Herbal Supplement Industry Under Fire – Part II

On Monday, March 30, GNC reached an agreement with the New York Attorney General requiring testing standards for their “Herbal Plus” supplements that exceed current Food and Drug Administration (FDA) requirements. This agreement comes almost two months after the NY Attorney General sent letters to GNC, Walmart, Walgreens, and Target for allegedly selling store brand herbal supplements with ingredients that could not be verified or ingredients that were not listed on the labels.

GNC has been fighting lawsuits that have resulted from the New York Attorney General’s announcement because the company believes the lawsuits to be “without merit.” Despite this, GNC reached the agreement with the New York Attorney General to give its consumers “even greater confidence” in its products.

Under the agreement, GNC will perform DNA barcode testing on all “active” plant ingredients listed on labels, and will test for contamination with allergens before and after production. GNC will also make these tests standard procedure before placing their products on any of their stores nationwide. Furthermore, the company will introduce new policies over the next 18 months and submit semi-annual safety reports to the New York Attorney General’s office. The agreement confirms that GNC’s products are in full compliance the FDA’s Current Good Manufacturing Practices. Finally, the agreement recognizes GNC’s full cooperation with the attorney general. As a result of its updated testing, GNC has restored its “Herbal Plus” products to its shelves.

This move is a major shift in the lightly-regulated market for herbal supplements. The herbal supplement industry is estimated to be worth $60 billion worldwide. However, herbal supplements are not subject to the same level of scrutiny as drugs are by the FDA.

The New York Attorney General’s actions have not only caused GNC to pay attention, but have caused other Attorney Generals to take note as well. In fact, on April 2, a group of 14 state Attorneys General asked the U.S. Congress to investigate the herbal supplements industry. The Attorneys General sent their letter to Kansas Senator Jerry Moran and Pennsylvania Representative Joe Pitts, chairmen of subcommittees on product safety and health. The Attorneys General asked the subcommittees to work with the FDA to determine whether the agency should develop enhanced quality assurance programs and other safety requirements. The attorneys general stated “we believe the safety and efficacy of these supplements is a matter of deep public concern across the country,” and they urged “swift action.”

While industry officials and others say the industry is already sufficiently regulated on a federal level, it is time to re-think federal regulation of herbal supplements. Consumers have a right to know what they are purchasing and putting in their bodies. Most importantly, consumers deserve to know that the claims on these products are validated and that these products are safe.

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