Where do I get an FDA certificate?

For food and cosmetics the FDA does not issue a “certificate,” and there is no “FDA certification.” The FDA requires facility registration and product compliance listing — the accurate term is “FDA registration/compliance.” Only drugs and medical devices have their own pre-market approval/clearance paths.

Do cosmetics still not need the FDA for the US?

They do now. After MoCRA (Modernization of Cosmetics Regulation Act), cosmetic facility registration and product listing moved from voluntary to mandatory, with adverse-event reporting and safety substantiation; the old “cosmetics need no registration for the US” belief is outdated.

Is FDA registration valid forever once done?

No. FDA registration must be renewed on a cycle — e.g. food facility registration every two years — and you must keep labeling, ingredients and manufacturing practices continuously compliant; it is not a one-off certificate.

US FDA Registration Explained · SINOQUAL

Many companies say “FDA certification,” but the FDA does not issue certificates for food and cosmetics — it requires facility registration and compliance listing. This guide explains what food/cosmetics/devices/supplements must do to enter the US, common misconceptions, and what “FDA registration” means.

Many companies say “FDA certification,” but strictly speaking — for most food and cosmetics the FDA does not issue a “certificate”; it requires company registration and compliance listing. What stops a product at the US border is not a missing “FDA certificate” but whether you have completed facility registration, product listing and compliance filing per FDA rules. This article explains what each category (food / cosmetics / medical devices / dietary supplements) must do to enter the US, common misconceptions, and what “FDA registration” actually means.

First, correct a common misconception: the FDA mostly does not issue a “certificate”. “We need FDA certification” is the most common phrasing among exporters, but it isn't accurate. For food and cosmetics, the FDA (US Food and Drug Administration) does not issue a “certificate,” and there is no such thing as “FDA certification.” The FDA's approach is to require facility registration, product listing/filing, and ongoing compliance with FDA regulations (labeling, ingredients, manufacturing practices).

So the accurate phrasing is “FDA registration” or “FDA compliance.” This matters because it changes what you prepare: not sitting an exam for a certificate, but completing registration/listing and keeping the product and facility continuously compliant. (Note: drugs and medical devices have their own pre-market approval/clearance paths, different from food and cosmetics.)

By category: what to do to enter the US. Food / beverages — exporters must complete FDA Food Facility Registration and designate a U.S. Agent; low-acid canned/acidified foods also need FCE/SID filing; importers must comply with FSVP (Foreign Supplier Verification Program). Cosmetics — after MoCRA (Modernization of Cosmetics Regulation Act) took effect, companies must complete facility registration + product listing (the former voluntary VCRP upgraded to mandatory), plus adverse-event reporting and safety substantiation. Dietary supplements — facility registration as food, compliance with DSHEA, with strict label and claim limits. Medical devices — establishment registration & device listing, and depending on risk class possibly 510(k) premarket notification; a far higher threshold than food/cosmetics. Drugs — the strictest pre-market approval, a separate path.

The most common pitfalls. Treating “registration” as “getting a certificate”: FDA registration is not a one-off certificate; it must be renewed on a cycle (e.g. food facility registration renews every two years) and kept continuously compliant. No U.S. Agent: a foreign company doing FDA registration must designate a U.S.-based agent as the contact point with the FDA — a hard requirement, not optional. Cosmetics requirements upgraded after MoCRA: many companies still hold the old belief that cosmetics need nothing for the US; after MoCRA, facility registration and product listing are mandatory. Non-compliant labels/claims: the FDA has clear rules on label format, nutrition labeling and functional claims; non-compliance leads to detention or required correction.

How SINOQUAL helps. SINOQUAL, with twenty years in international certification and market access, can help Chinese companies complete US FDA registration and compliance — including food facility registration, cosmetic MoCRA registration/listing, U.S. Agent arrangement and label compliance review — laying out the “compliance actions needed for the US” in one go, so companies don't fall into the “thought we were certified, but weren't compliant” trap. Over twenty years it has helped 6,000+ companies go global, across food, pharmaceuticals, cosmetics, chemicals and health products.

If you are preparing to sell food, cosmetics or related products into the US but can't tell what “FDA registration” actually involves, whether you need a U.S. Agent, or whether MoCRA affects your cosmetics, tell our consultants your product and target channel and we'll map a US market-access path for your situation.

FAQ

Where do I get an FDA certificate?: For food and cosmetics the FDA does not issue a “certificate,” and there is no “FDA certification.” The FDA requires facility registration and product compliance listing — the accurate term is “FDA registration/compliance.” Only drugs and medical devices have their own pre-market approval/clearance paths.
Does a foreign company need a U.S. Agent for FDA registration?: Yes. A foreign company doing FDA registration must designate a U.S.-based agent as the contact point with the FDA — a hard requirement, not optional.
Do cosmetics still not need the FDA for the US?: They do now. After MoCRA (Modernization of Cosmetics Regulation Act), cosmetic facility registration and product listing moved from voluntary to mandatory, with adverse-event reporting and safety substantiation; the old “cosmetics need no registration for the US” belief is outdated.
Is FDA registration valid forever once done?: No. FDA registration must be renewed on a cycle — e.g. food facility registration every two years — and you must keep labeling, ingredients and manufacturing practices continuously compliant; it is not a one-off certificate.

FAQ

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