AWG Regulatory Roundup — January 13, 2026
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- FDA Releases Draft Guidance on Mandatory Cosmetic Recalls and Report on PFAS in Cosmetics
- FDA Sends Warning Letters to Retailers in the Wake of the ByHeart Formula Recall
- FDA Proposes to Allow Bemotrizinol in Sunscreen
- Amazon Requires Third-Party Testing, Inspection, and Certification for All Dietary Supplements
- FTC Sends Warning Letters Over its Consumer Review Rule
- FTC and 21 States File Amended Complaint Against Uber for Alleged Deceptive Billing and Cancellation Practices
- New York Enacts First of its Kind AI Disclosure Law
- USDA’s FSIS Publishes Updated Label Approval Guideline
- Hemp Happenings®– Executive Order Directs Rescheduling of Marijuana & Improved Access to Hemp-Derived Cannabinoid Products
FDA Releases Draft Guidance on Mandatory Cosmetic Recalls and Report on PFAS in Cosmetics
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) gave FDA, for the first time, the authority to order mandatory recalls of cosmetic products. On December 16, 2025, FDA released Questions and Answers Regarding Mandatory Cosmetic Recalls: Guidance for Industry, which provides information on (1) criteria for determining when a mandatory recall is necessary; (2) the process FDA will follow when implementing a mandatory recall; and (3) expectations for industry compliance with mandatory recall orders. Comments on the guidance must be submitted by February 17, 2026.
In other MoCRA news, on December 29, 2025, FDA released a report evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products, as required by MoCRA. The agency’s evaluation, which included 25 of the most frequently used PFAS representing approximately 96% of PFAS intentionally added to cosmetic products, did not reach definitive safety determinations. However, it underscores significant uncertainty due to existing data gaps on PFAS exposure. The report further notes that FDA will continue to monitor emerging data, dedicate additional resources to address these gaps, and consistent with its enforcement policies, take action if necessary to address safety concerns.
FDA Sends Warning Letters to Retailers in the Wake of the ByHeart Formula Recall
On December 12, 2025, FDA sent Warning Letters to four major retailers for failing to remove ByHeart infant formula from store shelves following a recall due to a botulism outbreak tied to the product. In a press release announcing the Warning Letters, FDA raised concerns about recalls at the retail level and called for greater adoption of best practices in recall implementation, especially for recalls involving foods for infants and young children.
FDA Proposes to Allow Bemotrizinol in Sunscreen
As part of a broader initiative to advance sunscreen innovation, on December 12, 2025, FDA published a proposed rule to amend the Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use to add bemotrizinol (sold by the company dsm-firmenich under the name PARSOL® Shield) to the list of sunscreen active ingredients. Notably, this would be the first new OTC sunscreen active ingredient FDA has authorized in over 20 years. If finalized, the rule will allow use of the ingredient in concentrations of up to 6%. The comment period is open until January 26, 2026.
Amazon Requires Third-Party Testing, Inspection, and Certification for All Dietary Supplements
Amazon recently updated and expanded its dietary supplement policy to require all dietary supplements sold on its platform to demonstrate compliance with cGMPs through a third-party testing, inspection, and certification (TIC) service provider. Previously, the heightened requirements applied only to certain product categories, including sexual enhancement, weight management, sports nutrition, and joint health products. For supplements with existing Amazon pages, Amazon is making the change in a phased roll-out. Once contacted by Amazon, companies will have 90 days to comply with the current policy. Separately, Amazon has also begun rolling out a Compliance Fast-Track program for certain dietary supplements that are certified by BSCG, Clean Label Project, GRMA, INFORMED, NSF, or USP, to simplify and streamline the document submission process.
FTC Sends Warning Letters Over its Consumer Review Rule
On December 22, 2025, the FTC announced the issuance of Warning Letters to 10 companies for alleged violations of the Consumer Review Rule. The names of recipient companies have not been released, and the letters are not formal determinations of any violation; rather, they serve as a reminder of the rule and the potential civil penalties of up to $53,088 per violation. The Consumer Review Rule prohibits several deceptive review practices, including using reviews that misrepresent a consumer’s true experience and offering incentives to post positive reviews.
FTC and 21 States File Amended Complaint Against Uber for Alleged Deceptive Billing and Cancellation Practices
The FTC, along with 21 states and the District of Columbia, filed an amended complaint on December 15, 2025, in a case originally filed in April 2025 against Uber for its Uber One subscription program. The FTC filed the amended complaint to include the states and the District of Columbia. As in the original complaint, the parties allege that Uber charged consumers without their consent, failed to provide promised savings (such as a $0 delivery fee) and made it difficult to cancel subscriptions by requiring consumers to navigate up to 23 screens and take up to 32 actions.
New York Enacts First of its Kind AI Disclosure Law
On December 11, 2025, New York Governor Kathy Hochul signed into law Senate Bill 8420A, which regulates the use of artificial intelligence (AI)-generated “synthetic performers” in advertising. AI-generated synthetic performers are digitally created media that appear to be real people. The law requires advertisements using a synthetic performer to “conspicuously disclose” the use of such a synthetic performer, but does not specify the content or form of such disclosure. Failure to disclose can result in a civil penalty of $1,000 for a first violation and $5,000 for any subsequent violation. The law includes limited exceptions, such as for audio-only advertisements, and takes effect June 9, 2026.
USDA’s FSIS Publishes Updated Label Approval Guideline
USDA’s Food Safety and Inspection Service (FSIS), which has jurisdiction over labels for meat, poultry, and egg products, issued an update to its Guideline for Label Approval. The December 2025 guideline incorporates the agency’s “Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims” final rule, which goes into effect on January 1, 2026. Among other things, the guideline clarifies key definitions such as “raised” and “harvested,” specifies how origin requirements apply to single and multi-ingredient products, and addresses the use of U.S. imagery and state logos.
Hemp Happenings®– Executive Order Directs Rescheduling of Marijuana & Improved Access to Hemp-Derived Cannabinoid Products
On December 18, 2025, the President issued an Executive Order titled “Increasing Medical Marijuana and Cannabidiol Research.” In addition to directing the Attorney General to expedite the completion of the process of rescheduling marijuana from Schedule I to Schedule III of the CSA, the order also contains directives aimed at the hemp and CBD industry. The EO directs White House staff to work with Congress to improve access to “full-spectrum CBD products” by updating the recently amended definition of “hemp” and developing a regulatory framework for hemp-derived cannabinoid products, while also restricting the sale of unsafe products that pose serious health risks. The EO specifically calls for “development of guidance on an upper limit on milligrams of THC per serving with considerations on per container limits and CBD to THC ratio requirements.”
It also directs the Secretary of HHS, FDA Commissioner, the Administrator of the Centers for Medicare and Medicaid Services (CMS), and the Director of the NIH to improve access to hemp-derived cannabinoid products by developing research methods and models that use real-world evidence. During the EO’s signing ceremony, CMS Administrator Dr. Mehmet Oz announced a Medicare pilot program that would allow reimbursement for physician-recommended CBD products. In November, CMS separately issued proposed changes to its regulations covering Supplemental Benefits for the Chronically Ill to allow access to lawful hemp-derived products, including hulled hemp seed, hemp seed oil, and hemp seed protein powder.
