Who needs to register a facility under MoCRA?

Short answer: any establishment that manufactures or processes cosmetic products distributed in the United States — including an importer's establishment — must register with FDA and renew every two years from the initial registration date (FD&C Act §607, MoCRA).

Who is in, who is out

Situation	Must register?	Notes
You manufacture or process cosmetics distributed in the US	Yes	Includes establishments of importers
You are the brand (responsible person) but contract out all manufacturing	Your contract facilities register; you file the product listing instead	Listing is a separate duty, updated annually
Certain small businesses	Exempt from registration and listing	But the exemption does not apply to the products below
Exempt small business making: eye-mucosa contact products, injectables, internal-use products, or products altering appearance for more than 24 hours	Not exempt	The exemption is product-specific, not company-wide

How registration actually works

FEI number first. FDA uses the FDA Establishment Identifier (FEI) as the required facility registration number. Check the FEI Search Portal; if your firm has none, request one before submitting.
Submit through Cosmetics Direct (FDA's SPL authoring portal), or via the Electronic Submissions Gateway, or on paper Form FDA 5066. FDA strongly prefers electronic.
Renew biennially. Renewal is due every two years from the initial registration date — if FDA received your registration on February 20, 2024, your renewal was due by February 20, 2026. Renewals can be filed early.
Abbreviated renewal exists when nothing has changed since your last submission; use the full renewal submission when something has.

As of the FDA's own summary (data to June 30, 2026), there were 16,398 active facility registrations and 1,298,361 active product listings under MoCRA.

What registration is not

FDA clarified on September 9, 2026 that it does not issue certificates or verification documents for facility registration or product listing. A registration or listing number does not indicate FDA approval. If a retailer or distributor asks for proof, the number itself and the public FDA data are what exist — anyone promising an "FDA registration certificate" is selling something the agency does not provide.

FDA can also suspend a registration: if a product from the facility has a reasonable probability of causing serious adverse health consequences or death, and the failure is not isolated to that product, distribution of cosmetics from the facility becomes a prohibited act.

Common mistakes

Letting the two-year renewal lapse because “we registered once in 2024”.
Assuming the small-business exemption covers your eye cream or long-wear product. The four carve-outs void it.
Waiting on an FEI number until filing week. Request it as soon as you know a facility must register.
Paying for a "MoCRA compliance certificate". FDA does not issue one.
Confusing facility registration (the factory) with product listing (the SKU). Different filers, different cycles: biennial vs annual.

Sources

FDA, Registration & Listing of Cosmetic Product Facilities and Products — fda.gov, current 2026-09-09
FD&C Act §607 — 21 U.S.C. 364d
FDA, MoCRA overview — fda.gov
Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (December 2024) — fda.gov

Last verified: 2026-11-10.

Not legal advice, and not a guarantee of compliance or of FDA acceptance.

Want this checked against your own formula? Run the free label check. It returns an issue list and the MoCRA fields each product needs, not a print-ready label.