GNC Supply Chain Reform Pays Dividends In DoJ Settlement From DMAA Investigation
This article was originally published in The Rose Sheet
DoJ announces a "non-prosecution agreement" that requires GNC to pay $2.25m and to cooperate in dietary supplement market investigations conducted by FDA and other federal agencies, including the current litigation against USPlabs.
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Hi-Tech Pharmaceuticals CEO Jared Wheat and an associate face 18 criminal charges in federal court alleging they falsified FDA documents and distributed as supplements products containing steroid ingredient. Wheat is appealing the indictment to federal circuit court.
S.K. Labs VP Sitesh Patel was sentenced for his conviction in an April trial of single counts of conspiracy to defraud FDA and conspiracy to commit mail fraud and three counts of mail fraud. He faced up to 85 years in prison and up to $1.25m in fines.
Former FDA OCI Director George Karavetsos says GNC's supply chain guidelines for its vendors is the industry standard, while Sens. Hatch and Heinrich exceeded all standards by recommending DoJ get tougher on firms violating FDA supplement product regulations,