• 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.
  • On July 1, 2025, FTC Chairman Andrew Ferguson designated July as “‘Made in the USA’ Month,” and reiterated the Commission’s commitment to cracking down on deceptive MUSA claims.
  • The FTC quickly followed this announcement on July 8 by sending warning letters to four companies, reminding them to comply with FTC’s 2021 Made in USA Labeling Rule (MUSA Labeling Rule).
  • Significantly, the FTC also sent letters to Amazon and Walmart regarding allegedly deceptive MUSA claims made by third-party sellers on the two companies’ e-commerce websites. The FTC targeted various consumer products, such as work boots, baseball hats, whiskey glasses, pasta serving utensils, and American flags. Food products are subject to the same MUSA standard.
  • The FTC notices could signal a potential expansion of the compliance requirements imposed on online marketplaces for MUSA claims made by third-party sellers, with implications for all types of advertising claims appearing in listings developed by third-party sellers online and possibly at brick-and-mortar retailers. Read more here.
  • On May 28, 2025, the U.S. Food and Drug Administration (FDA) issued a “no questions” letter to Wildtype, Inc. in response to the California-based company’s pre-market evaluation filings for their cultured salmon cell material.
  • FDA’s letter marks the first instance FDA has issued a “no questions” letter for cultured salmon material, indicating the agency has no further questions regarding the product’s safety under its intended conditions of use. Wildtype’s cultured salmon joins cultured chicken cell material from GOOD Meat Inc. and Upside Foods and cultured pork fat cells from Mission Barns as one of four cell-cultured products to receive a “no questions” letter from FDA.
  • Although Wildtype’s salmon is already being sold at a restaurant in Portland, Oregon (see here), Wildtype may face challenges bringing their products to other markets.  As we have previously reported, many states have imposed cultivated product bans.
  • Keller and Heckman will continue to monitor developments involving cell cultivated food products.
  • Senior FDA officials recently signaled that the agency does not anticipate major disruptions to the issuance of guidance documents, even as federal agencies brace for the impact of Executive Order 14192, “Unleashing Prosperity Through Deregulation” which, as previously reported, mandates that federal agencies eliminate 10 regulations for every new regulation issued (the “10-1 Executive Order”).
  • Quoted in an article by Inside Health Policy, Grace Graham, Deputy Commissioner for Policy, Legislation and International Affairs at FDA, stated at the Drug Information Association’s annual conference last month that “I think if you look at the executive order, it’s very broad, a number of things can qualify as deregulatory and so we are still working on it and looking at it, but you will continue to see guidance come out of the agency, as you would have in the past.”
  • Further, citing the 10-1 Executive Order, among others, the Department of Health and Human Services (HHS) published a Request for Information (RFI) in the Federal Register on May 14, 2025 inviting public comment on regulations and guidance that should be revised, withdrawn, or repealed. The comment deadline on the RFI is next Monday July 14, 2025.
  • Keller and Heckman will continue to track developments surrounding the 10-1 Executive Order and its potential implications for FDA.