Oregon sues GNC, alleging use of illegal ingredients

Oregon Attorney General Ellen Rosenblum filed a lawsuit Thursday against General Nutrition Corporation, GNC, accusing it of selling nutritional and dietary supplements containing the illegal ingredients picamilon and BMPEA.

The lawsuit alleges that the company violated the Oregon Unlawful Trade Practices Act by misrepresenting certain products as lawful dietary supplements when they are actually unapproved drugs that may not be lawfully sold in the United States as a dietary supplement.

The complaint also alleges that GNC sold products labeled as containing botanical acacia rigidula that had been spiked with unlabeled BMPEA.

“It is scary to know that certain products sold by GNC contain an ingredient that is not even labeled—let alone approved in the United States,” Rosenblum said. “When Oregonians buy a dietary supplement, they deserve to know that the ingredients in the products are safe and comply with the law. There are 25 GNC stores in Oregon that sold thousands of these products over the span of a couple of years.”

The lawsuit, filed in Multnomah Circuit Court, also alleges that GNC sold thousands of units of products in Oregon that contained picamilon or BMPEA that were falsely labeled as a dietary supplement.

Picamilon is a synthetic chemical that is not approved in the United States, but is used as a prescription drug in some countries to treat neurological conditions. Products containing BMPEA, a powerful stimulant and amphetamine-like substance, are sometimes sold as weight loss or performance enhancing nutritional supplements.

Rosenblum once again commended the work of Assistant Attorney General David Hart and his DOJ team. In May, Hart led an Oregon settlement with the national retailer Vitamin Shoppe to ban BMPEA from its products. The Attorney General also commended the work of the U.S. Food and Drug Administration for their technical assistance in the investigation.

The complaint can be found here.

GNC responded Thursday by saying it no longer sells products containing those ingredients, The Associated Press reported. The company said it took that step in response to Food and Drug Administration statements about the regulatory status of the ingredients.

Another national retailer, Vitamin Shoppe, reached an agreement with Rosenblum earlier this year in which it agreed to stop selling products that contain BMPEA.

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Here’s a news release issued Friday by GNC:

PITTSBURGH — GNC Holdings, Inc. (NYSE: GNC), a leading global specialty retailer of health and wellness products, announced today that it has filed a motion to remove to Federal Court the lawsuit filed against it by the Oregon Attorney General. In making the filing the company issued the following statement:

“GNC believes that the lawsuit filed by the Oregon Attorney General is without merit, and the Company intends to defend itself vigorously against this unfair action.

Regrettably, despite our best efforts, we were unable to reach an agreement with the Oregon Attorney General. As a next step, the Company filed today to have the action moved to Federal court. Products sold by GNC are regulated by the U.S. Food and Drug Administration. GNC’s vendors certify that they are in full compliance with the Food, Drug and Cosmetic Act (FDC Act), and to guarantee that their products meet all applicable Federal and state laws.

Consistent with retail standard practice, GNC has appropriately relied on the guarantees of suppliers that their products are lawful. This is a basic tenet of retail sales and is recognized in federal law in the FDC Act and what is known nationally as the “FDA Guarantee.” GNC is contractually entitled to indemnification by its third-party vendors related to these guarantees and requires appropriate levels of third party vendor insurance.

GNC takes the quality of its products and compliance by third parties seriously, and the Company takes responsible measures to review any concerns when raised by the FDA or other regulatory bodies. With respect to the two ingredients at issue in the Oregon Attorney General’s lawsuit, picamilon was included as an ingredient in dietary supplements widely sold by major retailers up to the time of the filing of Oregon’s lawsuit on October 22, 2015 , and products containing BMPEA were also widely available until the FDA issued a warning letter in April, 2015. There is no basis for the Oregon Attorney General’s assertion that GNC or any other retailer “knew or should have known” that these ingredients were not legal for use in dietary supplements. As a matter of law, this critical legal issue remains undetermined as neither FDA nor any court has issued a legally binding determination of the status of these ingredients.

GNC stopped selling products with BMPEA and picamilon, immediately upon learning indirectly, rather than from notice directed at GNC, that FDA did not view BMPEA and picamilon as legal dietary ingredients. Neither picamilon nor BMPEA were included in a previous FDA warning letter or other FDA notification. Further, GNC took action to remove BMPEA and picamilon products even though the FDA did not raise any safety concerns with respect to these ingredients, and neither notice constituted a legally binding FDA action on the legal status of these ingredients. Products containing BMPEA and picamilon were produced by third parties and accounted for less than one percent of the Company’s sales.

GNC will continue to play a leading role in setting industry quality and compliance standards, as we always have. We are committed to providing our customers with the highest quality supplements available, using the purest and most effective ingredients, to help them live healthier lives.”