This update includes FDA updates, FDA warning letters, USDA updates, lawsuits, and other articles of interest, including increased certification fees for color additives, grants for AI-driven food safety research, alleged misleading mac & cheese advertising, and more.
FDA Updates
FDA Issues Final Guidance on Histamine Control in Fishery Products
November 4: The FDA released a final guidance document titled “Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and Histamine (CPG 7108.24) Compliance Policy Guide.” This compliance policy guide (CPG) is intended to provide FDA staff guidance on adulteration associated with decomposition and/or histamine identified during surveillance sampling and testing of fish and fishery products susceptible to histamine formation. More information can be found here.
FDA Extends Comment Period for Draft Guidance on Voluntary Sodium Reduction Goals in Processed Foods
November 4: FDA is extending the comment period for the draft guidance titled “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2).” This guidance outlines the next voluntary goals for sodium reduction over a three-year period in various food categories. The goals are intended to reduce excessive sodium intake, improve public health, and promote health equity. Comments must be submitted by January 13, 2025. More information can be found here.
FDA and EPA Approve First Antimicrobial Treatment for Pre-Harvest Agricultural Waste
November 4: The FDA and EPA announced the registration of the first antimicrobial product for pre-harvest agricultural water using a revised efficacy protocol. This approval allows the treatment of foodborne pathogens like Salmonella and E. coli in water used to grow produce, setting a new standard for food safety. Previously, chemical treatments were limited to managing algae, biofilm, or produce rot. This new product provides farmers with an important tool to reduce the presence of human pathogens in agricultural water, enhancing produce safety. More information can be found here.
FDA Releases Supplement to 2022 Food Code with Updated Safety Guidelines
November 4: The FDA published the 2022 Food Code Supplement, incorporating recommendations from the 2023 Biennial Meeting of the Conference for Food Protection. This Supplement, along with the Food Code, offers practical, science-based guidelines to help reduce the risk of foodborne illness in various retail and foodservice establishments. It is the model for retail food regulations in all 50 states, the District of Columbia, and territories. The Food Code and its Supplement are collaborative efforts by the FDA, CDC, and USDA-FSIS. The next complete revision of the Food Code will be published in 2026. More information can be found here. More information can be found here.
FDA Seeks Public Input on Export Certification Process for Human Food Products
November 7: The FDA is seeking public input on its approach to managing certification for the export of human food products. Exporters often need FDA certification to meet foreign requirements, which provides an official attestation of a product’s regulatory or marketing status. The FDA issues these certifications in the form of certificates or export lists. The Request for Information intends to gather feedback from stakeholders to help the FDA Human Food Program improve the export certification process. This includes addressing challenges, experiences with listing requirements, and suggestions for implementing fees to cover operational costs. Comments must be submitted by January 7, 2025. More information can be found here.
FDA Increases Certification Fees for Color Additives
November 8: The FDA issued a final rule to amend the color additive regulations, increasing the fees for certification services. The new fees include a $0.10 per pound increase for straight colors, including lakes. There are similar increases for repacks of certified color additives and color additive mixtures. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, certain color additives must be certified by the FDA before they can be used in food, drugs, cosmetics, and certain medical devices. Manufacturers pay fees for these certification services, which support the FDA’s color certification program. The final rule took effect on December 8, 2024. More information can be found here.
FDA Updates VQIP Guidance to Enhance Flexibility and Efficiency
November 14: The FDA released updated guidance for the Voluntary Qualified Importer Program (VQIP), part of the FDA Food Safety Modernization Act (FSMA). The revisions streamline processes, increase flexibility, and improve program efficiency. Updates include a new inspection approach that may reduce user fees, the ability for participants to add suppliers and foods throughout the year, and an extended deadline for enrollment steps. More information can be found here and the VQIP Guidance for Industry can be found here.
FDA Seeks Public Input on PFAS in Seafood
November 20: The FDA issued a request for information to help fill data gaps that remain regarding per- and polyfluoroalkyl substances (PFAS) in seafood. The purpose of this request is to help increase our understanding of the potential for PFAS exposure from seafood. They intend to use the information submitted in response to this request to help inform future activities to reduce dietary exposure to PFAS that may pose a health concern. Comments on this notice must be submitted by February 18, 2025. More information can be found here.
FDA Requires Accredited Mycotoxin Testing for Imported Foods Starting December 2024
November 22: Beginning December 1, 2024, owners and consignees of certain imported foods must conduct mycotoxin analyses by accredited laboratories under the Laboratory Accreditation for Analysis of Foods (LAAF) program. Detailed information on the LAAF final rule and to access the LAAF Dashboard can be found here. Additional information can be found here.
FDA Expands E. Coli Recall for Grimmway Farms Organic Carrots
November 26: The FDA updated the advisory for the outbreak of E. coli linked to whole and baby organic carrots from Grimmway Farms. On November 21, 2024, the recall was expanded to include additional bag sizes for organic whole carrots under the following labels: Bunny Luv 50-lb, Cal-Organic 15-lb and 50-lb, and Good & Gather 1-lb. These products are likely no longer available for sale in stores but could be in people’s homes. A full list of recalled products is on Grimmway Farms’ expanded recall announcement. More information can be found here.
FDA Warning Letters
Misbranded Cookies: The FDA issued a warning letter to Stew Leonard’s Holdings LLC following an inspection that found significant violations of the Federal Food, Drug, and Cosmetic Act. Following a consumer complaint about an anaphylactic death linked to Stew Leonard’s Florentine Cookies, the company recalled the cookies. The cookies contained peanuts and eggs, but the labels did not declare these allergens. The FDA identified that the Florentine Cookies were misbranded because the labels fail to list peanuts and eggs as required.
A database of warning letters can be found here.
USDA Updates
FSIS Leadership Changes
November 21: The FSIS announced changes to the agency’s leadership team. These changes reflect the agency’s continual effort to protect public health through science-based regulation, strong enforcement, and advancement of its prevention-first approach to eliminating foodborne illness. Dr. Denise Eblen, previously Assistant Administrator for the Office of Public Health Science (OPHS), is now the agency Administrator. Paul Kiecker will become Assistant Administrator in the Office of Investigation, Enforcement and Audit (OIEA). Dr. Kis Robertson Hale is named Acting Assistant Administrator for OPHS, and Melissa Moore will serve as Acting Office of Field Operations (OFO) Assistant Administrator. Paul Wolseley will transition to the role of Executive Associate for Regulatory Operations (EARO) within OFO. These changes take effect on December 9, 2024. More information can be found here.
FSIS Holds Public Meetings on Salmonella Framework for Raw Poultry Products
November 22: FSIS is hosting two virtual public meetings to give stakeholders an opportunity to discuss the Salmonella Framework for Raw Poultry Products proposed rule and proposed determination. The first meeting will cover the proposed final product standards under Component Three of the proposed framework, while the second will focus on regulatory amendments in Component Two to improve process control monitoring. The virtual public meetings were held on December 3, 2024 and December 5, 2024. More information can be found here.
FSIS Sets Uniform Compliance Date for Food Labeling Regulations
November 27: FSIS established January 1, 2028, as the uniform compliance date for new meat and poultry product labeling regulations that will be issued between January 1, 2025, and December 31, 2026. FSIS periodically announces uniform compliance dates for new meat and poultry product labeling regulations to minimize the economic impact of label changes. All meat and poultry food products that are subject to labeling regulations issued between January 1, 2025, and December 31, 2026, will be required to comply with these regulations on products introduced into commerce on or after January 1, 2028. More information can be found here.
Other Articles of Interest
The Growing Importance of Traceability in Agriculture
November 17: As consumer demands for transparency and safety grows, agricultural businesses must adapt by implementing traceability systems. Labels play a crucial role in tracking products, and with label design software, businesses can create, manage, and track labels that meet the highest standards of safety, compliance, and consumer trust. More information can be found here.
USDA Awards Grants for AI-Driven Food Safety Research
November 17: Professors at Florida State University have received $300,000 in grants from the USDA’s National Institute of Food and Agriculture for food safety research involving artificial intelligence. Hailey Kuang, Ph.D. was awarded $150,000 to develop an AI-powered, portable sensor to detect antimicrobial-resistant pathogens in meat and fresh produce. Her project seeks to address global food safety challenges and could lead to an educational program for future food safety leaders. Prashant Singh, Ph.D. was awarded $150,000 to develop a digital PCR test for quantifying Salmonella in beef samples. He is working to improve reproducibility and simplify DNA isolation protocols, with potential applications beyond ground beef. More information can be found here.
CDC Declares End to Boar’s Head Listeria Outbreak
November 25: The Centers for Disease Control and Prevention (CDC) declared the multistate listeria outbreak linked to Boar’s Head deli meat officially over. The outbreak affected 61 people across 19 states, resulting in 60 hospitalizations and 10 deaths. The CDC noted that the actual number of illnesses might be higher. All products involved are now past their shelf life. Despite the outbreak being over, investigations and lawsuits are ongoing. The USDA is reviewing the situation, and systematic reviews are being conducted at Boar’s Head facilities. A class action lawsuit filed in August was settled in November, but several wrongful death lawsuits are still pending. The outbreak, first reported on July 19, led to recalls of about 7.2 million pounds of product. Inspection reports revealed numerous noncompliance issues at the Virginia plant, which has since been permanently closed. The Boar’s Head listeria outbreak has significantly reduced demand for cold cuts across the industry. Experts caution that sales may remain low for a year or more as consumers continue to worry about contaminated deli meat. More information can be found here and here.
Trump Administration Nominees
November 26: President-elect Trump has nominated Robert F. Kennedy Jr. as Secretary of Health and Human Services. John Hopkins surgeon, Dr. Marty Makary, was nominated as head the FDA. Makary has criticized the use of pesticides on food and the industry turning against “natural fat”. Florida congressman, Dave Weldon, was nominated to take over the Centers for Disease Control and Prevention. Brooke Rollins, who heads think tank America First Policy Institute in Austin, TX, was nominated as Secretary of the Department of Agriculture. More information can be found here and here.
Congress Members Urge FDA Ban on Red 3
November 27: Two dozen Members of Congress, led by Rep. Rosa DeLauro, are urging the FDA to ban the carcinogenic food dye FD&C Red No. 3 (Red 3) in food. California banned Red 3 in 2023, making it the first U.S. state to do so. Lawmakers argue that a ban on Red 3 is both required and feasible, citing the availability of alternatives. The FDA banned Red 3 in cosmetics in 1990 due to its carcinogenic effects in rats, and various health organizations have confirmed its cancer-causing properties. California also found it causes neurobehavioral issues in children. The FDA is reviewing a petition from 24 organizations and scientists to ban Red 3 in food but has not yet ruled on it. Lawmakers emphasize the need for the FDA to act to ensure food safety, especially for products marketed to children. A copy of the congressional letter can be found here.
Lawsuits
Evian Microplastics Lawsuit Dismissed Over ‘Natural’ Labeling Claims
November 6: Danone Waters of America LLC successfully convinced a federal judge to dismiss a proposed class action lawsuit alleging that the company falsely advertises its Evian spring water as “natural” despite the bottles leaching microplastics into the water. The US District Court for the Northern District of Illinois ruled that the FDA’s regulation of “spring water” does not impose requirements related to microplastics. The judge stated that the terms “natural” and “spring water” are inseparable, as the regulation uses “natural” to describe the source of the spring water. The plaintiffs argued that the presence of microplastics in the water contradicts the “natural” label. However, the court found that consumer protection claims attempting to impose a different requirement for the term “natural” go beyond the regulatory requirements and are preempted. The judge noted that any claim imposing requirements beyond using “natural” to identify the water source is preempted by federal regulations. The case is Daly v. Danone Waters of Am., LLC.
Olly Faces Partial Dismissal in Dosage Mislabeling Lawsuit
November 13: Olly Public Benefit Corp. successfully convinced a federal judge to dismiss misrepresentation and warranty claims from a proposed class action lawsuit alleging deceptive dosage advertising for nine products. The judge for the US District Court for the Central District of California ruled that dosage details on the back panel do not constitute fraud. However, the company could not dismiss consumer protection claims under California laws. The plaintiff argued that the labels mislead buyers by not clarifying that the dosage is per serving, not per unit. The judge agreed that reasonable buyers could be misled and allowed these claims to proceed. The case is Tarvin v. Olly Public Benefit Corp.
Kraft Heinz Faces Lawsuit Over Alleged Misleading Mac & Cheese Advertising
November 14: Kraft Heinz Co. failed to convince a federal judge to dismiss a proposed class action alleging the company falsely advertised its macaroni and cheese products as free from artificial flavors, preservatives, and dyes, despite containing citric acid and sodium phosphate. The US District Court for the Northern District of Illinois found that the plaintiffs sufficiently connected the use of artificial citric acid and sodium phosphates to Kraft Heinz’s practices. The judge also noted that the consumers provided evidence that these ingredients function as preservatives, citing FDA guidance and other sources. However, the court dismissed the consumers’ claims for an injunction, as they are aware of the alleged deceptive practices and are not at risk of future harm. The case is Hayes v. Kraft Heinz Co.
Van Leeuwen Faces Class Action Over Misleading ‘Honeycomb’ Ice Cream Labels
November 15: Brooklyn-based Van Leeuwen Ice Cream LLC is facing a proposed class action lawsuit for allegedly misleading customers into believing that their “honeycomb” labeled ice creams contain actual honey or honeycomb, which they do not. The lawsuit, Ozuzu v. Van Leeuwen Ice Cream, LLC, filed in the US District Court for the Southern District of New York, claims that the high-priced products, such as Honeycomb, Peanut Butter Brownie Honeycomb, Honeycomb Fudge Ripple, and Honeycomb Caramel Ice Cream Sandwich, are falsely advertised. The plaintiffs argue that these products are priced significantly higher than average ice creams reflecting their positioning as luxury items. They also point out that other premium brands, like Tillamook, use honey in their formulations, and Van Leeuwen’s accurate labeling of other flavors like Pumpkin Cheesecake and Black Cherry Chip shows they know how to label correctly but chose not to for the honeycomb products. A copy of the complaint can be found here.
This Regulatory Update covers information from November 2024.
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