- FDA Seeks First Injunction Against Dietary Supplement Companies
- December 1, 2011 | Authors: Melvin S. Drozen; Frederick A. Stearns
- Law Firm: Keller and Heckman LLP - Washington Office
The Food and Drug Administration (FDA) is seeking an injunction against a Pennsylvania-based dietary supplement manufacturer for alleged violations of the Federal Food, Drug, and Cosmetic Act ("the Act") and corresponding regulations. On November 23, 2011, the U.S. Justice Department, on behalf of FDA, sought a permanent injunction in the United States District Court for the Western District of Pennsylvania to prevent ATF Fitness Products, Inc. (ATF), Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti, the owner and operator of ATF and MADE, from producing or selling their more than 400 dietary supplement products.
The complaint for injunction identifies three main violations of the Act. First, FDA alleges that the defendants adulterated their products by failing to conform to the current good manufacturing practice (cGMP) requirements for dietary supplements (21 C.F.R. Part 111). For example, the defendants allegedly (1) failed to follow a written master manufacturing record (MMR), (2) failed to accurately state the identity and measure of each ingredient in the supplements, (3) lacked effective quality control procedures, and (4) used unsanitary manufacturing equipment and facilities.
Second, the defendants allegedly misbranded their products by making various substitutions to the ingredients of the dietary supplements, without changing the products' labels accordingly. As a result, the dietary supplements' labels falsely declared absent ingredients and failed to declare ingredients that were present. Third, FDA states that the defendants allegedly failed to report serious adverse events associated with their dietary supplements, as required by law. The complaint cites a July 2010 event where the defendants' customer suffered a mild heart attack after taking the product "Kreation Powder." The defendants never reported this event to FDA.
The complaint for injunction follows a string of FDA enforcement measures against the defendants. In March 2004 and November 2004, FDA issued warning letters to the defendants regarding adulterated products. The government then seized the defendants' adulterated products in 2005 and again in 2006. A January 2010 outside audit of the defendants' facilities identified nearly 80 deviations from cGMP and a March-April 2011 inspection by FDA also identified a variety of cGMP violations. Despite being on notice about FDA's quality concerns, the defendants allegedly did not respond to FDA's inspection findings or make any promises to correct the deficiencies.
This is the first time FDA has sought an injunction to restrain violations of the dietary supplement cGMP regulations. It is consistent with the Agency's continuing focus on quality issues with dietary supplements and reflects FDA's willingness to take enforcement action in court against violative supplements.