Amazon's 2026 third-party verification rules now cover every supplement category. Suppressed listings, TIC documentation requests, and the FDA obligations most sellers don't know they carry. GummyGMP is the compliance department you don't have to hire.
The Risks Sellers Face
Most supplement sellers find out about their compliance obligations the hard way: a suppressed listing, a documentation demand, or an FDA letter.
Amazon can suppress your supplement listing for documentation gaps, labeling issues, or a failed TIC verification. Without a compliance dossier ready to upload, reinstatement takes weeks — and sales stop immediately.
Amazon's third-party verification program now sends documentation requests with a hard deadline. No extension. No GMP certificate, CoA, or lab results on file means your ASIN disappears at day 91.
If you private-label or own-label a supplement, you are an "own-label distributor" under 21 CFR Part 111. FDA holds you responsible for product quality, labeling accuracy, and adverse event reporting — regardless of who manufactured it.
Buying bulk product and relabeling it for sale? Under FDA's definition, you may be operating as a dietary supplement manufacturer — triggering facility registration, GMP compliance, and inspection obligations.
Services & Pricing
Every engagement is scoped and priced before we start. Pick the service you need — or combine them into the retainer that handles everything.
Lab and TIC fees are passed through at cost — no markup.
We prepare and manage the appeal; reinstatement decisions rest with Amazon.
Your ongoing compliance department — without the overhead of a full-time hire. Covers everything Amazon and FDA throw at you, month after month.
Add-On Services
Add any of these to a project engagement or include them in your retainer scope.
| Service | What's Included | Fee |
|---|---|---|
| FDA Facility Registration + US Agent |
FDA dietary supplement facility registration filing, designated US Agent service for foreign-registered facilities, annual renewal management.
Required if you repackage, relabel, or hold product for distribution.
|
$500 – $750 / yr |
| Serious Adverse Event Reporting (SAER) Program |
FDA-compliant SAER system setup, intake form design, reporting procedures, and trained point of contact. Includes ongoing monthly event monitoring and MedWatch submission management.
Required of every brand whose name appears on the label — serious adverse events must be reported to FDA within 15 business days.
|
$1,500 – $3,000 setup + monthly monitoring |
| Contract Manufacturer Qualification Audit + Quality Agreement |
On-paper qualification of your contract manufacturer against 21 CFR Part 111, GMP certificate review, CoA program verification, and a binding Quality Agreement between you and your CM.
Protects your brand if your CM faces an FDA inspection.
|
$2,500 – $5,000 |
Free Assessment
Tell us about your brand, your ASINs, and any compliance issues you're facing. We'll tell you exactly what's at risk and what it costs to fix it — no obligation.
By providing your phone number when booking, you agree to receive appointment-related texts from GummyGMP. Msg & data rates may apply. Reply STOP to opt out. See our Privacy Policy.
Book a free 30-minute assessment. We'll review your listings, your label, and your current FDA exposure — and tell you exactly what you need.
By providing your phone number when booking, you agree to receive appointment-related texts from GummyGMP. Msg & data rates may apply. Reply STOP to opt out. See our Privacy Policy.