NY AG's office affirms GNC supplements in full compliance with FDA regs
PITTSBURGH — GNC Holdings on Monday announced that it has reached an agreement with the New York Attorney General regarding the company’s Herbal Plus products. The agreement affirms that the relevant GNC products were in full compliance with the federal Food and Drug Administration “Current Good Manufacturing Practices” and acknowledges GNC’s full cooperation with the Attorney General’s inquiries.
“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 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’s deal with the NYAG successfully turns a lingering negative into a positive, in our view," noted Sterne Agee analyst Charles Grom. "To this end, the lifting of the C/D order/subsequent ability to re-stock Herbal Plus items on GNC shelves in N.Y. is certainly welcomed news. More importantly, however, we think GNC’s leadership in raising testing standards should garner positive media attention; improve consumers’ confidence in GNC products; and placate regulators, which should result in a more benign regulatory/headline risk environment."
In its response to the NYAG’s inquiry, and as highlighted in the agreement, 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 GMP 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 has preserved the specific product lots of the five products that were the subject of this inquiry for use in defending the company against the lawsuits that have been filed subsequent to the NYAG’s Feb. 2 letter, despite the fact that there is no prohibition against the sale of such products. The company 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.