Amazon US Supplement Testing Requirements: What You Need to Know

Fulfill Amazon’s US dietary supplement seller requirements with Informed Choice certification

In 2021, Amazon updated its requirements for dietary and sports supplement products being sold on the site in an effort to add additional quality assurance measures for consumers purchasing products on the retail platform. As a part of these new regulations, Informed Choice and LGC were named by Amazon as accepted means to fulfill these requirements.

What is a dietary supplement by definition? The US Food and Drug Administration (FDA) classifies these as “a vitamin, mineral, herb or other botanical, amino acid, or dietary substance for use to supplement the diet by increasing the total dietary intake or a concentrate, metabolite, constituent, extract, or combination of the preceding substances”. 

Amazon's updated policy for selling dietary supplements in the US requires documentation that the ingredients listed are compliant with regulations found in Chapter 21 of the Code of Federal Regulations (21 CFR)

Amazon's Documentation Requirements: Selling Dietary Supplements on Amazon

Those selling dietary supplements on Amazon must submit the following documentation:

• Nutritional Labeling of Dietary Supplements (part 101.36)
• Current Good Manufacturing Practice (cGMP) in manufacturing, packaging, labeling, or holding operations for dietary supplements (part 111)
• cGMP, Hazard Analysis and Risk-Based Preventative Controls (HARPC) for Human Food (part 117)

Amazon supplement requirements for its dietary supplement sellers include 

1. A Certificate of Analysis (CoA) issued by an ISO/IEC 17025 accredited laboratory, a COA from an in-house laboratory compliant with the current good manufacturing processes (cGMP), OR evidence of product enrollment or participation in a third-party quality assurance program. Product certification with Informed Choice fulfills this requirement and Informed Choice is listed as an Amazon-accepted certification. 
2. Product images that are legible, clearly show the entire product label and the product name and display the name and contact information of the brand owner and manufacturer. Further, the product images need to be a direct image of the product or its packaging.

Amazon has also created a compliance checklist outlining labeling, packaging, product ingredients, and the detail page of the products once they've been approved. This includes information on how to sell dietary supplements on the platform and helps ensure ethical marketing. 

Additional Testing Requirements for Weight Loss & Sexual Enhancement Products

In December 2021, Amazon issued requirements for weight loss supplements and sexual enhancement products requiring testing for specific compounds and prohibiting the sale of these products in single or double pack pill offerings. 

Sellers of weight management or sexual enhancement products must provide a CoA from an ISO/IEC 17025 accredited laboratory that reports the testing results and absence of a range of known adulterants/contaminants listed below in addition to the general CoA requirements. CoA's from in-house laboratories are not accepted for these compounds. Amazon has listed LGC/Informed Choice as an ISO 17025 accredited laboratory with testing capabilities for these substances. 

A full listing of CoA requirements and the documentation required for dietary supplements can be found on Amazon's Seller Central.

Ensure Amazon Compliance with Informed Choice

Developed in 2007, Informed Choice is a global banned substance testing and certification program that regularly tests dietary supplement products. Supplements are analyzed for 250+ banned substances, along with a robust audit of manufacturing quality processes. Informed Choice has more than 420 certified products sold in over 90 countries around the globe. With 55+ years of anti-doping experience combined with being internationally recognized by numerous nutrition organizations, supplement brands can trust their reputation to Informed Choice.