Navigating Nutraceutical Regulations for Selling Supplements on Amazon

In the fast-paced world of e-commerce, Amazon stands as a colossal marketplace where businesses can reach millions of customers. However, with great reach comes great responsibility, especially for companies selling dietary supplements. Recent updates to Amazon’s policies on dietary supplements have brought a wave of changes aimed at enhancing safety and compliance. Here’s what you need to know to certify that your nutraceutical business remains active and successful on Amazon.

Understanding Amazon’s New Dietary Supplements Policy

Amazon’s updated guidelines ensure that all dietary supplements sold on its platform meet high safety and compliance standards. This initiative is part of Amazon’s broader effort to protect consumers and maintain trust in its marketplace. Key aspects of the policy include:

  1. Mandatory Product Testing and Documentation: Sellers must provide comprehensive documentation to verify the safety and efficacy of their supplements. This includes Certificates of Analysis (CoAs) from ISO/IEC 17025 accredited labs, confirming that the product is free from contaminants and accurately labeled. This documentation must be submitted to Amazon directly from the lab, not the seller. 
  2. Adherence to FDA Regulations: Supplements must comply with the U.S. Food and Drug Administration’s (FDA) regulations, including Good Manufacturing Practices (GMP). This ensures that products are produced consistently and with quality.
  3. Labeling Requirements: Proper labeling is crucial. All supplements must have labels that accurately reflect the product’s ingredients, dosage and any potential allergens. Mislabeling can lead to severe penalties and removal from the platform.
  4. Prohibited Ingredients: Amazon has a list of banned substances that cannot be included in any dietary supplement sold on its platform. Staying updated on these prohibited ingredients is essential for compliance.

Steps to Ensure Compliance

To accurately follow these specifications and continue selling on Amazon, follow these steps:

  1. Conduct Regular Product Testing: Partner with ISO/IEC 17025 accredited labs for regular product testing. This not only ensures compliance but also builds trust with consumers who are increasingly vigilant about product safety.
  2. Maintain Comprehensive Documentation: Keep detailed records of all product testing, ingredient sourcing and manufacturing processes. Having this documentation readily available can streamline the compliance process with Amazon’s requirements.
  3. Stay Updated on Regulations: Regulations can change, and staying informed is key. Regularly review Amazon’s policies and the FDA’s regulations to ensure your products remain compliant.
  4. Invest in Quality Manufacturing: Partner with reputable manufacturers who adhere to GMP standards. Quality manufacturing not only ensures compliance but also enhances the overall credibility and success of your product. Products must be manufactured in a facility compliant with Current Good Manufacturing Practices set forth by the FDA (CGMPs (21 CFR 111/117 or equivalent)).  
  5. Accurate Labeling: Ensure that all product labels are accurate and comply with Amazon’s and FDA’s guidelines. This includes listing all ingredients, proper dosage instructions and highlighting any potential allergens.

The Importance of Trusted Manufacturers

Choosing a trusted manufacturer is critical in ensuring compliance with Amazon’s policies. Manufacturers with ISO/IEC 17025 certification are particularly valuable as they adhere to the highest standards of testing and quality assurance. It is essential to verify that your manufacturer is certified and capable of meeting these requirements.

Has Amazon Set the Trend for Future Supplement Manufacturing?

Amazon’s updated requirements may well be setting the standard for the future of supplement manufacturing. By prioritizing safety, quality and transparency, Amazon is pushing the industry towards higher benchmarks that benefit consumers and reputable manufacturers alike. As these policies become more widely adopted, we can expect a shift towards greater accountability and improved product quality across the nutraceutical sector.

How Somafina Can Help

At Somafina, we understand the complexities and frustrations of navigating nutraceutical regulations and confirming adherence. As a trusted contract manufacturer, we offer end-to-end solutions to help you meet Amazon’s stringent requirements.

  • Quality Assurance: Our products undergo rigorous testing and are produced in GMP-certified facilities, including our ISO/IEC 17025 accredited lab, ensuring the highest standards of safety and quality.
  • Regulatory Support: We provide comprehensive documentation and support to help you stay compliant with Amazon’s policies and FDA regulations.
  • Custom Formulations: Work with our expert formulators to create unique, high-quality supplements tailored to your customers’ needs.

In-House Testing: Ensuring Quality from Start to Finish

At Somafina, we conduct large-scale testing on both raw materials and finished goods in-house. This rigorous approach helps us identify and address any potential issues early in the production process, ensuring that our products meet the highest standards of quality and compliance.


Adhering to Amazon’s new dietary supplements policy is crucial for maintaining your presence in this vast marketplace. By following safety standards, proper labeling and regular product testing, you can protect your brand and build consumer trust.

Visit to learn how we can partner with you to navigate these regulations and create exceptional supplements that stand out in the market.

For more information on Amazon’s policies, you can refer to Amazon Seller Central guidelines.