Amazon Dietary Supplement Testing Requirements

Selling dietary supplements on Amazon is a lucrative business, but it comes with strict compliance requirements. Amazon enforces rigorous testing and certification standards to ensure that supplements sold on its platform meet safety, quality, and regulatory guidelines. For sellers, understanding and following these requirements is crucial to avoiding product removals, account suspensions, or worse—legal trouble.

So, what exactly does Amazon require when it comes to dietary supplement testing? From third-party testing to prohibited ingredients and labeling restrictions, this guide will break down everything sellers need to know to stay compliant and protect their business.

Understanding Amazon’s Dietary Supplement Policy

Amazon enforces strict regulations on dietary supplements to maintain product safety and consumer trust. Sellers must comply with specific testing, labeling, and certification requirements before listing their products. Failing to meet these standards can result in delisted products, account suspension, or even permanent bans from selling on the platform.

Overview of the Policy

Amazon’s Dietary Supplements Policy is designed to prevent the sale of unsafe or misrepresented supplements. While dietary supplements are regulated differently than prescription drugs, Amazon still requires sellers to provide verifiable proof of safety and compliance.

Key aspects of Amazon’s policy include:

• Mandatory third-party testing for supplement purity, potency, and label accuracy.
• Good Manufacturing Practices (GMP) compliance to ensure proper production standards.
• Prohibition of certain ingredients and misleading health claims that violate Amazon’s guidelines.
• Strict documentation requirements, including Certificates of Analysis (COAs) from accredited labs.

Key Components of the Policy

Amazon defines dietary supplements as products intended to supplement the diet and containing ingredients such as vitamins, minerals, herbs, amino acids, or other botanicals. However, not all supplements are treated equally—certain categories face additional scrutiny due to their potential risks or history of misuse.

Some supplement categories subject to stricter requirements include:

• Weight loss supplements – Products containing stimulants or metabolism boosters.
• Sports and performance enhancers – Such as pre-workout formulas, testosterone boosters, and protein powders.
• Sexual enhancement supplements – Due to past concerns about undisclosed pharmaceutical ingredients.
• Herbal and botanical extracts – Especially those with medicinal claims or unknown ingredient origins.

Amazon’s compliance team actively monitors listings in these high-risk categories and requires additional proof of safety and authenticity.

Mandatory Testing Requirements

To sell dietary supplements on Amazon, sellers must meet strict testing and certification standards. Amazon requires third-party testing, valid Certificates of Analysis (COAs), and compliance with Good Manufacturing Practices (GMP) to ensure product safety, potency, and labeling accuracy. These requirements help prevent adulterated, mislabeled, or unsafe supplements from reaching consumers.

Third-Party Testing and Certification

Amazon mandates that dietary supplements undergo independent third-party testing through approved laboratories. These tests verify:

• Purity – Ensuring the product is free from contaminants such as heavy metals, bacteria, and pesticides.
• Potency – Confirming that the supplement contains the exact amount of active ingredients listed on the label.
• Label Accuracy – Verifying that ingredient claims are truthful and match the product contents.

Sellers must work with Amazon-approved testing organizations to conduct these evaluations. Some of the commonly recognized third-party testing bodies include NSF International, USP (United States Pharmacopeia), and ConsumerLab.

Certificate of Analysis (COA) Requirements

A Certificate of Analysis (COA) is one of the most critical documents Amazon requires for supplement verification. This document must come from an ISO/IEC 17025 accredited lab and include:

• Product name and batch number.
• A complete breakdown of tested ingredients.
• Confirmation of potency and purity.
• Verification that the supplement is free from restricted or banned substances.

Amazon typically requires sellers to submit COAs during the listing process, but it may also request updated documentation at any time. Failure to provide a valid COA can result in product delisting or account suspension.

Why Amazon Requires Strict Testing

Amazon’s dietary supplement marketplace has faced significant scrutiny due to past incidents involving unsafe or mislabeled products. To maintain consumer trust, Amazon enforces tighter regulations than traditional retailers. These testing requirements help:

• Reduce the risk of counterfeit or unsafe products.
• Protect consumers from supplements with undisclosed or banned ingredients.
• Ensure compliance with FDA and international safety guidelines.

Sellers who fail to meet these requirements risk losing their ability to sell on Amazon, making compliance non-negotiable for long-term success.

Compliance with Good Manufacturing Practices (GMP)

Amazon requires all dietary supplements sold on its platform to be manufactured in facilities that comply with Good Manufacturing Practices (GMP). These guidelines, set by the U.S. Food and Drug Administration (FDA), ensure that supplements are produced, stored, and labeled under strict quality control measures. GMP certification helps prevent contamination, mislabeling, and ingredient inconsistencies, all of which can pose health risks to consumers.

GMP Certification and Why It’s Required

GMP certification verifies that a manufacturing facility follows standardized protocols to maintain product quality and safety. To meet Amazon’s dietary supplement testing requirements, sellers must provide proof that their supplements are produced in GMP-compliant facilities.

A valid GMP certificate should include:

• The certifying organization’s name (e.g., NSF International, USP, or the FDA).
• The facility’s name and address where the supplement is manufactured.
• The expiration date of the GMP certification.
• A statement confirming compliance with 21 CFR Part 111, the FDA regulation for dietary supplement GMPs.

If a seller cannot provide a valid GMP certificate upon request, Amazon may remove the product listing or restrict the seller from continuing sales.

GMP Compliance Checklist for Supplement Sellers

To remain compliant with Amazon’s requirements, supplement manufacturers must:

• Implement strict ingredient sourcing protocols to avoid contamination.
• Conduct in-house quality control testing before sending products for third-party verification.
• Maintain proper documentation for every production batch.
• Regularly audit manufacturing processes to meet evolving GMP standards.

Amazon may randomly request updated GMP certificates, so sellers should keep their documentation current and easily accessible.

Prohibited Ingredients and Claims

Amazon strictly regulates the ingredients and marketing claims allowed for dietary supplements. Sellers must ensure that their products do not contain banned substances and do not make misleading health claims that violate Amazon’s policies or FDA guidelines. Failure to comply can result in immediate listing removal, account suspension, or legal repercussions.

Restricted and Banned Ingredients

Certain substances are completely prohibited in dietary supplements sold on Amazon due to safety concerns, legal restrictions, or regulatory bans. Some of the most commonly restricted ingredients include:

• Ephedrine alkaloids – Stimulants often found in weight-loss and performance-enhancing supplements, banned by the FDA.
• Sibutramine – A prescription-only weight-loss drug, frequently found in adulterated supplements.
• DMAA (1,3-Dimethylamylamine) – A stimulant linked to cardiovascular risks.
• Kratom – A plant-based compound with opioid-like effects, flagged by the FDA for safety concerns.
• Colloidal silver – Often marketed for immune support, but has been deemed unsafe by the FDA.

In addition, Amazon frequently updates its list of restricted substances, meaning sellers must stay informed to avoid listing violations.

Marketing and Labeling Restrictions

Amazon prohibits unsubstantiated or misleading health claims that imply a dietary supplement can:

• Cure, prevent, or treat any disease.
• Replace prescription medications.
• Offer immediate or unrealistic health benefits.

For example, sellers cannot market supplements as “FDA Approved” since the FDA does not approve dietary supplements—it only regulates them.

Other common violations include claims like:

• “Clinically proven to cure diabetes” – Violates FDA and Amazon guidelines.
• “Boosts metabolism and burns fat overnight” – Misleading and lacks scientific backing.
• “100% risk-free cancer treatment” – False advertising and medical misinformation.

To ensure compliance, sellers should:

• Use scientifically accurate and legally permitted phrasing (e.g., “supports immune health” instead of “prevents illness”).
• Avoid testimonial-based medical claims (e.g., “Customers reported reversing high blood pressure”).
• Regularly review Amazon’s dietary supplement labeling policies for updates.

Amazon uses automated monitoring and manual reviews to flag non-compliant listings. If a product fails an Amazon compliance check, sellers may be required to update descriptions, remove prohibited claims, or submit supporting documentation.

Steps to Achieve Compliance

Meeting Amazon’s dietary supplement testing requirements isn’t just about avoiding penalties—it’s about ensuring consumer safety, maintaining a competitive edge, and protecting your brand from legal risks. Successfully listing a supplement on Amazon requires proactive compliance with testing, certification, and documentation processes.

Step 1: Initiate Third-Party Testing

Amazon mandates that all dietary supplements undergo third-party testing by an ISO/IEC 17025 accredited lab. To meet this requirement, sellers should:

• Select an Amazon-approved testing organization (e.g., NSF International, USP, or ConsumerLab).
• Submit product samples for testing, ensuring they meet Amazon’s requirements for purity, potency, and label accuracy.
• Obtain a valid Certificate of Analysis (COA) from the lab, verifying that the supplement contains exactly what’s listed on the label.

Testing timelines vary, but most third-party lab results take between 2 to 6 weeks, so sellers should plan ahead before listing new products.

Step 2: Verify GMP Compliance

Amazon requires proof that a supplement is manufactured in a Good Manufacturing Practices (GMP)-certified facility. Sellers must:

• Obtain GMP certification from a recognized certifying body (e.g., NSF, USP, or FDA-compliant auditors).
• Maintain detailed manufacturing records to ensure compliance with 21 CFR Part 111 (FDA’s supplement GMP guidelines).
• Provide GMP documentation upon request to avoid listing suspensions.

Many supplement manufacturers already hold GMP certifications, but sellers should verify this with their suppliers before submitting products to Amazon.

Step 3: Ensure Labeling and Claims Compliance

Since Amazon prohibits misleading or unapproved health claims, sellers must:

• Review product descriptions to ensure they follow Amazon’s dietary supplement advertising policies.
• Avoid language that implies curing, preventing, or treating diseases (e.g., “heals joint pain” should be replaced with “supports joint health”).
• Include all legally required supplement facts on labels, such as ingredient lists, serving sizes, and allergen disclosures.

Sellers should conduct routine compliance audits to prevent unintentional violations that could lead to listing removals or legal consequences.

Step 4: Submit Compliance Documentation to Amazon

Once testing and certification requirements are met, sellers must:

• Log in to Amazon Seller Central and navigate to the Manage Your Compliance Dashboard.
• Upload all required documents, including:
  • Third-party test results and COAs
  • GMP certification proof
  • Labeling and packaging compliance records
• Wait for Amazon’s approval before listing the supplement.

Amazon may request additional documentation at any time, so sellers should keep compliance records updated and easily accessible.

Consequences of Non-Compliance

Failing to meet Amazon’s dietary supplement testing requirements can have serious consequences for sellers. Amazon strictly enforces its compliance policies to protect consumers, and any violations can result in product removal, account suspension, or permanent bans. Sellers must stay proactive to avoid these risks and maintain their ability to sell supplements on the platform.

Potential Risks for Non-Compliant Sellers

Amazon takes immediate action against sellers who fail to provide required third-party testing, GMP certification, or accurate product labeling. Common penalties include:

• Product Listing Removal – Amazon may delist non-compliant supplements, preventing them from being sold.
• Account Suspension or Termination – Repeated violations can result in temporary suspensions or permanent bans from selling on Amazon.
• Legal and Financial Consequences – Non-compliance with FDA regulations or consumer protection laws could lead to lawsuits, fines, or regulatory action.

Sellers flagged for violations must correct the issue and submit proof of compliance before reinstating their listings.

Case Studies: When Amazon Took Action

Amazon has removed thousands of dietary supplements for non-compliance, including:

• Unapproved weight-loss products – Several brands were delisted for containing banned stimulants such as DMAA and sibutramine.
• Supplements with false claims – Products marketed as “cures” for diseases were taken down for misleading advertising.
• Unverified CBD supplements – Many sellers were suspended for selling CBD products without FDA approval, violating both Amazon and federal regulations.

These cases highlight the importance of following Amazon’s dietary supplement compliance policies to avoid sudden disruptions in sales.

How to Handle a Compliance Violation

If Amazon flags a supplement for non-compliance, sellers should act quickly to resolve the issue. The best approach is to:

1. Identify the violation – Check Amazon’s compliance dashboard for details.
2. Gather supporting documents – Provide COAs, GMP certificates, and updated labeling information to prove compliance.
3. Submit a Plan of Action (POA) – Amazon may require sellers to outline steps taken to prevent future violations.
4. Monitor compliance moving forward – Regularly review Amazon’s supplement regulations to stay ahead of policy updates.

Conclusion

Meeting Amazon’s dietary supplement testing requirements is essential for sellers who want to protect their business, maintain compliance, and build consumer trust. With Amazon tightening its regulations, ensuring that supplements are third-party tested, GMP-certified, and free from misleading claims is no longer optional—it’s a necessity.

By following Amazon’s strict testing, documentation, and labeling guidelines, sellers can avoid product removals, account suspensions, and legal risks. Staying informed about Amazon’s evolving supplement policies and working with reputable third-party testing labs can make the compliance process smoother and ensure long-term success in the marketplace.

If you need help navigating Amazon’s dietary supplement compliance process, Qalitex provides expert testing and regulatory guidance. Contact us today to ensure your supplements meet the highest safety and quality standards.

Sources:

• Amazon Dietary Supplement Requirements for Lab Testing [2025]: https://certified-laboratories.com/blog/amazon-dietary-supplement-requirements-for-laboratory-testing/
• Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements: https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements
• FAQ: Compliance with Amazon’s Dietary Supplements Policy: https://www.nsf.org/knowledge-library/amazon-dietary-supplements-policy-compliance-faq
• Dietary Supplements Guidance Documents & Regulatory Information: https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/dietary-supplements-guidance-documents-regulatory-information
• Listings Lounge: New Requirements for Dietary Supplements – Amazon Seller Forums: https://sellercentral.amazon.com/seller-forums/discussions/t/3c89099d-06aa-453f-95a6-a2eea54260ab
• Backgrounder on the Final Rule for Current Good Manufacturing Practices (CGMPs) for Dietary Supplements: https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/backgrounder-final-rule-current-good-manufacturing-practices-cgmps-dietary-supplements
• NSF Labs and the Amazon Dietary Supplement Policy: Q&A: https://www.nsf.org/knowledge-library/nsf-labs-amazon-dietary-supplement-policy-q-and-a
• CFR – Code of Federal Regulations Title 21 – Food and Drug Administration: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=111
• NSF Testing for Amazon Dietary Supplement Policy: https://www.nsf.org/knowledge-library/amazon-new-dietary-supplements-policy-enhancing-safety-compliance
• eCFR :: 21 CFR Part 111 — Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111?toc=1