NY AG shifts focus & subpoenas retailers on structure-function label claims

By Stephen Daniells

- Last updated on GMT

GNC: "All results demonstrated that our products are pure, safe and fully compliant"
GNC: "All results demonstrated that our products are pure, safe and fully compliant"

Related tags Attorney general Food and drug administration

A new twist has developed in the NY AG’s investigation into herbal products as subpoenas have been issued to GNC, Walgreens, Target and Walmart to demand evidence to support the structure-function claims on their labels.

The Attorney General’s office declined to comment to NutraIngredients-USA on the issue. However, according to the New York Times​, the subpoenas concern evidence to support the authenticity of claims on the products. (The subpoenas relate to structure-function claims and not ‘health claims’ as the NY Times​ states. ‘Health claims’ are legally a very different beast in the supplement realm)

A spokesperson for GNC told us: “We have cooperated fully with the request for information we received from the Attorney General and provided him with full and robust responses to every question raised in his letter, including original test results and the results of retesting that was performed on the products cited in his letter, and all results demonstrated that our products are pure, safe and fully compliant.

“The Attorney General has refused to provide us access to his test results and therefore we cannot comment on the allegations in this subpoena.”

Steve Mister, president & CEO of the Council for Responsible Nutrition, said that CRN is confident that the companies subpoenaed will be able to provide the substantiation to support the label claims on their products.

“Federal law already requires that any claims made by manufacturers or marketers of dietary supplements have substantiation to support those claims,” ​he said.

“The federal law requires that dietary supplements have ‘competent and reliable scientific evidence’ in support of any structure/function claims they make for their products. Under the law, dietary supplements cannot be sold with labeling that claims to treat, cure, prevent or mitigate a disease, and FDA has full authority to take action against companies that misbrand dietary supplements or make false or misleading claims. In addition, the manufacturing of dietary supplements is regulated by Good Manufacturing Practices regulations, enforced by the FDA. Similarly, the advertising for dietary supplements must be truthful, not misleading and substantiated with credible and reliable scientific evidence, enforced by the Federal Trade Commission.

“We continue to urge the Attorney General’s office to show the same transparency he is demanding of the industry by releasing the full DNA barcode testing report that started this inquiry.” 

‘Misdirection and misinformation’

Daniel Fabricant, PhD, CEO of the Natural Products Association, told us that the first thing the AG should have done is to contact the FDA to verify if the retailers had submitted the supporting evidence for their structure/function claims.

“This action seems to be less about substantiation of structure-function claims and more about trying to prove disease claims. If the FDA didn’t object to the structure-function claims then since when is this AG the expert on claims?

“It looks like a campaign of misinformation and misdirection.

"Moreover, the products being investigated by the attorney general contain some of the most widely researched ingredients in the industry," ​added Dr Fabricant. "Ingredients such as St. John’s Wort, Ginkgo Biloba, Ginseng and Echinacea have droves of scientific research behind them, which is readily available on ClinicalTrials.gov. The multiple clinical studies on these types of products support and substantiate the physical benefits of these ingredients made in structure/function claims.

"If Attorney General Schneiderman were properly informed in this area, he would have pursued action against products making egregious weight-loss claims or those with ingredients with little science behind them, as that is exactly what the Federal Trade Commission does and with much success. Since the attorney general appears to be more focused on making headlines than actually protecting consumers, he foolishly went after ingredients with hundreds of clinical studies behind them, substantiating the claims, an illogical and irresponsible tactic for law enforcement."

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FDA? NYAG? m-o-u-s-e

Posted by Bill Ziese,

Now the NYAG works for the FDA? I think Walmart, GNC, Target and anyone else affected should sue NY State and have this moron put in jail (without pay). Is he on Big Pharma's payroll or just plain stupid?

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Who Protect's Us From the Costs that Follow this Nonsense

Posted by Mark Rustad,

Dr. Fabricant's comments above are direct and wholly disarm the AG's case--as we know it. This apparent " illogical and irresponsible" misapplication of "Enforcement Action"--will only serve to enrich Esq.Schneiderman's "Esquire" American Bar Members who will now press forward Class Action claims against Federally Compliant Firms and their products. Where is our Gov. Cuomo on this issue. The Dietary Supplement Industry on Long Island is one of the last bastions of employment in the region. We are FDA registered and FDA inspected to ensure cGMP compliance--our product claims are consistent with published clinical trials and now this? Get off our backs and catch the Amino Spikers, the Ephedra Goons and the web criminals that lace their products with drugs--from pro hormones to amphetamines.

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News Media

Posted by Christina,

Love to know why we don't hear this information in main stream news media...tend to only hear the "bad news" about our industry and not the fact that GNC is doing exactly what every cGMP facility should be doing. I haven't heard one news station report that all the GNC items were tested prior to the NY AG's actions and again after and passed all USP VALIDATED test methods.

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