GNC: Tests and re-tests show that ‘products contain the ingredients stated on the labels at the levels indicated on the labels’

In a statement, GNC noted that the product lots in question were tested both during and after the production process and found to be pure and compliant prior to distribution.  The company also subjected the products to retesting following the AG’s letter, and found that the products “are pure, properly labeled and in full compliance with all regulatory requirements”​.  

“All GNC products are submitted to rigorous and generally accepted testing before they reach our customers,”​ said Michael Archbold, CEO of GNC. “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.”​

DNA barcoding vs validated methods​

The NY AG’s investigation is based on testing of herbal products using DNA barcoding. As reported by NutraIngredients-USA in 2013​, DNA barcoding offers a lot of potential for botanical testing, and is incredibly reliable, but only when performed on appropriate material. However, botanical extracts are particularly problematic because, while some extracts may contain DNA, it is often of low quality or degraded to a point that makes it impossible to perform proper authentication. 

Frank Davis, PhD, director of regulatory affairs for Regulatory Compliance Associates, 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.”​

In response, GNC has validated, widely used and generally accepted testing methodologies approved by standard setting  bodies, including the United States Pharmacopeia (USP), Association of Agricultural Chemists (AOAC), British Pharmacopeia (BP) and European Pharmacopeia (EP).

Robert Fish, a noted expert on FDA good manufacturing, reviewed the test results, and said: “[T]he 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.”​

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.