Earlier this week, the Office of Information and Regulatory Affairs (OIRA) published the Spring 2025 edition of its Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). This is the first Unified Agenda published by the current Trump administration and thus offers helpful insight into the administration’s regulatory priorities, including the administration’s approach to implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
As outlined in the table below, the Unified Agenda includes four proposed rules specific to cosmetic products, all of which also appeared in the most recent Fall 2024 Unified Agenda. The anticipated NPRM and final rule publication dates are aspirational, and FDA often misses these targets.
|
Rule
|
Summary
|
Anticipated Publication Date
|
|
|
Would identify certain substances as fragrance allergens and require the disclosure of fragrance allergens on the labels of cosmetic products, as required by MoCRA.
|
NPRM: May 2026 (updated from January 2025 in prior unified agenda)
|
Good Manufacturing Practice for Cosmetic Product Facilities (i.e., the Cosmetics GMP Rule)
|
Would establish good manufacturing practices for cosmetic product facilities to help ensure the safety of cosmetic products.
|
NPRM: To be determined (updated from October 2025 in prior unified agenda)
Of note: FDA moved the GMP Rule from the standard unified agenda to the long-term actions list, which means that the Agency is unlikely to publish the NPRM in the next 12 months.
|
Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products (i.e., the Talc Rule)
|
Would establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic product.
|
|
|
|
Would ban formaldehyde (FA) and other FA-releasing chemicals (e.g., methylene glycol) as an ingredient in hair smoothing or hair straightening products marketed in the United States.
|
NPRM: December 2025 (updated from March 2025 in prior unified agenda)
|
The Unified Agenda also indicates that FDA plans to publish two rules applicable to cosmetic products and also to other product categories. The Agency intends to—
- Publish an amendment to procedural requirements for color additive petitions in September 2026, and
- Finalize a proposed rule that would create an exemption from investigational new drug (IND) requirements for certain clinical studies on drug uses of lawfully marketed conventional foods, dietary supplements, and cosmetics in October 2025.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Cosmetics practice.
Back
