Want to sell cosmetics online in the U.S.?

Your marketplace may ask for an FDA registration certificate.

There’s just one problem:

The FDA says it doesn’t issue one.

On September 9, the FDA published a clarification after receiving more and more requests from cosmetics businesses for certificates, verification letters, or exemption letters proving compliance with cosmetic facility registration requirements. U.S. Food and Drug Administration

The agency even specifically noted that e-commerce platforms such as TikTok Shop may ask sellers for proof of FDA registration or for a letter confirming that they are exempt. U.S. Food and Drug Administration

But FDA’s position is clear:

cosmetic facility registration is not FDA approval

product listing is not FDA approval

FDA does not provide a certificate proving registration

it also does not provide a letter confirming that a company is exempt from registration U.S. Food and Drug Administration

So a company can be fully compliant with the regulator — and still struggle to satisfy the documentation requested by the platform it wants to sell through.

That’s a very real market-access problem.

Because international expansion is not always about understanding one regulation.

Sometimes it is about reconciling what the regulator requires with what the marketplace thinks the regulator requires.

And when those two don’t match, the missing document may be one that literally does not exist.

#MarketAccess #FDA #Cosmetics #Ecommerce #USMarket #Compliance #InternationalExpansion #Expio