FDA orders destruction of supplements worth $1.3m
The regulatory agency ordered US marshals to seize 23,000 bottles of three dietary supplement products marketed for use by body builders.
Distributed by Michigan-based LG Sciences, and sold under the brand names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL, the products were deemed to be a potential risk to consumers as they contained unapproved food additives and new dietary ingredients.
“There is inadequate information to assure that the ingredients do not present a significant or unreasonable risk of illness or injury,” said the agency, as the US District Court for the Eastern District of Michigan, Southern Division, ordered the destruction of the products, worth $1.3m.
“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.
The order comes at a time when the supplement industry is already struggling to defend its image against a barrage of negative media campaigns, prompted by the unscrupulous marketing of certain products.
However, the industry itself is top of the list of advocates calling for the scene to be cleared up, in order to restore its name and level out the playing field for well-researched and carefully substantiated products.
Indeed, one of the main criticisms that has been flying around of late is the accusation that the dietary supplement industry is not regulated. FDA said yesterday’s court order demonstrates its regulatory power:
“It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace,” said Chappell.
The agency said that its laboratory tests had found 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. The Formadrol Extreme XL supplement product contained ATD and 3,6,17-androstenetrione (also known as ‘6-OXO’).
Both of these substances are steroids that inhibit the activity of the enzyme aromatase and may be found in dietary supplements promoted to boost testosterone levels, said FDA.
The agency said it cannot yet confirm if the products pose a health risk, but advised consumers to report any adverse events via its MedWatch Adverse Event Reporting program.