GNC Holdings Inc. (NYSE:GNC), a leading global specialty retailer of health and wellness products, announced that it refuted the claims made by the New York State Attorney General in his Feb. 2 letter with full and robust responses to every question raised in the letter, including original test results and the results of retesting that was performed on the product lots cited in the letter. Like all GNC products, these product lots were tested both during and after the production process and found to be pure and compliant prior to distribution. The retesting results clearly and conclusively demonstrate that the Company’s products are pure, properly labeled and in full compliance with all regulatory requirements.
Michael G. Archbold, chief executive officer of GNC, said, “All GNC products are submitted to rigorous and generally accepted testing before they reach our customers. When industry-wide standards are used to authenticate the ingredients in our products, the results demonstrate they are pure, safe and fully compliant. We are committed to providing our customers with the highest quality supplements available, using the purest and most effective ingredients, to help them live healthier lives. We acted expeditiously in response to the Attorney General’s concerns, and we look forward to the Attorney General’s equally expeditious response to the information we have provided today.”
In performing its tests, GNC used only validated, widely used and generally accepted testing methodologies approved by standard setting bodies, including the United States Pharmacopeia, Association of Agricultural Chemists, British Pharmacopeia and European Pharmacopeia, the non-profit scientific organizations that set standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. In addition, GNC’s test results were reviewed by Robert Fish, a noted expert on FDA good manufacturing. Based on his review, Mr. Fish concluded that “…the products at issue were each manufactured in compliance with federal FDA requirements, that the products contain the ingredients stated on the labels at the levels indicated on the labels, that the products are not contaminated, and that the products are therefore not adulterated.”
Unlike the DNA barcoding test used by the Attorney General’s office, the industry-standard tests are able to identify ingredients that are stripped of their DNA in the manufacturing process. Because DNA barcoding is limited to measuring DNA, it is unable to identify all of the ingredients in approved supplements, making its results incomplete and unreliable.
In its response to the Attorney General, GNC also cited the analysis done by Frank S. Davis, PhD and Director of Regulatory Affairs for Regulatory Compliance Associates regarding lack of validity of the DNA-based testing. Dr. Davis said, “In my expert opinion, the allegations in the NY AG Letter regarding the results of DNA-based testing are not the product of reliable scientific principles and methods and therefore do not form a reliable basis for allegations of adulteration, mislabeling, or contamination of the GNC products identified in the NY AG Letter.”
Consistent with Dr. Davis’ opinion, the USP published the following statement in its April 2014 Pharmacopeial Forum: “Some of the botanical preparations, such as extracts used as ingredients for dietary supplement dosage forms, are subjected to conditions that would eliminate the DNA content rendering the DNA-based methods unusable for these types of ingredients.”
The Company said that it will continue to temporarily withhold the small number of affected products in its New York stores pending a timely response from the Attorney General.