AWG Regulatory Roundup — September 9, 2025
Subscribe here!
- GRAS and MoCRA Rules Included in FDA Unified Agenda
- FDA Adds Additional Substances to Food Chemical Assessment List
- FDA is Tracking Food Dye Phase Outs
- DOJ Seeks Information on State Laws Having Significant Adverse Effects on the National Economy or on Interstate Commerce
- FTC Sues Fitness Chain Over its Membership Cancellation Policy
- California EPR Updates
- Illinois Law Requires Disclosure of Heavy Metals in Baby Food
- Washington State Issues Rule Restricting Formaldehyde Releasers in Cosmetics
- NJ Recycled Content Reporting Portal Open
GRAS and MoCRA Rules Included in FDA Unified Agenda
Last week, FDA published its Spring 2025 Unified Agenda of Regulatory and Deregulatory Actions, which marks the first unified agenda released under the current Trump administration. Unified agendas report on the actions administrative agencies plan to issue in the near and long term. Significant rulemaking actions FDA announced include:
- A proposed rule to, among other things, amend the Generally Recognized as Safe (GRAS) regulations to require mandatory submission of GRAS notices for both human and animal food substances that are purported to be GRAS. FDA expects to publish the proposed rule in October 2025.
- A final rule to provide exemptions from investigational new drug (IND) requirements for certain studies on drug uses of lawfully marketed food, dietary supplements, and cosmetics, expected to be published in October 2025.
- A proposed rule likely directed at N-Acetyl Cysteine (NAC) that would provide it is not excluded from the dietary supplement definition, provided the product containing the ingredient is otherwise lawful under the FD&C Act. The agency expects to publish the proposal in January 2026.
- A proposed rule to identify certain substances as fragrance allergens and to require the disclosure of such allergens on cosmetic labels, expected to be published in May 2026.
- Of note, a proposed rule to establish Good Manufacturing Practices for Cosmetic Product Facilities appears on the Long-Term Actions list, which means the rule is under development but a regulatory action is not expected within the 12 months.
- A final rule for front-of-pack nutrition labeling and revision of certain nutrient content claim regulations, expected to be published in May 2026.
Like prior unified agendas (where some of these items previously appeared), the dates are aspirational and timing may change, or the action may not happen at all. However, the list provides valuable insight into the administration’s regulatory priorities.
FDA Adds Additional Substances to Food Chemical Assessment List
On August 19, 2025, FDA announced updates to its list of select chemicals under review as part of its Post-Market Assessment of Chemicals in the Food Supply program. The added chemicals include butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), azodicarbonamide (ADA), FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Yellow No. 6. In addition, lead as a food contact substance has been separated from lead as a contaminant and has been given its own entry on the updated list.
The announcement also notes that in the near future, FDA intends to seek data and information from stakeholders to facilitate its scientific assessments of BHA, BHT, and ADA. The agency is also reviewing the presence of opiate alkaloids in poppy seeds and is taking steps to expedite its review of phthalates, propylparaben, titanium dioxide, and other previously listed chemicals.
FDA is Tracking Food Dye Phase Outs
Also on the topic of food chemicals, FDA debuted a tracker that includes all companies that have pledged to remove petroleum-based dyes from their foods. The tracker, published on August 18, 2025, lists the companies that have made such pledges, the products and brands affected, the changes the companies have pledged to make, and the status of the changes.
DOJ Seeks Information on State Laws Having Significant Adverse Effects on the National Economy or on Interstate Commerce
On August 15, 2025, the Department of Justice (DOJ) published a Request for Information (RFI) on state laws that have a significant adverse effect on the national economy or that have a significant adverse effect on interstate commerce. DOJ is accepting comments via regulations.gov until September 15, 2025.
FTC Sues Fitness Chain Over its Membership Cancellation Policy
The Federal Trade Commission (FTC) filed a complaint against LA Fitness alleging that it uses “exceedingly difficult” cancellation procedures that prevent consumers from cancelling their memberships and other recurring charges in violation of the FTC Act and the Restore Online Shoppers’ Confidence Act (ROSCA). For example, customers are required to cancel their membership in person or send a cancellation notice by mail. Of note, the complaint comes about a month after the Eighth Circuit Court of Appeals vacated FTC’s Negative Option Rule, known as the “Click-to-Cancel” rule, which would have required businesses to provide easy cancellation methods for recurring subscriptions as well as clear disclosures and express consent before being charged.
California EPR Updates
As a reminder, companies subject to California’s Extended Producer Responsibility (EPR) reporting requirements had until September 5, 2025 to register with the Circular Action Alliance (CAA), the only Producer Responsibility Organization operating the EPR system in California. On September 15, CAA will open its reporting portal, and producers will have until November 15, 2025 to submit data.
Illinois Law Requires Disclosure of Heavy Metals in Baby Food
On August 15, 2025, Illinois’s Governor signed into law Senate Bill 73 , which requires manufacturers of baby food, or food meant for children under the age of 2, excluding formula, to report on their website the levels of arsenic, cadmium, lead, and mercury present in each product. If a product contains one of these heavy metals above a regulated action level, the product label must bear the statement “for information about the toxic element testing on this product, scan the Quick Response (QR) code,” where the QR code is linked to information about the levels of heavy metals in the product. Manufacturers must comply with the new law beginning January 1, 2027. Illinois is the fourth state to require disclosure of heavy metals in baby food, joining California, Maryland, and Virginia.
Washington State Issues Rule Restricting Formaldehyde Releasers in Cosmetics
On August 28, 2025, the Washington State Department of Ecology (DOE), as required by the state’s Toxic-Free Cosmetics Act, adopted a new rule that restricts the manufacture, sale, and distribution of cosmetic products that contain intentionally added formaldehyde releasers. The new restrictions take effect on January 1, 2027, and in-state retailers will have until December 31, 2027 to sell existing stock of products that contain these chemicals.
Notably, many of the ingredients are commonly used preservatives that are permissible even under the EU’s Cosmetic Directives. As such, companies should carefully review the list of restricted ingredients to ensure compliance by the January 2027 deadline. DOE will host a compliance webinar for retailers and distributors on the law and new restrictions on October 1, 2025.
NJ Recycled Content Reporting Portal Open
Under New Jersey’s Recycled Content Law, certain packaging and containers must now include minimum levels of post-consumer recycled content. Beginning in 2025, businesses that manufacture, sell, or distribute covered products in the state are required to submit annual compliance certification reports. Regulated containers and packaging covered by the law include rigid plastic containers, plastic beverage containers, glass containers, paper and plastic carryout bags, and plastic trash bags.
The New Jersey Department of Environmental Protection (NJDEP) announced that its online reporting portal for 2025 compliance opened on September 2, 2025, and reports must be submitted by December 31. Although the law exempts certain categories of products from the new minimum recycled content standards, including dietary supplements, medical devices, and cosmetics, annual registration with NJDEP is still required.
