Canadian brands expanding to Amazon.com often ask whether they need to "register their supplements with the FDA." The short answer is no, not the way they register products with Health Canada. The US system works differently. The FDA registers facilities, not supplement products, and it doesn't approve supplements before they're sold.
This page explains what the FDA does require, what changes in the 2026 renewal period and what Amazon asks for on top. It's general information. For questions about your own products, talk to a US regulatory specialist.
The big difference from Canada
In Canada, a natural health product needs a product licence and an NPN before it can be sold. See how an NPN application works.
In the US, dietary supplements don't need FDA approval before they're sold. That doesn't remove responsibility. The company is still responsible for the product's safety, its label and its claims. The FDA can act against products that don't meet the rules once they're on the market.
Facility registration: what it covers
Facilities that manufacture, process, pack or hold food for consumption in the US must register with the FDA. For this purpose, dietary supplements and their ingredients count as food. That applies to domestic and foreign facilities, including Canadian ones.
Registration is about places and activities, not about your product catalogue. Map every site in your supply chain:
- The manufacturer.
- The packer or labeller.
- Any warehouse that holds the goods.
For each site, ask the business that runs it whether it's registered or whether an exemption applies, and keep its confirmation on file. A brand that only owns the trademark and buys finished goods may not run any facility itself. It still needs to know which facilities are registered.
Foreign facilities also need a US agent for FDA communications.
The 2026 renewal period
Registrations must be renewed every two years. The FDA's September 29, 2026 notice sets out the current period:
- Renewal runs from October 1 to December 31, 2026.
- Renewal is done online through the facility's FDA Industry Systems account.
- There's no FDA fee for registration or renewal. A third-party service may charge for its own help.
- Each registration needs a unique facility identifier. The FDA currently accepts the DUNS number, and the address linked to it must match the registration.
- The FDA will treat a registration as expired if the facility doesn't renew by December 31, 2026.
Before renewing, check that the facility name, address and activities are current. Fix any mismatch with the DUNS record first. Keep the renewal confirmation in a secure business record, and don't share account logins across a product folder.
If your supplier says it has renewed, ask for the confirmation. Don't rely on last cycle's.
Labels and claims
US supplement labels follow FDA rules that differ from Health Canada's. The main elements include:
- The statement of identity, using the term "dietary supplement."
- Net quantity of contents.
- A Supplement Facts panel.
- Ingredient list.
- Name and place of business of the manufacturer, packer or distributor.
A Canadian NHP label can't be used as is. The format, the facts panel and the required wording are different.
Claims need care too. Supplements can't claim to diagnose, treat, cure or prevent a disease. Structure or function statements need a set disclaimer on the label, and the FDA must be notified within 30 days of first marketing a product with such a statement. Have a US specialist review the label and every claim before printing.
Other FDA rules to know about
- Manufacturing practices. Supplement makers must follow the FDA's current good manufacturing practice rules for dietary supplements.
- New dietary ingredients. Some ingredients not sold in the US before October 15, 1994 need a notification to the FDA at least 75 days before the product goes on sale.
- Prior notice. Food shipments, including supplements, imported into the US need prior notice to the FDA before they arrive.
Your manufacturer and customs broker will handle parts of this. Make sure someone owns each item.
What Amazon.com asks for on top
Amazon has its own dietary supplement policy. Since April 2, 2024, Amazon has required dietary supplements to be verified through a third-party testing, inspection and certification (TIC) organization.
Listings that need action show up in the Manage Your Compliance dashboard, with a due date. You start testing from that dashboard with one of the listed organizations, then work with them directly. Amazon can remove listings that aren't confirmed compliant by the due date.
FDA registration and Amazon's testing are separate. Having one doesn't satisfy the other.
Answering an Amazon request
Read the exact request before sending anything. Then match each item to the right evidence:
- Facility registration evidence or the documented exemption basis.
- Product labels, specifications and supplier records.
- Testing or verification evidence for that ASIN.
- The notice itself and your response.
Check that the product name, formula, pack size and manufacturer match across every document. A certificate bought from a service provider proves only what it says. Its look and wording don't change what facility registration means. For more, see Amazon compliance documents.
Keep the file current
- Assign an owner for each facility check.
- Mark unknown supplier information for follow-up.
- Save each FDA submission confirmation.
- Record any FDA correspondence.
- Update the file when a manufacturer or facility changes.
How we handle this
For brands selling on Amazon.com, we keep facility, label and testing records together and follow Amazon's compliance requests through to a result. See our Amazon operations work. For shipping between Canada and the US, see tariff classification for supplements.
Want an outside view of your listings first? Get a free Amazon check. No account access needed.