Recent Federal and State Initiatives Addressing Food Safety: MAHA Commission Driving Significant Changes in Food and Beverage Regulation and Enforcement Efforts

The food and beverage industries are seeing a fast-changing regulatory landscape at both the federal and state levels. These efforts are being driven primarily by the US Department of Health and Human Services (the “HHS”), Secretary Robert F. Kennedy Jr. and the Trump Administration’s “Make America Healthy Again (MAHA) Commission,” but their impacts are being felt at both the federal and state levels.

Changing regulatory and enforcement priorities are already having an impact across the food and beverage industries—including dietary supplements and infant formula products—affecting existing product lines, deal-making activities, and future investments. Following the issuance of the MAHA Report in May 2025, both federal and state regulators have taken unprecedented steps to force companies to address MAHA concerns about food ingredients, whether through formal rulemaking, targeted enforcement actions, or, more commonly, public demands and negotiations, as well as voluntary compliance.

All food and beverage manufacturers need to be focused on this rapidly evolving set of initiatives. In this Legal Update, we summarize key aspects of the recent FDA and state actions, as well as the implications surrounding them.

Synthetic Food Dyes

As we previously discussed in our May Legal Update, the HHS and the US Food and Drug Administration (the “FDA”) have prioritized the removal of synthetic food dyes from the nation’s food chain, including FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2. The MAHA report frames artificial dyes and other additives as key levers for reducing childhood risk, and FDA leadership has publicly defended a crackdown on dyes, with FDA Commissioner Martin Makary stating that “petroleum-based food dyes ... have no nutritional benefit.”

To date, the FDA has taken a two-pronged approach, calling for voluntary industry compliance while proceeding with regulatory efforts at formally revoking approvals of certain synthetic food dyes. But the thrust of the FDA’s efforts is to obtain voluntary industry acquiescence to eliminate all petroleum-based synthetic dyes from the US food and beverage supply by the end of 2026. To assist in those efforts, the agency announced in mid-August the launch of an Industry Tracker to tabulate industry and trade association “Pledges to Remove Petroleum-Based Food Dyes.”

Increased (and at times bipartisan) pressure on food and beverage manufacturers is also being seen at the state level. To date, California, Texas, Utah, Virginia, and West Virginia have all enacted laws banning certain synthetic food dyes, among other ingredients, in food sold in their states, or more narrowly, in public school meals. Many other states, including Florida, Louisiana, Missouri, and New York, have proposed legislation that would either ban synthetic dyes in school programs or require warning labels on packaged foods containing these color additives.

Ultra-Processed Foods

The MAHA Report explicitly targeted Ultra-Processed Foods (“UPFs”) in the context of children’s nutrition, alleging that these foods are a major contributor to both childhood obesity and chronic disease.

The FDA, in collaboration with the HHS and the US Department of Agriculture (the “USDA”), has launched several research initiatives, including a Nutrition Regulatory Science Program with the National Institute of Health (“NIH”). The FDA and the NIH also held a Nutrition Regulatory Science Workshop in December 2024, which included sessions addressing UPFs.

In July 2025, the FDA and the USDA issued a joint Request for Information (“RFI”) to “to gather information and data to help establish a federally recognized uniform definition for ultra-processed foods.” The FDA’s press release accompanying the announcement alleged that “numerous adverse health outcomes, including cardiovascular disease, Type 2 diabetes, cancer, obesity and neurological disorders” can be attributed to UPFs. The RFI requests comments and feedback from industry stakeholders before September 23, 2025 (although multiple stakeholders have requested a 60-day extension of the comment period).

A uniform federal definition is a likely precursor to additional federal regulatory actions, including ingredient bans, or labeling and marketing restrictions. Such an approach with UPF products would be consistent with related MAHA initiatives targeting PFAS and other chemicals in the food supply chain.

GRAS

The FDA’s regulation of food additives and ingredients generally require agency approval prior to marketing, with certain exceptions. A key exception—and one that Secretary Kennedy has roundly criticized—is the Generally Recognized As Safe (“GRAS”) standard. A substance is considered GRAS if it is widely recognized, among qualified experts, as safe based on either published scientific evidence or a history of safe use in food. Importantly, FDA regulations permit food and dietary supplement makers to self-certify their ingredients as GRAS.

In March 2025, Kennedy described this exception as a “loophole” that, in his view, has been “exploited” by ingredient manufacturers and sponsors, and directed the FDA to pursue rulemaking to eliminate this pathway. Such efforts would mark a sea change in the FDA’s approach to regulating food, beverages and dietary supplements—and any pre-marketing approval process would seem to require a significant increase in both industry resources (given the significant time and effort required to prepare and submit GRAS notices) as well as agency timelines for review (as has occurred in other recent cases involving a change in submission policies, such as new tobacco products, where the FDA has been heavily criticized for extended delays). Increased enforcement activity also seems possible, particularly in cases where significant concerns about ingredient safety or potential harm to children arise.

Infant Formula

Under the heading Operation Stork Speed, the HHS and the FDA announced in March a set of actions and initiatives focused on infant formula.

Among other activities, in May 2025 the FDA issued a Request for Information as part of an effort to assess the nutrient review process for infant formula. This will represent the first comprehensive review of infant formula nutrients and ingredients since 1998. The FDA also announced related activities, including extending the personal importation policy and increasing testing for heavy metals and other contaminants in infant formula products. Pressure on the FDA to act in this area continues to mount. In June, both Arizona and the District of Columbia

Attorneys General sent a letter to Commissioner Makary urging the FDA to “take immediate action to issue guidance … to prevent further harm to babies and young children from exposure to elevated levels of toxic elements in commercially available food products.”

At the state level, in August 2025 the Texas Attorney General’s Office opened an investigation into infant food manufacturers regarding potential presence of heavy metals in their products. A press release announcing the probe noted that Texas was exploring potential violations related to “deceptively advertising and selling products that contain dangerous levels of heavy metals.” Similar enforcement actions may be pursued by other states, as well as by federal authorities (possibly through the issuance of warning letters, as an initial measure).

Food Advertising

After the MAHA Report was issued in May 2025, industry has been awaiting the follow-up report —the “Make Our Children Healthy Again Strategy”—a draft of which was leaked in August 2025. According to news reports, the draft strategy document repeats many of the same concerns of the initial MAHA Report, but also asserts that the HHS and the Federal Trade Commission (the “FTC”) will “explore development of potential industry guidelines to limit the direct marketing of certain unhealthy foods to children.” This potential federal interest in targeting purportedly deceptive advertising and marketing claims directed at children dovetails with the recent action taken by Texas regarding infant formula products.

Implications for Regulated Industry

• Enforcement: In addition to state legislation described above, certain states have taken a more aggressive investigative approach. For example, the Texas Attorney General’s Office has issued Civil Investigative Demands (“CIDs”) to multiple large food companies, alleging misrepresentations of food products as “healthy,” despite the presence of synthetic food dyes. Notably, Texas announced resolutions with both General Mills, Inc. (in June 2025) and WK Kellogg Co. (in August 2025), in which the companies agreed to remove artificial food colorings from cereals and other food products, with deadlines in 2026 and 2027, but without making admissions of guilt. The resolution with Kellogg’s was described by Texas as a “historic Assurance of Voluntary Compliance”—an agreement as to certain specified terms, thereby resolving the investigation,. Notably, media reports about a leaked draft of the second MAHA report suggests that the HHS and the FDA also may rely heavily on voluntary compliance—referencing “potential industry guidelines to limit the direct marketing of certain unhealthy foods to children, including by evaluating the use of misleading claims and industry.”
• Litigation Risks: The increasing regulation of synthetic food dyes and UPFs presents a growing potential for litigation in the personal injury and mass tort space, as consumers and advocacy groups become more aware of the health risks associated with long-term consumption of these products. As governments introduce stricter labeling laws, marketing restrictions, and nutritional standards, food manufacturers may face legal challenges from individuals alleging that synthetic food dyes and UPFs contributed to chronic health conditions such as obesity, diabetes, and cardiovascular disease. These claims could be bolstered by emerging scientific evidence linking the substances to adverse health outcomes and by precedents set in tobacco and opioid litigation, where companies were held liable for failing to adequately warn consumers or for misleading marketing practices. As regulatory frameworks evolve, the legal landscape may shift toward greater accountability for food producers, opening the door for a new wave of personal injury claims rooted in dietary harm.
• Consumer Class Actions: We expect that consumer class actions will increase, targeting UPFs and food products with synthetic dyes. Labeling claims, including “natural” or “healthy” claims have long been the subject of consumer class actions, and the MAHA Report and state AG efforts may provide additional fodder for these types of actions.
• Transactions: Increased regulatory scrutiny and enforcement risk will add uncertainty to all M&A and investment activity across the food and beverage industries. Until there is better visibility into the potential cost and other implications of these legislative initiatives, M&A activity in the Food & Beverages sector, particularly for transactions involving industry participants that have a significant UPF product portfolio, will be muted. At a minimum, these legislative initiatives will have meaningful negative impact on target company valuations as well as the availability of financing.