On March 30, GNC (Pittsburgh, PA) announced that it has reached an agreement with the New York Attorney General (NYAG) that affirms the company’s Herbal Plus products were in full compliance with the federal U.S. Food and Drug Administration (FDA) current good manufacturing practice (cGMP) requirements and acknowledges GNC’s full cooperation with the AG’s inquiries.
In its response to the NYAG’s inquiry, GNC provided the results of rigorous tests conducted both internally and by independent third parties. These tests provided conclusive evidence that GNC’s products are safe, pure, properly labeled and in full compliance with all regulatory requirements. The testing also demonstrated that the Company’s products contain all herbal extracts listed on their respective labels.
In addition, a former senior FDA cGMP expert performed a comprehensive review of GNC’s manufacturing processes for the products at issue and found them to be in compliance with all applicable requirements. Accordingly, GNC has restored its full assortment of Herbal Plus products to all GNC stores in New York State.
GNC also announced that it will expand its testing processes deeper into its supply chain by leading ongoing industry efforts to integrate source material traceability standards including DNA barcoding where appropriate (prior to extraction processes) and enhance certain other aspects of its operations to provide consumers even greater confidence in its products.
GNC said that it believes these measures, which would not have impacted availability of the products subject to this review, will result in the adoption of stricter minimum standards across the broader industry.
“As our testing demonstrated, and this agreement affirms beyond any doubt, our products are not only safe and pure but are in full compliance with all regulatory requirements,” said Michael G. Archbold, CEO, GNC. “A robust testing regime, careful sourcing regimen and detailed manufacturing specifications have always been core elements to ensuring that we provide our customers with high-quality products. Our customers trust and value our products, and we are steadfastly committed to maintaining that trust and confidence. As an industry leader we have always gone above and beyond the minimum requirements in pursuing quality for our consumers, and we will continue to lead the efforts for higher standards. This is good for consumers, good for the industry and good for GNC.
GNC has preserved the specific product lots of the five products that were the subject of the NYAG inquiry for use in defending the Company against the lawsuits that have been filed subsequent to the NY AG’s February 2 letter, despite the fact that there is no prohibition against the sale of such products. GNC believes these lawsuits are completely without merit and will defend itself aggressively. Identical products to those that have been preserved remain available for sale to consumers at GNC stores in New York State.
For more information, visit www.gnc.com.