The company has now tested the products on four different occasions: During the production process; Post - production and prior to distribution; In response to the NY AG’s February 2, 2015 inquiry; And again, at its own initiative, by an independent third-party laboratory and reviewed by an independent expert.
“This additional round of tests leaves no doubt that our products are not only pure but are in full compliance with all regulatory requirements,” said Michael Archbold, CEO of GNC.
“When generally and widely accepted industry tests sanctioned by the global governing bodies that set standards for product purity and quality are used, GNC products are fully compliant. We share the Attorney General’s objective of ensuring that consumers can rely on companies like GNC to deliver pure, properly labeled products and, as expected, these results demonstrate that fact.”
Herbal supplements probe
New York Attorney General Eric Schneiderman publicly launched his investigation on February 2 with cease and desist letters to four major retailers – GNC, Target, Walgreens, and Walmart – after DNA barcoding tests found 79% of the products tested did not contain the labeled substance or contained other non-listed ingredients.
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.
GNC previously stated that it has responded to the NY AG’s probe 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.
The company subsequently subjected its products to a fourth round of testing by an independent third-party laboratory and reviewed by an independent expert. GNC has shared the results of the third party tests with the AG.
‘These lots are not adulterated or mislabeled’
Frank Davis, PhD, director of regulatory affairs for Regulatory Compliance Associates, reviewed the results and concluded: “Testing of the specified lots of products by accepted and reliable methods, and with reference to limits promulgated by the USP [United States Pharmacopeia], supports that these lots are not adulterated or mislabeled, contrary to the allegations of the NY AG Letter.
“It is therefore scientifically sound to accept results of the manufacturer and of the independent laboratories, and conclude that the tested lots meet the requirements for safety, identity, purity, strength and composition, to demonstrate the correct content of phytochemicals, without contamination from heavy metals or pesticides.”
Archbold added: “We continue to cooperate with the Attorney General’s office in this matter and have gone above and beyond what has been requested of us to clarify, in no uncertain terms, the quality of our products. GNC expects to make these same products available to our customers in due course.”
Despite strong calls from industry to release the data, the NY AG’s office stated that it would not be publishing the data as it is part of an ongoing investigation. The NY AG subsequently expanded his investigation to demanding documentation to substantiate structure-function claims on the select products.
The investigation was broadened further still on February 23 with letters sent to four leading manufacturers – NBTY, Pharmavite, Nature’s Way, and Nutraceutical Corp. – demanding detailed ingredient and quality control information on every herbal supplement they sell in his state.
This week, AG Schneiderman announced that Attorneys General from Connecticut, Indiana and Puerto Rico have formed a coalition with his office to further investigate the business practices of the herbal supplement industry.