What Brands Need to Know

Selling dietary supplements on Amazon offers brands access to millions of consumers, but it also comes with strict product compliance requirements. Amazon has strengthened its dietary supplement policy to help ensure that products sold in the US meet applicable safety, labeling, manufacturing and quality standards.

For supplement brands, understanding Amazon’s requirements is essential to maintaining an active listing and avoiding potential compliance issues, listing removal or suspension (1).

What is Amazon’s Dietary Supplement Policy?

Amazon’s dietary supplement policy applies to products sold in the United States. These products may include vitamins, minerals, herbs, botanicals, amino acids and other dietary ingredients and can be offered in formats such as capsules, tablets, powders, liquids and oral sprays.

Products with a Supplement Facts panel are generally subject to Amazon’s dietary supplement requirements. These requirements work alongside applicable FDA regulations, including the Federal Food, Drug and Cosmetic Act and the Dietary Supplement Health and Education Act (DSHEA).

Importantly, dietary supplements cannot contain undeclared drug ingredients or make claims that a product can diagnose, treat, cure, mitigate or prevent a disease (1).

Third Party Testing for Dietary Supplements

One of the most significant changes to Amazon’s dietary supplement requirements is the use of third-party testing, inspection and certification. Amazon announced that dietary supplement products would need to be verified through an approved third-party Testing, Inspection and Certification (TIC) organization. The requirement was initially focused on categories including sexual enhancement, weight management, sports nutrition and body building supplements before expanding across the dietary supplement category (2).

The purpose of this verification is to confirm that dietary supplements meet Amazon’s product quality, safety, ingredients, manufacturing and labeling standards. For applicable products, sellers initiate testing through Amazon’s Manage Your Compliance dashboard. The selected Amazon-approved testing organization then works directly with the seller to complete the required testing, with results submitted directly to Amazon (2).

What does Amazon Testing Look For?

Amazon’s dietary supplement compliance requirements address several important areas of product quality and safety (3):

  1.  Good Manufacturing Processes: Dietary supplements must be manufactured in facilities that comply with applicable FDA Current Good Manufacturing Practices (cGMPs), including applicable requirements under 21 CFR Part 111 and other relevant regulations. Strong manufacturing controls help ensure that supplements are produced consistently and meet established quality standards.
  2. Ingredient Accuracy: The ingredients in a dietary supplement must match what is represented on the product label. This makes ingredient identity and quality testing particularly important for supplement manufacturers and brands. Products should contain the ingredients claimed on their labels and should not contain undeclared active pharmaceutical ingredients.
  3. Contaminant Control: Amazon’s requirements also address contaminants that could pose a human health or regulatory concern. For supplement manufacturers, appropriate raw-material qualification, testing, quality control and finished-product testing can play an important role in demonstrating product safety and consistency.
  4. Accurate Labeling: Dietary supplement packaging and labeling must meet applicable FDA requirements. This includes appropriate use of the Supplement Facts panel, ingredient information, serving information and other required labeling elements. Brands should also ensure that their Amazon product detail pages accurately represent the physical product and its labeling.

Avoiding Disease Claims

Dietary supplements cannot make unauthorized disease claims. Product descriptions, bullet points, images, advertising and other marketing content should therefore be carefully reviewed to ensure that they do not suggest that a supplement can diagnose, treat, cure, mitigate or prevent a disease. Brands should also be cautious about language that compares a supplement directly with prescription drugs or controlled substances. Amazon’s broader guidance restricts claims suggesting that supplements provide the same effects as prescription drugs or controlled substances (3).

Why Compliance Matters

For supplement brands, compliance is more than a regulatory consideration, it can directly affect the ability to sell your products on Amazon. Amazon states that listings subject to compliance requests may be removed if the required compliance confirmation in not completed by the specified deadline. That means brands should not wait until a compliance request appears before reviewing their document and testing strategy.

How Brands can Prepare

A strong Amazon dietary supplement compliance strategy starts well before a product can be listed. Brands should establish a comprehensive quality and documentation program that should include (4):

  • Review of the product formula
  • Verify ingredient identity
  • Evaluate manufacturing controls
  • Review the label
  • Review marketing claims
  • Prepare for third-party testing
  • Monitor Amazon Seller Central

How Sensient Can Help

Effectively managing regulatory compliance remains a complex and evolving responsibility for organizations, especially within the pharmaceutical and nutraceutical markets, where precision and accountability are very important. Our team proactively tracks and interprets global regulatory frameworks, ensuring that our colors, flavors and coatings align with applicable laws, directives, and guidance across all markets in which we operate.

Beyond meeting baseline requirements, we are committed to consistently exceeding industry benchmarks for quality, safety, and security. We adhere to current Good Manufacturing Practices (cGMP) and comprehensive food safety standards, implementing robust quality management systems, supplier qualification programs, and traceability protocols to safeguard product integrity. From the receipt of raw materials to final release and distribution, our procedures are meticulously designed to ensure process reliability, protect consumers and support regulatory readiness across all operations.

Sources:
1. Amazon - Changes to Dietary Supplements Policy
2. Amazon Seller Central - Dietary Supplement Compliance Discussion
3. FDA - Current Good Manufacturing Practices for Food and Dietary Supplements
4. FDA - Label Claims for Conventional Foods and Dietary Supplements

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