The natural products industry is responding to a lawsuit filed by Oregon Attorney General (AG) Ellen Rosenblum alleging that supplement retailer GNC (Pittsburgh, PA) violated the state’s Unlawful Trade Practices Act.
The lawsuit accuses GNC of selling workout supplements containing picamilon, a prescription drug used to treat neurological conditions. Acting Deputy Director of the Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA) Cara Welch wrote in a signed affidavit on September 28 that picamilon “does not fit any of the dietary ingredient categories” under the law. Despite this assertion, the FDA has yet to use its enforcement power to restrict the ingredient.
Both the Natural Products Association (NPA) and GNC have responded to the lawsuit. NPA strongly criticized the FDA for its failure to take action in this case and for its decision to delegate authority to the state level.
“The FDA has both the authorities and tools in place to take action against harmful ingredients,” said Dan Fabricant, PhD, executive director and CEO of NPA. “It is concerning to us that the FDA is delegating its responsibilities to the states instead of using its own enforcement authority. If the FDA finds an ingredient to violate the law, then it should take immediate administrative action, not use taxpayer dollars to fund a state priority.”
The AG’s lawsuit also accuses the retailer of selling BMPEA, which the FDA did take action to remove from store shelves earlier this year. “In the case of BMPEA, the agency took the necessary steps to shield consumers against a product that it has found to contain an illegal, adulterated dietary ingredient,” said Fabricant. “NPA encourages this type of action in response to picamilon, instead of delegating its regulatory and enforcement authority to states.”
On October 23, GNC filed a motion to remove to Federal Court the lawsuit filed against it by the Oregon AG.
“Regrettably, despite our best efforts, we were unable to reach an agreement with the Oregon Attorney General,” said GNC in an issued statement. “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,” the statement continued.” 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.”