The short answer
No. FDA does not issue registration certificates. In FDA’s own words, it “does not issue a certificate of registration or product status”, nor does it recognize a certificate of registration issued by a private business. For cosmetics, FDA said the same thing again in September 2026: it does not provide certificates or other documents to verify compliance for cosmetic facility registration.
What FDA gives you is a registration number (and, for food facilities, a PIN). The only official way to confirm a registration is through FDA’s own systems.
Registration is not approval
Registering a facility tells FDA who you are and where you are. It is not an inspection, a quality approval or permission to sell any product. FDA says cosmetic registration and listing are “neither a cosmetic approval program nor a promotional tool”. Never describe a registered product as “FDA approved” or “FDA certified”.
What FDA actually issues
| Product | What you receive from FDA | Certificate from FDA? |
|---|---|---|
| Food facility | Food facility registration number and PIN (no fee to register) | No |
| Canned / acidified food | FCE number for the facility and SID numbers for filed processes | No |
| Cosmetics (MoCRA) | Facility registration number and product listing numbers | No |
| Medical devices | Establishment registration and device listing numbers in FDA’s database | No |
| Export documents | FDA does issue certain export certificates (for example Certificates to Foreign Government) for U.S.-made products | Yes — for exports only |
Why buyers still ask for a “certificate”
Importers, distributors and online platforms often ask exporters for an “FDA certificate”. Usually they want proof that the facility is registered. FDA has warned about this: in a July 2026 update, it flagged online seller platforms that ask food companies for a copy of their registration or a certificate during product listing.
The right answer is to give what the buyer genuinely needs — usually the facility name, address and registration number for Prior Notice — and nothing more.
What about certificates from registration agents?
Many registration agents and U.S. Agents — including Orionex — give clients a certificate or confirmation document after registering. These are private documents. They can be useful as a tidy record of your registration details and your U.S. Agent, but:
- They are not issued or endorsed by FDA, and FDA does not recognize them.
- They must never use the FDA logo or suggest FDA approval.
- They do not prove a registration is still active — a lapsed renewal makes the registration invalid, whatever the certificate says.
A trustworthy agent will explain this clearly and show you how to check your status with FDA.
How to check a registration properly
- 1Food facilitiesLog in to your own FDA Industry Systems (FURLS) account at access.fda.gov to see your registration and renewal status. FDA tells facilities to check status only on the official FDA website.
- 2Medical devicesFDA’s public Establishment Registration & Device Listing database shows registered device establishments and listed devices.
- 3CosmeticsYour Cosmetics Direct account shows your facility registration and product listings.
- 4Ask your agent for the confirmationA good agent sends you FDA’s confirmation details (registration number, renewal date) — not only its own certificate.
Example
A snack maker in Vietnam is asked by a U.S. distributor for its “FDA certificate”. Instead of sending its PIN or a screenshot of its account, it sends a short letter on company letterhead with the facility name, address and FDA registration number, and confirms the registration was renewed for the current period. That is what the distributor needs for Prior Notice.
Red flags
- Anyone selling an “official FDA certificate” or “FDA approval certificate” for food or cosmetics
- Certificates showing the FDA logo or an FDA signature
- A “registrar” asking for your PIN or FDA password just to “verify” your registration
- Claims that you must pay FDA a registration fee for a food facility — FDA charges no fee (21 CFR 1.231(c))
FDA food facility registration with U.S. Agent: $300 for 1 year or $450 for 2 years — with FDA confirmation details, D-U-N-S set-up and renewal reminders.
Frequently asked questions
Does FDA issue a certificate of registration?
No. FDA issues a registration number. It does not issue a certificate of registration or product status, and it does not recognize registration certificates issued by private businesses.
Is an FDA-registered product “FDA approved”?
No. Registration is not approval. Most foods and cosmetics are not approved by FDA before sale; registration only tells FDA about the facility.
Should I give my registration number to a buyer?
Give it only to those who need it — for imports, the party filing Prior Notice. FDA does not require you to share it with other third parties. Never share your PIN or account login.
Is there an FDA fee for food facility registration?
No. FDA charges no fee to register a food facility. Agents charge for their services, such as acting as your U.S. Agent.
Sources
- FDA — Questions regarding registration fees and private registration certificates
- FDA — FDA advises food facilities to protect their registration information (July 2026)
- FDA — FDA clarifies it does not provide certificates for cosmetic facility registration (September 9, 2026)
FDA statements checked against FDA sources on November 11, 2026. This article is general information, not legal advice.