Tips for navigating amazon’s compliance requirements

Brian Yam, VP of Regulatory Affairs and Quality Assurance at Blue Ocean Regulatory Inc.

To kick off the Convergenge '24 conference, October 9-11, in Salt Lake City, Utah, the Council for Responsible Nutrition (CRN) first held the WellComms forum—six presentations intended for marketing and communications professionals. In the first presentation, Brian Yam, VP of Regulatory Affairs and Quality Assurance at Blue Ocean Regulatory Inc. presented, “How To Last in the Amazon Game – How Brands Are Navigating Amazon’s Latest Compliance Requirements.” Yam covered the past, present, and potential future of Amazon requirements.

He first walked through the process of getting a brand on Amazon through a seller’s point of view in order to highlight the compliance and verification issues that naturally arise during this journey. Yam discussed the certification requirements from 2023, in which sellers needed, for example, to provide a certificate of analysis (COA) to Amazon. However, Amazon’s initial requirements enabled the retesting of a product until it produced a passing result, fabrications of a COA, or calculating the amount of an ingredient in a capsule, rather than actually testing for it.

In April 2024, Amazon’s requirements were updated to include new information needed from sellers, such as requiring specific contaminants to be tested for, and for all the required product documentation to be funneled through designated laboratories to verify the results, instead of directly through Amazon. “This was a huge wake up call for the brands,” Yam stated. Brands realized ingredients hadn’t been tested for quantity and the validity of manufacturers’ GMP certification was questioned.

He then presented six best practices for navigating Amazon’s latest requirements for today and for the long term:

1. Use accredited GMP certified manufacturers
2. Set explicit testing specifications for the product
3. Conduct third party testing now so issues can be resolved before the inventory leaves the facility
4. Establish non-compliance protocols with the manufacturing and what the manufacturer will to do to make it right
5. Invest in label compliance
6. Explore backup manufacturers

As a bonus tip, he explained the overlap between products that are NSF certified and compliance with Amazon’s policies.

Next, Yam explained three potential future directions for Amazon compliance:

1. Mandating that the set of products sent to laboratories for testing come from the Amazon warehouse
2. Increasing label surveillance
3. Minimizing friction for seller and reduce backlogs