Amazon recently announced flexibility for selling partners to demonstrate of Good Manufacturing Practices (GMPs) for dietary supplements. The new policy requires submission of three demonstrations of quality, two of which are mandatory. The third requirement provides flexibility, with two options for documentation.
First, Amazon’s two mandatory requirements are:
- (1) A valid GMP certificate issued by certain accredited third-party certification bodies that demonstrate a company’s compliance with 21 CFR 111 and 21 CFR 117.
- (2) Product images that show compliance with 21 CFR 101.36 – Nutritional Labeling of Dietary Supplements. Images must be legible and contain all required information per the CFR and make no unlawful claims.
Amazon provides two options for the third requirement. Either:
- (3a) A finished product Certificate of Analysis (COA) of declared dietary ingredients issued by an ISO/IEC 17025 accredited and GMP compliant per 21 CFR 111 and 21 CFR 117 laboratory or in-house laboratory. The valid COA must have the ISO accreditation number listed on the certificate being submitted.
Or
- (3b) Evidence of product enrollment or participation in an Amazon approved third-party quality certification program.
Sexual enhancement, weight management and weight loss products have additional CoA requirements. For complete details on Amazon’s policies, click here.
The world of on-line retail has created vast opportunity, but no matter where your products are sold, quality is everyone’s business. Let EAS help to improve your GMP compliance. Contact us for more information and to discuss your GMP questions.
Quick reference sheets for our services to the dietary supplement industry can be found below.
- Dietary Supplement Services
- GMP Services
- CA Prop 65 Compliance Services
- US Agent and Imports Services
- Virtual Consulting Services
Posted in Client Update, Dietary Supplements.