Over $1 Million in Dietary Supplements SeizedMay 12, 2009 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) announced that the U.S. District Court for the Eastern District of Michigan, Southern Division, just entered a consent decree in which about $1.3 million worth of dietary supplements have been condemned and forfeited to the United States for destruction.
“The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury,” said Michael Chappell, FDA’s acting associate commissioner for regulatory affairs. “It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace.”
The FDA reported that, at its request, U.S. Marshals seized over 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Michigan. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names: “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL,” said the FDA.
The agency also said that based on laboratory tests, it determined that the seized and condemned products contain one or more unapproved food additives and/or new dietary ingredients for which there exists inadequate information to ensure the ingredients do not present a significant or unreasonable risk of illness or injury. According to the FDA, Methyl 1-D and Methyl 1-D XL contained 1,4,6-androstatriene-3,17-dione, also known as “ATD” or 1,4,6-etioallocholan-dione; Formadrol Extreme XL contained ATD and 3,6,17-androstenetrione (also known as “6-OXO”). Both substances are steroids that inhibit the activity of the enzyme aromatase and may be found in dietary supplements promoted to boost testosterone—another hormone—levels.
The consent decree comes less than 2 weeks after the FDA ordered a recall of 14 Hydroxycut supplement products, after people taking them reportedly suffered liver damage. Recently, the agency appears to be taking a harder regulatory stance when it comes to policing dietary supplements.
In April 2008, federal agents for the FDA confiscated over $1.3 million in illegal dietary supplements from an LG Sciences, LLC warehouse; the products contained unapproved food additives or dietary ingredients that violate the law, according to a statement from the FDA. Although the products were labeled as dietary supplements, they are marketed to bodybuilders and were marketed and distributed online and in retail stores under the names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL.
In March 2006, the FDA warned Legal Gear—predecessor to LG Sciences—to stop distribution of another product marketed as a dietary supplement. In that case, the supplement was actually an unapproved new drug containing synthetic steroids.
Meanwhile, according to a sampling of dietary supplements the prior December, one-quarter contained traces of steroids and 11.5 percent contained banned stimulants. While the study does not reveal the names of the brands or their manufacturers, of the 52 supplements analyzed, 13 revealed steroid contamination. Results came about five years after an International Olympic Committee study sampling 240 supplements found nearly 19 percent contained steroids and stated that the presence of steroids and stimulants in supplement products is very much an issue, not all supplement manufacturers follow good manufacturing practices, and necessary controls are not always implemented to ensure athlete and consumer safety.
The FDA has no authority to order pre-market testing of dietary supplements unless they contain a “new dietary ingredient". In fact, since 1994 the FDA has had no effective regulatory authority over dietary supplements, unless they cause harm, as was the case with Hydroxycut.