Dietary Supplements Seller Requirements
Amazon sets various safety and compliance requirements for sellers who offer dietary supplements.
What are the Requirements for Selling Dietary Supplements on Amazon?
All products listed on Amazon must comply with all federal, state, and local laws and Amazon policies applicable to those products and product listings. For dietary supplements, this includes:
- 21 CFR 101.36 – Nutritional Labeling of Dietary Supplements
- 21 CFR 111 – Current Good Manufacturing Practice (cGMP) in manufacturing, packaging, labeling, or holding operations for dietary supplements
- 21 CFR 117 – Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk Based Preventative Controls (HARPC) for Human Food
What is the Required Documentation to Sell Dietary Supplements on Amazon?
For each dietary supplement product or Amazon Standard Identification Number (ASIN), a seller must submit the following documents:
- A valid good manufacturing practice (GMP) certificate issued by an accredited third-party certification body in compliance with 21 CFR 111, 21 CFR 117, or both. Amazon accepts GMP certificates from accredited third-party certification bodies, including NSF/ANSI 455-2, NSF/ANSI 173 Section 8, GRMA 455-2, UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.
- A finished product Certificate of Analysis (COA) of declared dietary ingredients issued by an ISO/IEC 17025 accredited laboratory or in-house laboratory located in the above facility that is compliant with current GMPs.
- Evidence of product enrollment or participation in one of the following third-party quality certification programs:
- NSF/ANSI 173 Product Certification
- NSF Certified for Sport®
- BSCG Certified Drug Free®
- Informed-Choice/Informed-Sport Program
- USP Dietary Supplement Verification Program
- Product Images
What are the Requirements for a Dietary Supplements Product Certificate of Analysis (COA)?
Sellers must submit a finished product Certificate of Analysis (COA) to support the amount per unit or per serving of each dietary ingredient claimed on the applicable facts panel. The COA submitted to Amazon needs to be issued within the past 12 months, be in PDF form, and contain the complete product name, batch number, and other pertinent information outlined by Amazon for selling dietary supplements.
ANAB Accreditation for Laboratory Testing and GRMA Certification
As the largest accreditation body in North America, ANAB accredits testing laboratories to ISO/IEC 17025:2017. The mark of ANAB accreditation for these labs provides additional assurance and confidence that dietary supplement products will meet or exceed Amazon requirements, and the international recognition of ANAB can help open products to new markets and help attain worldwide recognition.
ANAB has also launched a pilot program for the Global Retail and Manufacturer Alliance (GRMA) certification scheme, which includes accreditation for certification to NSF/ANSI 455-2-2018 for dietary supplements. The accreditation program operates in accordance with ISO/IEC 17065 for product, process, and service certification programs.