This update includes FDA and USDA updates, warning letters, lawsuits, and other articles of interest, including easing of federal guidelines around saturated fats, the expansion of bioengineered food labeling requirements, a push for federal ingredient standards, and more.
FDA Updates
Federal Dietary Guidelines to Ease Saturated Fat Restrictions
November 17: Health and Human Services Secretary Robert F. Kennedy Jr. announced at the Food Allergy Fund Leadership Forum that new federal dietary guidelines will mark “an end to the war on saturated fats,” and stressed the importance of protein and saturated-fat intake. Kennedy, who follows a carnivore-style diet rich in meat and fermented foods, believes the move will revolutionize the food system and food culture in the U.S. The guidelines, expected next month, will recommend higher consumption of butter, cheese, milk, and red meat. This is a departure from current advice that limits saturated fat consumption due to concerns about bad cholesterol and heart disease. More information can be found here.
FDA Warning Letters
Adulterated RTE Foods: The FDA issued a Warning Letter to Compass Group USA’s Fresh & Ready Foods division after an inspection found ready-to-eat sandwiches, salads, wraps, and snacks were produced under insanitary conditions that led to Listeria monocytogenes contamination. The facility was linked to a multistate outbreak that hospitalized ten people and caused one death. The FDA declared the products adulterated and cited violations of current Good Manufacturing Practices and the Hazard Analysis and Risk-Based Preventive Controls rule.
A database of warning letters can be found here.
USDA Updates
Appeals Court Rejects AMS Rule on Bioengineered Food Disclosure
November 1: The Ninth Circuit Court of Appeals ruled that the Agricultural Marketing Service (AMS) improperly excluded “highly refined” foods from its definition of bioengineered foods subject to disclosure. AMS adopted a rule in 2018 which allowed foods made with bioengineered ingredients to be excluded from the definition if the genetic materials of those ingredients were undetectable in the final product. The rule also outlined ways for manufacturers to establish non-detectability. The court found that AMS’s 2018 rule failed to address the sensitivity of detection methods and could let manufacturers bypass testing even as technology improves. The decision reverses a lower court ruling. A copy of the Court of Appeals opinion can be found here.
Other Articles of Interest
Missouri Issues Statewide Warning on Potent Kratom Derivative
November 3: Missouri health officials issued an alert about 7-hydroxymitragynine (7-OH), a highly potent, opioid-like compound derived from kratom and found in gummies, liquid shots, powders, and other products sold in convenience stores and online. The FDA reports 7-OH is 13 times stronger than morphine, and Missouri has seen a sharp rise in poison control calls and ER visits linked to these products. Officials warn that concentrated 7-OH poses severe risks, including addiction, overdose, and death. More information can be found here.
Why Combustible Dust Safety Still Matters in Food Processing
November 4: After an explosion at the Imperial Sugar Refinery in 2008, which killed 14 workers, combustible dust hazards in food plants are still a major concern. Common ingredients like sugar and flour can ignite when airborne in confined spaces, and failures in housekeeping, dust collection, and equipment design often precede such incidents. Experts stress that prevention requires integrating explosion safety into daily operations through standards-based systems like ATEX and IECEx that require classifying explosion risk zones, certifying equipment for dust atmospheres, and ongoing maintenance. More information can be found here.
Big Food Pushes Back Against State Ingredient Laws
November 6: After months of signaling cooperation with Health Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” (MAHA) agenda, major food companies are shifting to a more aggressive stance. A coalition of dye manufacturers recently sued West Virginia over its ban on artificial colors and industry groups opposed California’s prohibition of ultraprocessed foods in school meals. A new industry group, Americans for Ingredient Transparency (AFIT), backed by leading food and beverage companies like General Mills and Kraft Heinz, is calling for the FDA to serve as the sole regulator of federal ingredient standards that would override state-level rules. Industry representatives argue that inconsistent state laws increase costs and complicate compliance. This has sparked a backlash from health advocates and MAHA supporters who argue it would undermine state ingredient laws and efforts for stronger consumer protections.
Hemp Industry Urges Congress to Reject Federal Ban
November 7: The hemp industry is urging Congress to avoid a federal ban on hemp-derived products and let states regulate them. In a letter to Congressional leaders, the Attorneys Committee of the Hemp Beverage Alliance warned that a ban could cripple the $30 billion market and fuel illicit sales. It would also devastate small businesses and limit adult consumer access. Most states already have effective regulatory frameworks. The appeal counters a recent push by 39 attorneys general for a nationwide prohibition, highlighting industry support for clear, state-driven rules rather than an overbroad federal approach.
FDA Finds Low PFAS Levels in Bottled Water
November 10: The FDA recently completed testing of 197 bottled water samples, including purified, spring, artesian, and mineral water, purchased across U.S. retail outlets in 2023 and 2024. PFAS were detected in 10 samples, all below current EPA limits for PFAS. The FDA has not yet revealed specific brands or contamination levels. Consumers seeking extra assurance can look for treatments like activated carbon or reverse osmosis on labels. More information can be found here.
FDA Funding Restored, Traceability Rule Delayed Under Spending Bill
November 13: A bipartisan spending bill signed on November 12 ended the U.S. government shutdown and restored funding for FDA and USDA operations through September 30, 2026. Under H.R. 5371, the FDA will receive $6.96 billion including $1.17 billion dedicated to Human Foods Program activities such as inspections, investigations, and import oversight. At least $116 million was earmarked for state and local food inspection efforts. The law also delays enforcement of the Food Safety Modernization Act’s Traceability Rule until July 2028, while mandating that FDA engage quarterly with regulated entities such as farms, restaurants and retail food establishments and provide compliance flexibility recommendations. Additionally, the agency is barred from issuing new low-risk ready-to-eat foods Listeria guidance until it considers new science. More information can be found here.
Congress Moves Faster Than FDA on GRAS Reform
November 13: Congress is advancing several bills to overhaul the Generally Recognized As Safe (GRAS) process and end self-affirmed ingredient safety. Meanwhile, the FDA plans no formal rulemaking until spring 2026 as it is still in the exploratory stage. More than 1,200 listed GRAS substances and an estimated 3,000 unreviewed ones remain largely unregulated, highlighting a regulatory gap as Congress acts faster than the FDA. More information can be found here.
Congress Drops Ingredient Ban Preemption from Food Bill
November 17: Congress removed language from the Better Food Disclosure Act that would have blocked state-level ingredient bans, leaving companies to navigate a growing patchwork of state rules. The bill still tightens the GRAS process by requiring FDA notification and an 180-day review for new chemical uses. However, the bill preserves a loophole for companies to automatically receive approval for new ingredients if the FDA does not respond in 180 days. In response, industry groups have launched “Americans for Ingredient Transparency” to push for uniform federal standards, as discussed above. More information can be found here.
Lawsuits
Class Action Targets Black Rifle Coffee Over “Made in USA” Claims
November 4: A proposed class action filed in the U.S. District Court for the Eastern District of California alleges that Black Rifle Coffee Co.’s slogan “America’s Coffee” and use of patriotic imagery mislead consumers into believing its coffee is made in the United States. The complaint claims that most of the production process occurs overseas, violating California and New York consumer protection laws. The lawsuit follows the FTC’s 2024 guidance cracking down on false “Made in USA” claims, which require products to have negligible foreign parts and final assembly in the U.S. The plaintiffs said they bought Black Rifle’s Coffee because based on the products’ branding, they thought it was made in the U.S. A copy of the complaint can be found here.
Class Action Targets “No Preservatives” Claim on Sara Lee Bread
November 11: A proposed class action in U.S. District Court for the Eastern District of New York accuses Bimbo Bakeries USA of misleading consumers by labeling its Sara Lee Artesano breads as free of preservatives while listing citric acid among the ingredients. Plaintiffs argue citric acid is classified by the FDA as a preservative and is typically manufactured from a fungus, not citrus fruit, giving it antimicrobial properties. The suit claims this misrepresentation exploits health-conscious consumers who prefer food without artificial ingredients.
This Regulatory Update covers information from November 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.