FDA Seizes Illegal Dietary SupplementsApr 7, 2008 | Parker Waichman LLP
Federal agents for the US Food and Drug Administration (FDA) confiscated in excess of $1.3 million in illegal dietary supplements from a Brighton, Michigan business that markets products to bodybuilders, authorities announced Friday. US Marshals seized the supplements Wednesday at an LG Sciences, LLC warehouse on Whitmore Lake Road; the products contain unapproved food additives or dietary ingredients that violate the law, according to a statement from the FDA. Although the products are labeled as dietary supplements, they are marketed to bodybuilders. The supplements were marketed and distributed online and in retail stores under the names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL.
Methyl 1-D XL is pictured on the LG Sciences Website as a bottle of capsules that increases strength and muscle mass with related comments praising LG Sciences. The FDA said the seized supplements were previously tested and found to contain one or more unapproved food additives and/or dietary ingredients that had not been studied to ensure they wouldn't cause illness or injury. According to the FDA, anyone who has used the supplements should consult their doctor, the FDA said.
"Wednesday's action shows the FDA's commitment to protecting consumers from potentially harmful products," Margaret Glavin, the agency's associated commissioner of the Office of Regulatory Affairs, said in a prepared statement. Meanwhile, an attorney for LG Sciences, said all the company's products are legal and the ingredients are safe for consumers, calling the FDA seizure "merely a preliminary step in determining compliance with food regulations. Although LG Sciences feels the temporary restraint of its product by the FDA is inappropriate, the company appreciates that the FDA wishes to protect the public," according to the attorney.
In March 2006, the FDA warned a company called 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. US Attorney Stephen Murphy, whose Detroit office secured the warrants for the seizure, said the civil case likely won't involve prosecuting individuals, adding the "FDA wanted to get these things before they went out to stores."
Meanwhile, according to a sampling of dietary supplements last 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, surprising Travis Tygart, the CEO of the U.S. Anti-Doping Agency, who said no American athlete tested positive because of supplement contamination since 2004 and is hoping that the group conducting the study will provide the names of the contaminated products so that this illegal activity can be shut down. Results come about five years after an International Olympic Committee study sampling 240 supplements found nearly 19% contained steroids. The report stated that the presence of steroids and stimulants in supplement products is very much an issue and not all supplement manufacturers follow good manufacturing practices and that the necessary controls are not always implemented to ensure the safety of athletes and the general public who use the supplement products.