2026: No 'This Document,' No Dietary Supplement Sales!

Starting in 2026, to sell Dietary Supplements on Amazon, you will be required to submit a cGMP (Current Good Manufacturing Practice) certificate from an accredited third-party organization for all your products.

⚠️ Without this document, not only will your listings be removed, but your Account Health could also face severe issues.

Policy Background and Reinforcement

Amazon prioritizes consumer safety and regulatory compliance, continuously strengthening regulations, especially for ingestible products.

Currently, Amazon mandates third-party verification for all Dietary Supplement sellers. Beginning in early 2026, this policy will expand further, making proof of cGMP (Current Good Manufacturing Practice) compliance from an accredited third-party organization mandatory for all Dietary Supplements. This extends regulations previously applied only to high-risk categories (e.g., sexual enhancement, weight management, sports nutrition) to the entire Dietary Supplement category.

Amazon is implementing these measures to prevent consumer harm from non-compliant products and to address regulatory pressures stemming from reports of contaminated or mislabeled items.

Key Compliance Requirements

To sell Dietary Supplements on Amazon, you must adhere to the following key rules:

1. Submit an Accredited Third-Party cGMP Certificate: A valid cGMP certificate from an accredited third-party organization is essential to prove that your Dietary Supplement is manufactured in accordance with FDA cGMP regulations (21 CFR 111 or 21 CFR 117). Private audits, self-audits, consulting audits, or FDA inspection reports are no longer accepted. The certificate must be issued by an Amazon-approved certification body such as NSF/ANSI 455-2, NSF/ANSI 173 Section 8, UL GMP, USP GMP, or GRMA. 2. Prepare a COA (Certificate of Analysis) from an ISO/IEC 17025 Accredited Lab: A COA (Certificate of Analysis), verifying the product's ingredient content, heavy metal levels, and microbial contamination, must be issued by an ISO/IEC 17025 accredited laboratory. This COA must be ready for submission upon Amazon's request and include batch/lot numbers that match your product information. 3. Comply with Amazon and FDA Labeling Regulations: Product labels must be in English and clearly include a "Supplement Facts" panel, a complete list of all ingredients, net quantity, and manufacturer or distributor contact information. Furthermore, phrases like "FDA Approved" or claims of disease treatment are strictly prohibited on product labels unless officially approved by the FDA.

Serious Consequences of Policy Non-Compliance

Failure to comply with Amazon's Dietary Supplement policy can lead to the following severe consequences:

⚠️ Listing Removal: The most immediate consequence is the deletion of non-compliant product listings from the Amazon platform. Selling Privileges Suspension: For repeated or severe violations, selling privileges for the affected category or your entire account may be temporarily suspended. Account Health Score Decline: Policy violations negatively impact your seller account's Account Health score, potentially leading to more significant penalties for future policy breaches. Account Suspension: In the worst-case scenario, your Amazon account may be permanently suspended, preventing you from selling on Amazon altogether. Inventory Management Issues: FBA (Fulfillment By Amazon) inventory will become unsellable, potentially incurring return or disposal costs.

3 Action Plans to Implement Right Now

1. Check if Your Product Requires Approval: Use the ASIN or UPC of the Dietary Supplement you intend to sell to check if approval is required via the Inventory → Add a Product menu in Seller Central. 2. Partner with an Accredited Third-Party TIC (Testing, Inspection, and Certification) Service Provider: Select an Amazon-approved third-party TIC organization (e.g., NSF, UL, SGS) to commission cGMP compliance verification and necessary testing for your product. Amazon requires verification through these organizations rather than direct submission of test documents by sellers. 3. Continuously Check for the Latest Policies and Document Requirements: Amazon regularly updates its policies, so consistently review the "Categories and Products requiring approval" page and the "Dietary Supplements" policy page in Seller Central to stay informed about the latest document requirements.

Common Mistakes and Precautions

Here are common mistakes sellers make during the Dietary Supplement category approval process:

1. Submitting Invalid or Incomplete Documents: This includes submitting a COA or cGMP certificate that has expired or fails to meet all of Amazon's requirements. Notably, starting in 2026, Amazon will only accept cGMP certificates from accredited third-party organizations, meaning private audit reports and similar documents will be immediately rejected. 2. Non-Compliance with Product Labeling Regulations: Listings may be rejected or removed if labels lack English text, omit the "Supplement Facts" panel, or include false/exaggerated claims (e.g., disease treatment claims).