FDA Seizes More Than $1.3 Million in Dietary Supplements; Upswing in Enforcement?April 9, 2008
On April 2, 2008, upon FDA’s request, federal agents seized more than $1.3 million in dietary supplements from LG Sciences, LLC of Brighton, Michigan. According to FDA’s news release, the seized products contained “unapproved food additives and/or new dietary ingredients for which there [was] inadequate information to provide reasonable assurance that the ingredients do not present a significant or unreasonable risk of illness or injury.” This may be the first instance of a seizure for failure to comply with requirements applicable to new dietary ingredients.
FDA’s news release references a warning letter to Legal Gear (now LG Sciences) from March 2006. According to that warning letter, Legal Gear’s Methyl-1-P was determined to be an unapproved drug because the product contained synthetic steroids that did not qualify as dietary ingredients as defined in 21 U.S.C.§ 321(ff). LG Sciences no longer markets Methyl-1-P.
The seizure is a reminder that FDA has an array of enforcement options at its disposal that go beyond the issuance of warning letters. The manufacture and interstate shipment of adulterated or misbranded dietary supplements can lead to product seizures, injunctions and even criminal prosecution. This seizure and the February 28, 2008 indictment of five individuals and three companies for fraudulent marketing of dietary supplements with illegal claims suggest an upswing in enforcement activity.
- Earlier today FDA announced yet another seizure action.