• On March 19, 2025, the West Virginia Senate and House sent HB 2354 to the governor for final approval, which proposes banning various food additives and synthetic dyes.
  • The bill would prohibit the sale of any food product in the state that contains butylated hydroxyanisole (BHA), propylparaben, Red No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, or Green No. 3.  If enacted, the legislation would apply to food products in school nutrition programs beginning August 1, 2025, then extend to all food products in the state on January 1, 2028.
  • While there was some push back arguing that the state should wait for changes to come top down from the U.S. Food and Drug Administration (FDA) and that the ban will cause food prices to go up or limit the competitiveness of the state, the voting pattern shows that the opposition was minimal.  This article by West Virginia Watch stated that Senator Barrett, who spearheaded the effort, feels confident that the Governor will sign HB 2354.
  • The West Virginia bill is the latest state legislative effort to regulate food dyes, following California, Utah, Florida, and Virginia.
  • If passed, Maine’s SB130, titled An Act to Establish the PFAS Response Program and to Modify the Fund To Address PFAS Contamination, would be the first state law to establish PFAS limits in food (PFAS limits have been established for other categories of goods).
  • The bill would formally establish a PFAS response program to “respond to and address PFAS contamination affecting agricultural producers in the State, to assist commercial farms affected by PFAS contamination and to safeguard public health.” We note that the bill would in part codify existing portions of Maine’s PFAS response program, which has already set an action level for PFOS (a type of PFAS) in milk of 210 ppt. 
  • Specifically, under the proposed bill, the PFAS response program would, among other things:
    • Establish maximum levels for PFAS in farm products (defined as “plants and animals useful to humans” and includes, by way of example, products ranging from grains and food crops to Christmas trees).
    • Provide PFAS testing support to help agricultural producers understand the extend of PFAS contamination and provide technical support to assist in mitigation efforts.
    • Provide financial assistance to PFAS-impacted agricultural producers.
    • Establish baseline criteria that agricultural producers would have to adhere to in order to receive technical and financial assistance, including granting property access to conduct PFAS investigations and providing relevant information to program staff.
  • We will continue to monitor and report on PFAS regulation.
  • On March 7, 2025, FDA announced that is has no questions regarding a human food product made from cultured pork fat cells, finding that the defined production process results in a product that is as safe as comparable foods produced by other methods. The cultured cells are produced in a controlled environment using belly fat cells from domestic Yorkshire pigs to create cultured pork fat.
  • In addition to a pre-market consultation, FDA has inspected the facility where pork fat cells are cultured and grown and intends to conduct additional inspections after commercial production begins and on an ongoing basis. Before the product can be marketed for use in food, it must also meet USDA regulations as outlined in the joint agreement between USDA and FDA establishing the agencies’ shared oversight of food made with cultured animal cells.
  • FDA’s pre-market consultation process for food made with cultured animal cells allows developers to work with the Agency on a case-by-case basis to ensure they are producing food that does not violate the Federal Food, Drug, and Cosmetic Act. During the process, FDA evaluates the production process and resulting cell material, including the establishment of cell lines and cell banks, manufacturing controls, and reviews all components and inputs.
  • This is the third product made using cultured animal cells for which FDA has concluded it has no questions regarding the safety, following the first for a product made from cultured chicken cells in 2022. Keller and Heckman will continue to provide updates on the development of cell cultured meat products.
  • On March 10, 2025, the Secretary of the Department of Health and Human Services (HHS), Robert F. Kennedy Jr., met with executives at major companies across the food and beverage industry, including PepsiCo, General Mills, and others.  He informed industry leaders that eliminating artificial dyes is going to be a top priority for the Secretary.  Kennedy also expressed his desire to collaborate with industry but made it clear that he intends to act unless the industry proactively offers solutions. 
  • The movement to ban synthetic dyes has recently gained momentum, with California and FDA banning FD&C Red No. 3 as we previously blogged, as well and several states moving to ban foods that contain artificial dyes from school lunches.  
  • The public discussion regarding food colors has grossly misstated differences in the regulation of synthetic dyes in food, with critiques often pointing to the EU or Canadian markets as examples of regions that are more restrictive with food color regulation.
  • However – there are current 15 synthetic dyes approved in the European Union, 10 in Canada, and only 9 approved in the U.S.
  • Additionally, all food colors in the U.S. must submit a Color Additive Petition to FDA.  
  • While the EU and Canada have premarket requirements for many food colors, naturally derived concentrates and extracts in many cases are exempt from mandatory pre-market review in Canada.  
  • In the EU, ingredients that are derived from edible sources and are used because of their coloring properties are defined as “coloring foods,” which are not subject to a European Food Safety Authority (EFSA) evaluation prior to use and are not assigned an E number.
  • Keller and Heckman will continue to monitor the development of the new administration’s policy priorities and actions related to synthetic dyes and other food additives.
  • 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.