GMP Harmonization: NSF Is Approved for Amazon Supplement Sales Rules

Online retailer Amazon has established a set of compliance documentation rules for dietary supplement brands, requiring sellers to provide documentation that dietary supplements sold on its website meet and comply with applicable FDA regulations and quality/safety requirements. These Amazon requirements join the growing number of retailer requirements, all with the common goal of standardizing GMP audits, product testing standards and, as applicable, testing for athletic banned substances (ABS) for sports products.

Common to all these retailer trust programs is the acceptance of certain accredited standards, specifically:

• NSF/ANSI 455-2 for dietary supplement GMP audit certification
• NSF/ANSI 173 for dietary supplement contents certification

NSF also certifies products to Certification Guideline 306 for Certified for Sport^® athletic banned substances testing and certification. This guideline includes and requires NSF/ANSI 173 and NSF/ANSI 455-2 certifications.

The new Amazon rules require one of the following:

• Evidence of product/ASIN enrollment or participation in third-party quality certification programs such as NSF/ANSI 173 product certification or NSF’s Certified for Sport^® Certification Guideline 306
• A finished product certificate of analysis (COA) issued by an in-house laboratory compliant with current Good Manufacturing Practices (cGMPs) per 21 CFR 111 and 117, along with a valid GMP certificate for the manufacturing facility, such as provided through certification to NSF/ANSI 455-2 or NSF/ANSI 173 Section 8
• A finished product certificate of analysis (COA) issued by an ISO/IEC 17025 accredited lab (in-house or third-party); a seller must also submit a valid ISO certificate showing the name of the accreditation body and an accreditation number

“This is a paradigm shift for dietary supplement manufacturers, but it also presents a unique opportunity for brands to capitalize on the requirements,” said NSF’s Health Sciences Certification Managing Director David Trosin. “Global retailers are shifting the market toward increased product confidence as a competitive advantage. NSF upholds high public health standards through accreditation, which provides integrity to our certification services. When you overlay the needs of Amazon with those of global organizations like the Global Retailer and Manufacturer Alliance (GRMA) and national chains, one thing becomes clear – NSF is a single-source solution for brands with multiple certification needs.”

Amazon provides more detail on the requirements in Amazon Seller Central. Dietary supplement brands preparing for the new requirements can learn more about the levels of NSF certification at:

• NSF/ANSI 455-2 dietary supplement GMP audit certification
• NSF/ANSI 173 dietary supplement contents certification
• Certified for Sport^® certification (includes NSF/ANSI 173 and NSF/ANSI 455-2 certifications)