Regulatory Update: September 1 – September 30, 2023

This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including information collection activities for food and color additives, the new FSIS recall API data tool, and more.

FDA Updates

FDA Issues Advisory for Listeria Outbreak in Ice Cream
September 1:  As previously discussed, FDA is investigating an outbreak of Listeria monocytogenes infection linked to Soft Serve On the Go ice cream cups produced by Real Kosher Ice Cream of Brooklyn, NY.  Real Kosher Ice Cream and Ice Cream House of Brooklyn, NY, has voluntarily recalled all dairy and non-dairy products bearing the Ice Cream House logo that were manufactured in the Brooklyn, NY, facility.  FDA is advising consumers, restaurants and retailers not to eat, sell, or serve recalled Soft Serve on the Go cups and Ice Cream House products.  More information can be found here.

FDA Sponsors Workshops on the Use of Meta-Analysis in Nutrition Research and Policy
September 13:  FDA is sponsoring a series of three workshops to be hosted by the National Academies’ Food and Nutrition Board to discuss the usefulness of meta-analysis as a tool for nutrition research and developing nutrition policy.  The expert input and recommendations from the workshop will be helpful to FDA as it develops and implements evidence-based policies and regulations related to food labeling and labeling claims.  The workshops will be held on Tuesday, September 19; Monday, September 25; and Tuesday, October 3, 2023.  More information can be found here.

New FDA Animal and Veterinary Innovation Agenda Released
September 15:  FDA announced that it is taking new steps to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products. The Animal and Veterinary Innovation Agenda released by FDA lists four objectives and details the supporting actions by the agency’s Center for Veterinary Medicine to foster product development and implement risk-based approaches to regulating modern animal and veterinary products. The new agenda applies to products like novel food ingredients that work solely in the animal’s gut to increase nutritional efficiency and production; animal biotechnology products such as animal cell- and tissue-based products and intentional genomic alterations in animals; and cell-cultured animal food ingredients.  More information can be found here.

FDA Information Collection Activities Announced for Food and Color Additives
September 21:  FDA announced a proposed collection of information for the submission of petitions concerning food additive and color additive, including labeling. Respondents are businesses engaged in the manufacture or sale of food, food ingredients, color additives, or substances used in materials that come into contact with food.  Written comments (including recommendations) on the collection of information are due by October 23, 2023.  More information can be found here.

FDA Amends Yogurt Company’s Temporary Marketing Permit
September 25:  FDA is amending Chobani, LLC’s temporary permit to market test lower-fat yogurt products. The temporary permit is amended to allow the use of the test product as an ingredient in other non-standardized food applications including beverages, dips, and sauces. This amendment will allow the applicant to continue to test market the test product and collect data on consumer acceptance of the test product.  More information can be found here.

FDA Releases New Chapters to Draft Guidance Hazard Analysis and Risk-Based Preventative Controls for Human Food
September 27:  FDA announced the availability of two additional draft chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, designed to help food facilities comply with the preventive controls for human food rule mandated by the FDA Food Safety Modernization Act, which could result in safer food options for people with allergies to sesame and other food allergens.  The new draft chapters are Chapter 11—Food Allergen Program and Chapter 16—Acidified Foods.   Chapter 11 outlines ways to ensure protection from major food allergen cross-contact and to ensure that the finished food is properly labeled with respect to the major food allergens.  Chapter 11 also provides examples of ways manufacturers can significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices.  Chapter 16 applies to manufacturers of acidified foods (such as beans, cucumbers, or cabbage that have an overall pH of 4.6 or below). It explains how these manufacturers can use procedures, practices, and processes that they have established to meet requirements in the acidified foods regulations.

Comments on the draft guidance must be submitted by March 25, 2024.  More information, as well as the draft guidance and information for submitting comments, can be found here.

FDA Releases Video on Importing Safe and Compliant Food into the U.S.
September 29:  The FDA released a video titled “Importing FDA-Regulated Products: Human Foods” that provides basic information for importers, foreign suppliers/exporters, and customs brokers on the steps they need to take to successfully import safe and compliant food into the U.S.

FDA Warning Letters

Unapproved New Drugs: FDA issued a warning letter to a Colorado company alleging that its Osmosis skin elixir products are misbranded and unapproved new drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Baby Food: FDA inspected a ready-to-eat baby food product manufacturing facility in California following a consumer complaint involving infant botulism. During the inspection, FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule) and issued a warning letter to the company.

A database of warning letters can be found here.

USDA Updates

FSIS Launches New Recall and Public Health Alert API Data Tool
September 12:  FSIS launched a new feature on its website that enables software developers to access data on recalls and public health alerts through an application programming interface (API) increasing the transparency and availability of critical public health information.  More information about the FSIS recall API can be found here.

FSIS Implements Modernized Chemical Residue Quantitative Method
September 15: The USDA Food Safety and Inspection Service (FSIS) developed an innovative method for beef muscle samples that uses modern chemistry instrumentation for quantifying chemical residues.  The new quantitative method for veterinary drug residue analysis in bovine muscle samples, entitled “Quantitation of Animal Drug Residues by High-Resolution, Accurate-Mass Liquid Chromatography Mass Spectrometry (HRAM LC-MS)” (CLG-MRQ1), will be implemented on October 1, 2023 and include the ability to:

  • Quantitate multiple veterinary drug residue amounts simultaneously in a single analysis with high mass accuracy.
  • Quantitate several veterinary drugs that were previously difficult to measure.
  • Archive several single analyte or specific drug class quantitation methods that use older technology.
  • Archive traditional residue bioassay for several analytes.
  • Align detection limits with established drug residue tolerances.
  • Decrease time to result for presumptive positive residues.

FSIS also updated three methods to the new Chemical Laboratory Guidebook format: Quantitation of Salt (CLG-SLT); Quantitation of Fat (CLG-FAT); and Screening, Quantitation, and Confirmation of Beta-Agonists by UHPLC-MS-MS (CLG-AGON1). These new and updated methods can be found on the Chemical Laboratory Guidebook page of the FSIS website.

FSIS Revised Directive – Food Defense Tasks and Threat Notification Response Procedures for the Office of Field Operations
September 26:  FSIS issued a revised directive that provides instructions to conduct food defense activities assigned to inspection program personnel at meat and poultry establishments, Siluriformes fish and fish product establishments, egg product plants, and import inspection establishments. Food defense activities include performing food defense tasks and observing and reporting food defense vulnerabilities. This directive also outlines the internal FSIS communication protocol for addressing threats to the food and agriculture sector.  More information can be found here.

FSIS Microbiological Sampling of Egg Substitutes, Freeze-Dried, and Agglomerated Egg Products
September 29:  FSIS issued a notice that provides instructions to inspection program personnel for the sampling of egg substitutes, freeze-dried, and agglomerated egg products. Egg substitutes, freeze-dried, and agglomerated egg products will be eligible for sampling under the current routine sampling programs starting on November 1, 2023.  More information can be found here.

Other Articles of Interest

Exploratory Sampling Finds PFAS Presence in U.S. Food is Limited
September 12:  Government studies show that most U.S. food does not have excessive levels of per- and polyfluoroalkyl substances (PFAS) beyond food raised in certain contaminated areas.  The USDA FSIS has tested for PFAS in meat, poultry and catfish since 2020.  Out of 3,199 meat and poultry samples, less than 0.1% (2 bovine) had PFAS. Out of 616 catfish samples, 83 samples were positive for PFAS.  FDA’s tests on food have rarely detected high levels of PFAS, except within certain seafood.  More information concerning the FDA’s testing of PFAS in food can be found here.  More information concerning FSIS FY 2021 and FY 2022 Exploratory PFAS Sampling Data can be found here.

Judge Pares Back Class Action Lawsuit over Heavy Metals in Hershey Chocolate
September 12:  A federal judge for the US District Court for the Southern District of California scaled back a putative class action against The Hershey Co. saying the plaintiff did not show lead or cadmium levels in the company’s chocolate products “create an unreasonable safety hazard”, but the judge allowed the plaintiff claims seeking an injunction for Hershey to disclose the presence of the heavy metals.  The judge said the plaintiff’s suit failed to plead a duty to disclose, so the court granted Hershey’s motion to dismiss claims related to the alleged omission under California’s Consumer Legal Remedies Act. The court also concluded that the plaintiff failed to raise a viable claim for breach of implied warranty.  More information can be found here.

California Senate Passes Bill to Ban Certain Food Ingredients
September 13: The California Food Safety Act (AB418), which was passed by the State Assembly on May 15th, was passed by the State Senate.  AB418 seeks to ban harmful food additives already prohibited in the European Union.  The State Assembly version of AB418 bans Brominated vegetable oil, Potassium bromate, Propylparaben, titanium dioxide, and Red dye No. 3 from food. The State Senate bill took titanium dioxide off the banned list.  The fine for a first-time violation of the new law is $5,000, with each subsequent violation going to $10,000.  If the State Assembly concurs with the State Senate bill, the bill will then go to the Governor for signature.  More information can be found here.

New FDA Administrator Gets to Work
September 26:  On his first day as the FDA’s Deputy Commission for Human Foods, Jim Jones sent a letter to colleagues outlining his vision for transforming the agency into a single program that embraces coordination, prevention, and response activities.  He will be seeking ways to work more effectively with stakeholders to accomplish shared goals for a safer and more nutritious food supply.  More information can be found here.

Country Crock Class Suit Advances
September 27:  A proposed class suit was filed against Upfield US Inc.’s “Country Crock Plant Butter with Almond Oil” spread alleging that the label overstates the amount of almond oil in the plant-based spread.  The plaintiff alleged she was persuaded to by the product based on the almond oil representation and pictures of almonds on the container.  A judge for the U.S. District Court for the Southern District of New York allowed the action to proceed saying the words and images on the front of the container tell a reasonable consumer that the plant butter is made of almond oil. The judge dismissed the plaintiff’s breach of warranty, common-law fraud, and unjust enrichment claims.

Ancient Brands Avoids False-Ad Lawsuit Over Bone Broth Protein
September 27:  A judge for the U.S. District Court for the Northern District of New York said that bone broth consumers can’t sue Ancient Brands LLC for allegedly overstating the protein content of the product because federal food labeling law preempts their claims.  The plaintiffs alleged that the bone broth powders’ front label says “20g Protein,” and the nutrition facts panel says there are 20 grams of protein per serving.  The court said the plaintiffs’ contention that Ancient Grains should have used the corrected protein calculation is beyond what is required by the FDCA, and therefore expressly preempted because the law bars state requirements that aren’t “identical” to federal ones.  The plaintiffs were given 60 days to file an amended complaint.  More information can be found here.

Crafted Brand Sued Over Cocktail Mixers “No Preservatives” Label
September 28:  A proposed class suit was filed against Crafted Brand Co. alleging it deceptively markets Mai Tai and Pina Colada cocktail mixers as having no preservatives in the U.S. District Court for Southern California.  The plaintiff alleges that Crafted’s labeling is false because the products contain citric acid which is a common preservative.  A copy of the complaint can be found here.

Wendy’s and McDonalds Avoid False Advertising Lawsuit
October 3:  Wendy’s International LLC and McDonald’s Corp avoided a lawsuit alleging their ads make burgers look bigger than they are.  Lead Plaintiff, Justin Chimienti, alleged in a proposed class lawsuit that the eateries exaggerate the size of the burger patties in their ads by using uncooked meat which shrinks by about 25% when cooked.  The U.S. District Court for the Eastern District of New York said the ads were not misleading.  In addition, Chimienti failed to show he was financially harmed by the fast-food ads.  More information can be found here.

This Regulatory Update covers information from September 2023. Please contact Paul Benson, Taylor Fritsch, 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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