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The Council for Responsible Nutrition says it is “disappointed” by the outcome: “We believe it’s a mistake.”
New York Attorney General Eric Schneiderman has reached an agreement with one company, GNC, amidst the AG's ongoing investigation of dietary supplements. GNC today publicized a letter to the NY AG’s office documenting the agreement's terms, which allow GNC products back on New York State store shelves. While the agreement acknowledges that GNC’s investigated products met all FDA current Good Manufacturing Practices regulations, nevertheless GNC’s letter says the company “agrees” with the NY AG’s push for DNA testing for dietary supplements and will further integrate DNA testing into its own supply chain.
DNA testing is at the heart of February’s NY AG investigation that has taken hold of the dietary supplement industry and public interest. Based on DNA testing commissioned by the NY AG’s office, the results of which purportedly found products’ ingredient content did not meet label claims, the NY AG ordered products sold by major U.S. retailers and manufacturers pulled from store shelves. Attorney General Schneiderman’s office has since formed a coalition with other state attorney generals to investigate the dietary supplement industry at large.
GNC’s letter says the company's three-year agreement with the NY AG authorizes retail of GNC’s Herbal Plus line once more. During this time, the NY AG will discontinue its investigation of the Herbal Plus line, but it can bring action against GNC over other subjects and other products.
GNC’s letter emphasizes that neither the NY AG’s office nor third-party testing found evidence that any of the Herbal Plus products violated FDA’s GMP requirements and points out that the NY AG’s investigation “did not reach a final determination that the tested supplements were fraudulent.” In its letter, GNC says it disagrees with the NY AG’s allegations that current GMP testing requirements are not sufficient to protect consumers. (The company states it is saving the investigated product lots as proof for use in any consumer lawsuits.)
Although its products meet federal testing requirements, GNC says it nevertheless agrees with the NY AG “that DNA barcoding holds great promise for further authentication." The company agreed to adopt a number of initiatives for its Herbal Plus line with regard to DNA barcoding.
Among the terms, it will “implement source material traceability standards that utilize DNA barcoding to confirm the authenticity of the ‘active’ herbal/botanical ingredients prior to extraction, for all GNC Herbal Plus brand products, except in circumstances where no DNA barcode is available for the relevant species.” (Emphasis added.) The company will also share the scientific methods and DNA barcodes it uses in a publicly available DNA Barcode Library database. It will also require all facilities manufacturing the Herbal Plus line be third-party GMP-certified and that all of its ingredient suppliers use “a randomized allergen testing protocol” on all raw materials used in Herbal Plus products.
In an interview with Nutritional Outlook, Steve Mister, president and CEO of dietary supplement association the Council for Responsible Nutrition (CRN; Washington, DC) called the agreement between GNC and the NY AG “a mistake,” stating that the association is “disappointed in this outcome.” In particular, he criticized the NY AG for continuing to mandate DNA testing in its agreement with GNC.
“I think it’s bad for consumers as well as industry because it perpetuates the notion that DNA barcode testing is appropriate for dietary supplements,” he said. In the past two months, some DNA experts have claimed that DNA testing is not a suitable method for testing finished products, and a recently published white paper commissioned by CRN further explains why the method may also not always be suited for raw materials either.
NY AG's conditions per the GNC agreement, such as reporting the names and locations of all facilities in which DNA barcoding is performed, duplicate existing federal regulations such as those under the Food Safety Modernization Act’s facility registration mandate. “In some cases, I think [the NY AG/GNC agreement terms] duplicate federal requirements; in other cases, I think they actually go further," Mister said. "The requirement in the agreement is that [GNC has] to provide the name and address of facilities in which the DNA barcode authentication is performed, which is different than saying the facility where the product is made.”
Mister also criticized conditions that behold GNC to report to NY AG on a semiannual basis a list of materials rejected as a result of DNA barcoding, as well as the results of allergen testing. Because any rejected materials are excluded from product in the first place, this requirement “sounds like the New York Attorney General wants to do a twice-a-year press release to embarrass the industry," Mister said. "If the material was rejected, it did not end up in the supply chain. It’s not something that consumers would have access to. So why is that relevant? It’s basically substituting a state attorney general’s office for things that should properly be with the FDA.”
Most of all, Mister said, it’s unclear why the NY AG is setting forth such requirements for a company whose products were found to meet all federal regulations. “The company hasn’t been found to have done anything wrong, and now the state wants to impose requirements that go above and beyond what the company would do for FDA. That doesn’t make sense to me.”
GNC’s agreement with the NY AG hints that the AG’s office has retreated on some of its earlier positions, including its stance on using DNA testing on finished products, because the GNC agreement says that GNC will apply DNA testing to raw material, not extracts. “[The NY AG] is not admitting it, but the fact that they’re only going to require it on the raw materials-I don’t see how else you can read that except that it’s an admission that they got it wrong,” Mister said.
Moreover, allowing the GNC products back on store shelves would indicate that the NY AG office considers the products in fact safe for consumer purchase-which makes the requirements of the ongoing agreement even more perplexing, Mister said.
“When you read between the lines, the NY AG seems to be conceding that DNA testing is not the appropriate way to go about doing this, and that it got it wrong, but yet it’s plowing ahead and demanding DNA testing rather than admitting that maybe it is using the wrong test.”
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