Guide
There is no such thing as FDA certification: registration is not approval
FDA says so in as many words. The agency does not approve dietary supplements or cosmetics, does not approve food labels, and treats establishment registration as something other than approval. “FDA certified” on an Amazon badge is a claim FDA did not give you.
Updated 2026-08-24
FDA’s own sentence
On the page titled “Is It Really ‘FDA Approved’?”, FDA writes that mere registration of an establishment or listing of a drug or device does not denote approval of the establishment, the drug or device, or other products of the establishment, nor does it mean that a product may be legally marketed.
That sentence is the whole argument. A facility can be registered and still produce an illegal product. A product can be listed and still be misbranded. Amazon treating a registration number as a quality mark does not change the statute.
What FDA does not approve, in the categories Amazon sellers actually sell
Dietary supplements. By statute FDA does not approve them for safety and effectiveness. Many can be marketed without even notifying FDA. A new dietary ingredient generally needs a notification 75 days before marketing. That is not an approval.
Cosmetics. Cosmetic products and ingredients, and their labeling, do not require FDA approval. Colour additives other than coal-tar hair dyes do. MoCRA registration and listing, FDA says, is neither an approval programme nor a promotional tool, and FDA does not issue certificates for those filings.
Food labels. FDA does not approve individual labels, including Nutrition Facts and Supplement Facts. The label still has to be truthful and to carry the required elements.
What “FDA approved” does mean, so the phrase is not emptied
New human drugs and biologicals generally must be FDA approved before they are marketed. Some devices need premarket approval; many moderate-risk devices are cleared by 510(k), which is not the same word. Food additives and colour additives have their own approval routes.
Using “FDA approved” on a magnesium capsule, a face cream or a snack is therefore not a looser version of the same idea. It is a false statement about a process that never ran.
Where Amazon listings go wrong
Badges that say FDA certified, FDA registered factory, FDA approved formula, or that paste the FDA logo onto an A-plus module, are the usual pattern. FDA’s logo is for official government use. Using it to suggest endorsement can violate federal law.
A supplier’s “FDA certificate” is almost never an FDA document. Food facility registration is confidential, so a public certificate of that number is already suspect. Cosmetic filings do not come with certificates at all.
What we will and will not put on a page
We will file the registration that actually exists: food or supplement facility registration at $299, or $499 with a year of US agent; MoCRA facility registration including one listing at $549. We will not draft “FDA certified” onto an Amazon image. If the listing already says it, claim review at $249 is the service that takes it off.
Common questions
My factory is FDA registered. Can I say that on Amazon?
You can state a fact that is true, in words that do not imply approval. “The manufacturing facility is registered with FDA as a food facility” is a different sentence from “FDA certified.” Registration remains confidential as to the number itself.
Does a MoCRA listing mean the product is approved?
No. FDA says cosmetic registration and listing is not an approval programme and not a promotional tool.
Can I use the FDA logo if I have registered?
No. FDA’s logo is for official government use and should not be used to suggest that FDA endorses a private organisation, product or service.
Is a 510(k) clearance “FDA approved”?
FDA itself distinguishes clearance from approval. A 510(k) clearance means the device was found substantially equivalent to a predicate. It is not premarket approval.
If FDA inspected the plant, is the product approved?
No. FDA inspects facilities for compliance. Inspection is not product approval.
Sources
- FDA, Is It Really 'FDA Approved'? — registration is not approval; supplements, cosmetics and food labels are not approved; FDA logo — fda.gov
- FDA, Registration and Listing of Cosmetic Product Facilities and Products — not an approval programme; no certificates — fda.gov
- FDA, Questions Regarding Whether Food Facilities are Required to Pay Registration Fees and Private Businesses Claiming or Suggesting an Affiliation with FDA — fda.gov
This guide is general information about what FDA approval is, not legal advice, and it does not create a client relationship. Do not put “FDA certified” on a listing on the strength of a registration.
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