Amazon compliance for dietary supplement brands
LIVELE manages Amazon compliance for dietary supplement brands selling on Amazon.com. We track third-party testing, inspection and certification (TIC) results, current good manufacturing practice (cGMP) evidence, FDA facility registrations and label files for every ASIN, and check listing claims against FDA rules. Since April 2, 2024, Amazon has required supplements to be verified by a third-party TIC organization. Compliance Management costs $3,500/month and does not include PPC.
What US law requires of a supplement brand
The Food and Drug Administration (FDA) regulates dietary supplements as food, under rules written for supplements. Sources were last checked on October 7, 2026.
No approval before sale. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA does not approve supplements before they are marketed. The firm that makes or distributes a supplement is responsible for making sure it is not adulterated or misbranded (FDA, August 2026).
Manufacturing. The FDA's current good manufacturing practice rule for supplements is 21 CFR Part 111. It covers anyone who manufactures, packages, labels or holds supplements, including supplements imported into the US (eCFR, 21 CFR 111).
Labels and claims. The label carries a Supplement Facts panel (21 CFR 101.36). A structure/function claim such as "supports restful sleep" needs the FDA disclaimer on the label, and the manufacturer, packer or distributor must notify the FDA within 30 days of first marketing it. No supplement may claim to diagnose, treat, cure, mitigate or prevent a disease (21 CFR 101.93).
Adverse events. The label needs a domestic address or phone number for adverse event reports. Serious adverse events go to the FDA within 15 business days, and adverse event records are kept for 6 years (FDA guidance).
Facilities and new ingredients. Facilities that make, pack or hold supplements for the US register with the FDA and renew between October 1 and December 31 of every even-numbered year, so the current window closes December 31, 2026 (FDA, September 2026). An ingredient not marketed in the US before October 15, 1994 needs a new dietary ingredient notification at least 75 days before launch.
What Amazon asks supplement sellers for
Third-party verification. Since April 2, 2024, Amazon has required dietary supplements to be verified through a third-party testing, inspection and certification (TIC) organization (Amazon Seller Forums, April 2024). Amazon staff describe the check as annual, and it looks for manufacture in a facility that complies with the FDA's cGMP rules (Amazon Seller Forums, March 2025).
Results come from the provider, not from you. In July 2026 Amazon named its TIC providers as NSF International, Eurofins and UL, and said it no longer accepts compliance documents uploaded directly by sellers (Amazon Seller Forums, July 2026). Amazon says testing typically takes 30 days once the provider receives samples, and the request has to go in by the deadline in Amazon's notification to avoid listing suspension (Amazon Seller Forums, July 2026).
Category paperwork. Amazon's own guide to selling health and personal care products lists FDA registration, a cGMP certificate and a Certificate of Analysis for supplements (Amazon, April 2026).
What LIVELE keeps on file for each supplement ASIN
This is what "documentation, certification and regulatory tracking" means in Compliance Management for a supplement brand. We track and file. Labs test, manufacturers certify and the TIC provider reports to Amazon.
| Document | Who issues it | What we track |
|---|---|---|
| TIC verification | Amazon's TIC provider (NSF International, Eurofins or UL) | Status per ASIN, Amazon's deadline, sample shipment, annual renewal |
| cGMP evidence for the manufacturing facility | The manufacturer and its third-party auditor | Facility name and address, audit or certificate date, next audit |
| Certificate of Analysis | The manufacturer or an ISO/IEC 17025 accredited lab | Batch numbers matched to the inventory you send to FBA |
| FDA food facility registration | The facility, with the FDA | Registration number, US agent for foreign facilities, the 2026 renewal |
| Label file and claims | Your brand | Supplement Facts panel, structure/function wording, FDA disclaimer, date of the 30-day notification |
| Listing content | Your brand | Title, bullets and images say no more than the label, and make no disease claims |
| Adverse event contact and log | Your brand | Domestic address or phone on the label, report log kept for 6 years |
- We don't test products, sign certificates or give legal opinions on claims. A regulatory attorney reviews borderline claims.
Who this is for
Who it’s for
- Supplement brands with Brand Registry doing roughly $1.5 million or more a year on Amazon.
- Teams where nobody owns Amazon document requests, TIC deadlines and label files.
- Brands adding formulas or changing manufacturers, where every change touches TIC, labels and listings.
Who it’s not for
- Brands that want us to test products or sign their certificates. Labs and manufacturers do that.
- Sellers who need a legal opinion on a disease claim. That is a regulatory attorney's job.
- Resellers without Brand Registry, brands under about $1 million a year on Amazon or anyone looking for PPC management.
Questions supplement brands ask
Is FDA registration the same as FDA approval?
No. The FDA does not approve supplements before they are sold. Facility registration tells the FDA where a supplement is made, packed or held. It is not an endorsement of the product, so a listing should never say "FDA approved".
Can we upload our own lab reports to Amazon instead of using a TIC provider?
Not any more. In July 2026 Amazon said it no longer accepts compliance documents uploaded directly by sellers, and results must come from its TIC provider. Results from an ISO/IEC 17025 accredited lab can be given to the TIC provider.
How long does Amazon's TIC verification take?
Amazon says testing typically takes 30 days once the provider receives samples. Add time for shipping samples and for any retest, and start before the deadline in Amazon's notification.
What can a supplement listing claim?
A structure/function claim, such as "supports restful sleep", with the FDA disclaimer on the label and the 30-day notification filed. A disease claim, such as "treats insomnia", is not allowed for a supplement. Keep the Amazon listing within what the label says.
Our manufacturer is outside the US. What changes?
The foreign facility registers with the FDA and names a US agent, and each shipment needs FDA Prior Notice before it arrives. The cGMP rule in 21 CFR Part 111 applies to imported supplements too.
Do you run the TIC process for us?
Within Compliance Management we track which ASINs need verification, prepare what the TIC provider asks for, follow the case in Seller Central and keep the result on file. The TIC provider tests and reports to Amazon; we don't.
Talk to an Amazon specialist about your supplement catalog
Tell us how many ASINs you sell and what Amazon has asked for. If a listing is already deactivated or Amazon has set a deadline, choose "Urgent" in the form so we read it first.