>A article posted in a medical journal discusses a man suffering from a parasitic infection in the brain that were causing frequent and severe migraines. The parasite, Taenia solium, is a tapeworm that normally infects pigs and can infect humans when eating uncooked and undercooked pork. The worm is more of an issue in developing countries where pigs roam free.</p><p>"Consuming T. solium eggs or larvae most often leads to a condition called taeniasis, in which small enclosed sacs, or cysts, of the worm's larvae accumulate in a person's intestines. However, the man in this case developed another condition, called cysticercosis, a version of the infection in which the cysts embed themselves inside a different tissue, such as muscle or the brain. When they embed within the nervous system, the condition is called neurocysticercosis."<br /><br />Evidently, the patient denied eating raw or street food but admitted to a habit of eating lightly cooked, <br />non-crispy bacon for most of his life.</p><p>Following prompt treatment with anti-parasitic and anti-inflammatory drugs, the man survived the brain infection. He was successfully treated with drugs that reduced the size of the parasitic lesions, which also improved his headaches, the authors wrote in the case report.<br /><br />https://www.livescience.com/health/viruses-infections-disease/parasitic-worms-found-in-mans-brain-after-he-likely-ate-undercooked-bacon<br /><b>Parasitic worms found in man's brain after he likely ate undercooked bacon</b><br />News<br />By Emily Cooke published March 11, 2024<br /><br />A middle-aged man in the U.S. developed a parasitic infection in his brain after eating undercooked bacon.</p><span><a name='more'></a></span><p>Doctors in the U.S. got a nasty surprise when they discovered that a man visiting a clinic for migraines had parasitic worms growing in his brain. <br /><br />The 52-year-old man was infected with the larvae of Taenia solium, a tapeworm that normally infects pigs. This parasite can infect humans who inadvertently ingest pork that has not been thoroughly cooked, or those who consume poop containing the worm's eggs. This poop may come from a person already infected with the parasites, for instance.<br /><br />Consuming T. solium eggs or larvae most often leads to a condition called taeniasis, in which small enclosed sacs, or cysts, of the worm's larvae accumulate in a person's intestines. However, the man in this case developed another condition, called cysticercosis, a version of the infection in which the cysts embed themselves inside a different tissue, such as muscle or the brain. When they embed within the nervous system, the condition is called neurocysticercosis. <br /><br />Globally, between 2.5 million and 8.3 million people are estimated to have neurocysticercosis. The condition is common in developing countries, especially countries in which pigs are a primary food source and in areas where sanitation is poor. However, increased rates of international travel and immigration mean cysticercosis is becoming more common in developed countries, such as the U.S. <br /><br />Neurocysticercosis most often causes headaches and seizures, with the latter symptom experienced by up to 80% of patients. Symptom severity usually depends on which structures and tissues in the brain have been infected with the worms.<br /><br />The man in the recent case had a history of migraines but went to the doctor after his migraines suddenly became more frequent and severe and didn't respond to his usual treatments. He also had worsening pain across the back of his skull.<br /><br />At the clinic, a computed tomography (CT) scan revealed he had multiple cysts within the white matter, or insulated wiring, of his brain — specifically the nerve fibers located deep within the organ. He had a notable cluster of cysts in the bottom right-hand corner of his brain. Concerned by what they saw, doctors "urgently" admitted the man to a hospital. <br /><br />There, a magnetic resonance imaging (MRI) scan revealed further cysts in the front and middle part of the outer layer of his brain, as well as swelling, which further confirmed the diagnosis of neurocysticercosis.<br /><br />The man in the recent case had an "unremarkable" exposure history, according to a case report published March 7 in the American Journal of Case Reports. He'd not recently traveled anywhere or visited a farm, for instance, and he lived in a "modern home." <br /><br />However, he admitted to having a habit of eating undercooked, "soft" bacon for most of his life. The U.S. Food and Drug Administration recommends cooking pork to at least 145 degrees Fahrenheit (about 63 degrees Celsius). It is difficult to determine the temperature of cooked bacon, as it is thin meat. However, if cooked until crisp, it should have reached a safe temperature, according to the U.S. Department of Agriculture.<br /><br />The doctors involved in the man's case speculated that he may have first developed taeniasis due to his eating habits and then got cysticercosis by not properly washing his hands after using the bathroom.<br /><br />Following prompt treatment with anti-parasitic and anti-inflammatory drugs, the man survived the brain infection. He was successfully treated with drugs that reduced the size of the parasitic lesions, which also improved his headaches, the authors wrote in the case report. <br /><br />This article is for informational purposes only and is not meant to offer medical advice.</p>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-44991644725230300902024-03-13T07:16:00.000-07:002024-03-13T07:16:48.532-07:00Michigan Firm Recalls No Bake Cookies After Computer Error Causes Formulation Mistake and Adds Undeclared PeanutsWesco, Inc. of Muskegon, MI is recalling 750 units of Wesco Mint No Bake Cookie Bites, because it may contain undeclared peanut. The recall was initiated after it was discovered that Wesco Mint No Bake Cookie Bites containing peanut butter were distributed in packaging that did not reveal the presence of peanuts. Subsequent investigation indicates the problem was caused by incorrect product formulation within the manufacturing facility’s new software system.<br /><br />Validating software - when new software is installed, it must be thoroughly validated. Validation should continue through the start of use in production.<div>Verifying formulations - the strength of a HACCP based system is having double checks in place to ensure product safety. In this case, a manual check is there to ensure the proper formulation is in place, specifically addressing allergens. The allergens within the formulation must match what is on the package.<br /> <br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wesco-inc-issues-voluntary-recall-and-allergy-alert-undeclared-peanut-wesco-mint-no-bake-cookie<br /><b>Wesco, Inc. Issues Voluntary Recall and Allergy Alert on Undeclared Peanut in Wesco Mint No Bake Cookie Bites</b><br />Summary<br />Company Announcement Date: March 08, 2024<br />FDA Publish Date: March 11, 2024<br />Product Type: Food & Beverages<br />Reason for Announcement: Undeclared Peanut Allergen<br />Company Name: Wesco, Inc.<br />Brand Name: Wesco Fresh<br />Product Description: Mint No Bake Cookies<br />Company Announcement<br />Wesco, Inc. of Muskegon, MI is recalling 750 units of Wesco Mint No Bake Cookie Bites, because it may contain undeclared peanut. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.</div><span><a name='more'></a></span><div>The affected Wesco Mint No Bake Cookie Bites were distributed to Wesco convenience stores throughout the lower peninsula of Michigan.<br /><br /> Wesco Mint No Bake Cookie Bites (UPC 750308040474) are packaged in clear 9 oz plastic cups. The following Sell Thru dates were affected:03/15/2024, 03/16/2024, 03/17/2024, 03/18/2024.<br /><br />Symptoms of allergic reaction include: hives, flushed skin or rash, tingling or itchy sensation in the mouth, swelling of the face, tongue, or lips, vomiting and/or diarrhea, abdominal cramps, coughing or wheezing, swelling of the throat and vocal cords, difficulty breathing, and loss of consciousness. More information about food allergies can be found at www.fda.gov/food/food-labeling-nutrition/food-allergies.<br /><br />No illnesses have been reported to date.<br /><br />The recall was initiated after it was discovered that Wesco Mint No Bake Cookie Bites containing peanut butter were distributed in packaging that did not reveal the presence of peanuts. Subsequent investigation indicates the problem was caused by incorrect product formulation within the manufacturing facility’s new software system.<br /><br /><br /><br /><br />Consumers who have purchased Wesco Mint No Bake Cookie Bites with Sell Thru dates of 03/15/2024, 03/16/2024, 03/17/2024, 03/18/2024 are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 231-719-4385 or through email at recall@wescoinc.com.<p><br /></p><p> </p></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-19554909782797299102024-03-13T07:10:00.000-07:002024-03-13T07:10:30.595-07:00FDA Issues Warning Letter to Firm In Response to the Firm's Nonresponse FDA issued a Warning Letter to a Michigan firm after the firm failed to respond to FDA's request to provide corrective actions related to a recall the firm had conducted. The message here, respond to FDA requests.<br /><br /> A summary of the events:<br /><ul style="text-align: left;"><li>On September 12, 2023, the firm recalled Knickerbocker Homestyle Hamburger Buns after the firm discovered that the product contained milk, but the printed package did not contain an allergen statement or ingredient declaration for milk. </li><li>The firm became aware of this undeclared milk after being notified during a Michigan Department of Agriculture and Rural Development (MDARD) inspection at the facility on September 12, 2023 of a complaint received by MDARD on September 11, 2023 that indicated a customer had an allergic reaction to milk after consuming the product. </li><li>In documentation provided to FDA on September 15, 2023, the firm stated that they had reformulated the bun product to include milk powder without changing the packaging to reflect the change. This product had been manufactured on August 31, 2023, and September 1, 2, 6, 7, 8, 9, 11, 2023 at the facility with packaging that did not declare milk on the label.</li><li>On September 15, 2023, the firm provided documentation that stated that they had determined the root cause to be “Dough formulation change without changing the packaging to reflect the change.” The proposed action to prevent reoccurrence indicated that there would be no formulation changes without the signatures of the buyers and the owners.</li><li> On September 18, 2023, FDA sent the firm an email giving the firm an opportunity to provide FDA additional corrective actions to address the root cause of the undeclared major food allergen involved in your recall; however, <u>the firm did not respond. </u></li><li>Conclusion - Knickerbocker Homestyle Hamburger Buns, which contain milk, are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (milk).</li></ul><div><br />https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/knickerbocker-365-inc-673138-01292024<br /><br /><b>WARNING LETTER<br />Knickerbocker 365, Inc.</b><br /><br />MARCS-CMS 673138 — JANUARY 29, 2024</div><span><a name='more'></a></span><div>Recipient:<br />Mr. Firas Hanna<br />President<br />Knickerbocker 365, Inc.<br />26040 Pinehurst Drive<br />Madison Heights, MI 48071<br />United States<br />firashanna24@yahoo.com<br /><br />Issuing Office:<br />Division of Human and Animal Food Operations East VI<br />United States<br /><br />WARNING LETTER<br />CMS 673138<br /><br />January 29, 2024<br /><br />Dear Mr. Hanna:<br /><br />The United States Food and Drug Administration (FDA) has determined that your recalled product, Knickerbocker Homestyle Hamburger Buns (16 oz. retail unit, lot codes I31C, J01C, J02C, J06C, J07C, J08C, J09C, & J11C (UPC 611625100206)) are misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product label did not declare a major food allergen, milk. Further, we have determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at www.fda.gov.<br /><br />On September 12, 2023, your firm recalled Knickerbocker Homestyle Hamburger Buns after you discovered that the product contained milk, but the printed package did not contain an allergen statement or ingredient declaration for milk. Your firm became aware of the undeclared milk after being notified during a Michigan Department of Agriculture and Rural Development (MDARD) inspection at your facility on September 12, 2023 of a complaint received by MDARD on September 11, 2023 that indicated a customer had an allergic reaction to milk after consuming Knickerbocker Homestyle Hamburger Buns. In documentation provided to the Office of Human and Animal Food Operations (OHAFO) East 6 Recall Coordinator on September 15, 2023, you indicated that your firm reformulated Knickerbocker Homestyle Hamburger Buns to include milk powder without changing the packaging to reflect the change. This product was manufactured on August 31, 2023, and September 1, 2, 6, 7, 8, 9, 11, 2023 at your facility with packaging that did not declare milk on the label.<br /><br />On September 15, 2023, you provided documentation that stated that you determined the root cause to be “Dough formulation change without changing the packaging to reflect the change.” Your proposed action to prevent reoccurrence indicated that there would be no formulation changes without the signatures of the buyers and the owners. On September 18, 2023, FDA sent you an email giving you an opportunity to provide FDA additional corrective actions to address the root cause of the undeclared major food allergen involved in your recall; however, you did not respond. We will verify the adequacy and implementation of any corrective actions during FDA’s next inspection of your facility.<br /><br />Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)<br /><br />You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2). Specifically, you did not identify and implement food allergen controls at the packaging/labeling step to significantly minimize or prevent the hazard of undeclared allergens, as evidenced by your firm reformulating the Knickerbocker Homestyle Hamburger Buns to include the major food allergen milk without changing the ingredient labeling for buns manufactured between August 31 and September 11, 2023. This incorrect labeling resulted in undeclared milk, a major food allergen, in your Knickerbocker Homestyle Hamburger Buns.<br /><br />Misbranding<br /><br />Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], milk is considered a “major food allergen.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:<br /><br />The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, as required by section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or<br /><br />The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].<br /><br />Your Knickerbocker Homestyle Hamburger Buns, which contain milk, are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (milk).<br /><br />This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.<br /><br />This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.<br /><br />Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.<br /><br />Your written response should be sent to Compliance Officer Daniel Arrecis, via email at ORAHAFEAST6FirmResponses@fda.hhs.gov. If you should have any questions regarding this letter, please contact Daniel Arrecis, Compliance Officer, at (312) 596-4263 or via email, daniel.arrecis@fda.hhs.gov.<br /><br />Sincerely,<br />/S/<br />William R. Weissinger, MS<br />Program Division Director<br />Office of Human and Animal Foods East<br />Division 6</div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-28558043868401214332024-03-12T18:13:00.000-07:002024-03-12T18:14:19.253-07:00NC Company Issues Expanded Recall for Single Slice Carrot Cake and Chocolate Cake Due to Undeclared Soy AllergenKALO Foods, LLC of Stokesdale NC issue an expanded notice for the recall of Single Slice Carrot Cake UPC 8 53407 00418 4 and Single Slice Chocolate Cake UPC 8 53407 00418 4 due to a undeclared soy. The initial <a href="https://pennstatefoodsafety.blogspot.com/2024/03/a-nc-facility-recalls-carrot-cake-with.html">recall on March 5, 2024 was just for the carrot cake.</a><div><br /></div><div>Although the package is labeled Carrot Cake, but the ingredient panel and UPC Code is for their Chocolate Cake. The Chocolate Cake labeled products contain slices of Carrot Cake. The Carrot Cake contains soy which is not listed in the ingredient statement<br /><br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/expanded-press-release-kalo-foods-llc-recalls-single-slice-carrot-cake-and-chocolate-cake-due<br /><b>Expanded Press Release – Kalo Foods, LLC Recalls Single Slice Carrot Cake and Chocolate Cake Due to Undeclared Soy Allergen</b><br />Summary<br />Company Announcement Date: March 06, 2024<br />FDA Publish Date: March 08, 2024<br />Product Type: Food & Beverages<br />Reason for Announcement: Potential or Undeclared Allergen - Soy<br />Company Name: KALO Foods, LLC<br />Brand Name: KALO<br />Product Description: Single Slices of Carrot Cake & Chocolate Cake</div><span><a name='more'></a></span><div>Company Announcement<br /><br />KALO Foods, LLC is recalling Single Slice Carrot Cake UPC 8 53407 00418 4 and Single Slice Chocolate Cake UPC 8 53407 00418 4 due to a undeclared soy. Although the package is labeled Carrot Cake, but the ingredient panel and UPC Code is for their Chocolate Cake. The Chocolate Cake labeled products contain slices of Carrot Cake. The Carrot Cake contains soy which is not listed in the ingredient statement. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.<br /><br />No illnesses have been reported to date.<br /><br />On March 1, 2024, the firm was notified by one of their customers that packages labeled as Carrot Cake, contains the ingredient panel on the bottom is for Chocolate Cake and packages labeled as Chocolate Cake contains slices of Carrot Cake.<br /><br />Product affected are packages labeled Single Slice Gluten Free Carrot Cake that has the ingredient panel stating Chocolate Cake and packages labeled as Chocolate Cake contains slices of Carrot Cake.<br /><br />The products were distributed between 2/28/24 to 2/29/24. These products were packaged in clear plastic clam shells and sold primarily in retail stores located in the States of: North Carolina and Virginia.<br /><br />Consumers who have purchased these products are urged to return them to the place of purchase for a full refund or they may discard the product. Consumers with questions may contact Michael Cusato during our hours of operation Monday – Saturday 6:00am – 4:00 pm EST.<br /><br />This recall is being made with the knowledge of the Food and Drug Administration</div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-83621434502251569012024-03-11T09:48:00.000-07:002024-03-11T09:48:21.100-07:00Washington State Establishment Recalls RTE Breakfast Burritos After Sampling Finds ListeriaJen's Breakfast Burritos, LLC, an Auburn, Wash. establishment, is recalling approximately 144 pounds of ready-to-eat (RTE) breakfast burrito products that may be adulterated with Listeria monocytogenes. The problem was discovered after FSIS performed routine product testing and the results indicated the product may be contaminated with Listeria monocytogenes. <br /><br />https://www.fsis.usda.gov/recalls-alerts/jens-breakfast-burritos-llc-recalls-ready-eat-breakfast-burrito-products-due<br /><b>Jen's Breakfast Burritos, LLC, Recalls Ready to Eat Breakfast Burrito Products Due to Possible Listeria Contamination</b><br /><br />FSIS Announcement<br /><br />WASHINGTON, March 10, 2024 - Jen's Breakfast Burritos, LLC, an Auburn, Wash. establishment, is recalling approximately 144 pounds of ready-to-eat (RTE) breakfast burrito products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.<span><a name='more'></a></span><div><br /><br />The RTE breakfast burrito items were produced on February 29, 2024. The following products are subject to recall [view labels]:<br /><ul style="text-align: left;"><li>7-oz. individual wax paper packages containing "Smoked Bacon Breakfast Burrito" with lot code 060-1 on a sticker on the back of the package.</li><li>7-oz. individual wax paper packages containing "Ham Breakfast Burrito" with lot code 060-2 on a sticker on the back of the package.</li><li>7-oz. individual wax paper packages containing "Seasoned Pork Breakfast Burrito" with lot code 060-3 on a sticker on the back of the package.</li></ul>The products subject to recall bear establishment number "EST. 1826" inside the USDA mark of inspection. These items were shipped to "to-go" kiosk locations in Washington.<br /><br />The problem was discovered after FSIS performed routine product testing and the results indicated the product may be contaminated with Listeria monocytogenes.<br /><br />There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider.<br /><br />Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.<br /><br />Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.<br /><br />FSIS is concerned that some product may be in consumers' refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.<br /><br />FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution lists will be posted on the FSIS website at www.fsis.usda.gov/recalls.<br /><br />Media and consumers with questions regarding the recall can contact Michael Martinez, co-owner, at 253-753-3198 or michael@picoyourburrito.com.<br /><br />Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.</div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-5473440463775226762024-03-08T11:51:00.000-08:002024-03-08T11:51:08.860-08:00Minnesota Raw Pet Food Company Cited for Inadequate PAA Process Resulting in Pathogens in Finished ProductFDA issued a Warning Letter to Woody’s Pet Food Deli of West Saint Paul, MN., a processor of raw pet food products. During the inspection, FDA took samples and found that Woody’s Pet Food Deli Raw Free Range Turkey with Supplements pet food for dogs and cats, lot code 08/31/24, was contaminated with Salmonella Reading and Listeria monocytogenes.<div><br /></div><div>The firm uses an acetic acid, PAA, and hydrogen peroxide (b)(4), as the method to eliminate pathogens from the raw pet food products. During the inspection, FDA collected an in-process sample (FDA sample #1214888) of Woody’s Pet Food Deli Raw Free Range Turkey with Supplements, lot code 08/31/24, at a location immediately after the application of the spray and immediately prior to finished product packaging. This product tested positive for Salmonella Reading and Listeria monocytogenes. Thus the process is not adequate. Further, the company could not provide any information indicating the use of PAA in pet food is considered GRAS by qualified scientific experts.</div><div><br />FDA Warning Letter<br />https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agila-corporation-dba-woodys-pet-food-deli-670835-01262024<br /><b>Agila Corporation dba Woody’s Pet Food Deli</b><br />MARCS-CMS 670835 — JANUARY 26, 2024</div><span><a name='more'></a></span><div>Recipient:<br />Enrique A. Palma<br />Owner<br />Agila Corporation dba Woody’s Pet Food Deli<br />105 W. Kraft Road<br />West Saint Paul, MN 55118<br />United States<br /><br />Issuing Office:<br />Division of Human and Animal Food Operations West I<br />United States<br /><br />January 26, 2024<br /><br />WARNING LETTER<br />Refer to CMS 670835<br /><br />Dear Mr. Palma:<br /><br />The U.S. Food and Drug Administration (FDA) conducted an inspection of your pet food manufacturing facility located at 1245 Trapp Road, Suite 160, Eagan, Minnesota, on August 29 through September 12, 2023, in follow-up to an Untitled Letter issued to you on September 2, 2022.<br /><br />During the inspection FDA collected a sample (FDA sample #1214888) of your in-process Woody’s Pet Food Deli Raw Free Range Turkey with Supplements pet food for dogs and cats, lot code 08/31/24, from your facility. FDA laboratory analysis revealed this product was contaminated with Salmonella Reading and Listeria monocytogenes. Based on the analytical results, FDA considers the sampled product lot to be adulterated in that it bears or contains a poisonous or deleterious substance which may render it injurious to health.1 On September 19, 2023, you voluntarily disposed of Woody’s Pet Food Deli Raw Free Range Turkey with Supplements pet food for dogs and cats, lot code 08/31/24.<br /><br />Also, during the inspection FDA’s investigators found evidence of a significant violation of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements, Title 21, Code of Federal Regulations (21 CFR), Part 507, which causes your raw pet food products to be adulterated.2<br /><br />Furthermore, you are using the unapproved/unsafe animal food additive peroxyacetic acid (PAA). Use of an unsafe food additive causes a food to be adulterated.3<br /><br />The doing of any act to a food after shipment of the food and/or its components in interstate commerce and while the food is held for sale (whether or not the first sale) that results in the food being adulterated or misbranded is prohibited.4<br /><br />You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.<br /><br />At the close of the inspection you were issued a Form FDA-483, Inspectional Observations. We acknowledge your written response dated September 25, 2023. We reviewed your response to the noted violations and address your corrective actions below.<br /><br />Current Good Manufacturing Practice (CGMP) Requirements<br /><br />Your pet food facility is subject to the CGMP requirements found in 21 CFR Part 507, subparts A, B, and F. During our inspection of your facility FDA investigators observed evidence of a significant violation of these requirements:<br /><br />You failed to take measures, which are adequate to prevent adulteration of your animal food during the manufacturing, processing, packing, and holding of animal food, to significantly minimize or prevent the growth of undesirable microorganisms in your animal food, as required by 21 CFR 507.25(c)(2). Undesirable microorganisms include microorganisms that are pathogens, that subject animal food to decomposition, that indicate the animal food is contaminated with filth, or that otherwise may cause animal food to be adulterated (21 CFR 507.3).<br /><br />Specifically, your firm uses (b)(4), an acetic acid, PAA, and hydrogen peroxide (b)(4), as your method to eliminate pathogens from your raw pet food products. On August 31, 2023, FDA collected an in-process sample (FDA sample #1214888) of Woody’s Pet Food Deli Raw Free Range Turkey with Supplements, lot code 08/31/24, which subsequently tested positive for Salmonella Reading and Listeria monocytogenes. This sample was taken after the application of (b)(4) and immediately prior to finished product packaging. Therefore, your use of (b)(4) is not adequate to prevent adulteration of your animal food.<br /><br />FDA previously found undesirable microorganisms in your finished raw pet food products, indicating a recurring issue at your firm. A sample of your Woody’s Pet Food Deli Raw Cornish Hen Homemade Cat and Dog Food with Supplements, collected by FDA on November 30, 2021, tested positive for Salmonella enteritidis (FDA sample #1150234). In addition, your Woody’s Pet Food Deli Raw Chicken Homemade Cat and Dog Food collected by FDA on August 20, 2019, tested positive for Salmonella Infantis and Salmonella Kentucky (FDA sample #1046805).<br /><br />Evaluation of your response:<br /><br />Your response stated that use of PAA is a meat processing industry standard approved by the U.S. Department of Agriculture (USDA) and is (b)(4) and efficient ways of eliminating pathogens. You provided three scientific studies on the use of PAA as an antimicrobial during processing of raw poultry which were found on the internet.<br /><br />USDA does not regulate pet food.5 Regarding human food, USDA considers (b)(4) at certain levels to be safe and suitable for use as an antimicrobial agent for the water used in processing, e.g., rinsing, meat and poultry consistent with Food Contact Notification No. 1389 to the FDA.6 Food contact substances are not intended to have a technical effect in the food.7<br /><br />You also responded that you are unable to eliminate pathogens completely. This is a concern because Salmonella is a pathogenic bacterium that can cause serious and sometimes fatal infections in both humans and animals. Infections can be especially serious in young children, elderly people, and others with weakened immune systems. The association between human illness or outbreaks of salmonellosis and Salmonella-contaminated pet foods is well established.8 In 2019, Salmonella Reading was found in three lots of your Woody’s Pet Food Deli Raw Free Range Turkey and was implicated in part of a human illness outbreak investigated by the CDC.9,10 Association between Salmonella-contaminated pet food and pet illness has also been shown.11 Thus, FDA considers a pet food to be adulterated if it is contaminated with Salmonella.<br /><br /></div><div>You have been previously informed on other occasions of the FDA’s position regarding Salmonella in pet food, including in an Untitled Letter issued to your firm on September 2, 2022, and in teleconferences between FDA and your firm on August 30, 2019, and December 16, 2021.<br /><br />Your response is inadequate in that it did not propose changes to your process or add additional interventions to address the recurrence of Salmonella in your pet food.<br /><br />Use of Peroxyacetic Acid (PAA)<br /><br />During our inspection you provided the labeling and technical data sheet for (b)(4), which your firm uses as an antimicrobial treatment/kill step during processing of your raw meat pet food products. PAA is one of the substances that is in (b)(4). Our investigators noted you use a (b)(4) at a concentration of (b)(4) ppm for (b)(4) for all organ meat and a (b)(4) at a concentration of (b)(4) ppm for (b)(4) on all meat during production.<br /><br />Any substances that may become part of your pet food, such as PAA, must be used as described in an animal food additive regulation, be generally recognized as safe (GRAS) for the intended use as defined by the Act, or be otherwise not objectionable for use in animal food by definition in the Association of American Feed Control Officials (AAFCO) Official Publication. Although peroxyacids are permitted for use as an antimicrobial secondary direct food additive on certain meat products intended for human food (21 CFR 173.370), there is no food additive regulation in 21 CFR Part 573 for the use of PAA in animal food, and PAA is not listed in 21 CFR Parts 582 or 584 as a substance that is GRAS for the intended use. Furthermore, FDA is not aware of any data demonstrating that PAA is GRAS for any use in animal food. Under section 409(a) of the Act, 21 U.S.C. § 348(a)(2), an unapproved food additive is unsafe and food containing an unsafe food additive is deemed to be adulterated.12<br /><br />Evaluation of your response:<br /><br />Your firm’s response stated “We can lower the PAA concentration for non-poultry to around (b)(4) ppm…” and you provided three scientific studies found on the internet on the use of PAA as an antimicrobial during processing of raw poultry.<br /><br />Your response is inadequate in that it did not provide any information indicating your use of PAA in pet food is considered GRAS by qualified scientific experts.<br /><br /><br /><br /><br />Conclusion<br /><br />This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the cause of any violation and for preventing its recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.<br /><br /><br /><br /><br />This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal action including, without limitation, seizure and injunction.<br /><br /><br /><br /><br />We also offer the following comments:<br /><br /><br /><br /><br />1. In response to discussion with our investigators about the condition and your use of a wooden butcher block table during production, your response described actions you plan to take regarding this issue. Your response states metal or plastic boards are unsuitable for chopping meats and the butcher block tables are National Sanitation Foundation approved and food grade. Additionally, you stated that even though your butcher block table was relatively new, you would replace it with a new one. You also stated you thoroughly wash, clean, and sanitize after (b)(4). FDA’s concern with the use of wooden tabletops is they are porous, can be damaged during chopping, and are not easily cleanable. Therefore, the wooden butcher block table may serve as a source of contamination with environmental pathogens. Animal food-contact surfaces must be maintained to protect animal food from being contaminated and should be replaced when necessary so that the animal food does not become contaminated.<br /><br /><br /><br /><br />2. Your facility appears to meet the definition or a qualified facility in 21 CFR Part 507 and, therefore, may be subject to the modified preventive controls requirements in 21 CFR 507.7. A qualified facility is required to submit an attestation to FDA that the facility is a qualified facility, 21 CFR 507.7(a)(1). In addition, a qualified facility is required by 21 CFR 507.7(a)(2) to submit one of the following attestations to FDA:<br /><br /><br /><br /><br />An attestation that you have identified the potential hazards associated with the animal food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or<br /><br />An attestation that your facility is in compliance with State, local, county, tribal, or other applicable non-federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate State agency (such as a State department of agriculture), or other evidence of oversight.<br /><br />During the inspection you indicated that you submitted the qualified facility attestations via mail, but you were unable to provide documentation to substantiate this statement. As of the date of this letter, FDA does not have on file a qualified facility attestation form (Form FDA-3942b) for your firm.<br /><br /><br /><br /><br />We encourage electronic submission of your qualified facility attestation form (Form FDA-3942b) found at https://www.fda.gov/food/qualified-facility-attestation/instructions-submitting-qualified-facility-attestation. If you submit your form via mail, please include a copy of your submitted qualified facility attestation form with your firm’s response to this letter. (b)(3)(A)<br /><br /><br /><br /><br />For more information regarding qualified facilities, see FDA’s guidance, “Determination of Status as a Qualified Facility under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals,” at https://www.fda.gov/media/125438/download.<br /><br /><br /><br /><br />For more information about FDA’s current thinking on the CGMP requirements of 21 CFR Part 507, see “Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals,” https://www.fda.gov/media/97464/download.<br /><br /><br /><br /><br />Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the timeframe within which you will complete the correction. If you believe that you have complied with the Act and FDA regulations, include your reasoning and any supporting information for our consideration.<br /><br /><br /><br /><br />Your written response should be sent to the U.S. Food and Drug Administration, 250 Marquette Avenue, Suite 600, Minneapolis, MN 55401, to the attention of Compliance Officer Lauren Sanger. If you have questions you may contact Ms. Sanger at email Lauren.Sanger@fda.hhs.gov.<br /><br /><br /><br /><br />Sincerely,<br /><br />/S/<br /><br /><br /><br /><br />CAPT Chris van Twuyver<br /><br />Program Division Director, West Division 1<br /><br />Office of Human and Animal Food Operations<br /><br /><br /><br /><br />__________________<br /><br /><br /><br /><br />1 See section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(1).<br /><br /><br /><br /><br />2 See section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), and 21 CFR 507.1(a)(1)(ii).<br /><br /><br /><br /><br />3 See section 402(a)(2)(C)(i) of the Act, 21 U.S.C. § 342(a)(2)(C)(i).<br /><br /><br /><br /><br />4 See section 301(k) of the Act, 21 U.S.C. § 331(k).<br /><br /><br /><br /><br />5 USDA’s voluntary certified pet food provisions were withdrawn in 2022 because the regulations were out-dated and no companies were using the service, and because FDA has had regulatory authority over pet food since 1938. See 87 Fed.Reg. 30773 (May 20, 2022).<br /><br /><br /><br /><br />6 See FSIS Directive 7120.1, Rev. 58 (June 1, 2023), Table 2, available at https://www.fsis.usda.gov/sites/default/files/media_file/2021-09/7120.1_table_2.pdf.<br /><br /><br /><br /><br />7 The Act, section 409(h)(6), 21 U.S.C. § 348(h)(6).<br /><br /><br /><br /><br />8 Fod example, see the Centers for Disease Control and Prevention information on past Salmonella outbreaks related to pet food: https://www.cdc.gov/salmonella/pet-treats-07-19/index.html (pig ear dog treats), https://www.cdc.gov/salmonella/dog-food-05-12/index.html (dry dog food), and https://www.cdc.gov/salmonella/2007/pet-food-9-4-2007.html(dry dog food).<br /><br /><br /><br /><br />9 Outbreak of Multidrug-Resistant Salmonella Infections Linked to Raw Turkey Products | Multidrug-Resistant Salmonella Infections Linked to Raw Turkey Products | July 2018 | Salmonella | CDC: https://www.cdc.gov/salmonella/reading-07-18/index.html.<br /><br /><br /><br /><br />10 State Issues Consumer Advisory for Woody’s Pet Food Deli Raw Free Range Turkey Pet Food – MN Dept. of Health: https://www.health.state.mn.us/news/pressrel/2019/salmonella012819.html.<br /><br /><br /><br /><br />11 https://www.cdc.gov/healthypets/keeping-pets-and-people-healthy/pet-food-safety.html; https://www.avma.org/resources-tools/avma-policies/raw-or-undercooked-animal-source-protein-cat-and-dog-diets.<br /><br /><br /><br /><br />12 See section 402(a)(2)(C)(i) of the Act, 21 U.S.C. § 342(a)(2)(C)(i).</div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-80924200407570757202024-03-08T10:27:00.000-08:002024-03-08T10:27:19.922-08:00Illinois Facility Received Warning Letter for Continued Allergen Related RecallsFDA issued a Warning Letter to Gilster-Mary Lee Corporation of Chester, IL after they determined that the company's recalled “HyVee” brand Hamburger Chili Macaroni Skillet Meal (5.2 oz. retail unit, BEST BY FEB 08 24 Y18, UPC 75450-08552), was misbranded within the meaning of the regulation in that the finished product label did not declare a major food allergen, milk. The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited. The firm had initiated three other recalls involving mislabeled products resulting in undeclared major food allergens since 2019. Thus the reason they received a Warning Letter.<br /><b><br />WARNING LETTER</b><br /><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gilster-mary-lee-corporation-658271-08282023">https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gilster-mary-lee-corporation-658271-08282023</a><br /><br /><b>Gilster-Mary Lee Corporation</b><br />MARCS-CMS 658271 — AUGUST 28, 2023<span><a name='more'></a></span><div>Recipient:<br />Mr. Thomas B. Welge<br />President and CEO<br />Gilster-Mary Lee Corporation<br />1037 State Street<br />Chester, IL 62233<br />United States<br />twelge@gilstermarylee.com<br /><br />Issuing Office:<br />Division of Human and Animal Food Operations East VI<br />United States<br /><br />WARNING LETTER<br />CMS 658271<br /><br />August 28, 2023<br /><br />Dear Mr. Welge:<br /><br />The United States Food and Drug Administration (FDA) has determined that your recalled “HyVee” brand Hamburger Chili Macaroni Skillet Meal (5.2 oz. retail unit, BEST BY FEB 08 24 Y18, UPC 75450-08552), is misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product label did not declare a major food allergen, milk. The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited by section 301(a) of the Act [21 U.S.C. § 331(a)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at www.fda.gov.<br /><br />On March 24, 2023, your firm recalled meals labeled HyVee brand “Hamburger Chili Macaroni Skillet Meal” that contained “Hamburger Cheeseburger Macaroni Skillet Meal” because of the presence of an undeclared milk allergen due to the use of the incorrect carton. The “Hamburger Chili Macaroni Skillet Meal” carton does not include a milk ingredient declaration, and the “Hamburger Cheeseburger Macaroni Skillet Meal” contains milk. You initiated this recall after being notified of this mislabeling by a customer. In documentation you provided to the Office of Human and Animal Food Operations (OHAFO) East 6 Recall Coordinator on April 4, 2023, you indicated that you were scheduled to run “Hamburger Cheeseburger Macaroni Skillet Meal”; however, the line supplier mistakenly brought the incorrect cartons to the production line, and the lab tech failed to verify that the correct cartons were used.<br /><br />This product was manufactured and packaged on February 8, 2023, at your Gilster-Mary Lee Steeleville location, located at 10 Industrial Park Steeleville, IL 62288.<br /><br />In addition, your firm has initiated three other recalls involving mislabeled products resulting in undeclared major food allergens since 2019.<br /><br />On April 4, 2023, you also provided corrective and preventive control documentation, which states that you have provided re-training to employees on your firm’s procedures, and you will require production line operators for all lines to bring a carton, component, and case to the code room to be verified for every brand change. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.<br /><br />Misbranding<br /><br />Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], milk is considered a “major food allergen.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:<br /><br />The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or<br /><br />The common or usual name of the major food allergen in the list of ingredients is followed in parenthesis by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].<br /><br />Your HyVee “Hamburger Chili Macaroni Skillet Meal” that contained “Hamburger Cheeseburger Macaroni Skillet Meal” is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (milk).<br /><br />Additional comments<br /><br />Your facilities are subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule) (21 CFR Part 117). As such, you are required to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facilities will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 CFR 117.135(a)(1) and (c)(2)). The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (subparts A, C, D, E, F, and G) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].<br /><br />The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations.<br /><br />You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, including seizure and/or injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time within which you will do so.<br /><br />Your written response should be sent to Compliance Officer Daniel Arrecis, via email at Daniel.Arrecis@fda.hhs.gov. If you should have any questions regarding this letter, please contact Daniel Arrecis, Compliance Officer, at (312) 596-4263 or via email.<br /><br />Sincerely,<br />/S/<br />William R. Weissinger, MS<br />Program Division Director<br />Office of Human and Animal Foods East-Division 6</div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-81971337360165181542024-03-08T10:20:00.000-08:002024-03-08T10:20:07.030-08:00FDA Issues Warning Letter to CA Juice Company Processing Carrot Juice with PasteurizationFDA issued a Warning Letter to Barsotti Juice Company, Inc. of Camino, CA after the investigation found that they were processing a low acid carrot juice product with a pasteurization process that creates a Clostridium botulinum issue if the product were to be temperature abused. <br /><br />Findings:<br /><ul style="text-align: left;"><li>"HACCP / HARPC Plan Q2-2023 dated 25 April 2023 lists the following Critical Limits identified at the Pasteurization Critical Control Point (CCP) (b)(4) limit). You have defined Organic Carrot Juice as a Category III product with a (b)(4). The (b)(4) is not sufficient to inactivate the spores of Clostridium botulinum in carrot juice."</li><li>"Specifically, your HACCP / HARPC Plan Q2-2023 dated 25 April 2023 for fresh, refrigerated Organic Carrot Juice does not identify CCPs at labeling for maintaining product refrigeration, and of finished product refrigerated storage, to control the hazard of Clostridium botulinum growth and toxin formation in Organic Carrot Juice."</li></ul><div>The pasteurization process would eliminate vegetative cells, but not spores including spores of Clostridium botulinum. Those spores would survive the pasteurization, and if held at temperatures above refrigeration temperature for sufficient time, the spores would germinate, and then the cells would grow producing toxin.<br /><br />https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/barsotti-juice-company-inc-676447-01302024<br /><b>Barsotti Juice Company, Inc.</b><br /><br />MARCS-CMS 676447 — JANUARY 30, 2024<br /><br />Recipient:<br />Barsotti Juice Company, Inc.<br />2239 Hidden Valley Lane<br />Camino, CA 95709<br />United States</div><span><a name='more'></a></span><div>Issuing Office:<br />Division of Human and Animal Food Operations West V<br />United States<br /><br />WARNING LETTER<br /><br />January 30, 2024<br />WL 676447<br /><br />Dear Mr. Barsotti:<br /><br />We inspected your juice processing facility, located at 2239 Hidden Valley Lane, Camino, CA on November 20, November 21 and December 1, 2023. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR part 120), and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) in Title 21, Code of Regulations, Part 117 (21 CFR part 117). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your organic carrot juice is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the juice HACCP regulation and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.<br /><br />At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483, Inspectional Observations. You provide a written response to the inspection on December 15, 2023, which included a justification of your pathogen control measures, HACCP/HARPC Plan specific to organic carrot juice, and photographs. We have reviewed the documentation and continue to have serious concerns with your HACCP program.<br /><br />Your significant violations were as follows:<br /><br />1. Your HACCP plan does not include control measures that will consistently produce a 5-log reduction in the most resistant microorganism of public health significance that is likely to occur in the juice, for a period at least as long as the shelf life of the product, as required by 21 CFR 120.24(a).<br /><br />Specifically, Your HACCP / HARPC Plan Q2-2023 dated 25 April 2023 lists the following Critical Limits identified at the Pasteurization Critical Control Point (CCP) (b)(4) limit). You have defined Organic Carrot Juice as a Category III product with a (b)(4). The (b)(4) is not sufficient to inactivate the spores of Clostridium botulinum in carrot juice.<br /><br />You provided our investigator a challenge study entitled “(b)(4)” to support your critical limit and biological hazards identified for the Pasteurization CCP during the current inspection. Your written response included a justification which explained that “the current thermal processing eliminates all vegetative cells effectively.” Further, it explained “In the event of temperature abuse the growth of aerobic organism competitively prevents C. botulinum spore germination and growth, if present, and other undesirable biochemical changes cause the quality of the Carrot juice to degrade rapidly before the expiration date making the product undrinkable.”<br /><br />We reviewed your challenge study and written response and find them inadequate. The critical limits specified at the Pasteurization CCP (b)(4) is insufficient in ensuring control over any types of strains of C. botulinum, posing a serious risk to consumers due to the potential for spore growth and toxin production. (b)(4) for at least (b)(4).<br /><br />Your challenge study does not provide scientific rationale and sufficient data to demonstrate that C. botulinum is not a hazard in your carrot juice. Historical outbreak data demonstrates that C. botulinum is the pertinent microorganism in refrigerated carrot juice. Furthermore, the study does not support the shelf-life of the product which is defined as 28 days.<br /><br />2. Your HACCP plan does not list the critical control points for each of the identified food hazards that is reasonably likely to occur as required per 21 CFR 120.8(b)(2).<br /><br />Specifically, your HACCP / HARPC Plan Q2-2023 dated 25 April 2023 for fresh, refrigerated Organic Carrot Juice does not identify CCPs at labeling for maintaining product refrigeration, and of finished product refrigerated storage, to control the hazard of Clostridium botulinum growth and toxin formation in Organic Carrot Juice.<br /><br />As part of your written response, you provided a revised HACCP/HARPC Plan Q4-2023 for Processed Organic Carrot Juice which identifies Pasteurized Storage Tanks, Finished Food Storage and Labeling steps as critical control points for “biological.” The biological hazard is not defined to identify the pertinent microorganism of C. botulinum.<br /><br />Further, the current Juice HACCP Hazards and Controls Guidance, First Edition, states control measures for Low-acid juices, such as carrot juice “are likely to involve multiple measures, e.g., a combination of a process step to destroy the non-proteolytic spores and measures to ensure that "Keep Refrigerated" labeling is used for the juice if the juice does not receive a treatment sufficient to destroy the proteolytic spores.” As explained above, your pasteurization process is insufficient to destroy the non-proteolytic spores; therefore, these additional control measures alone do not adequately control the C. botulinum hazard.<br /><br />The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.<br /><br />We are concerned about your lack of 5-log reduction in the most resistant microorganism of public health significance which has been identified as clostridium botulinum and the limited controls you have in place. We believe a meeting with us to discuss the violations and corrective actions you may take would be beneficial to your firm and the FDA. A meeting would provide an opportunity for you to present any questions you may have regarding implementation of corrections and for the FDA to assist you in achieving full compliance.<br /><br />We have scheduled a regulatory meeting to be held through conference call on Wednesday, February 21, 2024 at 9:00 AM PST. Upon receipt of this letter please contact Kimberly M. Lichter, Compliance Officer at 949-608-2967 or at Kimberly.lichter@fda.hhs.gov within five (5) business days to confirm or request an alternate date. Please provide documentation of any corrective actions you have taken, or intend to take, five (5) business days prior to the conference call to allow for review by FDA prior to the conference call.<br /><br />Your written response should be sent to:<br />Sergio Chavez, Director, Compliance Branch<br />Food and Drug Administration<br />Office of Human and Animal Foods Division West 5<br />1201 Harbor Bay Parkway<br />Alameda, CA 94502<br /><br />Refer to Unique Identification Number 676447 when replying.<br /><br />If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.<br /><br /><br /><br /><br />If you have any questions regarding this letter, please contact Kimberly Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or (949) 608-2967.<br /><br /><br /><br /><br />Sincerely,<br /><br />/S/<br /><br /><br /><br /><br />Darla R. Bracy<br /><br />Program Division Director<br /><br />Office of Human and Animal Food Operations – West Division 5</div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-63538738879741187552024-03-08T10:01:00.000-08:002024-03-08T10:01:41.486-08:00Maine Facility Recalls Gluten Free Doughnut Mix for Containing WheatStonewall Kitchen of York, Maine is voluntarily recalling a limited amount of their Gluten Free Cinnamon Sugar Doughnut Mix because it may contain an undeclared allergen, wheat. The recall was initiated after the company received a consumer report of a reaction. Subsequent investigation discovered that product containing wheat was distributed in packaging that did not reveal the presence of wheat due to a packaging process error.<br /><br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stonewall-kitchen-issues-allergy-alert-wheat-limited-quantity-gluten-free-cinnamon-sugar-doughnut<br />Stonewall Kitchen Issues Allergy Alert for Wheat in Limited Quantity of Gluten Free Cinnamon Sugar Doughnut Mix<br />Summary<br />Company Announcement Date: March 07, 2024<br />FDA Publish Date: March 07, 2024<br />Product Type: Food & Beverages<br />Reason for Announcement: Potential or Undeclared Allergen - Wheat<br />Company Name: Stonewall Kitchen<br />Brand Name: Stonewall Kitchen<br />Product Description: Gluten Free Cinnamon Sugar Doughnut Mix<span><a name='more'></a></span><div><br />Company Announcement<br /><br />Stonewall Kitchen of York, Maine is voluntarily recalling a limited amount of their Gluten Free Cinnamon Sugar Doughnut Mix because it may contain an undeclared allergen, wheat. People who have an allergy or severe sensitivity to wheat (which contains gluten) may risk serious allergic reaction if they consume this product from impacted lots listed below.<br /><br />A limited quantity of this product was distributed nationwide to consumers through Stonewall Kitchen’s retail stores, stonewallkitchen.com and through third-party wholesale customers such as specialty grocers, department stores, or gourmet food shops.<br /><br />Potential affected products include the following details:<br /><br />Name:<br />Enjoy By Date: 03-09-2025 & 03-10-2025 (located on the bottom of the box)<br />UPC: 711381313329<br />Item #: 553429<br />Packaged in rectangular cardboard box<br /><br />The recall was initiated after the company received a consumer report of a reaction. Subsequent investigation discovered that product containing wheat was distributed in packaging that did not reveal the presence of wheat due to a packaging process error. This voluntary recall is being conducted with the knowledge of and in cooperation with the US Food and Drug Administration.<br /><br />If consumers with an allergy or sensitivity to wheat or gluten have any of the above product, they should discontinue use and return it to place of purchase for a full refund. If consumers purchased through stonewallkitchen.com, please return directly to Stonewall Kitchen for a full refund. Consumers who have an allergy to or a severe sensitivity to wheat or gluten run the risk of a serious or life threatening allergic rection if they consume the affected product from these two lots. One illness has been reported to date. There is no danger or risk of consuming the affected products from the two lots by consumers who do not have an allergy to or sensitivity to wheat or gluten, and those consumers may continue to safely enjoy the product, or they may return for a full refund it if they so wish.<br /><br /><br /><br /><br />Consumers should contact Stonewall Kitchen Premier Guest Services by email at guestservices@stonewallkitchen.com or by phone at 800-826-1735, Monday-Friday: 8:00am to 5:00pm EST. for refund instructions and to request any further information.</div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-79544938493985781262024-03-08T06:54:00.000-08:002024-03-08T06:54:26.643-08:00Wisconsin Establishment Recalls Turkey Kielbasa After Complaints for Pieces of RubberSalm Partners, LLC, a Denmark, Wis., establishment, is recalling approximately 35,430 pounds of Johnsonville turkey kielbasa sausage that may be contaminated with foreign materials, specifically pieces of rubber. The problem was discovered after the firm received complaints from consumers reporting they found pieces of rubber in the ready-to-eat turkey kielbasa products.<br /><br /><br />https://www.fsis.usda.gov/recalls-alerts/salm-partners-llc-recalls-johnsonville-polish-kielbasa-turkey-sausage-products-due<br /><b>Salm Partners, LLC, Recalls Johnsonville Polish Kielbasa Turkey Sausage Products Due to Possible Foreign Matter Contamination</b><br />SALM PARTNERS, LLC<br />FSIS Announcement<br /><br />WASHINGTON, March 7, 2024 - Salm Partners, LLC, a Denmark, Wis., establishment, is recalling approximately 35,430 pounds of Johnsonville turkey kielbasa sausage that may be contaminated with foreign materials, specifically pieces of rubber, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.<span><a name='more'></a></span><div><br />The turkey kielbasa sausages were produced between Oct. 30-31, 2023. The following products are subject to recall [view labels]:<br /><ul style="text-align: left;"><li>12-oz. vacuum-packed packages containing a single piece of "Johnsonville POLISH KIELBASA TURKEY" sausage and best by dates "05/17/24" and "05/18/24" printed on the side of the packaging.</li></ul>The products subject to recall bear establishment number "P-32009" printed on the side of the packaging. These items were shipped to retail locations nationwide.<br /><br />The problem was discovered after the firm received complaints from consumers reporting they found pieces of rubber in the ready-to-eat turkey kielbasa products.<br /><br />There have been no confirmed reports of adverse reactions or injury due to consumption of these products. Anyone concerned about an injury should contact a healthcare provider.<br /><br /><div>FSIS is concerned that some product may be in consumers' refrigerators. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.<br /><br />FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.<br /><br />Consumers and members of the media with questions about the recall can contact Stephanie Schafer, Director of Global Corporate Communications for Johnsonville, at 888-556-2728 or sschafer@johnsonville.com.<br /><br />Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.<br /></div></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-66880911708439540782024-03-07T07:00:00.000-08:002024-03-07T07:00:08.995-08:00CA Company Recalls 60,000 Pounds of Product For An Uncontrolled Marker PenCJ Foods Manufacturing Beaumont Corporation, a Beaumont, Calif., establishment, is recalling approximately 61,839 pounds of steamed chicken soup dumpling products that may be contaminated with foreign materials, specifically hard plastic from a permanent marker pen. The problem was discovered after the firm received complaints from consumers reporting they found hard plastic in Trader Joe’s steamed chicken soup dumplings.<div><br /></div><div>A permanent marker pen? A Sharpie? Someone drops a Sharpie and the company is recalling over 60,000 lbs of product. How much control do you have our your pens and markers? That is one expensive Sharpie.<br /><br /><br /><a href="https://blogger.googleusercontent.com/img/a/AVvXsEjiSSSKBzK46P4lLmUklbtuD5NLcQoTlIo2o-StXMaDbxZZ-PUMK2aCmpPLDIeGxS9rPg72B-kMEaJCc5wk9qQVqXVBhuTSArBdVayAgKRBR7XnFD3UwoAHBinneas3xebNE1zHfW3MSGiPHKPvZ_IKsYw7VI4Ns7Zg6OPQnJY4-Sxo8vqogrKv1zKJTYkf" style="margin-left: 1em; margin-right: 1em; text-align: center;"><img alt="" data-original-height="445" data-original-width="616" height="231" src="https://blogger.googleusercontent.com/img/a/AVvXsEjiSSSKBzK46P4lLmUklbtuD5NLcQoTlIo2o-StXMaDbxZZ-PUMK2aCmpPLDIeGxS9rPg72B-kMEaJCc5wk9qQVqXVBhuTSArBdVayAgKRBR7XnFD3UwoAHBinneas3xebNE1zHfW3MSGiPHKPvZ_IKsYw7VI4Ns7Zg6OPQnJY4-Sxo8vqogrKv1zKJTYkf" width="320" /></a><br /><br />https://www.fsis.usda.gov/recalls-alerts/cj-foods-manufacturing-beaumont-corporation-recalls-trader-joes-chicken-soup<br />CJ Foods Manufacturing Beaumont Corporation Recalls Trader Joe’s Chicken Soup Dumplings Due to Possible Foreign Matter Contamination<br /><br />CJ FOODS MANUFACTURING BEAUMONT CORPORATION<br /><br />FSIS Announcement<br /><br />WASHINGTON, March 2, 2024 – CJ Foods Manufacturing Beaumont Corporation, a Beaumont, Calif., establishment, is recalling approximately 61,839 pounds of steamed chicken soup dumpling products that may be contaminated with foreign materials, specifically hard plastic from a permanent marker pen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.</div><span><a name='more'></a></span><div>The steamed chicken soup dumplings were produced on Dec. 7, 2023. The following products are subject to recall [view labels]: <br /><br />6-oz. boxes with plastic trays containing six pieces of “TRADER JOE’S Steamed Chicken Soup Dumplings” with lot codes “03.07.25.C1-1” and “03.07.25.C1-2” printed on the side of the box.<br /><br />The products subject to recall bear establishment number “P-46009” inside the USDA mark of inspection. These items were shipped to Trader Joe’s retail locations nationwide. <br /><br />The problem was discovered after the firm received complaints from consumers reporting they found hard plastic in Trader Joe’s steamed chicken soup dumplings.<br /><br />There have been no confirmed reports of adverse reactions or injury due to consumption of these products. Anyone concerned about an injury should contact a healthcare provider. <br /><br />FSIS is concerned that some product may be in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.<br /><br />FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.<br /><br />Consumers with questions about the recall can contact the CJ Foods Manufacturing Beaumont Corporation’s Consumer Experience Department at 800-544-6855. Members of the media with questions can contact CJ Foods Manufacturing Beaumont Corporation's media relations team at 507-537-8550 or questions@schwans.com.<br /><br />Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.</div><div><div class="separator" style="clear: both; text-align: center;"><br /></div><br /><br /></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-68561183331105048182024-03-07T06:52:00.000-08:002024-03-12T18:00:56.674-07:00FDA Issues Health Alert on Cinnamon Product Due to Elevated Lead Content, Recalls Issued"Following the October 2023 recall of cinnamon apple puree and applesauce products due to elevated lead levels linked to the cinnamon in those products and the concern for lead toxicity in children, the FDA initiated a targeted survey of ground cinnamon products from discount retail stores and analyzed the samples for lead and chromium."<div><br /></div><div>Companies producing product with elevated lead as determined by FDA testing issued recalls.</div><div><div><ul style="text-align: left;"><li>El Chilar Rodriguez LLC of Apopka, FL is recalling 127 cases (12 bags/case) of El Chilar Ground Cinnamon “Canela Molida” (1.25 oz bag).</li><li>Raja Foods LLC of Skokie, Il is recalling its 3.5 ounce package of "SWAD CINNAMON POWDER"</li><li>Colonna Brothers of North Bergen, NJ is recalling its 1.5oz Marcum Ground Cinnamon & 2.25oz Supreme Tradition Ground Cinnamon </li><li>Raja Foods LLC of Skokie, Il is recalling its 3.5 ounce package of "SWAD CINNAMON POWDER"</li><li>La Fiesta Food Products, La Mirada California is recalling Cinnamon Ground .87oz </li></ul></div><div>First, this is a great reminder of why it is important to pay attention to recalls and health alerts. If you are an importer of a product or ingredient, that that ingredient was involved in major outbreak, it is just a matter of time before regulatory authorities are taking a broader look at other issues. It does not have to be from the same supplier or originate from the same country.</div><div><br /></div><div>The levels were not anywhere as high in these implicated products compared to the levels in the cinnamon apple sauce involved in the lead poisoning outbreak.<br /><br />"Based on results from the survey, the FDA is recommending recalls of ground cinnamon from six distributors whose products had elevated lead levels ranging from 2.03 to 3.4 parts per million (ppm) (see table above for a full list of lead levels in these products). These levels are significantly lower than the levels of lead associated with the ongoing investigation into ground cinnamon from Ecuador supplied by Negasmart to Austrofoods, the manufacturer of the apple puree and applesauce products, which were between 2,270 ppm to 5,110 ppm in the cinnamon."<div><br /></div><div>What level is unsafe?<br /><br /><a href="https://www.fda.gov/food/environmental-contaminants-food/lead-food-and-foodwares#:~:text=Although%20no%20safe%20level%20for,blood%20(%C2%B5g%20%2FdL).">FDA.gov</a> - "Although no safe level for lead exposure has been identified, the FDA has calculated an IRL for lead based on the Centers for Disease Control and Prevention’s (CDC) blood reference level of 3.5 micrograms of lead per deciliter of whole blood (µg /dL). The blood reference level is the level at which the CDC recommends clinical monitoring of lead exposure in children."<br /><br />"The IRL for lead includes a 10x safety factor. This means that it is nearly ten times lower than the amount of lead intake from food that would be required to reach the CDC’s blood reference level. The calculated IRLs are 2.2 micrograms (µg) per day for children and 8.8 µg per day for females of childbearing age. The IRL for females of childbearing age is to protect against possible fetal exposure in women who are unaware that they are pregnant and to protect against infant exposure during nursing:.<br /><br />https://www.fda.gov/food/alerts-advisories-safety-information/fda-alert-concerning-certain-cinnamon-products-due-presence-elevated-levels-lead<br /><b>FDA Alert Concerning Certain Cinnamon Products Due to Presence of Elevated Levels of Lead<br /></b><br />March 6, 2024<br /><br />What is the problem?<br /><br />Through product testing, the FDA has determined that the ground cinnamon products listed in the table below contain elevated levels of lead and that prolonged exposure to these products may be unsafe.<br /><br />The FDA is advising consumers to throw away and not to buy these ground cinnamon products. The FDA has recommended that the firms voluntarily recall these products, with the exception of the MTCI cinnamon. The FDA has been unable to reach MTCI to share our findings and request that the company initiate a recall. The FDA will update this notice with the communications from firms that voluntarily agree to recall as we receive them.<p></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEh1CYTVIvxSXDaony2YyVD4fZZSCkKCg088ZINY2txT7nHb08KpNCRPrn0J_ZdwafyTSlhic-lzrSKOtqKvLba7Pr6aGcIchoei1Zz4RxqDWfW03pskU8ddWS-d9narbDoh005CO1JRXB5lvWiC4CffpYXHEqwQlg8zcHdKQvqYxeTGRduwjmQrNgtUVKa6" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="1474" data-original-width="883" height="1119" src="https://blogger.googleusercontent.com/img/a/AVvXsEh1CYTVIvxSXDaony2YyVD4fZZSCkKCg088ZINY2txT7nHb08KpNCRPrn0J_ZdwafyTSlhic-lzrSKOtqKvLba7Pr6aGcIchoei1Zz4RxqDWfW03pskU8ddWS-d9narbDoh005CO1JRXB5lvWiC4CffpYXHEqwQlg8zcHdKQvqYxeTGRduwjmQrNgtUVKa6=w670-h1119" width="670" /></a></div><br /><p></p><span><a name='more'></a></span><p>Purpose <br /><br />The FDA is advising consumers to throw away and not to buy the ground cinnamon products listed above because samples of these products were found to contain elevated levels of lead. Based on FDA’s assessment, prolonged exposure to these products may be unsafe and could contribute to elevated levels of lead in the blood. Long-term exposure (months to years) to elevated levels of lead in the diet could contribute to adverse health effects, particularly for the portion of the population that may already have elevated blood lead levels from other exposures to lead. No illnesses or adverse events have been reported to date in association with these products. <br /><br />While the ground cinnamon products in this alert may not be a food targeted to young children, cinnamon is used in many foods young children consume. Consistent with the agency’s Closer to Zero initiative, which focuses on reducing childhood exposure to lead, the agency is recommending voluntary recall of the products listed above because prolonged exposure to the products may be unsafe. Removing the ground cinnamon products in this alert from the market will prevent them from contributing elevated amounts of lead to the diets of children.<br /><br />Summary and Scope of the Problem<br /><br />Following the October 2023 recall of cinnamon apple puree and applesauce products due to elevated lead levels linked to the cinnamon in those products and the concern for lead toxicity in children, the FDA initiated a targeted survey of ground cinnamon products from discount retail stores and analyzed the samples for lead and chromium. <br /><br />Based on results from the survey, the FDA is recommending recalls of ground cinnamon from six distributors whose products had elevated lead levels ranging from 2.03 to 3.4 parts per million (ppm) (see table above for a full list of lead levels in these products). These levels are significantly lower than the levels of lead associated with the ongoing investigation into ground cinnamon from Ecuador supplied by Negasmart to Austrofoods, the manufacturer of the apple puree and applesauce products, which were between 2,270 ppm to 5,110 ppm in the cinnamon. <br /><br />In addition to the FDA’s sampling and analysis, some states also analyzed samples of cinnamon through the Laboratory Flexible Funding Model. This is a cooperative agreement with states to help investigate, monitor and remove adulterated foods from commerce and aid regulatory programs. The Maryland and Missouri Departments of Health collected cinnamon samples included in this safety alert. <br /><br />FDA Actions<br /><br />The FDA will continue to work with manufacturers, distributors, and retailers to remove unsafe products from the market, and to further investigate the sources of the lead contamination as appropriate. <br /><br />The FDA is also continuing its Toxic Elements monitoring program, which includes testing of a variety of foods including colored spices offered for sale in the U.S. Our sampling at import has prevented some cinnamon with elevated lead levels from entering U.S. commerce; however, like all of our surveillance activities, these monitoring programs only evaluate a subset of the commodity being imported. FDA will follow-up on these findings as well as continue our activities at import to prevent unsafe cinnamon from reaching consumers in the U.S., including by adding firms and products to import alert where appropriate. Ultimately, it is the responsibility of the manufacturers and the importers to ensure the safety of the products that enter into the U.S. market. <br /><br />The FDA also sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the U.S. reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including in ground cinnamon products. The FDA will continue to work with firms to ensure they are meeting their responsibilities under provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. <br /><br />Potential Health Effects <br /><br />Based on FDA’s assessment, consuming these products could contribute to elevated levels of lead in the blood. Long-term exposure (months to years) to elevated levels of lead in the diet could contribute to adverse health effects, particularly for the portion of the population that may already have elevated blood lead levels from other exposures to lead. If you are concerned that you or anyone in your family may have symptoms of lead toxicity, the FDA recommends you contact your healthcare provider. <br /><br />The potential for adverse health effects from consuming food contaminated with lead vary depending on the level of lead in the food; age of the consumer; length, amount, and frequency of exposure to lead in the food; and other exposures to different sources of lead. For example, the very young are particularly vulnerable to the potential harmful effects from lead exposure because of their smaller body sizes and rapid metabolism and growth. High levels of exposure to lead in utero, infancy, and early childhood can lead to neurological effects such as learning disabilities, behavior difficulties, and lowered IQ. <br /><br />FDA’s Advice to Help Protect Against the Effects of Lead <br /><br />Good nutrition – like meeting the recommendations in the Dietary Guidelines for Americans – can help protect against the health effects from exposure to lead. Eating a variety of healthy foods can make it less likely for an individual to be exposed to the same contaminant from the same food many times and helps to provide the range of nutrients needed for health and, for children, healthy development. Having adequate nutrients stored in the body also can help to prevent lead from having harmful effects. To get adequate food variety, FDA recommends that consumers eat many different foods from the five food groups – vegetables, fruits, grains, dairy, and protein foods – and to alternate how often you provide the same food. <br /><br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/el-chilar-rodriguez-llc-issues-voluntary-recall-el-chilar-ground-cinnamon-canela-molida-due-elevated<br />El Chilar Rodriguez LLC. Issues Voluntary Recall of El Chilar Ground Cinnamon “Canela Molida” Due to Elevated Lead Levels<br />Summary<br />Company Announcement Date: March 06, 2024<br />FDA Publish Date: March 06, 2024<br />Product Type: Food & Beverages<br />Reason for Announcement: Potential Metal Contaminant - Lead<br />Company Name: El Chilar Rodriguez LLC<br /> Brand Name:El Chilar<br />Product Description: Ground Cinnamon “Canela Molida”<br /></p>Company Announcement<br /><br />El Chilar Rodriguez LLC of Apopka, FL is recalling 127 cases (12 bags/case) of El Chilar Ground Cinnamon “Canela Molida” (1.25 oz bag), because it may contain traces of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposure to higher levels of lead or chronic exposure to lead. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age/ body weight. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects. Lead can cause serious health problems if too much is ingested, such as damage to the brain and kidneys and can interfere with the production of red blood cells that carry oxygen to all parts of your body.<br /><br />The product was distributed by La Raza LLC, 8795 D'Arcy Rd, Forestville, MD 20747, which distributes to brick-and-mortar retail stores within the state of Maryland.<br /><br />The product can be identified by the lot codes D300 EX1024 and F272 EX1026, which is stamped on the front side of the packaging (see attached example).<br /><br />No illnesses have been reported to date.<br /><br />The recall was initiated after the Maryland Department of Health collected product samples and analysis came back with elevated concentrations of lead. Subsequent investigation indicates the problem might be caused by potentially adulterated raw material from the supplier.<br /><br />Consumers who have purchased El Chilar Ground Cinnamon “Canela Molida” with lot code D300 EX1024 and F272 EX1026 are urged to stop using the product immediately and to return it to the place of purchase for a full refund. Parents and caregivers of toddlers and young children who may have been exposed to lead should contact their health care provider to report their symptoms and receive care. Consumers with questions may contact EL CHILAR RODRIGUEZ LLC at 407-880-6007, on regular business hours (Mon - Fri 8:00AM – 4:30PM).<br /><br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/colonna-brothers-inc-issues-voluntary-recall-15oz-marcum-ground-cinnamon-225oz-supreme-tradition<br />Colonna Brothers, Inc. Issues a Voluntary Recall for “1.5oz Marcum Ground Cinnamon & 2.25oz Supreme Tradition Ground Cinnamon” Because of Possible Health Risk Due to Elevated Lead Levels<br />Summary<br />Company Announcement Date: March 06, 2024<br />FDA Publish Date: March 06, 2024<br />Product Type: Food & Beverages Spices, Flavors & Salts<br />Reason for Announcement: Elevated Lead Levels<br />Company Name: Colonna Brothers, Inc.<br />Brand Name: Colonna<br />Product Description: Marcum Ground Cinnamon & Supreme Tradition Ground Cinnamon<br /><br />Company Announcement<br /><br />FOR IMMEDIATE RELEASE – March 6, 2024 - Colonna Brothers of North Bergen, NJ is recalling its 1.5oz Marcum Ground Cinnamon & 2.25oz Supreme Tradition Ground Cinnamon because of a possible health risk due to elevated lead levels. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposure to higher levels of lead or chronic exposure to lead. The effects depend upon the amount and duration of lead exposure and age/ body weight. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects.<br /><br />The Cinnamon was distributed nationwide through retail stores and mail order. The products come in a clear plastic jar labeled with either “Marcum Cinnamon Ground 1.5oz” or “Supreme Tradition Ground Cinnamon 2.25oz”. Only the following lot codes (found on the jar above the label - below the cap) were affected:<br /><br />1.5oz Marcum Ground Cinnamon Best By:10/16/25 10DB<br />1.5oz Marcum Ground Cinnamon Best By: 04/06/25 0400B1<br />2.25oz Supreme Tradition Ground Cinnamon 09/29/25 09E8<br />2.25oz Supreme Tradition Ground Cinnamon 04/17/25 04E11<br />2.25oz Supreme Tradition Ground Cinnamon 12/19/25 12C2<br />2.25oz Supreme Tradition Ground Cinnamon 04/12/25 04ECB12<br />2.25oz Supreme Tradition Ground Cinnamon 08/24/25 08A<br />2.25oz Supreme Tradition Ground Cinnamon 04/21/25 04E5<br />2.25oz Supreme Tradition Ground Cinnamon 09/22/2025 09E20<br /><br />No illnesses have been reported to date in connection with these products.<br /><br />The recall was the result of a targeted sampling program of discount brands by the FDA, following heightened sensitivity around Cinnamon. Colonna Brothers is participating in this recall voluntarily as requested by the FDA. Colonna Brother’s has not violated any Federal guidelines/legislation/laws regarding levels of lead in Cinnamon/Spice nor any protocols requiring testing for heavy metals. The FDA is stating that the lot codes above contain elevated levels of lead that the FDA deems a potential health risk.<br /><br />Colonna Brothers has voluntarily ceased the production and distribution of all Cinnamon.<br /><br />Consumers who have purchased the Supreme Tradition Ground Cinnamon or Marcum Ground Cinnamon, with the lot codes listed above, can discard it or return it to the store for a full refund. Anyone concerned they may have been exposed to lead, should contact their healthcare provider to report their symptoms. Consumers with questions may contact us at 201-864-1115 between the hours of 9-5 EST.<br /><br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/raja-foods-skokie-il-recalling-swad-brand-cinnamon-powder-35oz-retail-packs-possible-lead<br />Raja Foods Skokie, IL Is Recalling “Swad Brand Cinnamon Powder 3.5OZ Retail Packs” for Possible Lead Contamination<br />Summary<br />Company Announcement Date: March 06, 2024<br />FDA Publish Date: March 07, 2024<br />Product Type: Food & Beverages<br />Reason for Announcement: Potential Metal Contaminant - Lead<br />Company Name: Raja Foods LLC<br />Brand Name: SWAD<br />Product Description: Cinnamon Powder<br />Company Announcement </div><div>Raja Foods LLC of Skokie, Il is recalling its 3.5 ounce package of "SWAD CINNAMON POWDER" because it has the potential to be contaminated with lead. Short term exposure to very low levels of lead may not elicit any symptoms. It is possible that increased blood levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposures to higher levels of lead or chronic exposure to lead. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age/body weight. If a child is exposed to lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects.<br /><br />The products included in this recall are, SWAD BRAND CINNAMON POWDER in clear plastic 3.5 OZ bags, UPC 0-51179-34280-4, from either of the following two batches and Best Before Dates: Batch KX21223 Best Before July 2026 and Batch KX08123 Best Before March 2026.<br /><br />Product was distributed thru retail grocery stores in the Midwest, Northeast, and Southeast regions of the United States. There have been no illnesses reported to date. The recall was the result of a routine sampling program by the FDA.<br /><br />Consumers who have purchased “SWAD CINNAMON POWDER 3.5OZ” are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 847.972.2865, Monday to Friday 9am to 4pm CST.</div></div></div><div><br /></div><div>https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/raja-foods-skokie-il-recalling-swad-brand-cinnamon-powder-35oz-retail-packs-possible-lead</div><div>Raja Foods Skokie, IL Is Recalling “Swad Brand Cinnamon Powder 3.5OZ Retail Packs” for Possible Lead Contamination</div><div><div>Summary</div><div>Company Announcement Date: March 06, 2024</div><div>FDA Publish Date:March 07, 2024</div><div>Product Type:Food & Beverages</div><div>Reason for Announcement: Potential Metal Contaminant - Lead</div><div>Company Name: Raja Foods LLC</div><div>Brand Name: SWAD</div><div>Product Description: Cinnamon Powder</div><div>Company Announcement</div><div>Raja Foods LLC of Skokie, Il is recalling its 3.5 ounce package of "SWAD CINNAMON POWDER" because it has the potential to be contaminated with lead. Short term exposure to very low levels of lead may not elicit any symptoms. It is possible that increased blood levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposures to higher levels of lead or chronic exposure to lead. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age/body weight. If a child is exposed to lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects.</div><div><br /></div><div>The products included in this recall are, SWAD BRAND CINNAMON POWDER in clear plastic 3.5 OZ bags, UPC 0-51179-34280-4, from either of the following two batches and Best Before Dates: Batch KX21223 Best Before July 2026 and Batch KX08123 Best Before March 2026.</div><div><br /></div><div>Product was distributed thru retail grocery stores in the Midwest, Northeast, and Southeast regions of the United States. There have been no illnesses reported to date. The recall was the result of a routine sampling program by the FDA.</div><div><br /></div><div>Consumers who have purchased “SWAD CINNAMON POWDER 3.5OZ” are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 847.972.2865, Monday to Friday 9am to 4pm CST.</div></div><div><br /></div><div>https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/la-fiesta-food-products-recalls-cinnamon-ground-because-possible-health-risk</div><div>La Fiesta Food Products Recalls Cinnamon Ground Because of Possible Health Risk</div><div><div>Summary</div><div>Company Announcement Date: March 06, 2024</div><div>FDA Publish Date: March 08, 2024</div><div>Product Type: Food & Beverages</div><div>Reason for Announcement: Potential Metal Contaminant - Lead</div><div>Company Name: La Fiesta Food Products</div><div>Brand Name: La Fiesta</div><div>Product Description: Ground Cinnamon</div><div>Company Announcement</div><div>03/06/2024, La Fiesta Food Products, La Mirada California is recalling Cinnamon Ground .87oz because it has the potential to be contaminated with lead.</div><div><br /></div><div>Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposure to higher levels of lead or chronic exposure to lead. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age/ body weight. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects.</div><div><br /></div><div>Lead is a toxic substance present in our environment in small amounts and everyone is exposed to some lead from daily actions such as inhaling dust, eating food, or drinking water. Exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and age of the person exposed.</div><div><br /></div><div>The affected product was distributed in California as well as Arizona, Washington, and Texas through distributors to retail stores from April 20, 2023 through May 3, 2023.</div><div><br /></div><div>The impacted Cinnamon Ground products are identified below:</div><div>La Fiesta Brand Cinnamon Ground .87oz UPC#032327000449</div><div><br /></div><div>La Fiesta Food Products became aware of the issue after the FDA collected samples of the product and lab analysis revealed elevated concentrations of lead. There have been no reports of illnesses to date. There have been no reports of illnesses to date.</div><div><br /></div><div>Consumers who have purchased this product are advised to dispose of it or return to place of purchase for refund. Anyone concerned about an injury or illness should contact a healthcare provider. Consumers with questions can contact 408-326-0487 or qualityassurance@lffp.com, Monday-Friday, 9am-4pm PST.</div></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-50146692326517680862024-03-06T13:41:00.000-08:002024-03-08T12:09:08.178-08:00CA Department of Health Issues Advisory for Canned Foods Sold by Cannery Not Registered with State Cannery ProgramAji Mori Sauce Corp. DBA Sushi Koo of Los Angeles, CA, is voluntarily recalling its CHILLIMAMI SAUCE because product was manufactured and distributed without the California Department of Public Health (CDPH) Cannery Program oversight, making them just susceptible to contamination with Clostridium botulinum.<br /><br />California has a Cannery Program that establishes requirements for California facilities that package both low acid and acidified foods in sealed containers. <div><a href="https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/FoodSafetyProgram/CanneryInspectionProgram.aspx">https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/FoodSafetyProgram/CanneryInspectionProgram.aspx</a></div><div>How is this different than FDA Acidified or Low Acid Canned food regulations?</div><div>According to the website, "Food processors (Canneries) manufacturing these types of foods must comply with California and federal requirements and operate under a valid Cannery License that is renewed every two years." Although, outside of this blurb, the necessity is not stated on the <a href="https://public.staging.cdph.ca.gov/Programs/CEH/DFDCS/CDPH%20Document%20Library/FDB/FoodSafetyProgram/Cannery/Procedure.pdf" target="_blank">procedures for obtaining a cannery license</a>.</div><div>Does California has issues with canneries producing without oversight?</div><div>Another <a href="https://www.cdph.ca.gov/Programs/OPA/Pages/NR24-003.aspx" target="_blank">advisory was issued in February of 2024</a> for a canner of acidified products. In 2023, CADPH issued a <a href="https://www.cdph.ca.gov/Programs/OPA/Pages/NR23-002.aspx" target="_blank">warning for pickled items for a botulism risk.</a></div><div><br /></div><div>Why should a state like CA have a sperate program from what the FDA already does? Could it be that the State of California has stepped in to help the FDA? Perhaps. Or they may be trying to make it easier for people to make and sell canned foods. But do we want that or need that? Is it better to require canneries processing products where Clostridium botulinum is a risk, to have to jump through some hoops to prove they have the capabilities? </div><div><br /></div><div>What's worse is the sensationalized media reporting. <a href="https://www.newsweek.com/sauce-recall-contamination-fears-spark-warning-toxins-1876688" target="_blank"><i>Sauce Recall as Contamination Fears Spark Warning of Toxins </i>(Newsweek, Mar 06, 2024)</a></div><div><br /></div><div>The interesting thing to note here is that this is probably an acid food, so neither an acidified food or a low acid food. Looking at the ingredients, probably safe, but only a quick pH test would be needed to verify.</div><div>Tomato Paste, Water, Organic Brown Sugar, Lemon Juice, Japanese Mixed Chili Pepper, Oil, Salt, Allspice, Japanese Mirin, Garlic.<br /><br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aji-mori-sauce-corp-dba-sushi-koo-issues-voluntary-recall-chillimami-sauce<br /><b>Aji Mori Sauce Corp. DBA Sushi Koo Issues Voluntary Recall of Chillimami Sauce</b><br />Summary<br />Company Announcement Date: February 29, 2024<br />FDA Publish Date: March 06, 2024<br />Product Type: Food & Beverages<br />Reason for Announcement: Potential Foodborne Illness - Clostridium botulinum<br />Company Name: AJI MORI Sauce Corp. DBA Susi Koo<br />Brand Name: AJI MORI<br />Product Description: CHILLIMAMI SAUCE<br />Company Announcement Product -Recall Important Information</div><span><a name='more'></a></span><div><br />Aji Mori Sauce Corp. DBA Sushi Koo of Los Angeles, CA, is voluntarily recalling its CHILLIMAMI SAUCE because product was manufactured and distributed without the California Department of Public Health (CDPH) Cannery Program oversight, making them just susceptible to contamination with Clostridium botulinum.<br /><br />The voluntarily recalled CHILLIMAMI SAUCE was distributed in 8474 w 3rd st, LA, CA 90048. It was also available online www.ajimorisauce.comExternal Link Disclaimer<br /><br />The product comes in a clear plastic bottle with nozzle and black product label, 250 ml Net Wt. Expiration date October 1/2024.<br /><br />NO ILLNESS HAVE BEEN REPORTED EVER TO DATE FOR THESE PRODUCT<br /><br />If you have purchased product you are eligibe to return them or dispose and receive for a full refund. Consumers with questions or concerns may contact the company at sales@ajimorisauce.com Monday to Friday from 8:00 AM to 5:00 PM PST.<br /><br /> </div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-39895943028468163302024-03-06T13:07:00.000-08:002024-03-06T13:07:24.872-08:00A NC Facility Recalls Carrot Cake with a Chocolate Cake Ingredient Statement Resulting in Undeclared Soy KALO Foods, LLC of Stokesdale, NC is recalling Single Slice Carrot Cake UPC 8 53407 00418 4 due to a undeclared soy. Although the package is labeled Carrot Cake, the ingredient panel and UPC Code is for their Chocolate Cake. The Carrot Cake contains soy which is not listed in the ingredient statement. On March 1, 2024, the firm was notified by one of their customers, that packages labeled as Carrot Cake, but the ingredient panel on the bottom is for Chocolate Cake.<div><br /></div><div><br /><a href="https://blogger.googleusercontent.com/img/a/AVvXsEgoFmyyQ6uxW2AY6Q07rPauqDpdFCawDeqGmsX3vzESOHjc-9jx8Ar6a-_CumG5KgRXioxmjLdurekL0EXV01KlvxbjOceDgypR57TYy5_acciAhB-4Ff3O5073Zvrennqpwjd_vPeb9W8Gl0CPQXmwhXV1syXVk2sLLYOtepgoP9dc3Bmh_pmXMw0LVaoN" style="margin-left: 1em; margin-right: 1em; text-align: center;"><img alt="" data-original-height="1194" data-original-width="649" height="400" src="https://blogger.googleusercontent.com/img/a/AVvXsEgoFmyyQ6uxW2AY6Q07rPauqDpdFCawDeqGmsX3vzESOHjc-9jx8Ar6a-_CumG5KgRXioxmjLdurekL0EXV01KlvxbjOceDgypR57TYy5_acciAhB-4Ff3O5073Zvrennqpwjd_vPeb9W8Gl0CPQXmwhXV1syXVk2sLLYOtepgoP9dc3Bmh_pmXMw0LVaoN=w217-h400" width="217" /></a><br /><br /><br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kalo-foods-llc-recalls-single-slice-carrot-cake-due-undeclared-soy-allergen<br /><b>Kalo Foods, LLC Recalls Single Slice Carrot Cake Due to Undeclared Soy Allergen</b><br />Summary<br />Company Announcement Date: March 05, 2024<br />FDA Publish Date: March 05, 2024<br />Product Type: Food & Beverages<br />Reason for Announcement: Undeclared Soy<br />Company Name: KALO Foods, LLC<br />Brand Name: KALO<br />Product Description: Carrot Cake Slice</div><span><a name='more'></a></span><div>Company Announcement<br /><br />STOKESDALE, NC – March 5, 2024 – KALO Foods, LLC is recalling Single Slice Carrot Cake UPC 8 53407 00418 4 due to a undeclared soy. Although the package is labeled Carrot Cake, the ingredient panel and UPC Code is for their Chocolate Cake. The Carrot Cake contains soy which is not listed in the ingredient statement. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.<br /><br />No illnesses have been reported to date.<br /><br />On March 1, 2024, the firm was notified by one of their customers, that packages labeled as Carrot Cake, but the ingredient panel on the bottom is for Chocolate Cake.<br /><br />Product affected are packages labeled Single Slice Gluten Free Carrot Cake that has the ingredient panel stating Chocolate Cake.<br /><br />The products were distributed between 2/28/24 to 2/29/24. These products were packaged in clear plastic clam shells and sold primarily in retail stores located in the States of: North Carolina and Virginia.<br /><br />Consumers who have purchased these products are urged to return them to the place of purchase for a full refund or they may discard the product. Consumers with questions may contact Michael Cusato during our hours of operation Monday – Saturday 6:00am – 4:00 pm EST.<br /><br />This recall is being made with the knowledge of the Food and Drug Administration.<div><div class="separator" style="clear: both; text-align: center;"><br /></div><br /><br /></div></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-76127149406498576982024-03-01T11:53:00.000-08:002024-03-01T11:53:33.082-08:00FDA Updates Investigation of Lead Contamination in ApplesauceFDA issued an update on lead contaminated applesauce. FDA stated, "After additional analysis of the cinnamon collected from the manufacturer in Ecuador (Austrofoods), FDA has confirmed that the lead and chromium previously detected in the cinnamon are from lead chromate"<div><br /></div><div>FDA goes on to state, "Historically, lead chromate has been illegally added to certain spices increase to their weight and enhance their color, which increases the monetary value of the adulterated spices. FDA’s leading hypothesis remains that this was likely an act of economically motivated adulteration." This was an issue related to the supplier of the cinnamon, and not the facility that made the applesauce.</div><div><br /><div>FDA reports 90 confirmed cases while CDC reports a total of 468 cases (Confirmed Cases: 111, Probable Cases: 320, Suspect Cases: 37)<br /><br />The FDA reports follows a <a href="https://www.nytimes.com/2024/02/27/world/europe/lead-applesauce-food-safety.html" target="_blank">NY Times report</a> that discusses this case as demonstrating a weak link in our food supply chain....the supply chain of foreign processors.<br /> <br /><br />https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-chromium-levels-cinnamon-applesauce-pouches-november-2023<br /><b>Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce Pouches (November 2023)</b><br />Do not eat, sell, or serve multiple brands of recalled apple cinnamon fruit pouches. FDA’s investigation is ongoing.<br /><br />Current Update<br />February 29, 2024</div><span><a name='more'></a></span><div><br />After additional analysis of the cinnamon collected from the manufacturer in Ecuador (Austrofoods), FDA has confirmed that the lead and chromium previously detected in the cinnamon are from lead chromate. People who ate recalled products, especially if they had elevated blood lead levels, may have been exposed to chromium and should inform their healthcare provider so they can monitor health and provide supportive care, as needed. Healthcare providers can refer to CDC’s Clinician Outreach and Communication Activity (COCA Now) announcement for information for additional guidance.<br /><br />Historically, lead chromate has been illegally added to certain spices increase to their weight and enhance their color, which increases the monetary value of the adulterated spices. FDA’s leading hypothesis remains that this was likely an act of economically motivated adulteration.<br /><br />Further, FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing prior to export. Thus, the FDA has limited ability to take direct action with Negasmart (the supplier of cinnamon to Austrofoods) or Carlos Aguilera (the processor of the cinnamon sticks).<br /><br />Ecuadorian officials in Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) have reported that Carlos Aguilera of Ecuador, is the likely source of contamination and is not in operation at this time.<br /><br />Previous updates not captured by the initial timeline below are in the Previous Updates section. FDA will update the advisory as information becomes available.<div><br /></div><div>https://www.cdc.gov/nceh/lead/news/lead-poisoning-outbreak-linked-to-cinnamon-applesauce-pouches.html</div><div><div>Lead and Chromium Poisoning Outbreak Linked to Cinnamon Applesauce Pouches</div><div>Apple Cinnamon Fruit Puree Pouches & Cinnamon Apple Sauce</div></div><div><br /></div><div><div>Data updated on February 23, 2024.</div><div><br /></div><div>CDC has received the following reports from state and local health departments:</div><div><br /></div><div>Total Cases: 468</div><div>Confirmed Cases: 111</div><div>Probable Cases: 320</div><div>Suspect Cases: 37</div><div>States: (44 total) AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV</div><div>Recall: Yes</div><div>Investigation status: Active</div><div>Cases are reported to the CDC through state health departments. State health departments receive reports of potential cases from various sources, and then follow up to determine whether the case definition is met. In order to be considered in CDC’s case count, the person must have had a blood lead level of 3.5 ug/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit purée product after November 2022. Based on the amount of information available, CDC asks states to further classify cases as “suspect”, “probable”, and “confirmed”. As the investigation progresses, cases might be assigned to different case categories.</div></div></div></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-37724273892872346552024-03-01T11:40:00.000-08:002024-03-01T11:40:06.981-08:00Family Dollar Penalized $41.6 Million for Warehouse with Rat Issue<p>Family Dollar pleaded guilty to allowing FDA regulated products to become contaminated when they failed to rectify a rodent issue in their warehouse. The financial penalties,"a sentence of a fine and forfeiture amount totaling $41.675 million'" is said to be one of the largest ever. </p><blockquote style="border: none; margin: 0px 0px 0px 40px; padding: 0px; text-align: left;"><p>"Family Dollar Stores, a subsidiary of Dollar Tree Inc., pleaded guilty Monday to holding food, drugs, cosmetics and other items under “insanitary” conditions at a now-closed, rodent-infested distribution center in West Memphis, Arkansas, federal prosecutors said."</p><p>"Family Dollar faced one misdemeanor count of causing FDA-regulated products to become adulterated while being held under insanitary conditions at the facility, the U.S. Department of Justice said in a news release. The company entered into a plea deal that includes a sentence of a fine and forfeiture amount totaling $41.675 million, the largest-ever monetary criminal penalty in a food safety case, the department said."</p></blockquote>As you may recall, FDA issued a <a href="https://pennstatefoodsafety.blogspot.com/2022/02/fda-investigators-issue-warning-for.html">Warning Letter in 2022 </a>to the company and issued a health alert for products in a six state area after thousands of rats were found in the facility. <br /><br />The nail, so to speak, was that the company received complaints from stores starting in 2020 indicating that there were rodent dropping on shipments, and later in 2020, reports that shipments contained the actual rodents. Employees were aware of rodent issues in January of 2021, but the company continued to ship products until an FDA inspection in January of 2022. At the time, fumigation of the facility resulted in the finding of 1270 rats.<br /><br /><div><br /></div><div>Produce News</div><div>https://theproducenews.com/headlines/rodent-infested-retailer-fined-416m-food-safety-issues<br /><b>Rodent-infested retailer fined $41.6M for food-safety issues</b><br /><br />February 28, 2024<br /><br />Family Dollar Stores LLC pleaded guilty to holding food, drugs, medical devices and cosmetics under insanitary conditions, related to a rodent infestation at the company’s West Memphis, AR, distribution center, leading to the largest-ever monetary criminal penalty in a food-safety case.</div><span><a name='more'></a></span><div><br />A criminal information charged Family Dollar with one misdemeanor count of causing FDA-regulated products to become adulterated while being held under insanitary conditions. The company, a subsidiary of Dollar Tree Inc., entered into a plea agreement that includes a sentence of a fine and forfeiture amount totaling $41.675 million. The plea agreement also requires Family Dollar and Dollar Tree to meet robust corporate compliance and reporting requirements for the next three years.<br /><br />“When consumers go to the store, they have the right to expect that the food and drugs on the shelves have been kept in clean, uncontaminated conditions,” said Acting Associate Attorney General Benjamin C. Mizer.<br /><br />“It is incomprehensible that Family Dollar knew about the rodent and pest issues at its distribution center in Arkansas but continued to ship products that were unsafe and insanitary," said U.S. Attorney Jonathan D. Ross for the Eastern District of Arkansas. "Knowingly selling these types of products not only places the public’s health at risk but erodes the trust consumers have in the products they purchase.”<br /><br />In pleading guilty, the company admitted that its Arkansas distribution center shipped FDA-regulated products to more than 400 Family Dollar stores in Alabama, Missouri, Mississippi, Louisiana, Arkansas and Tennessee. According to the plea agreement, the company began receiving reports in August 2020 of mouse and pest issues with deliveries to stores. By the end of 2020, certain stores reported receiving rodents and rodent-damaged products from the warehouse.<br /><br />The company admitted that by no later than January 2021, some of its employees were aware that the insanitary conditions caused FDA-regulated products held at the warehouse to become adulterated in violation of the Federal Food, Drug and Cosmetic Act.<br /><br />According to the plea agreement, the company continued to ship FDA-regulated products from the warehouse until January 2022, when an FDA inspection revealed live rodents, dead and decaying rodents, rodent feces, urine, and odors and evidence of gnawing and nesting throughout the facility.<br /><br />Subsequent fumigation of the facility resulted in the reported extermination of 1,270 rodents. On Feb. 18, 2022, the company voluntarily recalled all drugs, medical devices, cosmetics, and human and animal food products sold since Jan. 1, 2021 in the 404 stores that had been serviced by the warehouse.<br /><br />Fortune<br /><br />https://fortune.com/2024/02/27/family-dollar-agrees-pay-417m-rodent-infested-warehouse-largest-ever-monetary-criminal-penalty-food-safety-case-doj/<br /><br />Family Dollar agrees to pay $41.7m for rodent-infested warehouse, the largest-ever monetary criminal penalty in a food safety case, DOJ says<br /><br />BYTHE ASSOCIATED PRESS<br /><br />February 27, 2024 at 6:00 AM EST<br /><br />Family Dollar Stores, a subsidiary of Dollar Tree Inc., pleaded guilty Monday to holding food, drugs, cosmetics and other items under “insanitary” conditions at a now-closed, rodent-infested distribution center in West Memphis, Arkansas, federal prosecutors said.<br /><br />Family Dollar faced one misdemeanor count of causing FDA-regulated products to become adulterated while being held under insanitary conditions at the facility, the U.S. Department of Justice said in a news release. The company entered into a plea deal that includes a sentence of a fine and forfeiture amount totaling $41.675 million, the largest-ever monetary criminal penalty in a food safety case, the department said.<br /><br />"When consumers go to the store, they have the right to expect that the food and drugs on the shelves have been kept in clean, uncontaminated conditions,” said Acting Associate Attorney General Benjamin C. Mizer. “When companies violate that trust and the laws designed to keep consumers safe, the public should rest assured: The Justice Department will hold those companies accountable.”<br /><br />A company spokesperson said it cooperated extensively with the DOJ’s investigation.<br /><br />“In 2022, Family Dollar issued a voluntary recall of product that allowed customers to return goods for a full refund without proof of purchase. While we are not aware of any consumer becoming ill due to conditions at the distribution center, 14 consumer class actions were brought against the company, and we have reached a tentative settlement in those cases without any admission of liability or wrongdoing,” the spokesperson said in an email. “We look forward to putting the litigation behind us so that we can focus on our business of providing affordable products to our customers, with quality and safety at the heart of what we do.”<br /><br />The plea agreement also requires Family Dollar and Dollar Tree to meet robust corporate compliance and reporting requirements for the next three years, the DOJ said.<br /><br />In pleading guilty, the company admitted that its Arkansas distribution center shipped FDA-regulated products to more than 400 Family Dollar stores in Alabama, Missouri, Mississippi, Louisiana, Arkansas, and Tennessee. According to the plea agreement, the company began receiving reports in August 2020 of mouse and pest issues with deliveries to stores. The company admitted that by January 2021, some of its employees were aware that the insanitary conditions caused FDA-regulated products held at the warehouse to become adulterated in violation of federal law.<br /><br />According to the plea agreement, the company continued to ship FDA-regulated products from the warehouse until January 2022, when an FDA inspection revealed live rodents, dead and decaying rodents, rodent feces, urine, and odors, and evidence of gnawing and nesting throughout the facility.<br /><br />Subsequent fumigation of the facility resulted in the reported extermination of 1,270 rodents.<br /><br />Dollar Tree Chairman and CEO Rick Dreiling, in a news release, said the company is moving forward with its “business transformation, safety procedures and compliance initiatives.”<br /><br />Since joining Dollar Tree’s Board of Directors in March 2022, Dreiling said they have “worked diligently to help Family Dollar resolve this historical matter and significantly enhance our policies, procedures and physical facilities to ensure it is not repeated.”<br /><br />Dollar Tree also recently announced that Family Dollar plans to return operations to West Memphis with a fully reimagined and refreshed distribution center. The new facility, which is expected to staff 300 new jobs, is expected to be open by fall 2024.<br /><br />Subscribe to the CFO Daily newsletter to keep up with the trends, issues, and executives shaping corporate finance. Sign up for free.<br />Sponsored<br /><br /><br /></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-20671021041934183602024-03-01T10:46:00.000-08:002024-03-01T10:46:44.040-08:00NY Establishment Recalls Raw Meat Products After Machine Oil Provider Ships Mislabeled NON-Food Grade OilMF Meats, a Falconer, N.Y. establishment, is recalling approximately 93,277 pounds of raw meat products, which may have been contaminated with non-food grade mineral seal oil, which is not approved for use in meat processing. The problem was discovered after the firm received four complaints from restaurants reporting a chemical taste in the meat products. After investigating, the firm determined that its mineral oil supplier sent them a drum containing non-food grade mineral seal oil labeled as food grade mineral oil. The non-food grade mineral seal oil was applied to food contact surfaces and not directly to the meat products.<br /><br />Wow, this is new one. Food grade oil is used on equipment where there is an interface with the food, because if that oil gets onto food, you don't want a situation like this. As we know, many operations go to great lengths to ensure food grade oil is used in these potential food contact situations, but to have the supplier mislabel the oil, that is just awful.<br /><br />https://www.fsis.usda.gov/recalls-alerts/mf-meats-recalls-raw-meat-products-due-contamination-a-non-food-grade-substance<br /><b>MF Meats Recalls Raw Meat Products Due to Contamination by a Non-Food Grade Substance</b><br /><br />MF MEATS<br /><br />WASHINGTON, Feb. 29, 2024 – MF Meats, a Falconer, N.Y. establishment, is recalling approximately 93,277 pounds of raw meat products, which may have been contaminated with non-food grade mineral seal oil, which is not approved for use in meat processing, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.<span><a name='more'></a></span><div>The raw meat items were produced from Nov. 26, 2023 through Feb. 16, 2024. The following products are subject to recall [view example label]: <br /><br />Various weights of meat cuts and ground meat. The products display Julian dates of 330-365 (November 26 - December 31) and 1-47 (January 1 - February 16). View the product list here.<br /><br />The products subject to recall bear establishment number “EST. 569” inside the USDA mark of inspection. These items were shipped to restaurants in New York, Ohio and Pennsylvania. <br /><br />The problem was discovered after the firm received four complaints from restaurants reporting a chemical taste in the meat products. After investigating, the firm determined that its mineral oil supplier sent them a drum containing non-food grade mineral seal oil labeled as food grade mineral oil. The non-food grade mineral seal oil was applied to food contact surfaces and not directly to the meat products.<br /><br />There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider. <br /><br />FSIS is concerned that some product may be in restaurants’ refrigerators or freezers. Restaurants are urged not to serve these products. These products should be thrown away or returned to the place of purchase.<br /><br />FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.<br /><br />Consumers and members of the media with questions about the recall can contact Doug Neckers, President, MF Meats, at 716-483-4050 or info@mfmeats.com.<br /><br />Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.</div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-12664317648779696012024-03-01T10:25:00.000-08:002024-03-01T10:25:33.061-08:00NY Firm Recalls Meat Samsa Products Due to Undeclared Sesame<div>M&P Production LTD, a Brooklyn, N.Y. establishment, is recalling approximately 669 pounds of raw lamb and beef samsa products due to misbranding and an undeclared allergen, the product contains sesame seeds, a known allergen, which is not declared on the product label. The problem was discovered by FSIS during routine in-plant verification activities.</div><div><br /></div>Samsa, similar to samosas, are baked pastry dough products stuffed with meat and spices. In this case, sesame may have been sprinkled on top of the pastry.<br /><br /><br />https://www.fsis.usda.gov/recalls-alerts/mp-production-ltd-recalls-raw-lamb-and-beef-samsa-products-due-misbranding-and<br /><b>M&P Production LTD Recalls Raw Lamb and Beef Samsa Products Due to Misbranding and an Undeclared Allergen</b><br />FSIS Announcement<br />WASHINGTON, Feb. 28, 2024 – M&P Production LTD, a Brooklyn, N.Y. establishment, is recalling approximately 669 pounds of raw lamb and beef samsa products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains sesame seeds, a known allergen, which is not declared on the product label.<div><span><a name='more'></a></span><span><br /></span>The raw, frozen lamb and beef samsa items were produced between Jan. 2, 2024, and Feb. 22, 2024 and have a shelf-life of one year. The following products are subject to recall [view labels]:<br /><br />16-oz. plastic-wrapped tray packages containing “SAMSA HALAL” with “USE BEFORE” dates of 01/02/25 through 02/22/25.<br />12-oz. plastic-wrapped tray packages containing “M&P DELICACIES Lamb Dumplings Lamb Samsa” with “USE BEFORE” dates 01/02/25 through 02/22/25.<br />The products subject to recall bear establishment number “EST. 18832” inside the USDA mark of inspection. These items were shipped to retail locations in Massachusetts, New Jersey, New York and Pennsylvania.<br /><br />The problem was discovered by FSIS during routine in-plant verification activities.<br /><br />There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider. <br /><br />FSIS is concerned that some product may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.<br /><br />FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.<br /><br /><div>Consumers and members of the media with questions about the recall can contact Peter Raziyev, owner, M&P Production LTD, at 718-438-5197 or email at mpfood@optimum.net.<br /><br />Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.<br /><div><div><br /></div></div></div></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0tag:blogger.com,1999:blog-3471115125887216836.post-56343057934122293432024-02-29T11:04:00.000-08:002024-02-29T11:04:14.909-08:00PA Firm Recalls Red Velvet Cake with Cream Frosting Due to Undeclared MilkElectric City Sweets of Scranton, PA is recalling 1,644 Red Velvet Milk Chocolate Bars, due to undeclared milk in the ingredient statement and allergen statement. The recall was initiated after a consumer reported the issue to the retailer where they had purchased the affected item. The milk-containing product was distributed in packaging identified with the allergen on the front panel display however it did not reveal the presence of milk in the ingredient list as required.<div><br /></div><div>They forgot to include the cream frosting in the ingredient statement.<br /><div class="separator" style="clear: both; text-align: center;"><br /></div><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg1XVMkIa52qj-6cSVRJ3e5-Z14YVDOd5s2oCF5312VjG4XBTZUWu3c2zFtxXI8kLMbH6x0r0IPFigxYUaai808bPV4uMusfJmNTAK3ZKSJFCJF82XAO9KbEugVnYiL0_ItBI1IKfVfyaSIMYTrChgNyszCWgnwQ0v_4kvX-gaNjP_ZwDabNWnMAWaYt6w9/s1384/cake.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em; text-align: center;"><img border="0" data-original-height="1384" data-original-width="1020" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg1XVMkIa52qj-6cSVRJ3e5-Z14YVDOd5s2oCF5312VjG4XBTZUWu3c2zFtxXI8kLMbH6x0r0IPFigxYUaai808bPV4uMusfJmNTAK3ZKSJFCJF82XAO9KbEugVnYiL0_ItBI1IKfVfyaSIMYTrChgNyszCWgnwQ0v_4kvX-gaNjP_ZwDabNWnMAWaYt6w9/w295-h400/cake.jpg" width="295" /></a><br /><br />Scranton PA is nicknamed Electric City in that it was the first city to have electric street cars (1886) and one of the first to have electric street lights (1880). Well before places like Johnstown, PA.<br /><br />https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/electric-city-sweets-issues-allergy-alert-undeclared-milk-electric-city-sweet-175oz-red-velvet-milk<br /><b>Electric City Sweets Issues Allergy Alert On Undeclared Milk in Electric City Sweet 1.75oz Red Velvet Milk Chocolate Bars</b><br />Summary<br />Company Announcement Date: February 28, 2024<br />FDA Publish Date: February 29, 2024<br />Product Type: Food & Beverages<br />Reason for Announcement: Due to Undeclared Milk<br />Company Name: Electric City Sweets<br />Brand Name: Electric City Sweets<br />Product Description: Red Velvet Milk Chocolate Bars</div><span><a name='more'></a></span><div><br />Company Announcement<br /><br />Electric City Sweets of Scranton, PA is recalling 1,644 Red Velvet Milk Chocolate Bars, due to undeclared milk in the ingredient statement and allergen statement. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.<br /><br />The recall was initiated after a consumer reported the issue to the retailer where they had purchased the affected item. The milk-containing product was distributed in packaging identified with the allergen on the front panel display however it did not reveal the presence of milk in the ingredient list as required.<br /><br />The product was distributed through online ordering at Electric City Sweets.comExternal Link Disclaimer and Wholesale accounts, which services:<br />- Scranton, PA<br />- Milford, PA<br />- Delray Beach, FL<br />- Marina Del Rey, CA<br />- Orlando, FL<br />- North Carolina<br /><br />This action relates only to:<br />ELECTRIC CITY SWEET 1.75OZ RED VELVET MILK CHOCOLATE BARS (UPC #860005974467) A 1.75oz milk chocolate candy bar with Lot 0101461635, Best By Date of 05/16/2025 and Lot 0101542739, Best By Date of 05/29/2025<br /><br />Only two specific lot codes are impacted. No other Lot Codes, or any other Electric City Sweets products, are involved in this action.<br /><br />No illnesses have been reported to date.<br /><br />For more information or assistance, please contact us at 1-570-430-8999 (Monday to Friday, 9:00 a.m. to 5:00 p.m. EST) or via our website at ELECTRIC CITY SWEETSExternal Link Disclaimer.<br /><br />Sweet Regards,<br />Michele Polito<br />CEO<div class="separator" style="clear: both; text-align: center;"><br /></div><br /></div>mwb124http://www.blogger.com/profile/00096980947327360217noreply@blogger.com0