This update includes FDA updates, FDA warning letters, lawsuits, and other articles of interest, including a streamlined process for FDA complaints, PFAS limits for bottled water, an update on the salmonella outbreak linked to eggs, and more.
FDA Updates
FDA’s Unified Human Foods Program Reorganization Goes into Effect
October 1: The FDA launched the Unified Human Foods Program, marking the largest reorganization in its history. This new program seeks to enhance public health by preventing foodborne illnesses, reducing diet-related chronic diseases, and ensuring food safety. The reorganization impacts over 8,000 employees and includes restructuring the Office of Inspections and Investigations to improve collaboration and efficiency. Additionally, the FDA will pilot a new online consumer complaint form to better handle public health risks. The goal is to build a stronger, more integrated, and modernized agency to better meet public health goals. More information about FDA’s reorganization can be found here. A webpage dedicated to FDA’s Human Foods Program can be found here.
FDA Streamlines Complaint Process for Food and Supplements
October 4: The FDA Human Foods Program announced a new, streamlined approach for processing complaints, including whistleblower complaints related to FDA-regulated products. Complaints can be about health issues or defects in food, dietary supplements, or cosmetics. The public will be able to direct complaints about foods and dietary supplements to the Human Foods Program through online reporting forms, and by phone to 1-888-SAFEFOOD. More information can be found here.
Listeria Outbreak Leads to Injunction Against Rizo Lopez Foods Following FDA Investigation
October 8: The U.S. District Court for the Eastern District of California issued a consent decree against Rizo Lopez Foods Inc. and its co-owners, prohibiting them from manufacturing and selling certain products until they comply with federal laws. This follows an investigation by the FDA, in collaboration with state and local partners, into a Listeria outbreak linked to their cheeses, which resulted in 26 illnesses, 23 hospitalizations, and two deaths across 11 states. The FDA found Listeria in their facility, leading to a recall of all dairy products. The consent decree requires corrective actions and FDA approval before resuming operations. More information can be found here.
Update on Salmonella Outbreak Linked to Eggs
October 18: The CDC declared the Salmonella outbreak linked to eggs from Milo’s Poultry Farm LLC over and the FDA’s investigation is complete. As previously reported, the FDA issued an advisory regarding a Salmonella outbreak linked to eggs from Milo’s Poultry Farm LLC. The eggs were distributed to retailers and foodservice distributors in Wisconsin, Illinois and Michigan. Milo’s Poultry Farm voluntarily recalled all eggs supplied by their farm and all eggs should now be off the market and beyond shelf life. More information can be found here.
FDA Considers PFAS Limits for Bottled Water Industry
October 24: The FDA is evaluating whether to regulate PFAS levels in bottled water, following a new EPA rule limiting the chemicals in tap water, potentially affecting the $62 billion bottled water industry. The FDA must decide by April 2029 whether to regulate PFAS in bottled water. The decision will be based on findings from recent studies and surveys. If PFAS are found in the water used for bottling, the FDA’s regulations must align with the EPA’s standards for public health. Recent studies indicate that PFAS, particularly PFOA and PFOS, are prevalent in bottled water globally, although most levels are below health risk thresholds. However, some samples did exceed these limits, highlighting the need for monitoring. The International Bottled Water Association (IBWA), representing about 73% of the market, has already set its own PFAS limits and is preparing to comply with upcoming EPA regulations. They argue that the FDA’s decision will have minimal impact on their members, who are already taking steps to address PFAS contamination. The FDA’s upcoming decision could significantly affect bottled water safety and regulation, especially as many Americans rely on groundwater that may contain these chemicals.
FDA Responds to Objections on Phthalate Food Contact Uses
October 29: The FDA responded to objections on its final rule that eliminated authorized food contact uses of most phthalates because these uses were abandoned by the industry. After reviewing the objections, the FDA concluded they did not warrant changes to the rule. However, the agency is conducting an updated safety assessment of the remaining authorized uses and is considering new information received through a request for information. Phthalates are also included in the FDA’s list of select chemicals under review. More information can be found here and here.
FDA’s Human Foods Program Unveils FY 2025 Priority Deliverables
October 30: The FDA’s Human Foods Program (HFP) has released its 2025 Priority Deliverables, outlining key activities for its first year following a major reorganization that began on October 1, 2024. This initiative seeks to enhance public health through three main risk management areas:
- Microbiological Food Safety: Collaborating with various stakeholders to prevent foodborne illnesses.
- Food Chemical Safety: Ensuring the safety of food chemicals and advancing dietary supplement safety.
- Nutrition: Promoting nutrition science and policies to combat diet-related chronic diseases and ensure safety of infant formula.
These deliverables are designed to strengthen regulatory oversight, advance scientific understanding, and foster partnerships. The HFP is also working to fully operationalize its program, including enhanced risk modeling and regulatory workforce development. More information can be found here.
FDA Warning Letters
Adulterated Ice Cream Products: FDA issued a warning letter to Ice Cream House LLC for violations of the Current Good Manufacturing Practice and Preventive Controls regulations following an inspection of its ready-to-eat ice cream manufacturing facility in Brooklyn, NY. Samples collected by the FDA during the inspection revealed the presence of Listeria monocytogenes at the facility. As a result, the FDA determined that the ice cream products are adulterated due to being prepared under insanitary conditions.
Marketing of Infant Formula: The FDA issued a warning letter to Healthwest Minerals, Inc. dba Mt. Capra Products alleging that their Goat Milk Formula Recipe Kit met the definition of an infant formula under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA claimed the product was marketed as mimicking breast milk and an alternative to commercial baby formula. Since Mt. Capra had not previously manufactured an infant formula, they were required to make a submission under the FD&C Act before introducing the product into interstate commerce.
A database of warning letters can be found here.
Other Articles of Interest
FDA Launches Webpage on Microplastics and Nanoplastics in Foods
October 1: FDA recently published a webpage containing information about microplastics and nanoplastics in foods. According to the FDA, microplastics and nanoplastics may be present in food, primarily through environmental exposure but there is no sufficient scientific evidence to show that microplastics and nanoplastics from plastic food packaging migrate into foods and beverages. Although microplastics and nanoplastics have been found in various foods, current research does not indicate that they pose a significant health risk. The FDA is actively monitoring this issue. The FDA’s microplastics and nanoplastics webpage can be found here.
Serious Health Risk Prompts Class 1 Recall of Wisconsin Eggs Amid Salmonella Outbreak
October 7: The FDA has upgraded a recall of eggs from Milo’s Poultry Farms in Bonduel, Wisconsin, to “Class 1 status,” indicating a serious health risk. This follows a multistate salmonella outbreak linked to the farm, with 65 people falling ill across nine states, including 42 in Wisconsin. No deaths have been reported, but 24 people were hospitalized. The recall affects eggs with expiration dates of Oct. 12 or earlier from brands like Milo’s Poultry Farms, M&E Family Farms, Tony’s Fresh Market, and Happy Quackers Farm. Consumers are advised not to eat, sell, or serve the recalled eggs and to clean any surfaces they have touched. Cases of salmonella have also been reported in California, Colorado, Iowa, Illinois, Michigan, Minnesota, Utah, and Virginia. More information can be found here.
Bimbo Bakeries Challenges FDA Allergen Labeling Warning
October 10: Bimbo Bakeries USA is resisting an FDA warning to change its allergen labeling for certain Sara Lee and Brownberry products. Despite the FDA’s concerns, Bimbo maintains its labeling of sesame as an ingredient to prevent accidental consumption, citing a conservative approach for consumer safety. The FDA warned that Bimbo could face recalls, fines, and criminal charges if it doesn’t comply. However, Bimbo did clarify its labeling around tree nuts, changing the labels to inform consumers that the product includes hazelnut, rather than “tree nuts.” A copy of Bimbo’s response to FDA’s warning letter can be found here. More information can be found here.
Updates on California’s Revised SB 54 Packaging Regulations
October 16: California’s SB 54 extended producer responsibility for packaging was open for public comment again until October 29. This follows a previous 61-day comment period and a public hearing earlier this year. Changes include updated definitions and reorganization of sections. The rules specify reuse and refill criteria, requiring items to be reused multiple times to reduce plastic waste. Items must be returnable at the purchase location or within a mile, and returns should not impose extra burdens on consumers. Additional details were added regarding exemptions, recycling rates, and the treatment of chemical recycling. The rules also clarify responsibilities for producers and set a registration deadline of July 1, 2025. More information can be found here.
FDA and Purdue University Collaborate to Combat Salmonella in Southwest Indiana
October 21: The FDA initiated a multi-year study in collaboration with Purdue University and the Indiana produce industry to investigate human pathogens, particularly Salmonella, in the Southwest Indiana agricultural region. This follows several Salmonella outbreaks linked to cantaloupe from the area, where no specific contamination source was identified. The study will assess how Salmonella is distributed and survives in the environment, focusing on factors like water quality, soil, dust, and animal intrusion. Research teams will collect samples from various environmental sources to better understand the persistence and transfer of pathogens. The findings will help inform effective food safety practices and enhance the safety of food produced in this region. More information can be found here.
FTC’S Rule Banning Fake Consumer Reviews Goes Into Effect
October 21: The Federal Trade Commission (FTC) issued a final rule to combat fake reviews and testimonials which went into effect on October 21, 2024. The rule prohibits the sale or purchase of fake reviews and allows the FTC to seek civil penalties against violators. The rule bans reviews that misrepresent the reviewer’s identity or experience, including AI-generated reviews. It prohibits compensating for reviews with specific sentiments. It requires disclosure of reviews by company insiders and prohibits undisclosed insider reviews. It also bars using threats or false claims to suppress negative reviews and prohibits buying or selling fake social media influence indicators. More information can be found here.
Lawsuits
Judge Allows Class Action Against Snapple Over ‘All Natural’ Labeling to Proceed
October 14: A consumer, Albert Fried, filed a class action in the US District Court for the Southern District of California against Snapple Beverage Corp. claiming that the “All Natural” labeling on its teas and juices is misleading because they contain manufactured citric acid. Fried also alleged that the false labeling of the products as “All Natural” allowed Snapple to charge more. Snapple tried to dismiss the case, but the judge allowed the claims regarding citric acid to proceed, stating it was plausible consumers could be deceived. However, the judge dismissed claims about the use of juice concentrates for color, as the product labels clarified their use, and no reasonable consumer would be misled by the “All Natural” label in that context.
Court Dismisses Deceptive Advertising Claims Against Sun-Maid Over Yogurt-Covered Raisins
October 14: A consumer’s lawsuit against Sun-Maid Growers of California alleging deceptive advertising of its “yogurt-covered” raisins was dismissed because they are preempted by federal regulations. The US District Court for the Southern District of California said the FDA clarified in 2021 that “yogurt-covered” products do not need live cultures but must contain yogurt powder. The court ruled that the plaintiff’s claims do not violate the Federal Food, Drug, and Cosmetic Act. The court dismissed the suit without prejudice, allowing the plaintiff until October 22 to amend the complaint.
Walmart Wins Dismissal of Fish Oil Heart Heath False Advertising Lawsuit
October 21: Walmart Inc. defeated a proposed consumer class action alleging it deceptively advertised its Spring Valley Fish Oil Omega-3 supplements as beneficial for heart disease prevention. The US District Court for the Northern District of California ruled that the “heart healthy” claims on the packaging were preempted by federal regulations as function claims, not implied health claims. The plaintiff, Pearl Magpayo, did not provide specific evidence to support her claims of misleading labeling. The judge noted that the heart symbol and “supports heart health” statement were a “close call” but pointed out disclaimers on the packaging. The claims were dismissed without prejudice, allowing for potential amendment. Walmart’s request to stay the case was denied, as the FDA has already provided guidance on such claims.
Class Action Against Campbell Soup Co. Proceeds Over Misleading Preservative Claims
October 23: Campbell Soup Co. failed to convince a federal judge to dismiss a class action alleging false advertising of its Cape Cod chips as free from artificial preservatives, despite containing citric acid. A judge for the US District Court for the Northern District of California ruled that whether citric acid acts as a preservative in the chips is a question of fact unsuitable for dismissal at this stage. The plaintiffs’ claims under New York and California laws were allowed to proceed, as they sufficiently alleged potential consumer deception. However, the plaintiffs request for an injunction was dismissed, as there’s no ongoing threat of deception due to the ingredient list.
Martian Sales Challenges FDA’s Warning on O.P.M.S. Black Liquid Kratom
October 24: Martian Sales Inc., the trademark owner of O.P.M.S. Black Liquid Kratom, is challenging the FDA’s warning that its product is linked to serious health effects, including death. The company filed a complaint in the US District Court for the District of Columbia, claiming the FDA acted unlawfully by issuing an “unwarranted sanction” and falsely characterizing its product. Martian Sales argues that the FDA’s warning lacks scientific evidence and is based on an anonymous report without specific information linking their product to the alleged death. The company seeks a court declaration that the FDA acted unlawfully, an injunction against the agency’s actions, and other appropriate relief.
Chubby Snacks Faces Class Action Over Alleged Sugar Mislabeling
October 25: Chubby Snacks Inc. is facing a proposed class action lawsuit for allegedly misrepresenting the sugar content in its crust-less sandwiches. The complaint, filed in the Northern District of California, claims the company’s peanut butter and grape sandwich nutrition labels state the product contains three grams of sugar, while independent tests show over six grams. Plaintiff Ifonia Gelin alleges she overpaid for the product due to these misrepresentations. The lawsuit includes claims of false advertising, unjust enrichment, and breach of warranties, seeking damages for California and nationwide consumer classes.
LA County Sues PepsiCo and Coca-Cola Over Misleading Recycling Claims
October 31: Los Angeles County filed a lawsuit against PepsiCo and the Coca-Cola Company, in the Los Angeles County Superior Court, accusing them of misleading consumers about the recyclability of their plastic bottles. The county claims these companies are major plastic polluters and have promoted recycling as a sustainability strategy, despite many plastics being non-recyclable or only recyclable once. The lawsuit alleges that the companies use recycling to distract from real solutions like reducing plastic use and investing in sustainable materials. It also accuses them of unfair competition and false advertising, seeking to stop misleading practices and impose penalties. The American Beverage Association denies these allegations, citing California’s high recycling rates and industry efforts. More information can be found here.
Deep River Snacks Reaches $4 Million Settlement Over Misleading Non-GMO Claims
October 31: Old Lyme Gourmet Co., operating as Deep River Snacks, reached a $4 million settlement with consumers over deceptive advertising claims. The lawsuit alleged that the company misled consumers by using a “non-GMO” graphic similar to the Non-GMO Project’s certification. Magistrate Judge Taryn A. Merkl of the US District Court for the Eastern District of New York recommended preliminary approval of the settlement. Consumers with proof of purchase can claim $5 for the first product and $0.50 for each additional product, up to $10. Class counsel plans to seek over $1.3 million in attorneys’ fees.
This Regulatory Update covers information from October 2024.
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