This update includes FDA and USDA updates, warning letters, lawsuits, and other articles of interest, including final guidance for ready-to-eat fresh cut produce, a new FDA Commissioner, a bill requiring front-of-package nutrition warnings, and more.
FDA Updates
FDA Outlines Inspection Modernization Efforts
August 3: The U.S. Food and Drug Administration (FDA) announced ongoing efforts to modernize its inspection program through a more coordinated, risk-based, and transparent approach to oversight. Key initiatives include establishing the Inspectional Affairs Council to align inspection priorities across the agency, expanding the use of tools such as remote evaluations and records reviews, increasing unannounced inspections of foreign facilities, and strengthening investigator training and career development. More information can be found here.
FDA Proposes to Replace Voluntary GRAS Notification with Mandatory Reporting
August 10: The FDA has proposed a new rule that would require manufacturers of human and animal food substances to notify the agency when concluding that a substance is generally recognized as safe (GRAS), replacing the longstanding voluntary GRASS notification program. The proposal would apply to both new and existing substances in interstate commerce, unless an exemption applies, and it is intended to increase transparency and improve FDA oversight of food ingredients. FDA is accepting public comments on the proposal through December 9, 2026. More information can be found here and in the Michael Best Client Alert here.
FDA Issues Final Guidance for Ready-to-Eat Fresh-Cut Produce
August 12: The FDA released final guidance to help fresh-cut produce manufacturers comply with the Food Safety Modernization Act’s preventive controls requirements for human food. The guidance focuses on minimizing biological contamination risks in ready-to-eat fresh-cut fruits and vegetables, such as chopped lettuce, cut cantaloupe, and shredded carrots, which do not undergo a pathogen-killing step before sale. The guidance provides recommendations and practical examples for implementing preventive controls, reflects stakeholder feedback received on the 2018 draft guidance, and replaces the agency’s 2008 fresh-cut produce guidance. More information can be found here.
FDA Reviews Petitions to Expand Uses of Natural Color Additives
August 19: The FDA announced the filing of three color additive petitions that could expand the use of naturally derived color ingredients in foods and beverages. The petitions seek additional approved uses for gardenia (genipin) blue, authorization of safflower extract in numerous food categories, and permission to use acetone in carrot oil manufacturing together with updated heavy metal specifications and naming provisions. The notices initiate FDA review and do not represent final agency action. More information regarding the gardenia blue petition can be found here. More information about the safflower extract petition can be found here. And more information about the acetone petition can be found here.
Heidi Overton Nominated as FDA Commissioner
August 19: President Trump nominated Dr. Heidi Overton as the next commissioner of the FDA. Dr. Overton currently serves as Deputy Director of the White House Domestic Policy Council and previously held policy leadership roles at the America First Policy Institute. She would succeed interim FDA chief Kyle Diamantas, who was appointed following the resignation of Marty Makary. The nomination now moves to the Senate for confirmation. More information can be found here.
FDA Warning Letters
Adulterated Oranges: The FDA issued a warning letter to Friend’s Stable and Orchard, Inc. following an inspection of its California farm that identified a significant violation of the Produce Safety Rule. Inspectors observed untreated raw manure in citrus tree canopies and in direct contact with growing oranges. FDA concluded that the firm’s oranges and mandarins were held under insanitary conditions and therefore adulterated under federal law.
A database of warning letters can be found here.
USDA Updates
USDA and DHS Sign Agreement to Strengthen Agricultural Biosecurity and Threat Response
August 11: U.S. Department of Agriculture (USDA) Secretary Brooke Rollins announced a new memorandum of understanding between USDA and the Department of Homeland Security (DHS) to strengthen coordination in protecting U.S. agriculture from threats such as New World screwworm. The agreement calls for enhanced threat detection using technologies including artificial intelligence and unmanned aircraft systems, expanded real-time information sharing, joint training and response planning, and increased research collaboration on detection and mitigation tools. USDA said the partnership is intended to improve preparedness and agricultural biosecurity. More information can be found here.
FSIS Announces Leadership Changes
August 28: USDA Food Safety and Inspection Service (FSIS) announced leadership changes across several key offices. Jeremy “Todd” Reed was named Deputy Administrator for Science and Policy after serving as FSIS’ Chief Operating Officer since 2018. Karen Hunter will serve as acting Chief Operating Officer, and additional acting leadership appointments were announced in the Office of Public Health Science and the Office of Public Affairs and Training. More information about FSIS leadership on the FSIS website.
Other Articles of Interest
Study Questions Retailers’ Use of AI to Assess “Made in USA” Labeling Claims
August 4: A study from Columbia Law School’s Center for Law and the Economy found that AI shopping assistants used by Amazon and Walmart can identify inconsistencies between “Made in USA” claims and other product listing information, but retailers are not using those capabilities to address potentially false labeling, and chatbot responses cited business considerations when asked why suspicious listings are not flagged. The report also noted that FTC rules require products advertised as “Made in USA” to be “all or virtually all” made in the United States.
Senate Bill Would Require Front-of-Package Nutrition Warnings
August 4: The Food Labeling Modernization Act of 2026 (S.5166), recently introduced in the U.S. Senate, would revise federal food labeling rules by requiring front-of-package warnings for foods high in added sugar, sodium, or saturated fat. It would also require warning statements on foods containing non-nutritive sweeteners stating they are not recommended for children. In addition, the bill would direct the FDA to define claims that a food is not ultra-processed and would bar use of those claims on foods that do not meet FDA’s definition of “healthy.” Other provisions would address potentially misleading whole grain, fruit, and vegetable claims; require more ingredient disclosures; expand labeling information for online grocery shoppers; and require gluten disclosure. More information can be found here. (Subscription required.)
FDA Submits UPF Definition as White Paper
August 10: The FDA and Department of Health and Human Services submitted a proposed definition of ultra-processed foods (UPFs) to the Office of Management and Budget as a nonbinding white paper, rather than a proposed rule. Because the white paper is not legally binding, it would not immediately affect labeling, formulation, or compliance obligations. The submission comes as Congress and California consider separate UPF definitions, highlighting the possibility of different approaches to identifying and regulating UPFs. More information can be found here.
Farm Linked to Cyclosporiasis Outbreak Went Seven Years Without FDA Inspection
August 12: The FDA had not inspected Taylor Farms de Mexico, a farm linked to an ongoing multistate cyclosporiasis outbreak, for seven years before the outbreak. The situation has drawn attention to continuing gaps in FDA’s foreign food inspection program, with the agency conducting fewer than 1,000 foreign food safety inspections in 2025, well below targets established under federal law. Budget constraints and staffing reductions have been cited as factors affecting inspection capacity. More information can be found here.
New EU Packaging Requirements Take Effect
August 12: The European Union’s (EU) Packaging and Packaging Waste Regulation took effect on August 12, 2026, beginning a phased rollout of new packaging rules across the EU. Early requirements include declarations of conformity for certain packaging and new restrictions on PFAS in food-contact packaging. Requirements for recyclability, reuse, labeling, and other packaging targets will follow over time as the European Commission issues additional guidance and implementation measures. More information can be found here.
FDA Expands Warning on Products Containing Toxic Yellow Oleander
August 13: The FDA expanded its safety alert for products containing toxic yellow oleander, adding three additional products after testing confirmed the presence of the poisonous plant. Yellow oleander can cause serious neurological, gastrointestinal, and cardiovascular effects and may be fatal. The agency continues to test botanical weight-loss products and investigate products marketed as tejocote root, Mexican hawthorn, and related names. FDA also warned that some dietary supplements not labeled as containing tejocote root may contain yellow oleander. More information can be found here.
AI Tools Help Small Food Manufacturers Manage Compliance Documentation
August 25: Artificial intelligence is helping small and mid-sized food manufacturers reduce compliance paperwork by assisting with routine administrative tasks. Common applications include drafting HACCP plans for review, cross-checking certificates of analysis against product specifications, and generating corrective action reports when deviations occur. These uses can help streamline recordkeeping and document management while allowing food safety personnel to focus on reviewing information and making compliance decisions. More information can be found here.
Produce Industry Seeks More Targeted Cyclospora Messaging as Sales Fall
August 27: The International Fresh Produce Association asked the FDA and the Centers for Disease Control and Prevention (CDC) to provide more precise communications during a Cyclospora outbreak linked to iceberg lettuce, arguing that broad warnings have contributed to reduced consumer confidence and declining produce sales. The group cited polling and market data showing impacts across produce categories. The FDA and CDC said their priority is to provide clear, science-based information that identifies affected products without creating unnecessary concern about safe foods. More information can be found here.
FDA Classifies Taylor Farms Lettuce Recall as Class I
August 28: The FDA classified the July 2026 recall of Taylor Farms de Mexico iceberg lettuce as a Class I recall, the agency’s most serious designation, following a multistate Cyclospora outbreak linked to the product. The FDA explained that the classification reflects the agency’s assessment of the recall’s public health risk and does not change the scope of the original recall. As of August 27, the outbreak had been associated with nearly 11,000 illnesses, more than 450 hospitalizations, and two deaths. The agency believes all recalled lettuce has been removed from the market. More information can be found here.
Texas Protein Powder Probe Highlights Broader Reach of Proposition 65
August 31: A Texas Attorney General investigation into protein powder manufacturers is highlighting the growing influence of California’s Proposition 65 beyond state warning-label requirements. Prop 65 testing data, settlements, supplier controls, and reformulation commitments have created a public record that regulators and plaintiffs can use when evaluating contaminants such as heavy metals, PFAS, and glyphosate. As a result, companies may face increased scrutiny of their testing, supplier controls, marketing claims, and decisions regarding product warnings and reformulation. More information can be found here. (Subscription required.)
FDA Considers Guidance on Caffeine Labeling
August 31: The food and beverage industry is awaiting FDA action on caffeine labeling after the agency identified the issue in June as a priority for 2026. The FDA is expected to begin with voluntary guidance outlining best practices for disclosing added caffeine in foods and beverages rather than imposing mandatory requirements. Current regulations generally require added caffeine to be listed as an ingredient when added to a product but do not require disclosure of caffeine amounts. Any mandatory labeling requirements would require a separate, formal rulemaking process and could take years to develop. More information can be found here.
Lawsuits
Ninth Circuit Revives Portions of FODMAP Labeling Challenge
August 3: The U.S. Court of Appeals for the Ninth Circuit revived portions of a lawsuit challenging FDA and USDA restrictions on the use of FODMAP-related information on food labels, allowing certain First Amendment claims to proceed. The court found that both a consumer seeking FODMAP labeling information and a food company wishing to provide it had adequately alleged standing to challenge the regulations. However, the court upheld dismissal of the company’s USDA claims for failure to exhaust administrative remedies. The ruling allows certain constitutional challenges to federal food-labeling restrictions to move forward. A copy of the Court’s decision can be found here.
Federal Court Orders USDA to Revise Bioengineered Food Labeling Rules by 2028
August 4: The U.S. District Court for the Northern District of California issued a decision ordering the USDA to revise key portions of its bioengineered food labeling regulations after earlier court rulings found aspects of the rule unlawful. The case challenged provisions that exempted highly refined or ultra-processed GMO/bioengineered foods, such as certain corn and soy-derived ingredients, from disclosure requirements and permitted QR code-only disclosures in some cases. The court rejected USDA’s proposed timeline extending revisions to 2029 and instead ruled that USDA has until January 1, 2028 to implement updated bioengineered food labeling regulations. More information can be found here.
Industry Groups Seek Injunction Against New Mexico PFAS Labeling Rule
August 27: A coalition of trade associations led by the American Chemistry Council has asked the US District Court for the District of New Mexico to issue a preliminary injunction preventing enforcement of a New Mexico rule requiring labels on PFAS-containing products beginning January 1, 2027, while litigation against the rule proceeds. The groups argue the requirement violates First Amendment protections, could mislead consumers, and would impose significant compliance costs. State officials contend the label provides factual product information and is part of implementing New Mexico’s PFAS Protection Act, which seeks to phase out products containing nonessential PFAS. More information can be found here.
Lawsuits Target Zero-Sugar Labels Containing Allulose
August 31: More food and beverage companies marketing products as “zero sugar” while containing allulose are facing increased class action litigation following a federal judge’s decision to allow a lawsuit against Chobani to proceed. The ruling followed an FDA amicus brief stating that allulose falls within the legal definition of sugar. New lawsuits against Liquid Death and the maker of David protein bars allege that consumers may be misled by zero-sugar claims despite the presence of allulose. More information can be found here.
This Regulatory Update covers information from August 2026. 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.