GNC Holdings Inc. said Monday that it has reached a deal with New York Attorney General Eric Schneiderman over its Herbal Plus products.
In February, Schneiderman's office sent letters to GNC, Target, Walmart and Walgreens for allegedly selling store brand herbal supplement products in New York that either could not be verified to contain the labeled substance or were found to contain ingredients not listed on the labels.
Tests commissioned by Schneiderman's office used DNA barcoding to test the authenticity of popular supplements such as echinacea, ginkgo biloba, ginseng and St. John's wort. Schneiderman said four out of five supplements tested showed no trace of the labeled herb's DNA.
But industry groups and some consumer advocates criticized Schneiderman's methods, saying manufacturing processes can break down a plant's DNA while leaving its active chemical components intact.
Schneiderman acknowledged in a statement Monday that the Food and Drug Administration does not mandate the use of DNA-based technologies to authenticate herbal supplements, instead allowing companies to support their claims through other methodologies. But he said given the existence of chemically-similar natural or synthetic substitutes, he remains concerned that these alternate methodologies do not provide adequate assurances of the authenticity of herbal supplements.
"When consumers take an herbal supplement, they should be able to do so with full knowledge of what is in that product and confidence that every precaution was taken to ensure its authenticity and purity," Schneiderman said.
The company said its agreement affirms the relevant products were in full compliance with FDA "Current Good Manufacturing Practices." The agreement also recognizes GNC's full cooperation with the attorney general's inquiries.
GNC said that in responding to the attorney general, it provided results of internal tests and those conducted by independent third parties. The Pittsburgh company said the tests gave "conclusive evidence" that its products are safe, properly labeled and in full compliance with regulatory requirements.
In addition, GNC said that the tests showed that its products contain all herbal extracts listed on their respective labels.
In its agreement with Schneiderman's office, GNC said that within 18 months, it would start using DNA barcoding to confirm the authenticity of all plants used in its herbal supplements prior to processing. It also agreed to do randomized testing of its products for common allergens including milk, eggs, peanuts, shellfish, soy and wheat.
The retailer said the full assortment of Herbal Plus products have returned to all of its stores in the state of New York. The company also said it will expand its testing processes for supplement suppliers.
GNC said that lawsuits were filed against it after the New York Attorney General's announcement in February. The company said that it believes the lawsuits are "completely without merit" and that it will defend itself aggressively.
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AP Writer Mary Esch contributed to this report from Albany, N.Y.
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