AWG Regulatory Roundup — May 20, 2025
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- FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities
- FDA Extends Front-of-Pack Nutrition Labeling Proposed Rule Comment Period
- FDA Approves “Natural” Food Dyes
- FDA and NIH Announce Joint Nutrition Regulatory Science Program
- HHS/FDA Launch RFI As Part of Deregulation EO
- Operation Stork Speed Takes Flight
- Texas AG Takes Action Against General Mills, Investigates Marketing of Children’s Fluoride Toothpaste
- State Legislation Would Require Reporting of GRAS Substances
- VA Passes Baby Food Safety Law
- FTC Extends Compliance Deadline for Click-To-Cancel Rule
- FTC Publishes FAQs on Unfair or Deceptive Fees Rule
FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities
FDA announced that it intends to expand unannounced inspections of foreign facilities manufacturing foods and medicines intended for the American market. In the May 6, 2025, announcement, FDA Commissioner Makary is quoted as saying, “For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning.”
FDA Extends Front-of-Pack Nutrition Labeling Proposed Rule Comment Period
On May 8, 2025, FDA published an update extending the comment period on its proposed rule on front-of-pack (FOP) nutrition labeling. The comment period now closes on July 15, 2025 (originally May 16, 2025). As a reminder, the proposed FOP nutrition label would list the relative amounts of saturated fat, sodium, and added sugars in a serving of food and designate the amounts as “High,” “Med,” or “Low.” The rule also requires the information to appear on the front label of food packaging so that it is immediately visible to consumers.
FDA Approves “Natural” Food Dyes
On May 9, 2025, FDA approved three “natural” color additive petitions for foods. These actions reflect the Department of Health and Human Services’ (HHS) priority to phase out petroleum-based dyes as part of the administration’s “Make America Healthy Again” initiative. The approved petitions are for:
- Galdieria extract blue, a blue color derived from the unicellular red algae Galdieria sulphuraria. The petition allows its use in a range of foods, including beverages, juices, certain dairy and non-dairy alternative products, candies, and desserts.
- Butterfly pea flower extract, a blue color produced through the water extraction of the dried flower petals of the butterfly pea plant. Although already approved for use in several foods and beverages, this recent petition expands its use as a coloring for ready-to-eat cereals, crackers, snack mixes, hard pretzels, and various types of chips.
- Calcium phosphate, a white color approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.
FDA and NIH Announce Joint Nutrition Regulatory Science Program
Also as part of HHS’ “Make America Healthy Again” initiative, on May 9, 2025, FDA and the National Institutes of Health (NIH) announced a joint nutrition regulatory science program intended to accelerate “a comprehensive nutrition research agenda that will provide critical information to inform effective food and nutrition policy actions to help make Americans’ food and diets healthier.” The program aims to answer the following questions:
- How and why can ultra-processed foods harm people’s health?
- How might certain food additives affect metabolic health and possibly contribute to chronic disease?
- What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?
HHS/FDA Launch RFI As Part of Deregulation EO
On May 13, 2025, HHS and FDA announced a Request for Information (RFI) to identify and eliminate outdated or unnecessary regulations. The RFI is part of broader federal efforts to reduce regulatory burdens in accordance with Executive Order 14192, “Unleashing Prosperity Through Deregulation.”
Under the “10-to-1” deregulatory policy outlined in the EO, for every new regulation proposed, at least ten existing regulatory actions will be rescinded. Notably, the order applies not only to formal regulations but also to guidance documents, memoranda, policy statements, and similar directives. During the 60-day comment period, stakeholders are encouraged to submit their ideas for deregulatory actions through the Regulations.gov docket (AHRQ-2025-0001) or the newly launched online portal at Regulations.gov/Deregulation.
Operation Stork Speed Takes Flight
As part of the nutrient review process for infant formula, on May 13, 2025, FDA issued an RFI seeking information and data related to the nutritional adequacy of infant formula. The agency is also seeking “data on potential adjustments to existing minimum or maximum levels, recommendations for additional nutrients to consider, and how such changes may improve health outcomes.” The comment period closes on September 11, 2025.
Texas AG Takes Action Against General Mills, Investigates Marketing of Children’s Fluoride Toothpaste
About a month after announcing an ongoing investigation into Kellogg’s for potentially violating Texas consumer protection laws, on May 13, 2025, Texas Attorney General Ken Paxton issued a press release announcing his office has sent General Mills a Civil Investigative Demand (CID) as part of a new investigation into the food company for allegedly misrepresenting its products as “healthy.” The press release states that General Mills products, such as Trix and Lucky Charms, are often marketed as a “good source” of vitamins and minerals and as “healthy” despite containing petroleum-based food colorings.
The week prior, AG Paxton sent CIDs to both Colgate-Palmolive and Procter & Gamble over their marketing of toothpaste products in allegedly deceptive and dangerous ways that “encourage kids to ingest fluoride toothpaste and mislead their parents to use far more than the safe and recommended amount of fluoride toothpaste.” Paxton claims that the fluoride content in the products is unsafe, and exposure leads to lower IQ scores in children.
State Legislation Would Require Reporting of GRAS Substances
The Pennsylvania legislature is considering House Bill 1130, which would require companies using GRAS substances in food to file a report with the state, along with the data and information supporting the GRAS determination. The reports would be included in a publicly available database, and the state may refuse to list a substance if the report does not contain the required information. The bill exempts substances that FDA has already reviewed, including GRAS-notified substances and those that were the subject of a successful New Dietary Ingredient Notification.
VA Passes Baby Food Safety Law
On May 2, 2025, Virginia’s Governor signed into law the Baby Food Protection Act, which places testing and labeling requirements on baby food products and prohibits baby food manufacturers from selling products that exceed certain limits of heavy metals. The law is effective January 1, 2026.
FTC Extends Compliance Deadline for Click-To-Cancel Rule
On May 9, 2025, the FTC quietly issued a statement extending the Negative Option (also known as “Click-To-Cancel”) Rule’s compliance deadline to July 14, 2025. This follows a previous extension, as well as a flurry of litigation and legislative activity opposing the Rule. Of note, the final sentence of the statement indicates that the Commission is “open to amending the Rule” if enforcement leads to compliance problems – an unusual move, but not surprising given current FTC Chair Andrew Ferguson voted against the Rule’s adoption last October.
While its future at the federal level is somewhat uncertain, companies still must prepare for compliance with the Click-To-Cancel Rule, especially as many provisions mirror existing state requirements.
FTC Publishes FAQs on Unfair or Deceptive Fees Rule
The FTC recently published a frequently asked questions document to help explain its rule on unfair or deceptive fees, which took effect on May 12, 2025. The FAQs cover topics including what businesses are covered by the rules and their requirements, examples of live-ticketing events and short-term lodging that are covered, and fees or charges that must be included (or can be excluded) from the total price.
