GNC's agreement with Schneiderman sets bad precedent, observers say
GNC, one of the four original companies targeted by NY AG Schneiderman in his investigation launched in early February, said the agreement, reached on Friday, affirms that the company’s Herbal Plus products meet FDA GMP requirements and thus validates their quality. But the company also has agreed to a testing regimen that will be administered by the AG’s office and has agreed to consumer-facing messaging in stores that more clearly explains the difference between herbal extracts and whole herb products.
“I think this is a real disservice to the consumer and to the industry. It gives credence to the notion that there was something wrong with these products on February 2 when there was not. The fact that the attorney general is refusing to be transparent about this investigation, and the fact that he is continuing to push DNA testing on raw materials as if this is a substitute for quality should give industry pause,” Steve Mister, president and CEO of the Council for Responsible Nutrition told NutraIngredients-USA.
“There is a federal standard for quality. I’d like to know as a former regulator how it is that Schneiderman or those in his office suddenly have become experts on this. Having hyperactive attorneys general in every state think they know more about food and drug law than experts on the federal level is a bit presumptuous,” said Dan Fabricant, PhD, CEO of the Natural Products Association.
The agreement
Despite widespread disagreement in the industry and at FDA about the validity of using DNA barcoding as some sort of ‘gold standard’ testing methodology, Schneiderman’s office is not backing down pinning his entire investigation to this technology. Under the terms of the agreements, GNC has agreed within the next 18 months to “implement source material traceability standards that utilize DNA Barcodingto confirm the authenticity of the "active" herbal/ botanical ingredientsprior to extraction, if any, for all GNC Herbal Plus brand products,except in circumstances where no DNA Barcode is available for the relevant species. GNC will implement source material traceability standards utilizing DNA Barcoding for any active herbal/botanical raw material ingredient used in the GNC Herbal Plus brand products as soon as a DNA Barcode becomes available.”
GNC further agreed to upload results of these tests to the publicly accessible DNA Barcode Library and to supply a report every six months on its testing results to the attorney general’s office. The company also agreed to an allergen testing and verification program specified by the NYAG’s office.
Pressure relief
GNC has been the most forward of the four orignal companies involved (the other three are Target, Walgreens and Walmart) in making public the results of the tests it did itself on the products in question and in publicizing the positive results of third-party testing. So it comes as something of a surprise that the company was the first to fold its cards, and agree to what amounts to a second, state-administered dietary supplement regulatory scheme to go along with the existing federal one.
“We certainly appreciate the pressures the four retailers are under with the wave of plaintiff class actions that have been spawned by this silly test,” Mister said. “It’s unfortunate that (GNC) was persuaded to agree to something like this to get out from under this avalanche of legal issues.”
“They were under a lot of pressure here. We understand why they did what they did,” Fabricant said (GNC is an NPA member).
Fabricant said NPA will continue to encourage members and others to keep up the social media pressure on the NYAG’s office.
“The message remains: There is a federal standard for a reason. What is this based on? Does Schneiderman have some knowledge of the statute the rest of us don’t have?” Fabricant said.
