Amazon's TIC verification model has changed the rules. Qalitex helps supplement sellers on Amazon.com and Amazon.ca build a defensible evidence pack — before the delisting notice arrives.
Since April 2024, Amazon requires third-party TIC verification — not just a document upload. Listings are removed if compliance isn't confirmed by the stated deadline.
Dietary supplement listings in flagged categories must be verified through an Amazon-approved Testing, Inspection & Certification organization via the Manage Your Compliance workflow. COAs submitted directly by sellers are not accepted.
For bodybuilding, sports, sexual enhancement, weight management, and joint health: Amazon explicitly requires heavy metals, microbial, adulterant testing (NSF/ANSI 173-2024), and label claim tolerances per 21 CFR 101.36.
Facility cGMP compliance must be certified by an accredited third party. First-party audits, consulting audits, and FDA inspection records are explicitly not accepted. Expired certificates are equally disqualifying.
Amazon issues removal notices for extract amounts deemed inaccurate or misleading under 21 CFR 101.36 — even for botanical extracts. Violations can trigger account deactivation warnings.
Products positioned with anxiety, depression, arthritis, pain, or similar terms are flagged. Amazon has stated it will not consider reinstatement until such claims are removed from the detail page and all images.
If Amazon identifies your product as an NHP or drug product on Amazon.ca, the listing may be blocked unless you hold a valid Health Canada license. Unlicensed NHPs cannot legally be listed or sold.
Amazon supplement compliance fails when evidence is internally inconsistent — label vs COA vs lot traceability. We align every layer.
We review your label, COA, and cGMP certificate against Amazon's current requirements and assign a written risk score with a recommended testing panel and remediation roadmap.
Starting pointWe design the right panel for your product form and intended use — metals, microbial, potency, pesticides, adulterants — and coordinate with ISO 17025-accredited labs using production-run sampling.
Core serviceCOAs are checked for lot linkage, ISO 17025 scope alignment, unit harmonization with label declarations, method references, and Amazon-required attributes. Corrected layouts provided where needed.
Submission readinessWe provide sampling SOPs, tamper-evident chain-of-custody forms, and shipping condition guidance to ensure your testing results are defensible from production floor to lab receipt.
DefensibilityWe validate your third-party cGMP certificate, confirm it isn't expired, and map the audited facility to your active SKUs — creating a submission-ready evidence packet.
Gate 3 complianceFor Canadian marketplace sellers, we review NPN/DIN licensing status, bilingual labelling requirements, priority allergen compliance, and Health Canada product facts table alignment.
Canada-specificWhen a test fails or Amazon issues a notice, we help investigate root cause, design a retesting strategy, draft CAPA documentation, and package a resubmission evidence pack.
RemediationAnnual renewal reminders, rolling COA library management, multi-SKU submission calendars, and ongoing claims/labelling monitoring to keep your entire portfolio in active status.
Ongoing retainerCosts vary by matrix complexity and analyte count. Ranges below reflect typical market pricing from ISO 17025-accredited commercial labs.
| Test Category | Typical Turnaround | Typical Cost Range | Amazon Status |
|---|---|---|---|
| Heavy Metals (As, Cd, Hg, Pb via ICP-MS) |
5–10 business days | ~US$80–$250 | Explicit — Required |
| Microbial Indicators (APC, yeast/mould, E. coli, coliforms) |
2–6 business days | ~US$60–$250 / panel | Explicit — Required |
| Pathogens (Salmonella, Staph — matrix dependent) |
3–7 business days | ~US$40–$150 each | Risk-based |
| Adulterants Screen (NSF/ANSI 173-2024 reference list) |
7–15 business days | ~US$250–$1,200+ | Explicit — High-risk intents |
| Pesticide Multi-Residue (botanical-heavy or component-flagged) |
7–14 business days | ~US$200–$800 | Risk-based / component review |
| Potency / Label Claim (active verification per 21 CFR 101.36) |
5–15 business days | ~US$130–$350 / analyte | Explicit — Label tolerance |
| Identity Testing (dietary ingredient verification) |
3–10 business days | ~US$80–$300 | cGMP baseline |
| Stability / Shelf-life (expiry date substantiation) |
Weeks to months | ~US$500–$5,000+ | Best practice / Health Canada |
A typical compliance cycle from gap assessment to live listing runs 6–10 weeks depending on panel scope and whether remediation is needed.
We screen your ingredient list, claims, and label declarations for high-risk intents (bodybuilding, weight management, sexual enhancement, joint health, sports nutrition), disease-adjacent language, and quantitative accuracy against 21 CFR 101.36.
We validate your facility's third-party cGMP certification, confirm accreditation body and expiry status, and map the audited facility to the SKU(s) in scope. Private, first-party, and consulting audits are flagged for replacement.
We produce a sampling SOP specific to your product form and lot, provide tamper-evident chain-of-custody forms, and confirm shipping conditions (temperature, carrier, timeline) to ensure the COA is defensible for production-run origin.
Samples are sent to ISO 17025-accredited labs with scope covering the required methods and matrices. We coordinate results across metals, microbial, potency, and any required adulterant or pesticide panels simultaneously.
Every COA is checked for lot linkage, ISO 17025 scope match, unit alignment with label declarations, method references, and recency (six-month conservative standard). The full evidence pack is formatted for TIC submission.
We support submission through the Manage Your Compliance workflow with the TIC provider, ensure all documentation is in acceptable format (PDF, complete product name, batch number, recency), and track confirmation status.
Amazon.ca may identify your supplement as a Natural Health Product (NHP) or drug product, blocking the listing until you hold a valid Health Canada NPN or DIN. Qalitex reviews your product's NHP classification risk, licensing status, and labelling requirements before Amazon flags you.
All NHPs and drug products must be licensed by Health Canada. Listings of unlicensed products are prohibited on Amazon.ca.
Canadian labels require bilingual text, lot number, expiry date, and compliance with the improved labelling framework including priority allergens.
Products you believe are foods or cosmetics may be classified as NHPs by Health Canada. We flag classification risk before Amazon does.
All models include a compliance gap assessment. Final quotes are customized to your SKU count, product forms, and required testing scope.
Upload your label, COA, and cGMP certificate (if available) and receive a written panel recommendation, estimated cost/timeline, and submission checklist — aligned to the current TIC verification model.
Thank you. A Qalitex compliance specialist will review your submission and respond with a written risk score, recommended testing panel, and timeline estimate within 1 business day.
Check your inbox — we'll send a confirmation with a document upload link so you can share your label, COA, and cGMP certificate ahead of your call.