• The Reagan-Udall Foundation (RUF) has released its Roadmap to Produce Safety: Summary of the Produce Safety Dialogue, which reflects input from produce sector stakeholders and is intended to serve as a “foundation for transformative change in produce safety management through collaboration.”
  • According to the Roadmap, “the burden of illness associated with microbial and chemical contamination of fresh produce is the most significant and disruptive food safety problem still affecting the U.S. food system,” while fresh produce is also a category that consumers are encouraged to consume more of as part of a healthy diet.
  • The Roadmap makes two primary recommendations to promote the availability of safe produce despite numerous foodborne illnesses and recalls challenging consumer trust and confidence:
    • First, the produce supply chain should “implement a shared responsibility approach,” in which all stakeholders actively participate in risk-based produce safety efforts.
    • Second, the supply chain should “form a structured, stakeholder led collaboration . . . led by influential stakeholders representing the diversity of the produce supply chain.”
  • FDA has stated its commitment to engagement and collaboration with stakeholders to implement strategies to prevent foodborne illness from produce, including seeking executive leadership of the Office of Produce Safety, established under the 2024 reorganization of the Human Foods Program, which we previously blogged about.
  • Keller and Heckman will continue to report on activities related to produce safety.
  • On July 9, 2025, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced a significant update to its procedures for reviewing petitions seeking a determination of nonregulated status for genetically engineered organisms. These changes aim to align APHIS’s petition review process with recent legal developments, particularly amendments to the National Environmental Policy Act (NEPA) and the agency’s authority under the Plant Protection Act (PPA).
  • Under the revised approach, APHIS will focus its review on whether a genetically modified organism (GMO) poses a greater plant pest risk compared to an appropriate comparator. If the organism is found not to be a plant pest, APHIS will conclude its review and issue a determination that the organism is not subject to regulation under 7 C.F.R. part 340.
  • Historically, APHIS included environmental impact assessments as part of its petition process. However, the agency clarified that this practice was discretionary, not mandatory. The 2023 amendments to NEPA, enacted through the Fiscal Responsibility Act, reinforce this position by specifying that federal agencies are not required to prepare environmental documents for nondiscretionary actions where they lack authority to consider environmental factors.
  • Despite these changes, APHIS will continue to publish draft reviews of petitions in the Federal Register, allowing for public comment before final determinations are made.
  • Keller and Heckman will continue to monitor developments related to NEPA implementation and APHIS’ regulatory authority under the Plant Protection Act.
  • On July 23, 2025, the U.S. Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA) announced a joint Request for Information (RFI) to help the agencies establish a federal definition for ultra-processed foods (UPFs). Specifically, the agencies are requesting comments on what factors and criteria should be included within the UPF definition. The pre-publication RFI is available here and it will be published in the Federal Register on July 25, 2025.
  • Currently, there is not a single, universally accepted definition of UPFs. In its announcement, HHS said that “[a] uniform definition of ultra-processed foods will allow for consistency in research and policy to pave the way for addressing health concerns associated with the consumption of ultra-processed foods.” HHS Secretary Robert F. Kennedy, Jr. also stated that defining UPFs “with a clear, uniform standard” will further empower the agency to fulfill its mission to “Make America Healthy Again.”
  • The UPF RFI follows an announcement on May 9, 2025, that FDA and the National Institutes of Health (NIH) are launching the “Nutrition Regulatory Science Program,” which aims to “implement and accelerate a comprehensive nutrition research agenda” that will inform future food and nutrition policy actions. One of the goals of the program is to understand how and why UPFs harm people’s health. To administer the program, FDA will provide guidance on regulatory science, and NIH will provide the infrastructure for the solicitation, review, and management of scientific research.
  • A uniform definition of UPFs could have broad implications and influence future public health guidance and state or federal legislative efforts. Additionally, foods that are covered under the Supplemental Nutrition Assistance Program (SNAP) could be restricted.
  • Keller and Heckman will continue to monitor developments related to UPFs.
  • Last week, at the opening of the USDA’s new Midwestern Food Safety Laboratory in Normandy, Missouri, U.S. Secretary of Agriculture, Brooke Rollins, unveiled a 5-part plan to reduce foodborne illness.
  • Specifically, USDA’s plan includes the following 5 key elements:
  1. Enhancing Microbiological Testing and Inspection Oversight
    • USDA has upgraded its laboratory infrastructure (notably the new Midwestern Food Safety Lab) and has increased foodborne illness testing—namely Listeria monocytogenes (citing a 200 percent increase in samples tested for Listeria in 2025 from 2024).
  2. Equipping FSIS Inspectors with Updated Training and Tools
    • Inspectors are now using expanded tools like a weekly questionnaire to collect data on specific Listeria monocytogenes-related risk factors.
    • FSIS has also issued new procedural instructions and Listeria-specific training for frontline inspection personnel.
  3. Approach to Address Salmonella in Poultry
    • The Secretary has directed FSIS to find a “more effective and achievable approach to address Salmonella in poultry products.”  This will start with stakeholder listening sessions.
  4. Strengthening State Partnerships
    • USDA is increasing financial and technical support for state-level meat and poultry inspection programs and enhancing its oversight over Talmadge-Aiken (TA) state cooperative programs.
  5. Empowering FSIS Inspectors to Take Action to Drive Compliance
    • USDA is stepping up enforcement actions and deploying field supervisors for follow-up visits when systemic issues are identified.
  • Keller and Heckman will continue to monitor ongoing developments related to USDA and FSIS.

  • On July 14, 2025, the U.S. Food and Drug Administration (FDA) announced its approval of the use of the color gardenia (genipin) blue in various foods and beverages at levels consistent with good manufacturing practices. Specifically, FDA has approved gardenia (genipin) blue for use in sports drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy. The color additive petition was submitted by the Gardenia Blue Interest Group (GBIG) in 2021.
  • Gardenia (genipin) blue is derived from the fruit of Gardenia jasminoides Ellis, a flowering evergreen shrub. The additive is a dark purple or dark blue liquid or powder that is prepared through the polymerization of genipin with soy protein hydrolase. Because soy is considered a “major food allergen” under the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)), and it is used in the manufacturing process of gardenia (genipin) blue, the color additive requires allergen labeling (21 U.S.C. 343(w)(1)). On September 29, 2022, GBIG submitted a petition to FDA requesting an exemption from this labeling requirement. The petition is currently under review.
  • The approval of gardenia (genipin) blue continues FDA’s efforts to provide more color additive options. FDA issued an order revoking the authorization of FD&C Red No. 3 in foods and dietary supplements on January 15, 2025, but gave manufacturers until January 15, 2027, to reformulate their products. On April 22, 2025, the U.S. Department of Health and Human Services (HHS) published an announcement requesting that food manufacturers remove FD&C Red No. 3 prior to the 2027 deadline. Now, following the approval of gardenia (genipin) blue and other colors derived from natural sources on May 9, 2025, FDA is asking food companies to stop using FD&C Red No. 3 in their products “as soon as practically possible.”
  • Keller and Heckman will continue to post updates on new FDA color additive approvals.
  • On July 15, 2025, FDA sent warning letters to seven different companies for the illegal marketing of products containing 7-Hydroxymitagynine (7-OH). 7-OH is a naturally occurring chemical component of Kratom, a tropical tree native to Southeast Asia.
  • 7-OH and Kratom are prohibited from being marketed in the U.S. as a drug product, dietary supplement, or food additive. FDA views 7-OH as a novel potent opioid that has “not been proven safe or effective for any use.”
  • The warning letters targeted a variety of products, including over-the-counter medications, dietary supplements, and drink mixes. Respectively, the warning letters pertained to using 7-OH in unapproved new drugs, in adulterated dietary supplements, and in adulterated human foods as an unsafe food additive.
  • Keller & Heckman will continue to monitor FDA warning letters related to food additives and dietary supplements.
  • FDA released a press release yesterday which announced it was either revoking or proposing to revoke fifty-two “obsolete and unnecessary” standards of identity (SOI) for various food products including SOIs for canned fruits and vegetables, dairy products, baked goods, and macaroni products.
  • FDA published a direct final rule which revoked “standards for eleven types of canned fruits and vegetables that are no longer sold in U.S. grocery stores,” seven of which were for fruits containing saccharin or sodium saccharin. FDA also issued a companion proposed rule in case the direct final rule is withdrawn.
  • FDA published two other proposed rules, which would revoke SOIs. One proposed rule would revoke SOIs for eighteen types of dairy products, while the other would revoke standards for twenty-three types of food products including “bakery products, macaroni and noodle products, canned fruit juices, fish and shellfish, and food dressings and flavorings.”
  • The press release notes that this initiative aligns with President Trump’s Executive Order 14192 “Unleashing Prosperity Through Deregulation,” which requires executive agencies to identify at least ten existing regulations to be repealed whenever it “promulgates a new regulation.”
  • On July 14, 2025, the U.S. Food and Drug Administration (FDA) announced an extension to the public comment period for its proposed method for ranking chemicals in food for post-market assessments by 30 days from July 18, 2025 to August 18, 2025.  Extension of the comment period had been requested by the Food Packaging Coalition, the Environmental Defense Fund, the International Food Additives Council, the Essential Minerals Association, and the Food and Beverage Issue Alliance. 
  • As previously discussed on this blog, FDA’s proposed “Post-market Assessment Prioritization Tool” would assign chemicals a score based on various public health criteria (e.g., toxicity) and “other” criteria (e.g., stakeholder attention).  The score would then be used to rank post-market chemical assessment by priority.
  • FDA continues to encourage public comments to respond to the questions regarding its methodology outlined in Section 4 of the method description document. Comments should continue to be submitted to Docket No. FDA-2025-N-1733. As of today, 31 comments have been submitted, but all appear to be from individual members of the public.
  • On July 9, 2025, FDA Commissioner Marty Makary published a letter encouraging manufacturers of infant formula, baby food, and foods intended for children to improve their product recall communications. The letter urges industry leaders to adopt FDA’s “radical transparency” efforts to help protect what Commissioner Makary calls “our most vulnerable consumers—our children.” Specifically, Commissioner Makary calls on industry leaders to “consider expanded use of public notification as appropriate to ensure that consumers have access to the most timely and comprehensive information.”
  • FDA outlines both short-term and long-term goals within the letter. In the short term, FDA plans to create a “centralized, consumer-focused webpage for streamlined access to recall information” for infant formula, baby food, and foods intended for children. FDA also mentions that the Agency hopes to improve its own communications about recalls “by leveraging focus group research and other stakeholder feedback on risk communication strategies.” In the long term, FDA aims to improve recall process efficiency “by redesigning and digitizing key recall documentation to support automated data extraction and AI-assisted analysis,” as well as modernize the digital platform where manufacturers submit recall information.
  • The letter is an extension of a March 18, 2025, FDA announcement of its new initiative known as “Operation Stork Speed.” This initiative seeks to improve product recall communications with consumers, and encourage companies to work alongside FDA to “[increase] transparency” and create “clearer labeling” on their products. Before transitioning to the current administration, FDA had also released a strategy in January 2025 outlining goals to improve safety requirements and “resiliency” in the infant formula market by addressing vulnerabilities in production and regulatory oversight.
  • Keller and Heckman will continue to report on FDA announcements and updates that impact the infant formula and children’s food space.
  • FDA published a press release written by FDA Commissioner Marty Makary that highlighted his efforts to “make food healthier for children and families, accelerate meaningful cures and treatments, and modernize the agency with transparency, gold-standard science and common sense.”
  • Highlights regarding the food industry included: (1) replacing synthetic food dyes with natural dyes, (2) improving infant formula, (3) expediting chemical reviews, (4) exploring rulemaking to require generally recognized as safe (GRAS) submissions, (5) revising broken dietary guidelines, and (6) defining ultra-processed foods.
  • As an example of “gold-standard science & common sense,” Commissioner Makary also noted the convening of an expert panel to review health risks associated with talc, which we have written about previously.
  • Relatedly, Commissioner Makary attended an interview to discuss his first 100 days, hosted by NewsNation, in which he largely talked about the FDA’s efforts to replace synthetic dyes. He also spoke about the approval of a new natural food dye, which was announced today, and emphasized that the FDA wants to “focus on food.”
  • Keller and Heckman will continue to report on FDA announcements and updates that impact the food industry.