Why MoCRA Has Cosmetics Brands Filing Twice: Facility Registration and Product Listing

Brands that sell cosmetics in the United States may have to file with the Food and Drug Administration under the Modernization of Cosmetics Regulation Act of 2022, known as MoCRA. The law sets duties for facility registration, product listing and reporting of serious adverse events.

The filings follow a set order. A brand subject to these requirements files twice: once for the facilities that make its products, and once for each product it markets. The FDA’s guidance and MoCRA pages set the deadlines, and a law firm’s summary of a later guidance update adds detail.

Who Has to Register and List Under MoCRA

The owner or operator of a facility submits the facility registration, according to the FDA’s final guidance. The responsible person must obtain a registration number for each facility where its cosmetic products are manufactured or processed, and that number is used when the product is listed.

The FDA’s announcement of the final guidance says it covers who must submit, what information to include, how and when to submit, and certain exemptions.

Exempt small facilities without an FEI can list their name and address instead, according to the FDA. BD Law says MoCRA was enacted in December 2022.

Renewal and Update Cycles
Facility registrations must be renewed every two years, and any updates to each marketed cosmetic product’s listing must be provided annually, according to the FDA.

Facility Registration, the FEI Number and the Two-Year Renewal

The FDA’s final guidance is dated Dec. 18, 2023. It names the FDA Establishment Identifier, or FEI, as the required facility registration number. A company without one must obtain an FEI before registering. The FDA’s FEI Search Portal shows whether a number already exists.

The FDA’s MoCRA page says manufacturers and processors must renew their facility registration every two years. The FDA can suspend a registration when a product made at the facility has a reasonable probability of causing serious adverse health consequences or death, and other products from that facility may be similarly affected. Distributing or selling products from a suspended facility is a prohibited act.

The FDA set July 1, 2024 as the date it would begin enforcing registration and listing. The FDA describes that as an additional six months after the statutory deadline of Dec. 29, 2023. The FDA says it issued guidance on Nov. 8, 2023 on its intent to delay enforcement. The same date applied to facilities that began manufacturing after Dec. 29, 2022, and to products first marketed after that date.

BD Law describes July 1, 2024 as the date by which registration and listing were due.

The FDA’s guidance says filings are made through Cosmetics Direct, the FDA’s electronic portal. Paper Forms FDA 5066 for registration and FDA 5067 for listing were still in development at the time of the announcement, and the FDA said it expected them to be available soon. Questions can be directed to the FDA at 1-888-INFO-FDA (1-888-463-6332).

Product Listing and the Annual Update

The responsible person must list each marketed cosmetic product with the FDA, including its ingredients. Any updates to listings must be provided annually, according to the FDA’s MoCRA page.

The FDA says the responsible person needs the FEI for each facility that makes or processes its cosmetics, because product listings require it.

A brand with several lines must list each marketed cosmetic product.

Adverse Event Reports, Records and Mandatory Recalls

Responsible persons must report serious adverse events to the FDA within 15 business days and include a copy of the product label. If new medical or other information arrives within one year of the first report, it must be submitted within 15 business days as well. The FDA’s MoCRA page describes reporting as mandatory.

Companies that manufacture or market cosmetics have a responsibility to ensure the safety of their products. Responsible persons must ensure and maintain records supporting adequate safety substantiation. Existing relevant safety data can be used. The FDA says neither the law nor its regulations require specific safety tests. Animal testing is not required, but supporting data must come from scientifically robust methods.

When certain conditions are met, the FDA can access and copy certain cosmetic records, including safety records. It can also access adverse event reports during inspections.

If the FDA determines there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to it will cause serious adverse health consequences or death, and the responsible person refuses a voluntary recall, the FDA can order a mandatory recall. The FDA’s MoCRA page lists final guidance on mandatory cosmetics recalls dated Oct. 29, 2026.

A brand subject to these requirements files twice: once for the facilities that make its products, and once for each product it markets.

The Small-Business Exemption and Its Limits

The FDA’s MoCRA page says the law exempts certain small businesses from good manufacturing practice rules, facility registration and product listing requirements.

The exemption does not apply to products that regularly contact the mucous membrane of the eye under customary use, to injected products, to products intended for internal use, or to products meant to alter appearance for more than 24 hours without consumer removal.

Some products and facilities that fall under drug or device requirements are also exempt, according to the FDA.

The December 2024 FAQ Update and Recent FDA Steps

The December 2023 final guidance finalized an Aug. 8, 2023 draft. Its new Appendix B, which holds FAQs, was a draft open for public comment, according to the FDA.

BD Law’s alert, dated Jan. 6, 2025, reports that the FDA issued an updated version of the registration and listing guidance in December 2024. The related Federal Register notice, 89 Fed. Reg. 100508, is dated Dec. 12, 2024. The update added three frequently asked questions to the 19 in the December 2023 final guidance, bringing the total to 22.

The new questions appear on the last two pages of Appendix B. They cover the role of a U.S. agent, which BD Law describes as limited and generally about facilitating communication between FDA and foreign establishments.

Another question covers when one FEI can cover multiple buildings. BD Law lists the conditions as: the buildings are within 3 miles of each other, their activities are closely related to the same business enterprise, they are under the same supervision, and FDA can inspect them in a single inspection.

The third covers free samples or gifts. BD Law says that in most situations, free samples or gifts must have a product listing, and the guidance describes narrow exceptions.

BD Law says comments on the FAQs were due Jan. 13, 2025. BD Law also reports that the Dec. 29, 2024 deadline for responsible persons to add contact information to product labels had passed by the time of its alert.

The FDA’s MoCRA page also lists other dated items: a proposed rule on asbestos testing methods for talc-containing cosmetics in December 2024, withdrawn in November 2025; an FDA report on PFAS in cosmetics published Dec. 29, 2025; and an FDA Voices blog on MoCRA implementation dated May 4, 2026.