Regulatory Update: November 1 – November 30, 2022

This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the final rule issued for records of products on the Food Traceability List, warning letter for unapproved CBD products, the Biden administration’s investment in meat and poultry processing, and more.

FDA Updates

Draft Guidance on Question and Answers for Allergen Labeling Released  
The FDA released draft guidance that, when finalized, will explain FDA’s current thinking on several issues related to the labeling of food allergens, including requirements in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act).  Comments can be submitted until January 30, 2023. The Register Notice can be found here.

Final Rule Issued for Records of Products on the Food Traceability List 
The FDA is issuing a final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods that the agency designated for inclusion on the Food Traceability List (FTL). The final rule adopts provisions requiring these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods. FDA is issuing this regulation in accordance with the Food Safety Modernization Act (FSMA). More information from FDA can be found here.

Comment Period for “Healthy” Definition Extended through February
The comment period for the proposed rule entitled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy’ ” was extended by FDA through February 16, 2023.

FDA Allows Spirulina as a Color Additive After Petition
In a response to a petition filed by GNT USA, Inc., the Food and Drug Administration is amending the color additive regulations to allow the safe use of spirulina (Arthrospira platensis) extract as a coloring agent in certain products. The notice can be found here

 FDA Issues Updated Manufactured Food Regulatory Program Standards
The U.S. Food and Drug Administration (FDA) has issued revised food safety standards for state regulatory programs, known as the Manufactured Food Regulatory Program Standards (MFRPS), that oversee food facilities that manufacture, process, pack, or hold foods. The update includes changes to defined terms, new job aides, as well as updates to the current standards. More information can be found here.

FDA Warning Letters

Grain Elevator: CHS River Plains was issued a warning letter after an inspection revealed evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.

Feed Mill Warned for VFD Violation: Land View, Inc. was issued a warning letter for various violations at its Rupert Feed Mill. Notably, the letter cited VFD requirement violations after feed was produced with an incorrect level of oxytetracycline.

CBD Companies Warned: Five companies that produce CBD gummies, fruit snacks, lollipops, pet treats, and more were issued warning letters for selling unapproved CBD products. The warning letters emphasized the products’ appeal to children. This could explain the focus on the CBD product despite the largely temperate response the agency has to CBD which is not allowed in foods sold interstate commerce.

Response to Hepatitis A in Strawberries: Bainbridge Beverage West was issued a warning letter for serious violations of the FDA’s juice Hazard Analysis and Critical Control Point (HACCP) regulation related to their response to a potential contamination of Hepatitis A in strawberries used in their products.

Cardiovascular Claim Crackdown: In November, FDA warned seven companies for selling dietary supplements with claims to treat cardiovascular disease. The warning letters were issued to: Essential Elements (Scale Media Inc.); Calroy Health Sciences LLC; BergaMet North America LLC; Healthy Trends Worldwide LLC (Golden After 50); Chambers’ Apothecary; and Anabolic Laboratories, LLC.

Winfrey’s Olde English FudgeA Massachusetts fudge company was issued a warning for misbranding and adulteration after inspectors found labeling and preventive control violations.

Claims for Herbal TeasWise Woman Herbals was issued a warning letter for making multiple drug claims on their website.

Dollar Tree: Dollar Tree was issued a warning letter for serious pest issues. Highlights include numerous dead animals found through the warehouse, and samples of human food products were tested and found to be contaminated with rodent urine, excreta, and hair.

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

USDA Updates

USDA Organic Standards Board Updates National List
The Organic Standards Board submitted recommendations for updates to the National List of Allowed and Prohibited Substances. The National List identifies the synthetic substances that may be used and the non-synthetic (natural) substances that may not be used in organic crop and livestock production.  This rule allows low-acyl gellan gum and paper-based crop planting aids, adds a definition for “paper-based crop planting aids” to 7 CFR 205.2, and replaces the term “wood resin” at 7 CFR 205.605(a) with the term “wood rosin” to reflect the popular spelling. The Federal Register notice can be found here.

Biden-Harris Administration Invests in Meat and Poultry Processing
USDA Secretary Tom Vilsack announced the investment of $73 million in projects through the first round of the Meat and Poultry Processing Expansion Program (MPPEP). The goal is to increase meat processing capacity and competition to deliver lower meat costs to working families. The press release can be found here.

USDA Updates Listeria and E. Coli Procedures in Two Directives
The FSIS’s new directive provides Enforcement, Investigations and Analysis Officers (EIAOs) with instructions for collecting samples under the routine risk-based Listeria monocytogenes (RLm) sampling program. Information on the new sampling procedures can be found here. Similarly, FSIS expanded its routine testing of beef for six Shiga toxin-producing E. Coli strains. Information for those testing procedures can be found here.

Other Items of Interest

GAO Weighs In on FDA’s Role in Food Packaging
A report issued by the Government Accountability Office suggested the FDA could do more to ensure that food packaging products, like bags around salads or bread, are safe. There has been recent interest on whether compounds such as PFAs could leech into the food. The GAO has made two recommendations to FDA in support of their oversight of food packaging. The first recommends that the agency request specific legal authority from Congress to compel companies to provide the information needed to reassess the safety of substances. The second recommendation is for the FDA to track the dates of the last reviews for all food contact substances to allow FDA to easily identify substances that may need review.  The recommendation can be found here

Food Illness Outbreak Report for 2020 Released
On November 4, 2022, the Interagency Food Safety Analytics Collaboration’s (IFSAC) newest annual report, “Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States,” was released. The update helps to shape agency priorities and determine if prevention measures are working. While the report attributes Salmonella to a variety of foods, it links E. coli O157 to vegetable row crops and Listeria monocytogenes to dairy products, fruits, and vegetable row crops. The full report can be found here.

Consumer Brands Association Urges FDA to Modernize
Sarah Gallo, vice president of product policy for the Consumer Brands Association (formerly known as the Grocery Manufacturers Association), urged the FDA to “create a modernized regulatory system, paired with key structural and governance changes, to better provide for consumer safety and keep pace with rapidly evolving consumer preferences and growing opportunities to introduce innovative products to the marketplace.” The article includes nine policy points by the CBA and can be found here.

This Regulatory Update covers information from November 1 – November 30, 2023. 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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