Monday, December 21, 2020

USDA Issues Health Alert for Chinese Chicken Wings with False USDA Mark of Inspection

USDA FSIS issued a public health alert for raw frozen New Orleans -Roasted Chicken Wings products imported and labeled with a false USDA mark of inspection. A recall was not requested because the known affected product is no longer available in commerce for consumers to purchase.

"Di-Da Di-Da USA Corp., a Saratoga, Cal., establishment received and distributed ineligible imported frozen chicken wings products from The Peoples Republic of China to U.S. commerce for retail sale. The frozen chicken wings products are labeled with a false USDA mark of inspection bearing “P-40478”, an establishment number that does not exist. The problem was discovered when FSIS received a consumer complaint reporting a product suspected of being illegally imported being sold at a location. After investigation, FSIS determined that the product was ineligible and misbranded with a false USDA mark of inspection."

https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2020/pha-12192020-01
FSIS Issues Public Health Alert for Ineligible Imported Raw Frozen New Orleans - Roasted Chicken Wings from the Peoples Republic of China 

Frozen Meals Recalled Due to Complaints of White Plastic Pieces, Broken Conveyor May Be to Blame

Nestlé Prepared Food facility in Springville, Utah is recalling approximately 92,206 pounds of LEAN CUISINE Baked Chicken meal products "after receiving five consumer complaints involving hard white plastic found in the product. The firm believes the mashed potatoes used in the production of the baked chicken meals products had pieces of a plastic conveyor belt that broke during production."

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2020/recall-030-2020-release
Nestlé Prepared Foods Recalls Lean Cuisine Baked Chicken Meal Products Due to Possible Foreign Matter Contamination
Class I Recall
030-2020
Health Risk: High
Dec 19, 2020 

Friday, December 18, 2020

FDA Issues Advisory on Green Gorilla Root Juice

FDA issued an Advisory for consumer to avoid Green Gorilla Root Juice.

Green Gorilla Root Juice is made by the Green Gorilla Root Juice Company in St. Louis, MO. It contains Cayenne Pepper, apple juice, and a proprietary blend of natural herbs. One of those "natural herbs" was discovered by FDA to be Yohimbine.

Yohimbine is botanical compound extracted from the bark of the Pausinystalia yohimbe tree. It has been used to treat ED, with varying degree of success. It has been looked at for treating other health issues as well. However, it does have side effects.  "Yohimbine has been associated with heart attacks, seizures and other serious side effects, as well as confusion, dizziness, anxiety, tremors, headaches and skin flushing, and may interact with medications."

In the case of Green Gorilla Root Juice, the ingredient Yohimbine was not declared on the label and product "samples tested by the FDA contained 147 milligrams of Yohimbine in one 16 ounce bottle, which is at least several times higher than what would normally be recommended for use by a physician."

https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-consumers-avoid-green-gorilla-root-juice-due-potentially-harmful-undeclared-ingredient
FDA Advises Consumers to Avoid Green Gorilla Root Juice Due to a Potentially Harmful Undeclared Ingredient
December 18, 2020

FDA Warning Letter - Acidified Food Processor Fails

FDA issued a warning letter to an acidified food manufacturing facility (salsas and sauces) located in Albuquerque, New Mexico.  

First, the firm failed to file an updated scheduled process are they are required to do as part of the Acidified Foods regulations.  "The critical parameters [the company] are currently following during production of the same Flame Roasted Green Chile product are based on a process authority letter dated 12/20/2019. The critical parameters listed in the 12/20/2019 process authority letter are different than the critical parameters filed with FDA in 2016. your recall of the Trader Jose’s Hatch Valley Salsa manufactured on April 06, 2020 that had a documented equilibrium pH of 6.65."    It also seems that they were not following the process as required.

A pH of 6.65 is far from good. 

Then along with that, the firm failed to handle the process deviation when the pH was high or when the process was not followed.  Finally,  when these deviations did occur, the process was not under the supervision of someone who has attended a Better Process Control School as required by 21 CFR 114.83.

Good reminder for those who pack acidified foods of the necessity to follow the regulations.  These items are too often considered bulletproof, but they can be botulism death bombs if the process is not properly controlled. The regulations are there for a reason.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/desert-premium-group-llc-612030-12022020

WARNING LETTER
Desert Premium Group, LLC

MARCS-CMS 612030 — December 02, 2020

This Week in Mislabeled Product for Week Ending December 17, 2020

Online Sales of Improperly Packaged Snack Sticks - The U.S. USDA FSIS is issuing a public health alert for ready-to-eat (RTE) pork snack stick products due to misbranding and an undeclared allergen. The product may contain milk which is not declared on the product label.   The RTE product labeled as “Country Meats HOT BBQ Flavor Smoked Pork Snack Sticks” may actually contain Chili Cheese flavor pork snack sticks and was produced on November 6, 2020. These items were sold online to individual customers who further sold the product as a fundraiser item. The problem was discovered when the producing establishment received consumer complaints reporting cheese in the Hot BBQ flavored snack sticks. 

Pecans in Cookies but Not on Label - George DeLallo Co., Inc. of Mt. Pleasant, PA is recalling Publix Bakery 20 OZ Holiday Cookie Platters because they may contain undeclared pecans.  The recall was initiated after it was discovered that the pecan-containing product was distributed in packaging that did not reveal the presence of pecans. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's packaging processes.

Report - Foodborne illness source attribution estimates for 2018 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter

CDC issued a report "Foodborne illness source attribution estimates for 2018 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States" that uses outbreak data to identify the sources of foodborne illness. "

The report is from the Interagency Food Safety Analytics Collaboration (IFSAC), a tri-agency group created by the US CDC), FDA, USDA-FSIS. IFSAC developed a method to estimate the percentages of foodborne illness attributed to certain sources using outbreak data from 1998 through the most recent year for four priority pathogens: Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter.

They analyzed outbreaks that were confirmed or suspected to be caused by the four priority pathogens from 1998 through 2018. (Excluded outbreaks that met one or more of the following conditions: occurred in a U.S. territory; had no identified food vehicle or contaminated ingredient; were caused by more than one pathogen (including pathogens not included in this report); were caused by both E. coli O157 and another E. coli serogroup; or were caused by both Salmonella serotype Enteritidis and another Salmonella serotype.)

Quick take-aways...
  • First, nothing really new was presented in this report.
  • Salmonella had the largest amount of cases and there were cases in nearly every category.  Why? Salmonella is so prevalent in the environment.
  • E.coli was predominately an issue in row crops (leafy greens) and beef.  Why? Ruminants carry it and it gets onto the row crops through irrigation of those crops with contaminated water.
  • Listeria cases were primarily in dairy, fruit, and raw crops.  Meat items are further down the list, much of this due to how well the meat and poultry industry has focused on controlling it.
  • Campylobacter - Chicken and raw milk (although numbers from raw milk were excluded).  People focus on Salmonella in raw chicken, but Campylobacter is an equal or greater concern.  Both handled through the same ways...proper handling and cooking.
Directly from that report:
Overall Key Results
  • The results are based on 905 outbreaks caused or suspected to be caused by Salmonella, 255 by E. coli O157, 44 by Listeria, and 104 by Campylobacter (after 151 outbreaks due to Dairy were excluded).
  • Estimated Salmonella illnesses were more evenly distributed across food categories than illnesses from Campylobacter, E. coli O157, and Listeria; most of the illnesses for the latter pathogens were attributed to one or two food categories.
  • The credibility intervals overlap for the Salmonella and Listeria categories with the highest attribution percentages, indicating no statistically significant difference among them.
Salmonella Key Results
  • Over 75% of illnesses were attributed to seven food categories: Chicken, Seeded Vegetables (such as tomatoes), Pork, Fruits, Other Produce, Eggs, and Turkey.
  • The credibility intervals for each of the seven food categories that account for 75.6% of all illnesses overlap with some of the others
E. coli O157 Key Results 
  • Over 75% of E. coli O157 illnesses were attributed to Vegetable Row Crops (such as leafy greens) and Beef. 
  • Vegetable Row Crops had a significantly higher estimated attribution percentage than all other categories. • Beef had a significantly higher estimated attribution percentage than all categories other than Vegetable Row Crops. 
  • No illnesses were attributed to Eggs or Oils-Sugars.
Listeria monocytogenes Key Results 
  • Over 90% of illnesses were attributed to non-meat food categories. 
  • Over 75% of illnesses were attributed to Dairy and Fruits. 
  • The credibility intervals for the Dairy, Fruits, and Vegetable Row Crops categories were quite wide, partly due to the small total number of outbreaks (44). The credibility intervals overlapped each other, and the intervals for the Fruits and Vegetable Row Crops categories overlapped those for some food categories with much smaller estimated attribution percentages, such as Sprouts. 
  • No illnesses were attributed to Other Meat/Poultry, Game, Eggs, Other Seafood, Grains-Beans, OilsSugars, Seeded Vegetables or Other Produce.
Campylobacter Key Results 
  • Over half of non-Dairy Campylobacter illnesses were attributed to Chicken (58.3%). 
  • The credibility interval for Chicken did not overlap with the credibility intervals for the other categories, indicating a significantly higher estimated attribution percentage for Chicken than for any other food category. • No significant differences in the estimated attribution percentages were found among most other food categories. 
  • The majority (33/56, 59%) of chicken-associated Campylobacter outbreaks were attributed to chicken liver products, which are not widely consumed in the United States. All six chicken-associated Campylobacter outbreaks caused by both C. jejuni and C. coli were attributed to chicken liver products. • No illnesses were attributable to Eggs, Grains-Beans, or Sprouts.
  •  An attribution percentage for Dairy is not presented partly because most foodborne Campylobacter outbreaks were associated with unpasteurized milk, which is not widely consumed in the United States. The attribution percentages before removing Dairy were Dairy 56.5%, Chicken 25.4%, Other Seafood 4.6%, Turkey 3.6%, and Other Meat/Poultry 3.0%, and were less than 2% for each of the other categories. The Chicken attribution percentage increased to 58.3% after removing Dairy.
  • Note - The attribution percentages for Dairy are not presented in the figures for Campylobacter for several reasons. Most Campylobacter Dairy outbreaks included in the database were associated with unpasteurized milk, which is not widely consumed by the general population. Moreover, an analysis of 38 case-control studies of sporadic campylobacteriosis found a much smaller percentage of illnesses attributable to consumption of raw milk than chicken.
https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2018-report-TriAgency-508.pdf

Trader Joes Branded Frozen Edamame Imported from Asia Recalled for Potential Listeria

Trader Joe's frozen edamame (soy beans) is being recalled for potential Listeria contamination. The product was imported form southeast Asia through Tesoros Trading Company / Food Company.  The notice does not provide information on how the issue was discovered.

Not much information on Tesoros Trading Company, but likely linked to Teroros Foods.  While certain lots are listed, there would be concern for other lots or products packed in the same facility, especially if the packer did not have a robust Listeria control program.  As part of the importer's FSVP , they would have needed to identify Listeria as a hazard and then had sufficient verification support that the packer had adequate and verifiable environmental controls in place.

Tesoros Trading Company Recalls Product Because of Possible Health Risk
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tesoros-trading-company-recalls-product-because-possible-health-risk
Summary
Company Announcement Date:December 16, 2020
FDA Publish Date: December 16, 2020
Product Type: Food & Beverages Vegetable Protein Product
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name: Tesoros Trading Company
Brand Name: Trader Joe’s
Product Description: Frozen Lightly Salted Edamame

FDA Proposes Removing Standard of Identity for French Dressing

The US FDA announced that it was proposing to remove the Standard of Identity for French Dressing. The Standard of Identity, as we know, provides a standardized definition for a food item, in this case, French Dressing, so that when a consumer buys it from the store, they sort of know what they are buying.
"This proposed rule, if finalized, would revoke the standard of identity for French dressing. This action, in part, responds to a citizen petition submitted by the Association for Dressings and Sauces (ADS) (petition). We tentatively conclude that the standard of identity for French dressing no longer promotes honesty and fair dealing in the interest of consumers and revoking the standard could provide greater flexibility in the product’s manufacture, consistent with comparable, nonstandardized foods available in the marketplace.
"So what is French Dressing?
According to the online dictionary, French Dressing is:

n.
1. A salad dressing of oil, vinegar, and seasonings.
2. A commercially prepared creamy salad dressing that is usually pale orange to reddish-orange in color and often sweet.
From the US  Code of Federal Regulations, the Standard of Identity for French Dressing (entire listing below) states that it contains acidifying agents, vinegar and/or lemon juice, and has not less than 35 percent by weight of vegetable oil. Optional ingredients include egg and tomato juice.

The FDA proposal to remove this standard reasons:
"The petition states that there has been a proliferation of nonstandardized pourable dressings for salads with respect to flavors (Italian, Ranch, cheese, fruit, peppercorn, varied vinegars, and other flavoring concepts) and composition (including a wide range of reduced fat, “light,” and fat-free dressings) (petition at page 3). The French dressing standard of identity, according to the petition, no longer serves as a benchmark for other dressings because of the wide variation in composition to meet consumer interests (id.). Instead, the petition claims that the standard of identity has become marginalized and restricts innovation (id.). Therefore, the petition states that the French dressing standard of identity no longer promotes honesty and fair dealing in the interest of consumers (id.).

One key factor in the standard is the required level of oil.  With the demand for lower fat varieties, this standard limits that.  

When the standard of identity was established in 1950, French dressing was one of three types of dressings we identified (15 FR 5227). We generally characterized the dressings as containing a fat ingredient, an acidifying ingredient, and seasoning ingredients. The French dressing standard allowed for certain flexibility in manufacturers’ choice of oil, acidifying ingredients, and seasoning ingredients. Tomatoes or tomato-derived ingredients were among the seasoning ingredients permitted, but not required. Amendments to the standard since 1950 have permitted the use of additional ingredients, such as any safe and suitable color additives that impart the color traditionally expected (39 FR 39543 at 39554-39555).
Most, if not all, products currently sold under the name “French dressing” contain tomatoes or tomato-derived ingredients and have a characteristic red or reddish-orange color. They also tend to have a sweet taste. Consumers appear to expect these characteristics when purchasing products represented as French dressing. Thus, it appears that, since the establishment of the standard of identity, French dressing has become a narrower category of products than prescribed by the standard. These products maintain the above characteristics without a standard of identity specifically requiring them.
Additionally, French dressing products are manufactured and sold in lower-fat varieties that contain less than the minimum amount of vegetable oil (35% by weight) required by 21 CFR 169.115(a). We are unaware of any evidence that consumers are deceived or misled by the reduction in vegetable oil when these varieties are sold under names including terms such as “fat free” or “low-fat.” By contrast, these varieties appear to accommodate consumer preferences and dietary restrictions. Therefore, after considering the petition and related information, we tentatively conclude that the standard of identity for French dressing no longer promotes honesty and fair dealing in the interest of consumers consistent with section 401 of the FD&C Act. "

Should we care?  This is such a non-specific standard to begin with, brand specific variations may not make much difference to the consumer.  But FDA is "interested in any information, including data and studies, on consumer expectations regarding French dressing and whether the specifications in § 169.115 are necessary to ensure that French dressing meets these expectations."
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 169
[Docket No. FDA-2020-N-1807]

RIN 0910-AI16
French Dressing; Proposed Revocation of a Standard of Identity
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.

Monday, December 7, 2020

Lawsuit Filed Against Washington State Juice Processor for Mold Toxins and High Arsenic Levels

A lawsuit was filed against a now-defunct company for selling substandard juice made from rotting fruit.  The company processed juice that made its way into the school lunch program.

(perhaps they should have called it kombucha.....) 

City Herald 
https://www.tri-cityherald.com/news/state/washington/article247154559.html
‘Putrid and decomposed’ fruit used in juice for students, Washington lawsuit says
By Brooke Wolford
November 13, 2020 02:04 PM

A Washington company that is no longer in business used rotting fruit to make juice for school children, the Food and Drug Administration said in a lawsuit filed in federal court in Washington.
The Valley Processing plant in Sunnyside, Washington supplied nearly 3 million servings of apple juice a year to the federal school lunch program, the lawsuit said.