Regulatory Update: October 1 – October 31, 2022

This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the role of seafood consumption in children’s development, the recall of a frozen falafel product sold at ALDI, and more.

FDA Updates

FDA Solicits Comments on Information Collection Provisions of HACCP Principles Regarding the Processing and Importing of Fruit and Vegetable Juices
The FDA is seeking comments regarding the regulations mandating the application of hazard analysis and critical control point (HACCP) principles to the processing and importing of fruit and vegetable juices. The notice can be found here.

FDA Launches an Independent Study on the Role of Seafood Consumption on Children’s Development
The FDA announced the launch of an independent study by the National Academies of Sciences, Engineering, and Medicine (NASEM) on the Role of Seafood Consumption in Child Growth and Development. This joint project seeks to support the goals of the FDA’s Closer to Zero Action Plan for reducing the exposure of babies and young children to mercury, arsenic, lead, and cadmium from foods.

FDA Announces Effective Date of October 31, 2022 for the Updates of Two Final Rules
The FDA announced an effective date of October 31, 2022 for requirements related to establishing and implementing supply-chain programs, records documenting supply-chain programs, and onsite audits in two final rules promulgated under the Food Safety Modernization Act (FSMA): (1) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and (2) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, both of which appeared in the Federal Register of September 17, 2015. The notice can be found here.

FDA Releases Guidance for Foreign Food Establishments Relating to Refusal to Permit Entry 
In October, FDA released final guidance titled, “Refusal of Inspection by a Foreign Food Establishment or Foreign Government: Guidance for Industry.” The guidance will provide information for foreign food establishments subject to FDA inspection, as well as foreign governments, on when the agency may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by FDA as provided in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Guidance can be found here.

Recall Alert

E. Coli Outbreak in Falafel Sold at ALDIs
Cuisine Innovations issued a voluntary recall of its frozen falafel product sold at ALDIs after a multistate outbreak of E. coli was linked to Earth Grown Frozen Falafel. Michigan and Wisconsin had the greatest incidents of infection related to this strain. 

FDA Warning Letters

Happy Sprouts: October’s lone Warning Letter related to food was for mung bean and soybean sprout products that were deemed adulterated because they were prepared, packed, or held under insanitary conditions.

A database of warning letters issued by the FDA can be found here.

USDA Updates

AMS Seeks More Comments on USDA Regulations of Inert Ingredients In Pesticides Used in Organic Production
The Agricultural Marketing Service (AMS) is providing additional time for the public to submit comments and information about how to update USDA organic regulations on inert ingredients in pesticides used in organic production. AMS seeks comments on alternatives to its existing regulations that would align with the Organic Foods Production Act of 1990 (OFPA) and the EPA’s regulatory framework for inert ingredients. Comments must be submitted on or before December 31, 2022. The original notice can be found here.

USDA Proposes Changes to Poultry Industry to Reduce Food Poisoning
There has been significant regulatory movement geared toward addressing salmonella in the poultry industry over the last few months. To curtail salmonella outbreaks in poultry, the AMS is proposing a regulatory framework that would include testing incoming flocks of chickens and turkeys for the bacterial disease that commonly affects the intestinal tract and affects 1.3 million people annually with symptoms that may include diarrhea, nausea and vomiting which could last for several days. An overview of the changes and opportunities for comments can be found here.

Other Items of Interest

Farm Bureau Releases Priorities for 2023 Farm Bill
The American Farm Bureau Federation released its priorities for next year’s bill, including maintaining the funding level from the 2018 Farm Bill, which the Congressional Budget Office estimated at about $428 billion. The legislation, which Congress writes every five years, includes funding for key programs like farm conservation and federal nutrition aid.

FDA Releases Video on How the FDA Responds to Foodborne Outbreaks
The FDA released a video entitled “How Does the FDA Respond to Foodborne Outbreaks?” It explains a “complex web of steps” and is useful to producers looking to understand the Agency’s approach. The video can be found here.

FDA FOIA Request Reveals Trouble Looming for Peanut Producer
The Salmonella outbreak linked to JIF peanut butter earlier this year was caused by defective flanges that allowed rainwater and air to enter the peanut roasters, according to a report from Food Safety News. According to information gleaned from an FDA FOIA request, management at the company’s Lexington, Kentucky plant was supposedly aware some products were tainted. The Agency’s action against management could be the first test of the FDA/DOJ’s strengthened use of the Responsible Corporate Officer Doctrine since the Blue Bell Creameries case earlier this year.

EPA Faces Food Safety Org Lawsuit Over Pesticides
A group of food safety organizations are alleging that more than half of inert ingredients in pesticides are considered “hazardous air and water pollutants of at least moderate risk” and hundreds of them have also been used as active ingredients in other formulations. Additionally, the groups said, inert ingredients can increase the toxicity of active ingredients when they are combined in a pesticide formulation — adding greater concern to the EPA’s alleged practice of ignoring them.

Developments in Notable Labeling and Marketing Claims Actions
Several active lawsuits took steps, both forward and backwards, to resolutions. These cases largely relate to labeling and marketing claims. Below is a summary of cases and the recent action:

  • Dark Chocolate: Mondelez toppled a proposed class suit over dark chocolate label. A judge in the federal district court for the Southern District of New York dismissing a proposed class action suit over a “dark chocolate” label, finding that the label was not misleading because the products actually contained cacao derivatives.
  • Carbon Neutral Statements on Water: A California woman has filed a proposed class action suit against Danone Waters of America Inc., arguing that Danone deceptively markets Evian water as “carbon neutral.” The plaintiff states the company engages in “greenwashing” to attract environmentally conscious consumers.
  • Iced Tea Preservative: Arizona iced tea buyers recently saw their “no preservative” claims advance. The claimants were allowed by a New York federal court to pursue most of their claims in a proposed class suit alleging Arizona Beverages USA LLC and affiliated companies misleadingly market the drinks as having “no preservatives” despite the inclusion of citric acid.
  • Protein Labeling in Pancakes:  Birch Benders will face a class action lawsuit claiming that its pancake and waffle mix packaging omitted necessary information about the amount of protein.
  • Smoked Gouda: Kroger Co. lost its bid to end consumer litigation over an artificially flavored Gouda cheese brand it labels “smoked,” but a federal judge in Milwaukee narrowed the proposed class action, throwing out claims for fraud, breach of warranty, and unjust enrichment.
  • Black Raspberry Flavoring: A Costco consumer’s contention that red coloring, a picture of two black raspberries, and the words “Black Raspberry Flavor” meant that there was actual black raspberry juice in the sparkling water was dismissed by a federal judge.
  • Palm Oil in Pudding: A consumer plaintiff alleged Conagra misled consumers by including the words “Pudding,” “NEW SMOOTHER RECIPE!,” and “Made with Real Milk” on the front of Snack Pack packages. Instead of being made mostly with whole milk, the pudding contains palm oil, which is considered a cheaper alternative. The suit has been voluntarily dropped after a federal judge rejected one of her theories as “fanciful.”
  • White Chocolate Label: A price tag abbreviating Target Corp.’s White Baking Morsels as “WHT CHOCO” could lead a reasonable consumer to believe that they’re made of white chocolate, a California appeals court said, reinstating a proposed class suit alleging the retailer deceptively markets its store brand product.
  • “100% Real Fruit”: A Mott’s applesauce consumer’s belief that “Made From 100% Real Fruit” means nothing other than fruit is “extremely reasonable,” according to a federal court in Illinois, advancing a proposed class suit alleging the inclusion of corn syrup and ascorbic acid made the label deceptive.

This Regulatory Update covers information from October 1 – October 31, 2022. Please contact Paul BensonTaylor FritschLiz Simonis or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit

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