FDA Will Never Issue You a Registration Certificate: What the September 2026 Clarification Means for Foreign Brands

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On September 9, 2026, the U.S. Food and Drug Administration told cosmetic facilities, retailers, and responsible persons something it had apparently grown tired of repeating: it does not issue certificates, letters, emails, or any other official document verifying compliance with cosmetic facility registration or product listing. It will not even send you a letter confirming that you are exempt from registration.

Why FDA said this now

According to the agency, it has been receiving a growing volume of requests from people trying to get certificates or other paperwork proving their registration — or official FDA confirmation that they don’t need to register at all.

Part of the pressure is coming from e-commerce marketplaces. FDA specifically noted that platforms including TikTok Shop may ask sellers to furnish evidence of FDA registration before they can list products. And where registration isn’t required, platforms may ask for an official FDA letter or email confirming the exemption status. FDA’s answer to both requests is: no, we don’t do that.

What this means for your brand

  1. There is no such thing as an “FDA registration certificate” for cosmetics. If a consultant, agent, or website offers to sell you one — or shows you a framed-looking document with an FDA-style logo — it is not real. FDA does not create them, and never will. Do not pay for one.
  2. Your registration number is not an approval. Getting a facility registration number or product listing number from FDA’s Cosmetics Direct portal does not mean FDA approved your facility or your products. FDA has always said registration and listing are “neither a cosmetic approval program nor a promotional tool.” Marketing a serum as “FDA approved” because you registered the facility is misbranding — and it can get you into enforcement trouble.
  3. Your U.S. agent is the contact that matters. For foreign facilities, FDA’s registration form names a U.S. agent — a person or company physically present in the United States who serves as the agency’s contact for the facility. When a marketplace, distributor, or partner has questions about your registration, that agent is the channel FDA recognizes. There is no certificate to point to instead.
  4. Exemptions come with no paperwork either. If you believe you qualify for an exemption — for example, the small-business exemption — FDA will not confirm that in writing. Keep your own documented analysis of why you are exempt, because no official letter is coming.

What to do now

  • Keep your Cosmetics Direct records. When a marketplace or business partner asks for proof of registration, give them your facility registration number and product listing number, plus the confirmation records from your Cosmetics Direct submissions. Cite FDA’s September 2026 clarification that no certificates exist.
  • Never claim FDA approval or endorsement in marketing, on packaging, or in marketplace listings. Registration is a notification, not a blessing.
  • If you haven’t registered yet, registration and product listing have been enforceable since July 1, 2024. Facility registrations renew every two years; product listings get annual updates. The clock is already running.
  • If someone is selling you an “FDA certificate,” walk away. That money is better spent on the actual filings.

Sources

This article is for educational purposes only and is not legal advice. US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. Regulatory details are based on published sources current as of September 2026; always verify requirements against FDA’s official sources before acting.

Stay compliant — for free

MoCRA compliance starts with knowing exactly what applies to your brand. Run the free MoCRA compliance checklist and the MoCRA eligibility checker to see where you stand before your next marketplace listing asks questions you can’t answer.

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