The FDA Does Not Issue a Cosmetic Registration Certificate

What exactly did the FDA confirm?

On September 9, the FDA issued a notice addressed to cosmetic product manufacturing and processing facilities, retailers and responsible persons, stating that it does not provide certificates or other documents verifying compliance with cosmetic product facility registration and product listing requirements. It likewise does not issue letters of good standing, verification emails or any similar documentation. The stated background was a rise in requests for official documents confirming that a facility is lawfully registered or exempt from the registration requirement.

The registration obligation itself is unchanged. Under section 607 of the Federal Food, Drug, and Cosmetic Act, as amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), owners or operators of facilities that manufacture or process cosmetic products are generally required to register with the FDA and renew that registration every two years. The FDA also made clear that facility registration is neither a cosmetic approval program nor a promotional tool, and that assignment of a facility registration number does not indicate FDA approval of the facility or its cosmetic products.

It is worth remembering that this notice clarifies a misunderstanding rather than changing the system. It does not mean registration and listing can be skipped, and no new requirement has been added. The other parts of MoCRA also remain in progress: one legal analysis noted that as of January 2026 the FDA had not yet issued final cosmetic GMP regulations, with draft regulations or guidance expected. Practical workload may shift again once those rules are finalized.

1. A registration number is neither approval nor a quality guarantee

The point the FDA repeated concerns what a registration number means. A facility registration number is not a mark of FDA approval of that facility or the cosmetics made there, and facility registration is neither an approval program nor a promotional tool. If 'FDA registration complete' has been sitting on your product pages or sales decks as evidence of quality, it is time to revisit the wording.

Part of why 'FDA registration' has circulated among Korean brands as a kind of certification is the impression the word registration creates. But registration is closer to a notification that lets the FDA know who is making what. It is not the outcome of a review of safety or efficacy, so converting that fact into marketing copy removes the basis for the claim.

The standard for reviewing product information and channel copy is simple: are we describing what we did, or describing something the FDA did not do as though it had?

• A full sweep of every 'FDA' reference on product pages and sales decks
• Rewording to separate the fact of registration from approval or certification
• Whether the same wording needs recalling from materials already sent to overseas partners
• Conflicts with channel review standards in each market

2. Decide now what you send when a buyer asks for an 'FDA certificate'

The situation most often met in practice is a U.S. distributor or platform asking for proof of registration. If the FDA does not issue such a document, the answer is not to go and obtain a certificate but to explain that no such certificate exists and to present the records you actually hold alongside that explanation.

What to prepare in advance, then, is not a document but a format for explaining. A single page covering when the facility registration was submitted and when the next renewal falls due, which products appear in the product listing and with what information, and who is designated as responsible person will answer most requests. Attaching the FDA's own notice that it does not issue certificates makes the explanation considerably simpler.

In the Korean structure, where brands outsource manufacturing, the registering party and the listing party may differ. Facility registration is an obligation of the owner or operator of the manufacturing or processing site, so you first need to settle what your brand performs directly and what the manufacturer performs before you can answer a buyer precisely.

3. A 'certificate' a counterparty hands you is something to check

Turning it around, there is also the problem of being on the receiving end. Legal analyses note that if a supplier, contract manufacturer or business partner presents a document purporting to be an FDA-issued certificate of compliance for cosmetic facility registration, it should be treated as a red flag. If a document the FDA does not issue exists, its source is not the FDA.

The accompanying advice is not to rely on third-party 'compliance certificates.' A confirmation that an agency performed the registration work and a document in which the FDA confirmed compliance are entirely different in nature, and using the former in a transaction as though it were the latter blurs where responsibility sits.

For a brand newly starting U.S. volume, it is worth writing this item into the contract: who performs registration and listing, which records are provided as evidence, and who updates the information by when if it changes.

4. Registration is a state that returns every two years, not a one-time task

Facility registration generally has to be renewed every two years. The absence of a certificate actually raises the stakes here. With no piece of paper in hand, it is easy to be left with only the memory of having registered at some point, and there is no visible signal when a renewal deadline slips past.

So registration status should be managed through a calendar and an owner rather than a document. One table holding the initial submission date, the next renewal deadline, the owner and account access, and the agency contract expiry if an agency is used, is enough. A change of personnel is the riskiest moment, so it belongs in the handover checklist.

The same applies to product listing. If a product is discontinued, reformulated or renamed and the listing information stays as it was, the registered information and the product actually in distribution no longer match.

5. MoCRA does not end at registration

Registration and listing are the most visible requirements under MoCRA but not the whole of it. The FDA has stated that the number of adverse events reported by industry rose more than threefold following MoCRA's implementation. Adverse event reporting, safety substantiation and labeling requirements operate on a separate track from registration.

There are also figures that help with a sense of scale. The FDA has said there are over 15,000 unique, active cosmetic product facility registrations and over 1 million unique, active cosmetic product listings. These are registration and listing counts, not market size or sales performance, and should be read as cumulative figures at a point in time.

A brand treating the U.S. as a principal market is better off building a checklist for what comes after registration: who judges an adverse event when one arrives and by when it must be reported, where safety substantiation is kept for each product, and whether mandatory label content matches current requirements—each with a named owner.

The first question for the brief

Put this one line in the brief: if a U.S. buyer asks for proof of registration tomorrow, what do we send? The fact that the FDA issues no certificate is not bad news but a signal that the standard has become clear. Precisely because a single sheet of paper can no longer stand in for it, the brand that is ready is the one that can explain its own registration date, renewal deadline, listing contents and responsible person.