The Internet has created access to more products and services than ever imaginable. You can buy almost anything on Amazon. The site has made getting things or selling things easier.
Unfortunately, loose regulation has caused a rise in adulterated or tainted supplements being readily available for consumer purchase. These products are meant for the purpose of promoting health, so consumers want to know the quality and benefits of the products they are purchasing. Plus, health is a major topic of discussion in today’s post-pandemic world. Amazon took notice and changed their policy for selling these dietary supplements in 2021.
What is a Dietary Supplement?
The United States Food and Drug Administration (FDA) defines a dietary supplement as:
“[A] product intended for ingestion that, among other requirements, contains a ‘dietary ingredient’ intended to supplement the diet. The term ‘dietary ingredient’ includes vitamins and minerals; herbs and other botanicals; amino acids; ‘dietary substances’ that are part of the food supply, such as enzymes and live microbials (commonly referred to as ‘probiotics’); and concentrates, metabolites, constituents, extracts, or combinations of any dietary ingredient from the preceding categories.
There are two types of ingredients that may be used in dietary supplements: ‘dietary ingredients,’ discussed above, and ‘other ingredients.’ These ‘other ingredients’ include substances such as fillers, binders, excipients, preservatives, sweeteners, and flavorings.”
In other words, dietary supplements are products that are taken orally for the purpose of adding extra nutrients to your diet. They’re not subject to the same rigorous testing and approval process as prescription drugs. Generally speaking, dietary supplements can be purchased over the counter (OTC) without prescriptions.
Children’s vitamins and fish oil capsules are two types of dietary supplements.
Amazon Dietary Supplement Requirements
Amazon requires sellers to verify via an approved third-party verifier that their supplements meet Amazon’s dietary supplement regulations, which includes but isn’t limited to:
- Products are manufactured in a facility compliant with the FDA’s Current Good Manufacturing Practice regulations (cGMPs, 21 CFR 111.117 or equivalent)
- Products do not contain contaminants that may pose a human health or regulatory concern
- Products contain the ingredients claimed on the product label
- Products do not contain undeclared active pharmaceutical ingredients
- Products are labeled according to guidelines set forth by the FDA and do not contain illegal or disease claims
Sellers who feel that their products shouldn’t require compliance with Amazon regulations can appeal the request for verification through their “Manage Your Compliance” dashboard.
Compliance Responsibility
The seller, not the lab making the dietary supplements, is responsible for complying with these requirements. The seller is responsible for ensuring the product they sell on Amazon meets regulatory compliance and can be held liable if it’s found in violation of regulations.
Meet Amazon Accreditation Requirements With A2LA
As the only independent, non-profit accrediting body in the United States, A2LA accredits more than 75 dietary supplement testing laboratories for compliance with ISO/IEC 17025.
Labs performing testing can help ensure their sellers meet Amazon’s requirements by becoming accredited to ISO/IEC 17025 (and the optional 2024 AOAC guidelines) by applying on our website. The accreditation process is straightforward, and it can take as little as four months to become accredited.
Contact A2LA to discover how A2LA sets your organization up for compliance success.