Do I need FDA registration to sell supplements on Amazon? Three cases

Updated 2026-08-24

Registration is about the facility, not the store

Section 415 of the FD&C Act requires domestic and foreign facilities that manufacture, process, pack or hold food for consumption in the United States to register with FDA. Dietary supplements are food for this purpose, which is why a supplement plant is a food facility.

Amazon does not register the seller’s storefront. The owner, operator or agent in charge of the facility does. A brand that never manufactures, processes, packs or holds the product in a facility of its own is usually not the registrant. The contract manufacturer is.

Three situations we actually see

One. You are a US brand. A US plant makes the bottles. That US plant registers. You do not name a US agent. You still have to make sure the plant is registered, because a missing or expired registration is the plant’s problem until a shipment is held and it becomes yours.

Two. You are a US or China seller. A plant in China makes the bottles for FBA. The Chinese plant is a foreign facility. It must register, name a US agent, and keep a D-U-N-S number whose address matches the registration. Each shipment of food into the United States also needs prior notice.

Three. You only pick, pack and ship from your spare room, or you never touch the goods because Amazon does. A private residence is not a “facility” under 21 CFR 1.227 and does not register. Amazon’s fulfilment centre is Amazon’s facility. Neither fact excuses the overseas manufacturer from registering.

What registration is not

FDA does not approve dietary supplements for safety and effectiveness. Many supplements can be marketed without even notifying FDA, except that a new dietary ingredient generally needs a notification at least 75 days before marketing.

Mere registration of an establishment does not denote approval of the establishment or of the product, and it does not mean the product may be legally marketed. Putting “FDA registered” on an Amazon listing as if it were a quality mark is the kind of claim that gets listings pulled, because it reads like approval.

Exemptions people quote that usually do not help

Farms, retail food establishments, restaurants, nonprofit food establishments, certain fishing vessels, and facilities regulated exclusively by USDA are exempt. A foreign facility can also be exempt if food from that facility undergoes further manufacturing or processing by another facility outside the United States.

An Amazon seller is not a restaurant. FBA is not a retail food establishment exemption for the factory in Guangdong. If someone sold you a package labelled “Amazon sellers are exempt from FDA registration,” that package is wrong.

What it costs to put the filing in correctly

FDA charges nothing for food facility registration. Our fee for a food or supplement facility registration, or the biennial renewal, is $299 in three business days once the file is complete, or $499 with a year of US agent. If the plant still needs a D-U-N-S number, that filing is $149; Dun and Bradstreet charges nothing for the number itself.

Common questions

Does Amazon require FDA registration, or does FDA?

FDA requires the facility to register. Amazon may separately refuse a listing until you produce a number. Those are two different demands.

I use a US contract manufacturer. Do I still register?

The manufacturer’s facility registers. You register only if you also manufacture, process, pack or hold the supplement in a facility of your own that is not exempt.

Are dietary supplements FDA approved if the factory is registered?

No. FDA does not approve dietary supplements. Registration of the facility is not approval of the product.

Does a foreign ingredient supplier have to register if a US plant makes the finished bottle?

A foreign facility can be exempt if the food from that facility undergoes further manufacturing or processing by another facility outside the United States. Whether a particular supplier fits that exemption depends on what happens to the material, and where. Do not assume it.

When do I have to renew?

Food facility registrations renew every two years, from 1 October to 31 December of each even-numbered year. The 2026 window is 1 October to 31 December 2026.

Sources

• FDA, Registration of Food Facilities and Other Submissions — section 415, facility registration and biennial renewal — fda.gov
• FDA, Food Facility Biennial Registration Fact Sheet — who must register and which establishments are exempt — fda.gov
• FDA, How to Start a Food Business — private residence is not a facility under 21 CFR 1.227; dietary supplements are not approved before marketing — fda.gov
• FDA, Is It Really 'FDA Approved'? — FDA does not approve dietary supplements — fda.gov

This guide is general information about FDA facility registration, not legal advice, and it does not create a client relationship. Registration is not approval. Confirm the position for your own supply chain before you rely on it.