Retailer responds to NY AG’s investigation

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

By Stephen Daniells contact

- Last updated on GMT

“When industry-wide standards are used to authenticate the ingredients in our products, the results demonstrate they are pure, safe and fully compliant" - Mike 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" - Mike Archbold, CEO of GNC

Related tags: Ny ag, Attorney general, Cease and desist

GNC Holdings has responded to the NY Attorney General’s actions with full and robust responses to every question raised in the cease and desist letter, including original test results and the results of retesting that was performed on the product lots cited in the letter.

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.

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7 comments

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government ineptness

Posted by Bill Ziese,

As usual the government fails again. The legitimate companies self-regulate in order to remain in business.

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In-house testing?

Posted by Linda,

I am always suspicious of 'in-house' testing. It's like doing a science experiment in your basement. You know what results you want and so of course, you get them. I would feel much safer about GNC products if there was 3rd party, clinical testing. Until then, I will continue to question these results.

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GNC maybe fine. The ohters not so much

Posted by Larr,

GNC makes their own products so it stands to reason that they are willing to spend the money in testing. As fat as Wal-Mart and the others, they buy form contract manufacturers. Finding wheat/gluten as a filler should tell us that not everything that is submitted to the FDA is true. Many companies play these games with supplements. Unless there is mandatory third party testing from an accredited FDA lab this will continue to happen.

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