This update includes FDA and USDA updates, warning letters, and other articles of interest, including a new commissioner for the FDA, new Food Traceability Rule training for the industry, a request for information on uses of BHT, and more.
FDA Updates
FDA Commissioner Makary Resigns
May 12: Food and Drug Administration (FDA) Commissioner Marty Makary resigned, ending a 13‑month tenure marked by internal tensions, leadership turnover, and policy disputes with the White House, lawmakers, and industry stakeholders. His departure follows months of pressure tied to regulatory decisions, including disputes over abortion medication reviews and flavored vaping product approvals. Kyle Diamantas has been named acting commissioner. More information can be found here.
What to Know About New Acting FDA Commissioner Kyle Diamantas
May 13: Kyle Diamantas was named acting FDA commissioner following Marty Makary’s resignation. A former corporate lawyer who represented food, beverage, and consumer product companies, Diamantas joined FDA in 2025 and later served as deputy commissioner for food, overseeing nutrition and food safety programs. He has supported the administration’s food policy agenda, including stronger oversight of food ingredients and reforms to food chemical reviews. More information can be found here.
FDA Seeks Information on BHT and ADA Uses and Safety
May 13: The FDA is requesting information on the current uses and safety of butylated hydroxytoluene (BHT) and azodicarbonamide (ADA) in food and food contact materials as part of its post-market review process. The agency says the information will help determine whether these substances remain safe under current conditions of use. Stakeholders interested in submitting input have until July 13, 2026, to provide comments. The FDA also finalized its new proactive food chemical safety post-market assessment program that creates a risk-based process to monitor, prioritize, and reassess chemicals already in the food supply. More information can be found here.
FDA Advances Collaborative Strategy to Strengthen Food Safety Practice
May 13: The FDA’s Human Foods Program announced new efforts to develop a more collaborative, prevention-based approach to food safety, highlighting stronger engagement with industry and other stakeholders. The agency released two new web resources outlining how companies can partner with FDA to develop best practices and use root cause analysis to better identify, address, and prevent food safety issues. FDA will provide technical support to industry to help ensure that their best practice guidelines comply with existing FDA regulations. More information can be found here.
Donald Prater Named Acting Head of FDA Human Foods Program
May 15: Veterinarian Donald Prater, who currently serves as the FDA’s deputy associate commissioner for human foods, will temporarily serve as acting head of the agency’s human foods program following leadership changes at the FDA. Prater brings more than 25 years of FDA experience, including senior roles in food safety, imported foods, and implementation of the Food Safety Modernization Act. More information can be found here.
FDA Launches Food Traceability Rule Training for Industry
May 21: The FDA and the Food Safety Preventive Controls Alliance launched a new training program to help industry understand and comply with the Food Traceability Rule. The curriculum covers key recordkeeping requirements, traceability plans, and supply chain data tracking for foods subject to the rule, providing practical guidance to support implementation and compliance efforts. More information can be found here.
FDA Advances Post-Market Review of Phthalates in Food Contact Materials
May 27: The FDA released a scientific evaluation of eight authorized phthalates used in food contact materials as part of its post-market safety review. The agency found that four phthalates—DEHP, DCHP, DIOP, and DINP—meet proposed criteria for grouping in a future cumulative risk assessment. FDA said the evaluation will inform its broader review of phthalates in food contact uses and is seeking public comment through July 26, 2026. More information can be found here.
FDA Reopens Comment Period on Food Additive Petition to Remove Solvents from Food Uses
May 28: The FDA reopened the comment period on a petition that seeks to amend food additive regulations to remove the solvents benzene, ethylene dichloride, methylene chloride, and trichloroethylene from certain authorized food-related uses. The agency said the reopened comment period will allow stakeholders to submit updated data and information generated since the petition was first announced in January 2024. FDA is also seeking input on potential impacts and challenges for food manufacturers if the requested changes are adopted. Comments must be submitted by June 29, 2026. More information can be found here.
FDA Reopens Comment Period on Color Additive Solvent Petition
May 28: The FDA reopened the comment period on a color additive petition that seeks to remove the solvents ethylene dichloride, methylene chloride, and trichloroethylene from certain color additive regulations, including uses related to annatto extract, paprika oleoresin, turmeric oleoresin, and food-use color additive mixtures. The agency is seeking updated data and information developed since the petition was first announced in 2024, as well as stakeholder input on potential impacts and challenges if the proposed removals are adopted. Comments are due June 29, 2026. More information can be found here.
FDA Seeks Input on Lot-Level Food Traceability Rule Challenges
May 28: The FDA is seeking stakeholder feedback on challenges associated with implementing lot-level food traceability requirements under the Food Traceability Rule. To support that effort, the agency released a discussion paper outlining potential compliance flexibilities and requesting input on approaches that could reduce implementation burdens while preserving the rule’s food safety and traceability objectives. The initiative follows congressional direction for FDA to explore additional flexibility as industry prepares for the delayed enforcement date of July 20, 2028. Comments are due by July 15, 2026. More information can be found here.
FDA Strengthens Pesticide Monitoring Program
May 28: The FDA updated its pesticide monitoring compliance program introducing changes designed to strengthen oversight of pesticide residues in domestic and imported foods. Key updates include a greater focus on risk-based sampling, particularly for foods commonly consumed by infants and children, streamlined laboratory testing methods to improve efficiency and consistency, and enhanced coordination with federal, state, and local regulatory partners. More information can be found here.
FDA Warning Letters
Misbranded/New Drug: FDA issued a warning letter to Diamond-Herpanacine of PA, Inc. citing significant dietary supplement manufacturing violations, including deficiencies in quality control, product specifications, and sanitation practices. The agency stated that these deficiencies caused the firm’s products to be adulterated under federal law.
A database of warning letters can be found here.
USDA Updates
FSIS Removes Standard of Identity for Canned “Tripe With Milk”
May 4: The USDA Food Safety and Inspection Service (FSIS) issued a final rule on May 4, 2026, removing the standard of identity for canned “tripe with milk,” finding that the existing requirement is no longer necessary. Effective June 3, 2026, the rule gives manufacturers more flexibility while relying on FSIS’ labeling requirements to ensure the products are not misbranded. More information can be found here.
FSIS Releases Revised Egg Products Food Safety Guideline
May 5: FSIS released a revised Food Safety Guideline for Egg Products, providing updated information to help producers meet federal safety requirements when processing egg products through methods such as pasteurization, heat treatment, cooling, freezing, or enzyme use. The revisions respond to stakeholder questions and incorporate new scientific insights to clarify expectations and support compliance. FSIS is seeking public comments on the revised guideline. Comments are due by July 6, 2026. More information can be found here and the guideline can be found here.
USDA Implements Whole Milk for Healthy Kids Act
May 8: The USDA issued a final rule implementing the Whole Milk for Healthy Kids Act, restoring whole and reduced-fat (2%) milk options in federal child nutrition programs for children and adults ages 2 and older. USDA said the change provides greater flexibility in school meal programs while supporting access to nutrition-rich dairy products. The rule follows enactment of the law in January 2026 and is part of USDA’s broader efforts to update school nutrition standards. More information can be found here.
FSIS Finalizes Visual Swine Inspection Rule
May 21: FSIS finalized a rule updating swine inspection procedures to rely primarily on visual post-mortem inspection, replacing routine manual incision of lymph nodes and palpation of viscera. The agency cited data showing that disease conditions in swine are effectively identified through visual observation and that reducing manual handling may help lower the risk of microbial cross-contamination. The rule also updates staffing standards, while preserving inspectors’ authority to conduct manual examinations when warranted. The changes take effect July 20, 2026. More information can be found here.
FSIS Revises Food Standards and Labeling Policy Book
May 22: FSIS updated its Food Standards and Labeling Policy Book by removing the “SOUJOUK (TK)” entry following a 2025 petition from the Food Safety Research Laboratory. The agency concluded that the entry was outdated and no longer necessary to protect consumers. FSIS said the Policy Book is intended to support consistent labeling decisions and that outdated provisions can undermine that objective. While the agency has not added new policy guidance to the book since 2013, it continues to revise or remove entries as needed to maintain consistency with current policies and regulations.
Other Articles of Interest
FDA Expands Use of AI to Enhance Efficiency while Maintaining Human Oversight
May 12: The FDA is expanding its use of generative artificial intelligence (AI) to improve efficiency across a range of internal functions, including summarizing documents, reviewing scientific literature, drafting materials, and assisting with Freedom of Information Act redactions and litigation document review. The agency has also launched an internal AI tool, known as “Elsa”, that can query centralized data sources to support staff work. While FDA leaders view AI as a valuable tool for handling large volumes of information, they emphasize that human experts remain responsible for all regulatory decisions and must carefully review AI outputs due to potential errors and inconsistencies.
Maine Ban on PFAS in Food Packaging Takes Effect
May 25: Maine’s ban on food packaging containing intentionally added PFAS took effect on May 25, 2026, prohibiting the sale and distribution of a wide range of food-service items, including takeout containers, wrappers, pizza boxes, and paper foodware. The measure is part of the state’s broader effort to reduce environmental and public health risks associated with PFAS contamination. Some businesses have raised concerns about potential cost increases. Supporters say the restrictions will help prevent future contamination and reduce long-term cleanup and remediation costs. More information can be found here.
Celiac Safety Act Seeks Stronger Gluten Disclosure Requirements
May 28: U.S. Representatives Emanuel Cleaver II (D-MO) and Betty McCollum (D-MN) introduced the Celiac Safety Act, legislation that would require FDA to classify gluten-containing grains as a major food allergen and mandate labeling of all gluten-containing ingredients, including barley and rye. Supporters say the measure would improve transparency and help protect the approximately 3 million Americans living with celiac disease, aligning U.S. labeling requirements more closely with those in Canada, the European Union, the United Kingdom, Australia, and New Zealand. More information can be found here.
FDA Commissioner Search Continues
May 19: Following the resignation of FDA Commissioner Dr. Marty Makary, attention has turned to the agency’s leadership transition and the search for a permanent successor. Kyle Diamantas is serving as Acting Commissioner, while several former FDA and federal health officials, including Stephen Hahn, Brett Giroir, and Ned Sharpless, have been discussed as potential candidates. Regulatory observers suggest FDA may operate under acting leadership through the 2026 midterm elections, with attention focused on maintaining regulatory stability and continuity across FDA programs during the leadership change. More information can be found here.
Kwik Trip Earns Top Food Safety Honor
May 26: Kwik Trip was awarded the 2026 Black Pearl Award by the International Association for Food Protection, recognizing excellence in food safety and quality. The award highlights the company’s commitment to strong food safety practices, employee training, regulatory compliance, and community programs. As the first convenience store chain to receive this honor, Kwik Trip’s recognition reflects its integrated operations, including in-house production and testing, and continued focus on maintaining high standards across the Midwest.
USDA Plan to Close Key Research Center Raises Food Safety Concerns
May 21: The USDA’s plan to decommission the Beltsville Agricultural Research Center and relocate its research units has raised concerns among scientists, lawmakers, and food safety advocates about potential disruptions to critical research. The move would shift key programs, including those focused on foodborne pathogens and produce safety, by September 2026. Critics warn the change could weaken federal research capacity and conflict with congressional directives. USDA says the change will modernize facilities and improve efficiency. More information can be found here. (Requires subscription)
This Regulatory Update covers information from May 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.