May 12, 2009
A federal court has authorized the destruction of $1.3 million worth of dietary supplements. The U.S. Food and Drug Administration (FDA) said the supplements were marketed as body-building products.
Tests by the FDA revealed the products -- sold under the names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL -- contained one or more unapproved food additives or new dietary ingredients. FDA officials said there wasn't enough information about these ingredients to assure they did not pose an unreasonable risk of illness or injury.
Mondays action comes on the heels of a consent decree entered by The U.S. District Court for the Eastern District of Michigan, Southern Division, which specifically condemns and forfeits to the United States the destruction of these products.
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, the FDAs 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.
U.S. Marshals -- acting on a request by the FDA -- seized more than 23,300 bottles of the so-called body building products, which were distributed by LG Sciences LLC, of Brighton, Michigan.
FDA officials said the company marketed the products to body builders and distributed them on the Internet and in retail stores.
Tests by the FDA revealed the 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. Tests also revealed the Formadrol Extreme XL contained ATD and 3,6,17-androstenetrione (also known as 6-OXO).
FDA officials said both of those substances are steroids, which inhibit the activity of the enzyme aromatase and may be found in dietary supplements promoted to boost testosterone levels. The FDA, however, said it has no scientific information about the safety of these products -- or their ingredients--and cannot determine if they pose a risk to consumers.
Under the circumstances, consumers who use or have used the products should discuss their use with their health care professionals, the FDA said.
The FDA also recommended that consumers contact their physicians if they have any adverse reactions they suspect are related to the products use.
