GNC agreed to pay $2.25 million in a settlement with the Department of Justice. The country's largest retailer of supplements agreed to pay the said fine in connection with the ongoing movement to crackdown supplements involved in mislabeling and adulterating practices.
The GNC case can be traced back from 2013 when the popular store chain unknowingly sold a misbranded dietary supplement manufactured by USP Labs. The supplement under investigation was a thermogenic fat burner called Oxy Elite Pro Advanced Formula.
According to USP Labs, natural plant extracts have been used to make the product. However it has been found out that synthetic stimulants synthesized in a Chinese factory are being used instead.
In November 2015, the company was indicted and awaited trial involving an alleged conspiracy with China in the import of ingredients coupled with false documentation and false labelling.
GNC halted all sales involving USP Lab products after the indictment.
GNC consented to improve in securing the products it brings in the market by removing any that may contain unregistered and dangerous ingredients.
Further, GNC did not concede to any misconduct in the settlement. The Department of Justice however reiterated a threat of prosecution if the company breaks any of the settlement agreements.
"A lengthy investigation conducted by the U.S. Food and Drug Administration (FDA), the U.S. Attorney's Office for the Northern District of Texas and the Consumer Protection Branch of the Department of Justice's Civil Division revealed that GNC's practices related to ensuring the legality of products on its shelves were lacking," confirmed DOJ.
"GNC engaged in acts and omissions that allowed a misbranded supplement - OxyElite Pro Advanced Formula, a product of Dallas-based USPlabs LLC (USP Labs) - to be sold at GNC locations nationwide in 2013."
Benjamin Mizer, head of the Justice Department's Civil Division ,reiterated the importance of ensuring safe products with tested ingredients, especially for companies like GNC.
DOJ further confirms that GNC needs to maintain an updated list of ingredients that should be prohibited from use in any of the marketed products by GNC.
GNC will further allot $500,000 for the training of farmers that supply botanical and herbal products as their ingredients.
The 1994 Dietary Supplement Health and Education Act (DSHEA) has exempted the vitamin and supplement industry from FDA's pre-marketing oversight--therefore providing minimum regulation on the multibillion dollar industry.
