On Monday, GNC Holdings Inc., one of the nation’s leading retailers of health and wellness products, committed to expand testing and authentication procedures for its herbal supplements beyond current U.S. Food and Drug Administration requirements. See GNC Press Release (Mar. 30, 2015); NY AG Press Release (Mar. 30, 2015).
NY Attorney General investigates herbal supplement
GNC’s decision follows an investigation by New York Attorney General Eric Schneiderman. In February, Schneiderman sent cease and desist letters to GNC – along with Target Corp., Wal-Mart Stores Inc., and Walgreens Boots Alliance Inc. – ordering these retailers to stop selling their store-brand herbal supplements in New York after DNA tests revealed many supplements did not contain the herbal ingredients indicated on their labels, and were frequently tainted with other ingredients. See NY AG Press Release (Feb. 3, 2015).
GNC agrees to new testing regimen
Although popular herbal supplements containing ingredients such as echinacea, ginseng and St. John’s Wort are often promoted as having health benefits, these products are not required to undergo FDA review and approval prior to sale. Provided these supplements include the familiar disclaimers, “This statement has not been evaluated by the FDA,” and “This product is not intended to diagnose, treat, cure, or prevent any disease,” the FDA does not regulate these products as drugs. While the Dietary Supplement Health and Education Act (DSHEA) makes supplement distributors responsible for safety and proper labeling, and requires manufacturers to follow current Good Manufacturing Practices (cGMP), supplement testing is often less rigorous than it is for drug products.
Although GNC maintained that its products were always produced in compliance with FDA guidelines, the company nonetheless agreed to begin performing additional DNA barcoding on “active” plant ingredients used in its products, in order to ensure that the supplements actually contain the herbal/botanical ingredients listed on the labeling. GNC will also begin testing its supplements for eight common allergens:
- Tree nuts;
- Soy; and
These tests will be performed both pre- and post-production by GNC’s suppliers and by GNC itself. GNC will also require that all “active” herbal/botanical ingredients used in its products are manufactured in cGMP compliant facilities that have been certified through a third-party accreditation body, such as the International Standards Organization (ISO), United States Pharmacopeia (USP) or National Science Foundation (NSF). GNC has also agreed to place signs in its stores and information on its website explaining to customers how its supplements are manufactured.
Reaction to GNC announcement
GNC is expected to implement the new procedures within 18 months, for the Herbal Plus products sold in its more than 6,600 stores. GNC’s move is already being hailed by some consumer and public health advocates as a major step toward improving quality and safety in the lightly-regulated herbal supplement market, which is estimated to be worth $60 billion worldwide.
A copy of the GNC Agreement (Mar. 27, 2015) can be found here.
GNC Holdings, Inc. GNC Reaches Agreement with New York Attorney General; Agreement Affirms GNC Products Meet all FDA Rules; GNC Restores Full Assortment of Herbal Plus® Products to Stores in New York State. March. 30, 2015
New York State Office of the Attorney General. A.G. Schneiderman Announces Agreement With GNC To Implement Landmark Reforms For Herbal Supplements. Mar. 30, 2015
New York State Office of the Attorney General. A.G. Schneiderman Asks Major Retailers To Halt Sales Of Certain Herbal Supplements As DNA Tests Fail To Detect Plant Materials Listed On Majority Of Products Tested. Feb. 3, 2015
Dietary Supplement Health and Education Act of 1994