On October 14, 2026, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register (91 FR 65219), announcing that the information collection on requirements for cosmetic products has been submitted to the Office of Management and Budget (OMB) for review, with a comment deadline of November 13, 2026. Parties with comments on this information collection may submit written comments via the OMB website (reginfo.gov) before November 13, 2026.
This information collection (OMB control number 0910-0599, revision) is intended to support the implementation of the various cosmetic regulatory requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA amended the Federal Food, Drug, and Cosmetic Act by adding, in pertinent part, sections 604, 605, 607, 608, and 609, which establish and update the definitions and requirements related to adverse events, facility registration, cosmetic product listing, safety substantiation, and labeling.
Overview of the Information Collection
The respondents to this information collection are primarily the “responsible persons” under MoCRA, i.e., the manufacturers, packers, or distributors identified on the product label. Enterprises may complete registration and listing through the Cosmetics Direct online submission tool, the Electronic Submission Gateway (ESG) NextGen, or by using Form FDA 5066, Registration of Cosmetic Product Facility, and Form FDA 5067, Cosmetic Product Listing.
FDA estimates that this information collection involves a total of 417,698 responses per year, with a total recordkeeping and reporting burden of approximately 367,777 hours, plus a burden of approximately 676,170 hours for product labeling disclosures.
CIRS Reminder
This information collection covers the core compliance obligations of cosmetic responsible persons under MoCRA. Cosmetic enterprises exporting to the U.S. market are advised to pay attention to the following aspects:
(1) Verify whether the obligations of facility registration and product listing have been fulfilled, and update them in a timely manner as required;
(2) Complete the safety substantiation files for products, and keep adverse event records for six years as required (three years for qualifying small businesses);
(3) Check the compliance of product labels for the U.S. market against 21 CFR Part 701, including ingredient declaration order, statement of identity, name and place of business, net quantity of contents, and contact information for adverse event reporting.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Our Services
- The United States Agent
- The United States FDA Cosmetic Facility Registration
- The United States FDA Cosmetic Product Listing
- The United States FDA OTC Drug Registration
- The United States Color Additive Batch Certification
- The United States Cosmetic/OTC Drug Labeling Review
- International Cosmetic Ingredient Name (INCI) Application
Further Information:
