Resources/FDA facility registration
FDA cosmetic facility registration & product listing under MoCRA
Disclaimer: The information provided in this guide is for educational and regulatory context purposes only and does not constitute formal legal advice. Compliance requirements can vary based on formulation, regional authority updates, and specific product claims. Consult a certified regulatory affairs professional or specialized legal counsel for official filings. See FDA.gov for current text.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), signed December 29, 2022 as part of the Consolidated Appropriations Act, 2023, added Section 607 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) — the first mandatory facility registration and product listing regime for US cosmetics.
Who has to register
Under FD&C Act § 607(a), any person who owns or operates a facility that manufactures or processes a cosmetic product for distribution in the US must register that facility with FDA — including foreign facilities, unless a US facility performs further manufacturing or processing before distribution.
Separately, under § 607(c), the responsible person for each cosmetic product — the manufacturer, packer, or distributor whose name appears on the label under FD&C Act § 609(a) or the Fair Packaging and Labeling Act § 4(a) — must submit a product listing.
The small-business exemption isn't absolute
FD&C Act § 612 exempts facilities/responsible persons with average gross annual US cosmetic sales under $1,000,000 (over the prior three years, inflation-adjusted) from registration and listing — but the exemption does not apply if the facility or product involves:
- Products that regularly contact the mucus membrane of the eye
- Injectable cosmetic products
- Products intended for internal use
- Products intended to alter appearance for more than 24 hours under customary conditions of use, where removal by the consumer isn't part of that customary use
Deadlines
- Facilities and products already on the market before MoCRA's enactment: registration and listing was originally due within a year of enactment, but FDA delayed enforcement to July 1, 2024.
- New facilities: register within 60 days of first manufacturing/processing for US distribution (or 60 days after the existing-facility deadline, whichever is later).
- New products introduced after December 29, 2022: list within 120 days of first marketing.
- Facility registration renews every 2 years; product listings need an annual update.
Getting an FEI before you register
FDA uses the FDA Establishment Identifier (FEI) as the facility registration number, so you need one before submitting a facility registration. Search FDA's FEI portal to see if your facility already has one; if not, request one by emailing FDA your facility's legal name, physical address (not a PO box), and contact details at feiportal@fda.hhs.gov. There's no fee — third parties that charge for FEI issuance are not required.
Submitting through Cosmetics Direct
FDA's free electronic portal for both filings is Cosmetics Direct, built on Structured Product Labeling (SPL) standards. Product listings require the product's category, the facility registration number(s) where it's made, and its full ingredient list in standard nomenclature — trade names or unresolved raw-material blend names for ingredients typically get rejected. Foreign facilities also need a named US agent who can receive FDA correspondence.
One common confusion: if a product makes a drug claim (SPF, anti-acne, etc.), it's regulated as an OTC drug and follows FDA's drug establishment registration process, not Cosmetics Direct.
Before you file a product listing, confirm every ingredient and concentration clears US and export-market limits — run a free INCI compliance scan, or sign in to check a full formulation across MoCRA, EU, and other markets at once.
Related: MoCRA overview for US brands, the EU equivalent (CPNP notification), cosmetic GMP status (ISO 22716 vs. MoCRA).