FDA Issues Draft Guidance that Plant-based Non-Milk Product Can Be Called Milk

FDA issued a proposal that says plant-based beverages can be called milk provided they list the plant material from which they were derived.  "The rules also call for voluntary extra nutrition labels that note when the drinks have lower levels of nutrients than dairy milk, such as calcium, magnesium or vitamin D. They would continue to allow labels that note when plant-based drinks have higher levels. Fortified soy milk is the only plant-based food included in the dairy category of U.S. dietary guidelines because of its nutrient levels."

AP News
https://apnews.com/article/us-food-and-drug-administration-business-health-nutrition-ed2acef14a014eef30a0fd24f98be07b
No cow needed: Oat and soy can be called milk, FDA proposes

Australia - Case of Botulism Linked to Almond Milk

In Australia, temperature abused almond milk was linked to a botulism case.

https://www.abc.net.au/news/2023-02-16/almond-milk-recalled-in-nsw-over-botulism-fears/101985952
Almond milk recalled in NSW after link to botulism poisoning

Posted Thu 16 Feb 2023 at 12:57amThursday 16 Feb 2023 at 12:57am, updated Thu 16 Feb 2023 at 1:37am

A brand of almond milk is being recalled in NSW after it was linked to a case of potentially life-threatening botulism.

Canada - French Wine Recalled for Presence of Glass Pieces

The CFIA issued a recall for Louis Latour brand Pinot Noir (2021) in the 375ml bottle due to foreign material in the form of glass.  For wine in glass, producers need to consider glass shards are a potential hazard.  This often occurs in the bottling process as the filler nozzle enters the top of the bottle or during capping / corking.

https://recalls-rappels.canada.ca/en/alert-recall/louis-latour-brand-pinot-noir-recalled-due-possible-presence-glass
Louis Latour brand Pinot Noir recalled due to possible presence of glass

Brand(s) Louis Latour  Pinot Noir Bourgogne 2021  375 mL
Last updated  2023-02-18

USDA Issues Health Alert RTE Breakfast Bowls After Distributor Temperature Abuses Product

U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that not-ready-to-eat meat products - breakfast bowls - that were subject to temperature abuse during storage at a distribution center prior to delivery to retailers, which may have resulted in the growth of spoilage organisms or pathogens.  The problem was discovered when the producing establishment notified FSIS that their customer reported storing the product in an unrefrigerated area. FSIS found that the product was held at an incorrect temperature and then shipped into commerce. All remaining inventory of the affected items have been removed from the stores and destroyed.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-frozen-not-ready-eat-signature-select-breakfast-bowl
FSIS Issues Public Health Alert for Frozen, Not-Ready-To-Eat Signature Select Breakfast Bowl Products Due to Possible Temperature Abuse at Distribution Center

FSIS Announcement

WASHINGTON, Feb. 15, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that not-ready-to-eat meat products were subject to temperature abuse during storage at a distribution center prior to delivery to retailers, which may have resulted in the growth of spoilage organisms or pathogens. FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed. A recall was not requested because the products are no longer available for purchase.

USDA Health Alert for RTE Chicken Entrée with Undeclared Soy and Milk Allergens

USDA-FSIS issued a public health alert due to concerns that the raw, ready-to-cook chicken entrée products may be missing labeling that includes the list of ingredients and cooking instructions. This product contains soy and milk, known allergens, which may not be declared on the finished product label.  A recall was not requested because the products are no longer available for purchase.  The problem was discovered when the establishment notified FSIS that the product was inadvertently misbranded when a printer did not place the bottom label on the product packaging. As a result, the list of ingredients and the cooking instructions are missing.


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-raw-ready-cook-stuffed-chicken-products-due
FSIS Issues Public Health Alert for Raw, Ready-To-Cook Stuffed Chicken Products Due to Misbranding and Undeclared Allergens

TAMPA BAY FISHERIES

FSIS Announcement

WASHINGTON, Feb. 14, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that the raw, ready-to-cook chicken entrée products may be missing labeling that includes the list of ingredients and cooking instructions. This product contains soy and milk, known allergens, which may not be declared on the finished product label. FSIS is issuing this public health alert to ensure that consumers with an allergy to soy and dairy are aware that these products should not be consumed and to ensure that consumers properly cook this product to an internal temperature of 165 degrees as measured by a food thermometer. A recall was not requested because the products are no longer available for purchase.

NY Establishment Recalls Pasta Product After Formulation Changes Adds Undeclared Egg

Whitson’s Food Service (Bronx) Corp., an Islandia, N.Y., establishment, is recalling approximately 8,713 pounds of frozen, ready-to-cook chicken alfredo with broccoli and penne pasta meals due to misbranding and undeclared allergens, in this case, the product contains egg, a known allergen, which is not declared on the product label.  The problem was discovered when the producing establishment received a consumer complaint and notified FSIS. The establishment investigated and determined that they updated the product formulation with a sauce containing egg, but the information was not provided to the nutrition department that creates the product labels. As a result, the immediate product labels do not list egg as an allergen and the case labels do not list egg in the ingredient statement.

https://www.fsis.usda.gov/recalls-alerts/whitsons-food-service-bronx-corp--recalls-frozen-ready-cook-chicken-alfredo-broccoli
Whitson’s Food Service (Bronx) Corp. Recalls Frozen, Ready-To-Cook Chicken Alfredo with Broccoli and Penne Pasta Products Due to Misbranding and Undeclared Allergens.

Food Importers Cited for Not Having FSVP - Jan-Feb 2023 Edition

FDA issued Warning Letter to the following food importers for not having a FSVP in place for their imported foods.

Sohgave LLC of Houston, TX did not develop, maintain, and follow an FSVP for any imported foods including Honey from one foreign company and Agave Syrup, honey, coconut syrup and inulin syrup imported from another.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sohgave-llc-646874-01192023

AMO and Wing Inc. dba T and H Trading Co. of Oakland, CA - as "a very small importer is must obtain written assurance, in accordance with 21 CFR 1.512(b)(3), before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act. Specifically, you did not provide written assurances from your foreign suppliers for any of the foods you import, including dried noodle and dried bean curd from (b)(4); and vermicelli from (b)(4)."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amo-and-wing-inc-dba-t-and-h-trading-co-638293-12072022

HST Produce, Inc. of Houston, TXdid not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, the firm did not develop, maintain, and follow an FSVP for any of their imported foods including each of the following foods:
Fresh prickly pear imported from (b)(4), Fresh jalapeno pepper imported from (b)(4), Peruano beans imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hst-produce-inc-639794-11072022

S&S Quality Wholesale Inc. of El Cajon, CA did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). for any of thier imported foods including:  Bashan Koftelik Bulgur Fine imported from (b)(4), located in (b)(4), Bread Sticks imported from (b)(4), located in (b)(4),Wheat Kernal Habiya imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ss-quality-wholesale-inc-630772-06012022

Leimax, Corp of Yonkers, NY did not develop an FSVP for any of the their imported foods including each of the following foods: Lollipops ((b)(4)) manufactured by (b)(4). Cola flavored soft drink manufactured by (b)(4). (b)(4) hot sauce manufactured by (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/leimax-corp-633364-10072022

Fuentes Farms LLC of McAllen, TX 7 did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).for any of their imported foods including: green onions imported from foreign supplier (b)(4) chayote imported from foreign supplier (b)(4)
broccoli imported from foreign supplier (b)(4)

"You import fresh produce, that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. § 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112)."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fuentes-farms-llc-642138-10142022

TL State Management of Brooklyn, NY did not develop an FSVP for any of their imported  food products including Pickled red tomatoes from (b)(4)  Puff pastry dough from (b)(4) and (b)(4) wafers from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tl-state-management-inc-634663-08302022

San-Rey Produce Inc.of Pharr, Texas. did not develop an FSVP for any of their imported foods including:  onions imported from foreign supplier, (b)(4), (b)(4) limes imported from foreign supplier, (b)(4) and coriander imported from foreign supplier,
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/san-rey-produce-inc-643593-12072022

FDA Issues a Warning Letter to Processor of Aseptic Nutritional Beverages for Inadequate Handling of Process Deviations

FDA issued a Warning Letter to Lyons Magnus, a CA company with a Wisconsin based processing operation for aseptically packaged nutritional beverages. The inspection was conducted in response to a recall that occurred in July of 2022 due to an under-processing issue of the low acid product that had the potential to allow pathogens such as Clostridium botulinum survive.

The issue that caused the recall was when the company identified gram positive rods in the product....but this was not the first time the company found organisms in the finished product. FDA states "Your notification to FDA occurred (b)(4) after your positive lab tests for gram-positive rods on (b)(4), and (b)(4) after lab testing confirmed the Bacillus subtilis result. Moreover, our review of your micro testing records dating back to (b)(4), noted your internal microbiological tests indicated gram-positive, gram-negative rods, and cocci in approximately 37 batches of finished products which were released and shipped. These test results demonstrate the presence of viable microorganisms in your commercial products, the majority of which you had not previously reported to FDA. "

FDA goes on to state, "We remind you that your aseptically packaged products containing viable microorganisms do not meet the definition of commercial sterility, per 21 CFR 113.3(e)(1)(i)(a) and are, therefore, adulterated. Shipping adulterated products into interstate commerce is a prohibited act under section 301(a) of the Act. Under 21 CFR 108.35(e) your firm must promptly alert FDA of lots shipped with known microbial contamination, not just those lots with confirmed species as identified in July 2022. Additionally, you shipped these products without conducting a full investigation into the cause of the microbial contamination. You indicated in your October 5, 2022, response that micro findings prior to April 2022 were attributed to laboratory error, yet you did not conduct an assessment of your laboratory practices prior to April 2022. Microbial findings in finished product indicate a loss of sterility during production of that batch and warrant further investigation. Per 21 CFR 113.40(g)(2)(ii)(B), “[i]n the event of loss of sterility, the system(s) shall be returned to a condition of commercial sterility before resuming packaging operations.”

It seems that much of the issue resulted when the company completed a process change that increased the volume run through the processor.  And although the company recognized a microbial contamination issue, they continued to run the modified process.  There were also indicators with the cleaning process was not effective.  There were some additional comments regarding their handling of process deviations.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lyons-magnus-llc-645766-01302023

WARNING LETTER
Lyons Magnus, LLC

MARCS-CMS 645766 — JANUARY 30, 2023
Recipient:
Edward Carolan
Chief Executive OfficerLyons Magnus, LLC

FDA Issues Warning Letter to Cruise Line for Not Maintaining Safe Water Supply

FDA inspected American Cruise Line's American Star and American Heritage vessels from in April 2022, through June 2022, and from June 2022, through August 2022. The investigation and inspections were initiated by FDA after three passengers who traveled in April 2021, September 2021, and September-October 2021 aboard these vessels were diagnosed with Legionnaires’ disease. FDA investigators collected biofilm swabs and potable water samples from these vessels and identified Legionella pneumophilia serogroup 1 and Legionella spp. in the potable water system of the vessels thus determine that the water is adulterated as defined by regulation..

FDA had issues with the response by the company in terms of response to the issue. There were issues with the test methodology the company was using..The company did "not monitor potable water parameters, such as free or total chlorine residual, temperature, and pH on the vessel when docked and not in operation or while in operation."