DALLAS (CN) — Diet-supplement retailer GNC Holdings on Wednesday agreed to pay $2.25 million and reform its practices to avoid federal prosecution for selling misbranded OxyElite Pro Advanced Formula.
Made by Dallas-based USPlabs, OxyElite Pro has been accused of including synthetic stimulants made in a laboratory instead of natural plant extracts as advertised.
The supplement maker and its top bosses were slapped with an 11-count criminal indictment in November 2015.
GNC has steadfastly denied that it knowingly sold supplements that violated federal law. But federal prosecutors said GNC did not request additional testing or require additional certifications to verify that the ingredients in its supplements were as represented.
The Department of Justice said it entered into the non-prosecution agreement because of GNC’s “acceptance of responsibility for its conduct,” its cooperation in the criminal investigation and its commitment to voluntary compliance.
GNC will establish two lists: a “restricted list” for ingredients not to be used in supplements, and a “positive list” of approved ingredients. While lacking force of law, the list will guide GNC to determine what products it will sell.
The company will also work to develop an industrywide “quality seal” program and will stop paying its sales staff bonus commissions to direct customers to non-seal products.
“GNC does not endorse, ratify or condone illegal conduct related to the manufacture, distribution or sale of dietary supplements,” Department of Justice said in the 12-page letter. “GNCs state that it has accordingly entered into this agreement for the benefit of consumers, state and federal regulators, and the broader dietary supplement industry (including raw material supplies, manufacturers and retailers).”
GNC said Wednesday that it was “pleased” to have reached the agreement about products it says has been off its store shelves for years.
"Ultimately, the DOJ found sufficient evidence that USP Labs provided false assurances and information and fake documentation to third parties, including GNC," the company said in a statement. "The DOJ and FDA [U.S. Food and Drug Administration] also concluded that GNC was unaware of any information that the products manufactured by USP Labs violated the [Federal Food, Drug, and Cosmetic Act], while recognizing GNC's representation that it did not knowingly sell products that violated the FDCA,” the company said.
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