• On March 10, 2025, the Department of Health & Human Services (HHS) Secretary Robert F. Kennedy Jr. announced that he is directing the U.S. Food & Drug Administration (FDA) “to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.”
  • This self-affirmation process is built into the 1958 Food Additive Amendments, which amended the definition of a “food additive” and allows certain substances to be exempt from premarket review if they are GRAS based on scientific procedures or history of use in food as determined by qualified experts. Notably, the announcement also specifically references “substances that come into contact with food.”
  • The announcement is made to promote oversight and transparency.  The announcement expresses a commitment to working with Congress to close the GRAS self-affirmation pathway and acknowledges that legislation will be pursued in tandem with potential future rulemaking.
  • Importantly, there is no immediate effect on ingredients currently marketed, allowing companies to continue their operations without disruption while FDA explores potential rulemaking. Keller and Heckman will continue to monitor developments related to the GRAS program.
  • Health and Human Services (HHS) will no longer use notice-and-comment rulemaking procedures for “matters relating to agency management or personnel or to public property, loans, grants, benefits, or contracts,” according to HHS Secretary Robert F. Kennedy, Jr.  The policy statement was published in the Federal Register on March 3, 2025.
  • Usually, agencies must publish proposed rules or notices in the Federal Register, open a time-limited comment period, review and assess those comments, and then publish a final version.  This policy statement rescinds the Department’s 1971 “Policy on Public Participation in Rule Making,” known as the “Richardson Waiver.”  According to the statement, “Effective immediately, the Richardson Waiver is rescinded and is no longer the policy of the Department.  In accordance with the Administrative Procedure Act (APA), ‘matters relating to agency management or personnel or to public property, loans, grants, benefits, or contracts,’ are exempt from the notice and comment procedures,” except “as otherwise required by law.  Agencies and offices of the Department have discretion to apply notice and comment procedures to these matters but are not required to do so, except as otherwise required by law.”
  • Rescinding the Richardson Waiver means that HHS will no longer follow the notice and comment requirements for certain types of rulemakings unless required by the APA or otherwise required by law.  HHS will now be able to make changes related to its programs that provide loans, grants, benefits, or contracts with less public awareness and feedback.
  • FDA recently posted two warning letters issued to companies for failure to comply with the foreign supplier verification program (FSVP) requirements in Section 805 of the Federal Food, Drug, and Cosmetic Act (21 USC 384a) and the implementing regulations in 21 CFR part 1, subpart L. FSVP is intended to verify that food imported into the U.S. is produced consistent with food safety standards that provide at least the same level of protection as the food safety standards that would apply to the food if it were produced in the U.S.
  • In one letter to Garcia Fresh Vegetables LLC, FDA indicated that the company had not developed an FSVP for any of the foods that it imports, including fresh produce. In another letter to Radhaswamy Inc. dba Raja Foods LLC, FDA stated that the company had failed to develop an FSVP for all but one of its products and had further failed to take any corrective actions following importation of a product that was added to an import alert due to pesticide adulteration.
  • Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at the end of the inspections. FSVP violations continue to be a significant source of warning letters.  
  • While several states are taking legislative action to restrict or ban the sale of cultivated meat, with legislators arguing that the bans would protect the meat industry, there is a different message coming from many groups in the industry itself. Critics of the bans argue that they would “restrict free trade and threaten food safety benefits.”
  • Nebraska, a state that ranks among the top 10 producers of beef and pork, is among many of the states that has proposed a cultivated meat ban, and the state’s governor issued an executive order in August 2024 barring state agencies from buying cultivated meat. However, ranchers and meat industry groups are pushing back on the ban, saying that “it’s up to the consumer to make the decision about what they buy and eat.” Industry groups say that they are “not worried about competition” from cultivated meat but prefer a different approach that would require the products to be clearly labeled as lab-grown.
  • The North American Meat Institute has similarly opposed cultivated meat bans, writing a letter in opposition to the Florida ban in February 2024. In its letter, the organization says that the bills would be preempted by the Federal Meat Inspection Act, which regulates the processing and distribution of meat products in interstate commerce. Further, the Meat Institute argued that the bans are “bad public policy that would restrict consumer choice and stifle innovation” and that USDA oversight of cell cultivated meat products places the products on a level playing field in terms of food safety and labeling requirements.
  • In addition, legislators in Wyoming and South Dakota have voted against cultivated meat bans in their states, citing free trade manipulation and urging instead for more packaging and labeling regulations to support informed decisions.
  • Keller and Heckman will continue to monitor cultivated meat legislation.
  • The introduction of state legislation purporting to regulate food colors and dyes, which saw more than a dozen states introducing bills in 2024, continues to move forward.  Recently, California issued an executive order to recommend actions to reduce foods with synthetic food dyes, and Utah recently introduced H.B. 402 seeking to prohibit foods containing various synthetic dyes.  Two new additional legislative efforts have emerged from Florida and Virginia.
  • Florida’s HB641
    • On January 15, 2025, Florida representatives introduced a new bill, HB641, which seeks to increase transparency for consumers regarding the presence of synthetic dyes in food products.  If passed, this bill would require food manufacturers to include a warning label on products containing synthetic dyes.
  • Virginia’s SB1289:
    • On February 10, 2025, both chambers of Virginia’s legislature passed SB1289, a bill that will eliminate certain color additives, including Red 40, Yellow 5, and Blue 1, from the food served in the state’s elementary and secondary schools. 
  • We expect to see continued activity at the state level, and following the FDA’s recent action on Red No. 3, advocacy at the federal level may increase.
  • Keller and Heckman will continue to monitor developments related to dyes and other food additives.
  • As we’ve previously blogged, the regulatory landscape for cultivated meat is rapidly evolving with states like Nebraska, Florida, and Alabama taking significant steps to restrict or ban these products.  The recent legislative actions in Georgia and South Dakota are the latest in various states’ efforts to regulate or restrict these products more stringently.
  • Georgia General Assembly- HB 163:
    • On February 27, 2025, the Georgia House of Representatives passed House Bill 163, which, if passed by the Senate, would require restaurants and other food vendors to disclose whether their menu items contain cultivated meat, plant-based meat alternatives, or both.  The bill defines “cell-cultured meat” as any food product artificially grown from cell cultures of animal muscle or organ tissues, designed to mimic conventional meat products.
    • Similarly, “plant-based meat alternatives” are defined as products derived from plants that share sensory characteristics with traditional meat.  The bill has passed the Georgia House of Representatives and is currently under review by the Senate Agriculture and Consumer Affairs Committee.
  • South Dakota- HB 1118
    • Meanwhile, South Dakota has taken a different stance with House Bill 1118, which has already passed into law.  This legislation prohibits the use of state funds for the research, production, promotion, sale, or distribution of cell-cultured protein.  
    • The bill defines “cell-cultured protein” as any product made wholly or in part from cell cultures or the DNA of a host animal, grown outside a live animal.
  • These bills represent the latest developments of state-level challenges being presented to the cultivated meat industry.  Keller and Heckman will continue to monitor for any further legislative developments.
  • Several states have recently introduced or passed legislation related to raw milk, reflecting a growing interest in unpasteurized milk despite the fact that raw milk can carry harmful bacteria such as Salmonella, E.coli, and Listeria, posing serious health risks. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) strongly advise against consuming raw milk due to these dangers and have implemented regulations to limit its sale. 
  • Despite the long-standing position at both agencies, the new Secretary of the Department of Health and Human Services (HHS) Robert F. Kennedy Jr., has been a vocal advocate for raw milk promoting its benefits and criticizing regulatory restrictions.  His support has brought renewed attention to the raw milk movement, influencing legislative efforts.
    • Arkansas Bill HB 1048: This bill would allow the sale of raw goat milk, sheep milk, and whole milk directly to consumers at the farm, at farmer’s markets, or via delivery by the farm.
    • Utah Bill HB414: This bill has passed the House and is now before the Senate.  This bill establishes enforcement steps for raw milk suspected in foodborne illness outbreaks, aiming to protect consumers.
  • Keller and Heckman will continue to monitor any developments related to the regulation of raw milk.
  • The Connecticut legislature is considering an anti-price-gouging bill (House Bill 6856) that would add new disclosure requirements for food companies that adjust product sizes without price changes (a practice referred to as “shrinkflation”). 
  • If passed, the bill would require companies to “provide a clear and conspicuous notice” for at least 12 months when they reduce the “quantity, amount, weight, or size of a product” without adjusting the price.  The bill applies to “essential groceries covered by federal Supplemental Nutrition Assistance Program (SNAP) regulations, including baby formula, bread, cereals, dairy products, meats and fish, non-alcoholic beverages, seeds, and snacks.”  The language excludes retailers and establishments, like restaurants, that ​“primarily sell food to the public for consumption.”
  • According to Connecticut Attorney General William Tong, “[a]lthough companies must update their labels to reflect product size changes, they are not currently required to advertise that they have made a change.  Since the pandemic, price sensitive consumers have started to notice these changes—for example when they open their favorite box of crackers or bag of chips only to realize that the box or bag is only half full.  This leaves consumers feeling deceived and like they are receiving less value for their hard-earned dollars.”
  • If passed, Connecticut would be the only state in the US to explicitly address shrinkflation. Keller and Heckman LLP will continue to monitor legislative developments.
  • Last month a lawsuit filed by plaintiffs including the Tucson Environmental Justice Task Force (TEJTF) filed suit against FDA and now former FDA commissioner Robert Califf alleging that FDA had unduly delayed in responding to a petition filed by TEJTF in 2023 which had requested that FDA set tolerances for 30 types of PFAS in lettuce and blueberries and 26 types of PFAS in bread, milk, eggs, salmon, clams, and corn silage.
  • The lawsuit argues that FDA has unduly delayed because it has not acted consistent with its statutory mandate to “promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner” (21 USC § 393) and the delay allegedly is to the detriment of the public health. The lawsuit argues that prior decisions holding that courts should defer to FDA on whether to promulgate tolerances is no longer good law post-Chevron and that the “only discretion FDA may exercise for such chemicals [harmful substances] is the level of tolerance to be set.”
  • We will continue to monitor and report on the regulation of PFAS and other chemicals, including any changes in approach that may be implemented by the new administration.

  • FDA has delayed the effective date of the final rule on use of the term “healthy” in food labeling until April 28, 2025, in response to a presidential memorandum recommending a regulatory freeze to review questions of fact, law, and policy that recently published rules may raise. We previously blogged about the “healthy” final rule here and the regulatory freeze here.
  • According to the Agency, the temporary delay “is necessary to give Agency officials the opportunity for further review and consideration of the new regulation, consistent with the memorandum described previously.” FDA is not seeking public comment due to the limited impact of the delayed effective date, since the February 25, 2028 compliance date remains unchanged. FDA also reiterated that “parties are free to begin implementing the rule earlier than the compliance date.”
  • Keller and Heckman will continue to share updates on the “healthy” rule and other FDA actions.