GNC to Strengthen Supplement Quality Controls – Implications for Suppliers

The New York Times reported that the GNC will institute “sweeping new testing procedures” on its herbal supplements following an investigation and accusations from the New York State attorney general’s office. New testing procedures will be rolled-out over the next 18-months. The new program will have lasting implications for the numerous suppliers of GNC private labels and other brands sold in its stores.

Suppliers will need to begin strict adherence to Part 111 (Dietary Supplement Good Manufacturing Practices (GMPs or cGMPs)). This will include robust identity, strength, and purity testing along with sample retention and testing for adulterants.

This is a common model of self-enforcement where large industry players are tasked with policing the compliance of their suppliers. Under additional scrutiny, the GNC is likely to demand suppliers comply or find other compliant suppliers.

The self-enforcement model will remain until large industry players seek to level the playing field and lobby for a change to the DSHEA.

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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