The short answer
FDA registration is for facilities: the places that make, pack, label or store food. So the question is which facility handles your product.
| You make or pack the food yourself | Your facility must register with FDA. |
|---|---|
| Private label: a manufacturer makes it for you | The manufacturer's facility must be registered. Ask for its registration confirmation. |
| You relabel or repack products | The place where you relabel or repack must register. |
| You store stock in your own warehouse | Your warehouse must register. |
| You only buy and sell finished, labeled products | You usually do not register, but your suppliers' facilities must. |
Facilities outside the U.S. must also name a U.S. Agent.
Other FDA rules for Amazon sellers
- U.S. labels: English, the Nutrition Facts format, allergen declarations and a correct ingredient list. Label problems are a common reason listings are removed.
- Importing: every food shipment needs Prior Notice before it arrives, using the manufacturer's FDA registration number.
- FSVP: the U.S. importer of food may need a Foreign Supplier Verification Program. If you are a foreign seller with no U.S. importer, see our FSVP importer service.
- Supplements: must be made under supplement manufacturing rules (21 CFR Part 111) and must not claim to treat or cure disease.
- Cosmetics: the manufacturing facility must register and products must be listed under MoCRA.
What Amazon may ask for
Amazon can ask sellers for compliance documents for some categories, such as proof of FDA registration of the manufacturer, product labels or test results. Keep your registration confirmation, your supplier's details and your labels ready. A Regovant certificate of registration, which buyers can verify online, is often useful here.
Questions
Does Amazon register my product with FDA?
No. Amazon does not register your facility or products with FDA. That is your responsibility, or your manufacturer's.
Does FDA approve food or supplements before I sell them?
No. FDA does not approve food or dietary supplements before sale. You must still follow FDA rules on facilities, labels and manufacturing.
I am a foreign seller using FBA. Who is the importer?
It depends on how the goods are shipped and who is named on the customs entry. Many foreign sellers need a U.S. importer of record and an FSVP importer. Ask us and we will explain your options.
How Regovant can help
Regovant LLC registers food, cosmetic, device and drug facilities with FDA, checks your D-U-N-S details and acts as your U.S. Agent. Food facility registration with U.S. Agent service is $269 per year. See all guides or services and prices.