Are you selling supplements on Amazon?
Manufacturers and Own Label Distributors (OLD) face strict Amazon dietary supplement requirements, much like those required by the U.S. FDA.
Here’s what you need to know to make sure your products are in compliance with Amazon’s Dietary Supplement Compliance Checklist.
What a Dietary Supplement Is…and Isn’t
There are many FDA requirements pertaining to the lawful sale of dietary supplements, including what ingredients they may contain.
Amazon has adopted many of these requirements as conditions of selling supplements on Amazon, with the aim of enhancing consumer safety by protecting people from adulterated products such as unapproved new drugs or dangerous and potentially harmful substances.
Per FDA’s Dietary Supplement Health and Education Act (DSHEA), a law passed by Congress in 1994, products using the term dietary supplement may include dietary ingredients like:
- Botanicals such as herbs
- Amino acids
- Other dietary substances or there constituents as a supplement to the diet, thereby increasing the total dietary intake of supportive dietary ingredients
The U.S. FDA Does Not "Approve" Supplements
Unlike FDA-approved prescription pharmaceuticals, dietary supplements do not undergo an FDA approval process.
Dietary supplements are not intended to “treat or cure a disease” and must never make any marketing claims on labels or marketing materials, including social media, to that effect.
However, dietary ingredients and their in-process and finished goods must still meet certain specifications for identity, purity, strength, and composition as established in monographs developed by the U.S. Pharmacopeia, or USP.
It is these specifications that establish the safety of a dietary supplement product and drive development of an FDA-required Supplement Facts Panel and associated labeling.
Amazon Supplement Requirements: Ingredient Specifications
Amazon’s focus on safety means that specifications demonstrating compliance with FDA and Amazon’s dietary supplement requirements, including identification and quantification of contaminants, must be confirmed through supplements laboratory testing.
Amazon requires this testing be completed in an ISO 17025-accredited laboratory.
For example, any product marketed as a dietary supplement that contains prohibited ingredients, including ingredients that are approved by FDA for use in prescription drug products, may never be sold on Amazon.
Remember – dietary supplements are regulated differently than prescription drugs, and even over-the-counter, or non-prescription, drugs. Dietary supplements have their own current Good Manufacturing Practices regulations (cGMPs) found in the U.S. Code of Federal Regulations 21 CFR 111 and specific labeling requirements found in 21 CFR 101.36 and an FDA Dietary Supplement Labeling Guide.
As dietary supplements are a subcategory of foods, manufacturers and OLDs must also comply with the Food Safety Modernization Act requirements found in 21 CFR 117, including conducting risk analyses to identify any known or foreseeable hazards that could make the product injurious to consumers.
Prohibited Ingredients in Dietary Supplements Sold on Amazon
- Examples of prohibited ingredients include pure powdered caffeine, and anything listed in Schedules I, II, III, IV, or V of the U.S. Drug Enforcement Agency’s (DEA) Controlled Substances Act. This includes Cannabidiol or CBD.
- Also prohibited for sale on Amazon are chemicals and their derivatives contained in the DEA’s Diversion Control Division List 1.
- How does a dietary supplement manufacturer or OLD confirm the ingredients that their product contains? Through laboratory testing and a subsequent Certificate of Analysis (COA).
- All dietary supplements must meet the manufacturer’s or OLD’s specifications for identity, purity, strength, and composition as dictated by USP monographs.
- Dietary supplement manufacturers and OLDs must also identify and quantify any contaminants that would render a product adulterated.
- Amazon has other prohibitions for selling products that contain more than 12% hydrogen peroxide, patches marketed as dietary supplements and/or detox products, and products named by the Federal Trade Commission (FTC) as making untrue marketing claims.
- A complete Amazon Compliance Checklist for sellers of dietary supplements can be found on the Amazon website.
Use of ISO 17025-accredited laboratories is one Amazon dietary supplement requirement.
Amazon Dietary Supplement Requirements for Laboratory Testing
- Amazon requires that dietary supplement specifications testing be conducted in an ISO 17025-accredited laboratory, both prior to entering into an agreement with the e-commerce retailer and annually as a method of demonstrating cGMP compliance and product quality.
- Amazon may at any time require sellers to submit specifications documentation to confirm their continual and diligent focus on compliance.
- Manufacturers or OLDs of certain products sold on Amazon, including sexual enhancement, weight loss, weight management, and sports nutrition must test finished products for specific compounds at least annually at an independent third-party ISO 17025 accredited laboratory.
- The results of these tests must include actual test data and observations rather than pass/fail statements. Amazon may at any time require proof of these test results submitted via a COA.
The specific compounds for which Amazon requires annual third-party testing include:
Sexual Enhancement Supplements
Weight Loss/Weight Management Supplements
Sports Nutrition Supplements
It’s important to note that Amazon’s compliance testing for dietary supplements can change, so contact us for the latest required tests.
What Do Amazon Supplement Requirements Mean to Me?
If you are a dietary supplement manufacturer or OLD, compliance with Amazon’s dietary supplement requirements is a must. Their requirements go a long way to meeting those of FDA, ensuring that your products meet specifications requirements and are free of or have only safe amounts of any contaminants.
While not all the testing required by Amazon must be conducted in a third-party laboratory, all laboratories that test products that will be sold on Amazon must be ISO 17025-accredited. Amazon goes a step further with certain particularly risky dietary ingredients, requiring those to be independently tested and verified in a third-party laboratory.
Certified Laboratories can help you meet Amazon supplement requirements. With our high throughput and state-of-the-art LC-MS/MS technology, we can provide accurate results quickly, helping your products reach customers faster.
Click below to get a quote for your Amazon dietary supplement laboratory testing.
Please note that ABC Testing Inc., Micro Quality Labs, and Microconsult Inc. are now Certified Laboratories. Same locations with expanded service and capabilities.