• On May 15, 2026, the U.S. Department of Agriculture (USDA) issued a Request for Information (RFI) seeking stakeholder input on the regulatory framework governing modified organisms under the Plant Protection Act (PPA). Comments are due by June 15, 2026.
  • The RFI follows significant recent developments in USDA biotechnology regulation. In 2020, USDA’s Animal and Plant Health Inspection Service (APHIS) finalized the SECURE rule, a comprehensive revision to 7 CFR Part 340 that shifted toward a product-based, risk-focused regulatory framework. However, in December 2024, a federal district court vacated the SECURE rule on Administrative Procedure Act grounds, resulting in a reversion to the pre-2020 regulations. USDA’s current request reflects an effort to reassess its regulatory approach in light of that decision and broader policy objectives.
  • USDA is specifically seeking input on whether genetically engineered organisms present materially different plant pest risks compared to conventionally developed organisms, and whether the agency should continue to distinguish between them in its regulations. The agency notes that its experience to date has not identified meaningful differences in risk profiles.
  • The RFI also invites detailed feedback on stakeholder experience under both the rescinded SECURE rule and the currently operative Part 340 regulations, including regulatory burdens, costs, and barriers to field trials and commercialization. In addition, USDA is exploring whether modified organisms could be regulated under 7 CFR Part 330, which governs plant pests and related articles, instead of Part 340, and what legal, practical, and trade considerations such a shift would entail.
  • Keller and Heckman would be happy to assist in preparing and submitting comments in response to this RFI. We will continue to monitor developments.
  • On April 28, 2026, three federal lawsuits were filed by members of the Coalition for Organic Dairy Exemption (CODE), including Aurora Organic Dairy, Horizon Dairy, and CROPP Cooperative/Organic Valley, challenging their required participation in the Federal Milk Marketing Order (FMMO) program.  Specifically, the CODE members argue that their forced participation in the program is unconstitutional.  A separate class action claim seeks compensation for six years of payments that farmers say were collected for FMMO without return.
  • The lawsuits argue that organic and conventional milk are treated the same under FMMO pricing and pooling regulations, even though they operate under different production systems.  Organic production includes higher feed certification and handling costs, and the lawsuits allege that while both organic and conventional dairy pay into the producer settlement funds, the benefits flow almost entirely to conventional producers, even though conventional milk cannot be used in organic production.
  • Prior to these lawsuits, CODE submitted proposals to the U.S. Department of Agriculture (USDA) in 2015 that were not advanced and presented organic-specific recommendations during the 2023 national FMMO hearing that were not considered.  Additionally, CODE filed administrative petitions with USDA in May 2025 challenging both the constitutionality and the legal adequacy of the FMMO system as to organic.
  • Keller and Heckman will relay any developments in this litigation.
  • FDA Commissioner Dr. Marty Makary is widely reported to have resigned yesterday, with President Trump thanking Dr. Makary and stating that Kyle Diamantas, the FDA Deputy Commissioner for Food, will serve as the acting FDA Commissioner in a Truth Social post yesterday afternoon. There has, however, not yet been a more official announcement of the change.
  • Dr. Makary’s tenure as FDA’s 27th Commissioner lasted a little over a year (he was confirmed March 25, 2025), but has been fraught with controversy, including the mass layoffs at the Agency last year. Reports surfaced last week that President Trump was not pleased with Dr. Makary’s performance and was considering his removal. However, the circumstances of his departure are not yet entirely clear. An NBC report, citing an anonymous source close to Health and Human Services (HHS) leadership, indicated that Dr. Makary chose to resign because he personally opposed FDA’s authorization of a fruit-flavored vape, a move that was pushed by industry and President Trump after FDA scientists concluded the age-gated devices met the appropriate for the protection of the public health (APPH) standard for new tobacco products. In contrast, a Politico report, citing a White House source, indicated that HHS Secretary Kennedy “made the call,” but that President Trump signed off.
  • A Reuters report last week indicated that former FDA ​Commissioner Stephen Hahn and former Acting Commissioner and ​Assistant Health Secretary Brett Giroir are among the nominees President Trump is considering for the role of FDA Commissioner.

  • On May 12, 2026, FDA announced that the Agency finalized its new “proactive food chemical safety post-market assessment program” and launched reassessments of butylated hydroxytoluene (BHT) and azodicarbonamide (ADA).
  • FDA released two documents to guide the post-market assessment program. The document “Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food” describes how FDA  will “identify food chemicals for review, prioritize identified food chemicals for assessment, structure scientific assessments, and communicate risk management plans.” The document describes “chemicals in food” to include “any substance found in or added to food, including nutrients, food additives, contaminants, and natural ingredients.”
  • The document “Post-Market Assessment Prioritization Tool” is intended to help “identify priority food chemicals for full scientific assessment by focusing on potential risk to public health.” The document covers decisional criteria, including toxicity, change in exposure, use or presence in food for susceptible subpopulations, and new scientific information and potential impact.
  • BHT and ADA have been common targets in recent state legislation, as well as listed priorities in FDA’s post-market review agendas, as we have previously blogged. BHT is used to prevent spoilage of fats and oils, and ADA is used as a whitening agent in cereal flour and as a dough conditioner in breadmaking.
  • Keller and Heckman will continue to monitor FDA’s post-market assessment activities.
  • On April 21, 2026, Colombia’s Ministry of Health released draft regulations proposing to further amend the country’s front‑of‑pack labeling (FOPL) framework for processed foods. The proposal would repeal and consolidate Resolution 810 of 2021 (the original FOPL regulation) along with Resolution 2492 of 2022 and Resolution 254 of 2023, which modified and corrected the original rule during early implementation. Together, these measures established Colombia’s mandatory octagonal warning labels for products high in sugar, sodium, saturated fat, trans fat, or containing sweeteners.
  • According to the Ministry, since implementation, local studies have shown high consumer awareness of warning labels and reported reductions in purchases of labeled products. Building on these findings, the April 2026 draft introduces a new front‑of‑pack warning for “ultra‑processed” products.
  • The draft adds new definitions for “ultra‑processed food and beverage products,” “ultra‑processed ingredients,” and “cosmetic additives.” A product would be classified as ultra‑processed if it contains at least one ultra‑processed ingredient, such as high‑fructose corn syrup, maltodextrin, modified starches, or hydrogenated oils, or a cosmetic additive, including substances added primarily to modify color, flavor, sweetness, texture, or appearance. Products meeting this definition would be required to display a new rectangular warning label reading “Advertencia Ultra Procesado,” alongside existing octagonal nutrient warnings.
  • Colombia’s proposal would place it among the first countries to require front‑of‑pack identification of ultra‑processed foods, rather than relying solely on nutrient‑based warning systems, which have become increasingly common across Latin America. As previously discussed on our blog, related policy interest is also emerging in the United States, where California has recently proposed a voluntary ultra‑processed‑food‑free certification program, despite the absence of a universally accepted regulatory definition of ultra‑processed foods.
  • Keller and Heckman will continue to monitor developments related to proposed ultra‑processed food labeling frameworks domestically and abroad.
  • On March 6, 2026, California Attorney General, Rob Bonta, issued an enforcement letter to baby food manufacturers, reminding industry of its obligations under AB 899, which requires that any baby food products sold or made in the state be tested for arsenic, cadmium, lead, and mercury.
  • As we previously reported, under AB 899, manufacturers of baby food (not including infant formula) for sale or distribution in California must test a representative sample of each production aggregate of the final baby food product at least once a month.  Test results must be provided to the California Department of Public Health upon request.  Starting January 1, 2025, manufacturers were also required to make publicly available on the manufacturer’s website, for the duration of the product shelf life for a final baby food product plus one month, the name and level of each toxic element present in each production aggregate of a final baby food product. 
  • The enforcement letter responds to Consumer Reports’ 2025 article which that found some baby food manufacturers were not making their product testing easily available.  Attorney General Bonta reiterated that “[f]ailure to comply with AB 899’s requirements may constitute a violation of California’s Unfair Competition Law, Business and Professions Code section 17200, and other applicable laws.”
  • Just weeks before the issuance of the enforcement letter, California also introduced AB 2302 in February 2026, which would require heavy metals testing and reporting for infant formula manufacturers. The bill is currently undergoing committee review.
  • Keller and Heckman will continue to relay any developments in baby food and infant formula regulation.
  • In a pair of April 23rd announcements USDA indicated that it is making organizational changes to its Food Safety and Inspection Service (FSIS) and its Research, Education, and Economic (REE) mission area that would move many of its personnel outside of the Washington, DC region. On April 30th it also announced changes to the Food, Nutrition, and Consumer Services mission area including the reorganization of the Food and Nutrition Service (FNS) into the Food and Nutrition Administration (FNA). This move would also relocate personnel to outside of the DC region.
  • FSIS changes: USDA plan to establish a new National Food Safety Center (NFSC) in Urbandale, Iowa, which will serve as the primary hub for FSIS administrative, technical, and support operations and will be its largest office with about 200 employees. FSIS will also establish a science center in Athens, Georgia which will expand its capabilities in microbiology, chemistry, and epidemiology, and an office in Fort Collins, Colorado to support international activities. The changes to FSIS will relocate approximately 200 of its DC region workforce to outside of the region but will not impact its inspection personnel which represent 85% of its employees.
  • Research, Education, and Economic (REE) mission area changes: The REE is composed of four agencies— the Agricultural Research Service (ARS), the Economic Research Service (ERS), the National Agricultural Statistics Service (NASS), and the National Institute of Food and Agriculture (NIFA)—and supports U.S. agriculture through research, analysis, and education. The announced changes include: (1) ERS and NIFA will relocate personnel, including from the DC region, to offices in Kansas City, (2) NASS will relocate personnel, including from the DC region, to St. Louis and other offices, and (3) ARS will begin to decommission its Beltsville Agricultural Research Center, the research functions of which will be distributed to other locations. The number of workers to be relocated with these changes was not announced.
  • Food, Nutrition, and Consumer Services mission area changes: The changes include reorganizing the Food, Nutrition Services (FNS), which administered nutrition assistance programs, into the Food and Nutrition Administration (FNA). The programs will be relocated to regional hubs in Indianapolis, Dallas, Kansas City (MO), Raleigh, and Denver. The FNA Administrator and a small footprint will remain in DC.
  • A group of dietary supplement companies, joined by an alternative medicine advocacy group, sued FDA (Law360 subscription required) for allegedly violating First Amendment commercial speech protections when the Agency blocked certain label claims connecting nutrients or ingredients to health outcomes.
  • According to the complaint, in September 2025, the plaintiffs filed a “Notification of Health Claims Based on Authoritative Statements” pursuant to 21 U.S.C. § 343(r)(3)(C). This provision permits “health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research; such claims may be used 120 days after a health claim notification has been submitted to FDA, unless the agency has informed the notifier that the notification does not include all the required information.”
  • In December 2025, FDA notified the plaintiffs via letter that 4 of the 118 submitted claims were not health claims; however, according to the plaintiffs, FDA denied authorization of use for the remaining 114 claims, which were based on statements published by the National Institutes of Health, the National Institutes of Health Office of Dietary Supplements, the NIH National Center for Complementary and Integrative Medicine, and the Centers for Disease Control and Prevention. The complaint states that FDA asserted that a number of the claims misrepresented the scientific literature.
  • According to the plaintiffs, FDA does not have authority to prevent these claims from being used on products that contain “the same ingredients and same dose amounts identified in the government research” because the statute was only intended to create a notification process, not an approval review. Further, the plaintiffs said that the U.S. Supreme Court’s 2024 ruling in Loper Bright Enterprises v. Raimondo, which stripped away Chevron deference, made it clear that FDA “is not entitled to deference for its narrow construction” of the statute and that the court must adopt a plain meaning construction of the statute, which would permit the health claims to be used.
  • Keller and Heckman will continue to monitor litigation related to claims made on labels and in labeling of food and dietary supplements.
  • On April 29, 2026, the U.S. Food and Drug Administration (FDA) announced the results of the largest and most comprehensive testing program ever conducted on infant formula sold in the United States. As part of Operation Stork Speed and the agency’s broader Closer to Zero initiative, FDA analyzed more than 300 retail products, generating over 120,000 data points across a wide range of potential chemical contaminants. The testing covered powdered, ready-to-feed, and concentrated liquid formulas and included analysis for heavy metals, pesticides, PFAS, phthalates, and other substances that may be present due to environmental or agricultural factors.
  • Overall, FDA’s findings reinforced that all infant formula products on the U.S. market meet a high safety standard, with most samples showing undetectable or very low levels of the contaminants tested. Agency leadership emphasized that these results are encouraging and affirm the general safety of the U.S. infant formula supply.
  • Specifically, all samples tested contained levels of lead, mercury, cadmium, and arsenic that were significantly below U.S. Environmental Protection Agency drinking water standards when prepared for feeding. Pesticides were not detected in 99 percent of samples tested, and none of the 25 out of 30 tested most commonly assessed PFAS compounds were detected in any sample. Among the remaining PFAS analytes, 95 percent of products had total PFAS levels at or below 28 parts per trillion, while 95 percent of samples showed phthalate concentrations at or below 116 parts per billion.
  • FDA plans to continue targeted and routine surveillance, expand testing to additional contaminants, and work with manufacturers to push contaminant levels as low as reasonably achievable. The agency also indicated it will continue developing formal action levels where appropriate.
  • Keller and Heckman will continue to monitor regulatory and policy developments affecting infant formula safety and supply.
  • A class-action lawsuit was filed in a district court in California last month alleging that Target’s Good and Gather branded seafood products were falsely and deceptively labeled as “sustainably caught.” The seafood products in question were also certified as “sustainable seafood” by the Marine Stewardship Council (MSC), a third-party certification program. 
  • The complaint alleges that a reasonable consumer would understand the claim to mean that the source fisheries “are maintaining healthy fish populations and protecting ocean ecosystems.” The complaint cites a back of package statement which, under a “sustainable seafood” heading, states that the “seafood is wild caught using sustainable practices to help protect ocean resources for future generations to enjoy.”  Other corporate materials and statements are also cited.
  • The complaint alleges that the seafood products in question are in fact a product of fishing practices such as longlines and purse seines (large nets) that indiscriminately capture all marine life. The complaint further alleges that the supply chain has little transparency and that MSC is a for-profit organization which has an inherent conflict of interest.
  • Sustainability claims are generally adjudicated based on the expectations of the “reasonable consumer” (as determined by the court). Statements made by the Defendant in its labeling and marketing materials may inform this inquiry.