Who has to register
Under Section 607 of the FD&C Act, added by MoCRA, any facility that manufactures or processes a cosmetic product for distribution in the United States must register with FDA — regardless of whether that facility is domestic or located overseas. "Manufacture or process" covers any step in making the finished product: mixing, diluting, blending, repackaging under your own label, or relabeling. It does not, on its own, cover pure downstream activity.
Facilities that only label, package, hold, or distribute a finished cosmetic — without touching the formulation — generally fall outside the registration requirement. Beauty shops and salons are exempt unless they manufacture or process products on-site. Retailers, distributors, and direct sellers are exempt in their retail capacity. Contract manufacturers only need a single registration to cover facilities they operate on behalf of a brand, so a brand that outsources production to an already-registered contract manufacturer doesn't need a second registration for that same site.
Deadlines: what actually applies in 2026
MoCRA's registration requirement took statutory effect on December 29, 2023, one year after the law's enactment. FDA then exercised enforcement discretion and pushed the practical compliance deadline to July 1, 2024. Facilities operating before that date needed to be registered by then; facilities that started manufacturing or processing for U.S. distribution after MoCRA's enactment must register within 60 days of first engaging in that activity.
If your facility registered in early-to-mid 2024, your first biennial renewal is likely due in 2026, tied to your specific registration anniversary date — not a fixed calendar deadline. See the renewal section of the main guide for how that timing works.
The FEI and Form FDA 5066
Registration happens through the Cosmetics Direct electronic submission portal using Form FDA 5066. As part of the process, your facility is issued a Facility Establishment Identifier (FEI) — a unique number that ties everything else in your MoCRA compliance record together: it must be referenced on every product listing linked to that facility, and it's what FDA and CBP check against at import screening.
The submission itself captures facility identity and location, ownership, contact information, the product categories manufactured there, and brand names associated with the site. Paper submission options exist but the portal is the standard path for most filers.
Foreign facilities: the U.S. Agent requirement
If your facility is located outside the United States, registration isn't complete without designating a U.S. Agent — a person or entity physically located in the U.S. who can serve as FDA's point of contact for that facility. This is separate from the Responsible Person requirement that applies at the product level (covered in the next guide), though in practice the same firm sometimes fills both roles for a foreign brand.
Small business exemption — and its limits
Facilities with average gross annual U.S. cosmetic sales under $1 million over the preceding three years are generally exempt from facility registration and product listing. That exemption disappears, regardless of revenue, if the facility manufactures or processes:
- Products that regularly contact the mucous membrane of the eye under customary use
- Injectable products
- Products intended for internal use
- Products intended to alter appearance for more than 24 hours where consumer removal isn't part of customary use
None of these exemptions reach adverse event reporting, safety substantiation, or labeling requirements — those apply regardless of size or revenue.
Keeping registration current
Any change to registration information — address, ownership, Responsible Person, U.S. Agent — must be reported to FDA within 60 days, and registrations must be renewed every two years on the facility's own anniversary date. FDA has the authority to suspend a facility's registration where a product presents a reasonable probability of serious adverse health consequences tied to a facility-wide failure, which halts legal distribution from that site until resolved.
What happens if you don't register
An unregistered facility's products are treated as misbranded once the registration requirement applies to them. In practice, that shows up at the border first: import screening checks shipments against active Cosmetics Direct registration and listing data, so an unregistered or lapsed facility is one of the more common reasons a cosmetics shipment gets held.