AWG Regulatory Roundup — March 25, 2025
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- State Legislation Banning Food Additives and Colors Enacted, Other Bills Pending Approval
- RFK Jr. Directs FDA to Explore Revisions to the Self-GRAS Pathway
- HHS, FDA Announce “Operation Stork Speed”
- HHS and FDA Unveil Contaminants Transparency Tool
- Dietary Guidelines for Americans Update and Process Change
- FDA Releases Summary Data on MoCRA Listings and Registrations
- President Fires FTC Commissioners
- John Squires Nominated to be the Next USPTO Director
- Google and NAD Partner for More Efficient Self-Regulation
- Attacks on Heavy Metals and “Greenwashing” Continue
State Legislation Banning Food Additives and Colors Enacted, Other Bills Pending Approval
On March 21, 2025, Virginia’s Governor signed into law House Bill 1910 and Senate Bill 1289, banning the use of Red No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3 in school meals effective July 1, 2027. In Utah, a similar bill (House Bill 402) is awaiting the Governor’s signature and would ban the same food dyes, as well as potassium bromate and propylparaben, in foods served at schools effective May 7, 2025. West Virginia House Bill 2354, which prohibits the sale of foods containing butylated hydroxyanisole (BHA), propylparaben, Red No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3, is currently before the Governor. If signed into law, the food dyes will be banned in school meals effective August 1, 2025, and for all food products, these substances will be banned beginning January 1, 2028. Similar bills are pending in other states across the country, including Delaware, Florida, Maryland, New York, Oklahoma, Rhode Island, and Virginia.
RFK Jr. Directs FDA to Explore Revisions to the Self-GRAS Pathway
On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed FDA “to take steps 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.” The press release also notes that HHS will work with Congress to explore legislation to “close the GRAS loophole” in tandem with potential future rulemaking. This action has the potential to impact numerous ingredients used in foods and dietary supplements, and AWG will be closely monitoring FDA’s next steps. In the meantime? Don’t panic, and read more about AWG’s take on this significant development in this article from NutraIngredients USA.
HHS, FDA Announce “Operation Stork Speed”
HHS Secretary Kennedy and Acting FDA Commissioner Sara Brenner announced steps FDA is taking to expand options for safe, reliable, and nutritious infant formula in the United States. Specific steps the agency will take include:
- Issuing a Request for Information to start the first comprehensive update and review of infant formula nutrients
- Increasing testing for heavy metals and other contaminants in infant formula and other foods children consume
- Extending the personal importation policy
- Encouraging companies to work with the FDA on any questions regarding increased transparency and clearer labeling
- Communicating regularly with consumers and industry stakeholders as significant developments occur to ensure transparency, including information regarding nutrients and health outcomes
- Collaborating with the National Institutes of Health and other scientific bodies to address priority scientific research gaps regarding short- and long-term health outcomes associated with formula feeding in infancy and childhood across the lifespan
HHS and FDA Unveil Contaminants Transparency Tool
On March 20, 2025, HHS and FDA released the Chemical Contaminants Transparency Tool (CCT Tool), described as “an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels, and guidance levels) that are used to evaluate potential health risks of contaminants in human foods.” The CCT Tool is part of FDA’s initiative to modernize food chemical safety.
Dietary Guidelines for Americans Update and Process Change
Following the inaugural meeting of the Make America Healthy Again Commission on March 11, 2025, USDA Secretary Brooke Rollins and HHS Secretary Kennedy announced the agencies’ commitment to releasing the final 2025-2030 Dietary Guidelines for Americans ahead of its statutory deadline of December 31, 2025. The Secretaries also announced that they are looking at ways to “make holistic process improvements to ensure transparency and minimize conflicts of interest.”
FDA Releases Summary Data on MoCRA Listings and Registrations
On March 13, 2025, FDA published summary data from mandatory registration of cosmetic product facilities and the listing of cosmetic products, as required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). As of January 1, 2025, FDA has received 9,528 unique active facility registrations and 589,762 unique active product listings.
President Fires FTC Commissioners
This week, President Trump fired Federal Trade Commission (FTC) Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter, the two Democrats serving on the five-member commission. According to news reports, Bedoya and Slaughter intend to file suit to block the President’s action.
John Squires Nominated to be the Next USPTO Director
President Trump has nominated John Squires, former Chief IP Counsel at Goldman Sachs, to serve as the Director of the U.S. Patent and Trademark Office (USPTO). Squires is well-known within the patent community, and his nomination suggests the second Trump Administration will be pro-innovation and pro-patent. Squires helped create Fortress Investment Group’s IP funding arm while working in private practice. Last year, Fortress Investment Group committed $6.6 billion to litigation finance and another $2.9 billion to intellectual property litigation, pursuing infringement cases against Apple and Intel. IP litigation funders are closely watching how Squires makes his mark on the agency. The nomination was transmitted to the Senate on March 10, 2025, and may be confirmed by the start of Summer 2025.
Google and NAD Partner for More Efficient Self-Regulation
On February 25, 2025, the Better Business Bureau’s National Advertising Division announced its collaboration with Google, aimed at informing Google of potential violations of its Ads policy. According to the announcement, “this collaboration enables [NAD] to share case outcomes involving advertising on Google directly via the Google Priority Flagger Program.”
Attacks on Heavy Metals and “Greenwashing” Continue
In litigation news, there’s no shortage of allegations against food companies involving the failure to disclose the presence of heavy metals in their products. “Greenwashing” complaints also continue to trend, with plaintiffs targeting “climate neutral” and regenerative farming claims that they say overstate the environmental impact, rendering the claims false and misleading.
