This update includes FDA updates, lawsuits, and other articles of interest, including proposed legislation for food additive warning labels in Wisconsin, claims of lead contamination in protein powder, movement around PFAS bans, and more.
FDA Updates
FDA Confirms Effective Date for Gardenia (Genipin) Blue Color Additive
October 1: The FDA published a final rule confirming the effective date of August 29, 2025, for the listing of gardenia (genipin) blue as a color additive exempt from certification. The regulation permits the use of gardenia (genipin) blue in specific food products including sport drinks, flavored or enhanced non-carbonated water, fruit drinks, ready-to-drink teas, hard candy, and soft candy at levels consistent with good manufacturing practice. More information can be found here.
FDA Implements Import Certification for Shrimp and Spices from Indonesia Due to Cesium-137 Contamination Risk
October 1: The FDA began requiring import certification for shrimp and spices from specific regions of Indonesia following confirmed contamination with the substance Cesium-137. This is the agency’s first use of its import certification authority under the Food Safety Modernization Act, aimed at preventing potentially hazardous food from entering the U.S. while maintaining trade for compliant products. The action is supported by Import Alert #99-52, which outlines the certification requirements for affected products. More information can be found here.
Other Articles of Interest
Walmart to Remove Synthetic Dyes from Private Brand Foods
October 1: Walmart U.S. announced plans to eliminate synthetic dyes and more than 30 other ingredients, including certain preservatives, artificial sweeteners, and fat substitutes, from all its private brand food products. The reformulation will cover brands such as Great Value, Marketside, Freshness Guaranteed, and bettergoods, aligning with growing consumer demand for simpler, more transparent ingredients. Walmart’s voluntary reformulation follows that of PepsiCo, McCormick, Kraft Heinz, and Archer Daniels Midland. Walmart said the move is one of the largest private brand overhauls in retail history. More information can be found here.
DOJ Creates Specialized Unit for Food Safety Enforcement
October 2: The U.S. Department of Justice (DOJ) established a new Enforcement & Affirmative Litigation Branch within its Civil Division to strengthen prosecution of food safety violations. The unit consolidates affirmative litigation and enforcement work, increasing its ability to hold companies accountable for introducing adulterated or misbranded food into interstate commerce with intent to defraud or mislead. DOJ officials say the restructuring reflects a commitment to aggressively protect consumers and enforce national policies under statutes such as the Federal Food, Drug, and Cosmetic Act (FDCA). Committing a prohibited act under the FDCA “with the intent to defraud or mislead” can bring felony charges, fines and jury convictions. More information can be found here.
Government Shutdown Slows FDA and USDA Food Safety Inspections
October 2: The recent government shutdown significantly curtailed food safety oversight. FDA suspended nearly all routine domestic and foreign facility inspections, focusing only on high-risk and outbreak-related cases, while import screening continued for select products. USDA’s Food Safety and Inspection Service maintained legally required daily inspections of meat, poultry, and egg facilities, but other activities, including export certifications and policy work, were delayed. Both agencies faced staffing shortages and operational strain, raising concerns about inspection backlogs and potential gaps in food safety oversight. More information can be found here.
California To Phase Out Ultra-Processed Foods in School Meals
October 9: Governor Gavin Newsom signed AB 1264, making California the first state to ban ultra-processed foods (UPFs) from K–12 school meals. The law provides the nation’s first statutory definition of UPFs describing them as products containing additives such as artificial colors, emulsifiers, non-nutritive sweeteners, and excessive levels of saturated fat, sodium, or sugar. Vendors are required to phase out those items from schools by 2029 with full compliance by 2035. The law also directs the state health department to identify targeted products by June 2028 based on scientific evidence of health risks. More information can be found here.
New Mexico Proposes Rules to Enforce PFAS Ban
October 9: The New Mexico Environment Department released proposed rules to implement the state’s PFAS Protection Act (HB 212), which phases out consumer products containing intentionally added per- and polyfluoroalkyl substances (“PFAS”). The law bans PFAS in cookware, food packaging, and juvenile products starting in 2027, expands to cosmetics, furniture, and carpets in 2028, and prohibits nearly all non-exempt products by 2032. The act also requires manufacturers to label products that include intentionally added PFAS. New Mexico joins Maine and Minnesota as the third state to codify a ban on PFAS in consumer products. If approved by the Environmental Improvement Board, the rules will take effect in July 2026. More information can be found here.
Industry Group Challenges West Virginia’s Food Color Ban
October 15: The International Association of Color Manufacturers (IACM) filed a lawsuit in the U.S. District Court for the Southern District of West Virginia challenging West Virginia’s newly enacted ban on several FDA-approved food color additives, including FD&C Red No. 40 and Yellow No. 5. IACM argues that the law (H.B. 2354), set to take effect in 2028, unlawfully overrides federal authority, disrupts interstate commerce, and lacks scientific justification. IACM is seeking a preliminary injunction and a court order to strike down the statute, which it claims targets ingredients deemed safe by food safety authorities worldwide. More information can be found here.
Wisconsin Proposes Food Additive Warning Label Legislation
October 15: The Wisconsin State Assembly introduced Assembly Bill 550, which would require manufacturers of packaged food products intended for human consumption to include prominent warning labels if the product contains any of the 51 ingredients specified in the bill. These include artificial colors, sweeteners, preservatives, and additives such as FD&C certified colors, titanium dioxide, BHA, BHT, and acesulfame potassium. Products containing any listed ingredient must display the warning: “WARNING: This product contains an artificial color, chemical, or food additive that is banned in Australia, Canada, the European Union, or the United Kingdom.” Violators of the bill may be subject to a civil penalty of up to $1,000 per violation. More information can be found here.
California Governor Vetoes PFAS and Microbead Restrictions
October 16: California Governor Gavin Newsom vetoed two bills related to PFAS and plastic microbeads. SB 682 would have prohibited the sale of food packaging and other products containing intentionally added PFAS by 2028, expanding restrictions to cookware and cleaning products by 2031. The PFAS proposal was described as among the most stringent in the country. The bill was opposed by the Consumer Brands Association and numerous packaging trade groups. AB 823 sought to ban plastic microbeads in non-rinse-off personal care items and cleaning supplies by 2029 and prohibit plastic glitter in cosmetics by 2030. Newsom vetoed the PFAS and microbead bills primarily due to concerns about affordability and product availability. More information can be found here.
RFK Jr. Pushes to End “War on Saturated Fats” in Upcoming Dietary Guidelines
October 20: Health and Human Services Secretary Robert F. Kennedy Jr. announced plans to release new federal dietary guidelines that emphasize the benefits of foods high in saturated fats, marking a sharp departure from decades of public health advice. Kennedy said the recommendations will promote foods like butter, cheese, milk, and red meat as part of a healthy diet. Current U.S. guidelines advise limiting saturated fat intake to 10% of daily calories, while the American Heart Association recommends less than 6% citing links to elevated cholesterol and heart disease risk. More information can be found here.
Food Manufacturers Struggle to Balance Trade Secrets and FDA Transparency
October 24: Food manufacturers are facing growing pressure to reconcile proprietary business practices with regulatory transparency requirements. Under FDA programs and Freedom of Information Act requests, manufacturers must disclose supply chain details that can reveal competitive information, especially during recalls. While advanced traceability systems improve safety and reduce recall scope, they require sharing sensitive data, forcing companies to redefine what counts as confidential versus safety-critical data. Experts stress that comprehensive food safety plans and standardized supply chain protocols are essential to meet compliance obligations without compromising trade secrets. More information can be found here.
Lawsuits
Class Action Targets Nestlé Over Carnation Breakfast Essentials Claims
October 6: A proposed class action filed in the U.S. District Court for the Eastern District of California accuses Nestlé Health Science of misleading consumers by marketing its Carnation Breakfast Essentials drink as a nutritious “breakfast essential” rich in protein, despite being primarily made of water and sugar. The complaint alleges that while the product highlights “10g protein” on its front label, each serving contains 12 grams of added sugar, which is 24% of the daily recommended limit, and lists water and glucose as its first two ingredients. Plaintiffs argue the labeling violates FDA and FTC guidance by emphasizing protein while downplaying sugar content, asserting claims under California consumer protection laws. The suit seeks damages and restitution, citing recent rulings that front-label protein claims can be deceptive without proper context. A copy of the complaint can be found here.
Naked Whey Faces Class Action Over Lead Contamination Claims in Protein Powder
October 22: A proposed class action filed in the U.S. District Court for the Eastern District of California accuses Naked Whey Inc. of falsely marketing its protein supplements as “clean” and “independently tested” despite allegedly containing dangerous levels of heavy metals such as lead. The complaint cites a recent Consumer Reports investigation that found Naked Nutrition’s Vegan Naked Mass Gainer contained 7.7 micrograms of lead per serving, far exceeding California’s maximum allowable dose level of 0.5 micrograms. Plaintiffs argue the company misled health-conscious consumers by promoting high quality, premium, safe ingredients while failing to disclose contamination risks. The suit seeks damages under California consumer protection laws and highlights growing scrutiny of protein powders following similar lawsuits against other brands. A copy of the complaint can be found here.
Judge Dismisses ‘Climate Neutral’ Label Lawsuit Against Mondelez
October 28: A judge for the U.S. District Court for the Northern District of Illinois dismissed a proposed class action accusing Mondelez International of misleading consumers by labeling Clif Kid Zbars as “climate neutral certified.” The court found the claim truthful because the certification came from a third-party organization, Change Climate Project, and the plaintiff did not allege the certification was inaccurate or violated standards. The judge ruled that Mondelez’s packaging made a true statement and rejected arguments that the label implied zero pollution, noting that the complaint failed to challenge the full “climate neutral certified” representation. More information can be found here.
This Regulatory Update covers information from October 2025. 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 michaelbest.com.