FDA Registration for Selling Dietary Supplements on Amazon US: What You Need in 2026

Selling dietary supplements on Amazon US means clearing three separate requirements. First, the FDA registration of the facility that manufactures, packs or holds the product. Second, a Supplement Facts label that meets U.S. rules. Third, Amazon’s own verification, which now requires third-party cGMP certification for every dietary supplement.

REGISTRO-FDA.US handles your FDA registration with the U.S. Agent included and the DUNS number included if the facility needs one. We also review your label before you print it. Below, we explain each requirement and which part we take care of.

The three requirements for selling supplements on Amazon US

Requirement	What is checked	Who handles it
FDA facility registration	Every facility that must register is registered and current, with a U.S. Agent if it is outside the U.S. and a DUNS number as its identifier	REGISTRO-FDA.US
Supplement label	Supplement Facts, ingredients, allergens, adverse event contact and claims	REGISTRO-FDA.US reviews; the brand corrects and prints
Amazon verification	Third-party cGMP certification and, for ASINs Amazon notifies, validation by an authorized TIC provider	Manufacturer, certification body and TIC provider

What Amazon requires from dietary supplements in 2026

Amazon’s dietary supplements policy requires all dietary supplements to be made in a facility that complies with FDA current Good Manufacturing Practice (cGMP, 21 CFR 111 or 21 CFR 117), on these terms:

• The cGMP audit or certification must come from an accredited third party.
• Amazon does not accept private, first-party or consulting audits, or FDA inspections.
• The certificate must be current.

For ASINs Amazon notifies you about, you work with an Amazon-authorized TIC provider (testing, inspection and certification). You no longer send documents to Amazon: the TIC provider reviews them and submits them for you. If you already have certificates and test results, the TIC provider checks whether they qualify; if not, it orders new testing. Some categories may need additional product testing, and Amazon’s notice for each ASIN says which.

If a product fails testing or document review, Amazon deactivates the listing immediately until you submit compliant documents. Notices appear in the “Open” tab of Account Health and in Manage All Inventory.

Before you buy inventory: ask your manufacturer for its current cGMP certificate and confirm an accredited third party issued it. FDA registration does not replace that certificate. The registration tells FDA where the product is made; the cGMP certification shows how.

Which company needs FDA registration?

FDA registration applies to facilities that manufacture, process, pack or hold food for consumption in the United States, dietary supplements included, unless an exemption applies (FDA Q&A on food facility registration). Each facility has its own registration; one facility’s registration does not cover another.

If your brand uses a contract manufacturer (co-packer), owning the brand does not turn your sales office into a factory. What matters is that the facility that makes and packs the product is registered and current.

Example: a U.S. private-label brand sells vitamin D on Amazon. The capsules are made and bottled by a contract manufacturer in Colombia.

• The contract manufacturer makes and packs the product: it needs FDA registration, a U.S. Agent and a DUNS number.
• If a warehouse holds the product before export, it needs to be checked for its own registration duty.
• The brand’s office, which only sells, does not register as a factory.

We review your supply chain and register the facilities that need it, including your contract manufacturer’s if it authorizes us.

FDA registration, U.S. Agent and DUNS: what our plan includes

Every foreign facility that registers with FDA must designate a U.S. Agent, a U.S.-based contact for registration communications. FDA also requires a unique facility identifier (UFI). It currently accepts the DUNS number, and the address tied to the DUNS must match the registration.

Our FDA registration plan includes:

• Facility registration with FDA, new or renewal.
• U.S. Agent included for the full plan term.
• DUNS number included if the facility does not have one yet.
• Data review and hands-on support throughout the process.
• Registration confirmation when we finish.

FDA does not charge for registration; what you pay for is our management service. Full details are on our FDA facility registration page.

Supplement Facts label: review it before you print

A dietary supplement does not carry the Nutrition Facts panel used for food. It carries a Supplement Facts panel with its own format (FDA Dietary Supplement Labeling Guide). Here is what we check:

Element	What we check
Statement of identity	Product name with the words “Dietary Supplement” or an accepted equivalent
Net quantity	Capsule count, weight or volume, correctly stated
Supplement Facts	Serving size, servings per container, ingredients, amounts and % Daily Value
Other Ingredients	Excipients, fillers, colors and flavors in order of weight
Allergens	Major food allergens, including sesame
Responsible party	Name and address of the manufacturer, packer or distributor
Adverse events	U.S. address or phone number for serious adverse event reports (FDA guidance)
Claims and warnings	Directions, warnings and the FDA disclaimer whenever there is a structure/function claim

The most common mistake: translating a label made for another country. Serving conventions, units and Daily Values differ, and a translated label is not a compliant label. Reviewing it before printing costs far less than reprinting inventory.

Claims: your listing counts too

Amazon’s policy bars dietary supplements from making disease claims. Saying a product treats, cures or prevents a disease turns it into a drug, and a footnote disclaimer does not fix that. A supplement also cannot be presented as “FDA Approved.”

Structure/function claims (for example, “supports bone health”) are allowed on three conditions (FDA on supplement claims):

1. You have substantiation for the claim.
2. The label carries the FDA disclaimer.
3. You notify FDA within 30 days after you start marketing the product with the claim (claim notifications).

If the formula contains a new dietary ingredient (NDI), FDA may need a notification at least 75 days before marketing (NDI notifications).

Practical advice: make your Amazon title, bullet points and images say the same thing as the label.

Shipping to Amazon FBA: Prior Notice and FSVP

FBA is a logistics service. It stores and ships your product, but it does not take on your FDA obligations. If you ship supplements from another country:

• Every shipment needs Prior Notice before it reaches the United States.
• The importer may have FSVP obligations, with modified requirements for certain supplements (FDA on FSVP). The U.S. Agent on the registration is not automatically the FSVP importer; we explain why in what is FSVP.

How we work

1. Tell us about your operation: what you sell, where it is made and packed, and what each company does.
2. We review the supply chain and tell you which facilities need registration.
3. We register: for each facility we ask for two official or commercial documents showing the same name and address.
4. We review your label and send you a report with the changes to make.

Also selling on TikTok Shop? There the category is invite-only and the documents are different: see TikTok Shop dietary supplements FDA requirements.

Frequently asked questions

Does Amazon require FDA registration to sell supplements?

The law requires FDA registration for the facility that manufactures, packs or holds the supplement, and Amazon requires compliance with that law. On top of that, Amazon requires third-party cGMP certification for all supplements and, for ASINs it notifies, validation by a TIC provider.

Do I have to register each supplement with FDA?

No. FDA registration covers the facility, not the product. FDA does not approve supplements before they are sold; only certain new ingredients require a premarket notification.

If a contract manufacturer makes my supplement, do I need my own registration?

Your sales office does not need to register as a factory just because it owns the brand. The facility that makes and packs the product must be registered and current. We can handle that registration if the manufacturer authorizes us.

Does FDA registration replace the cGMP certification Amazon asks for?

No. They are different documents: the registration identifies the facility to FDA, and the cGMP certification shows how the product is made. Amazon requires both.

Is a DUNS number the same as FDA registration?

No. DUNS is the identifier FDA accepts for the facility. It is included in our FDA registration plan if the facility does not have one yet.

What happens if I don’t renew by December 31, 2026?

FDA considers the registration expired. An expired registration is no use as evidence for Amazon or your importer, and your shipments can run into problems at entry.

Do you review supplement labels?

Yes. We review the Supplement Facts panel, ingredients, allergens, adverse event contact and claims, and send you a report with the changes. Send us every panel of the label for a quote.

Does FDA approve dietary supplements?

No. FDA does not approve supplements before they are sold, so no product can be advertised as “FDA Approved.”

Get your facility and label ready before you launch

To sell supplements on Amazon US, start with what does not depend on Amazon: a registered, current facility and a correct label. With those in place, Amazon’s verification becomes paperwork instead of a roadblock.

REGISTRO-FDA.US is a private service of GL Trading Solutions LLC, not affiliated with FDA or Amazon. This guide is for information only and is not legal advice.