Amazon Supplement Seller Requirements ISO 17025:2017
To ensure only lawful and safe dietary supplements are sold on Amazon, Amazon announced new policies in November 2020 for supplement products. Amazon will take down supplement brands’ merchandise if the required documentation has not been provided. Documentation is required for products requiring a supplements fact panel according to the Federal Food, Drug, and Cosmetic Act (FD&C Act).
What are Dietary Supplements?
According to the National Institute of Health, dietary supplements are any products intended to supplement the diet. These supplements include minerals, vitamins, amino acids, fish oils, enzymes, herbs or botanicals, and many other ingredients taken to improve health and well-being. Supplements can come in many forms; pills, capsules, tablets, gummies, powder mixes, drinks, and bars.
What Documentation does Amazon Require for Dietary Supplements?
Amazon requires two types of documentation for dietary supplements.
- Finished Product Certificate of Analysis (COA) or Evidence of Product Participation in an Amazon Accepted Third-Party Quality Certification Program
- Product Images
Finished Product COA
A finished product COA can come from either:
- A third-party testing facility that is ISO/IEC 17025:2017 accredited
The COA must include the laboratory's ISO 17025 accreditation number. Though accreditation is for specific tests, Amazon accepts any laboratory testing from an active accredited laboratory. In general, obtaining accreditation means the lab demonstrates competence in calibration and/or laboratory testing performance.
or
- An in-house laboratory with GMP certification from an Amazon accepted third-party program
Only 10 third-party certification programs like the one operated by National Sanitation Foundation (NSF) are accepted by Amazon. The accepted third-party certification gives Amazon assurance that the product is manufactured under current good manufacturing practices (GMP).
Evidence of Product Participation or Enrollment
Amazon accepts six third-party quality certification programs like the one offered by NSF Certified for Sport®.
What are Amazon’s COA Requirements?
The COA must contain the following information:
- The full product name
- The name and address of the accredited laboratory issuing the COA
- The code for the testing date of the finished product sample and/or the product lot/batch number
- Assay laboratory results per unit or per serving for each dietary ingredient listed on the supplements facts panel (assay panel tests must include tests to assure only lawful and safe ingredients are in the supplement as defined in section 402 of the FD&C Act or Title 21 Section 342 Adulterated Food)
- The laboratory test methods used for each listed dietary ingredient
- All dietary ingredients’ names and measurements listed on the supplement facts panel must match those given on the COA
COA’s must be submitted electronically to Amazon in pdf format and updated within 12 months.
What are Amazon’s Product Images Requirements?
The submitted product images must:
- Contain the product name
- Display all sides of the product label: the supplemental facts panel including the active ingredients and full ingredient list, product warnings, and any certification logos
- Contain name and contact information of the manufacturer or brand owner
- Be a direct image of the product or product packaging
- Be legible
Advantages of Using CTLA for COA Documentation
CTLA is a full-service ISO/IEC 17025:2017 accredited laboratory offering all safety and identity testing required for dietary supplement ingredients and finished products according to all FDA requirements and FD&C regulations.
Experience
Put CTLA’s experience meeting Amazon’s ISO 17025:2017 requirements to work for you. Our experience with Amazon and subsequent in-house procedures streamlines the required testing and documentation processes to market your brand’s supplements on Amazon.
Cost
Slice Intelligence estimates 77% of all supplement sales are on Amazon. With our streamlined Amazon documentation procedures, CTLA’s services are efficient and cost-effective for even the smallest supplement companies.
Customer Service
Our focus at CTLA is outstanding customer service and open, honest communication. When you choose CTLA, you choose to be informed. You will know what tests are required, the testing methods and costs, and the turnaround times.
Contact CTLA today to streamline your supplement brand’s adherence to Amazon’s dietary supplements documentation requirements. We look forward to working with you.
Article by Jae O. Haroldsen
The content of CTLA’s website is for information only, not advice or guarantee of outcome. Information is gathered and shared from reputable sources; however, CTLA is not responsible for errors or omissions in reporting or explanation. CTLA gives no assurance or warranty regarding the accuracy, timeliness or applicability of the content.
Sources
“Dietary Supplements.” Amazon Seller Central. 2021. https://sellercentral.amazon.com/gp/help/external/55N3JF2WQS7RVNE“Dietary Supplements Labeling Guide: Chapter IV. Nutrition Labeling.” US Food and Drug Administration. 2018. https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide-chapter-iv-nutrition-labeling#4-2
Long, Josh. “Amazon’s GMP Policies Not Perfect, But Praised by Supplement Stakeholders.” National Product Insider. 2021. https://www.naturalproductsinsider.com/regulatory/amazons-gmp-policies-not-perfect-praised-supplement-stakeholders
