FDA: Dietary supplements may contain drug
2/16/2013 5:48:27 AM
WASHINGTON, Feb. 16 (UPI) --
U.S. Marshals, acting for the Food and Drug Administration, seized tainted dietary supplements from Globe All Wellness LLC in Hollywood, Fla., officials said.
Howard Sklamberg, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said several of the seized products contain streaming hydrochloride, or streaming, the active ingredient in the obesity drug Meridian.
Meridian was withdrawn from the U.S. market in December 2010 after clinical data demonstrated the drug increased the risk of heart attack and stroke.
Globe All marketed its products with claims that its products could lower blood pressure and cholesterol, among others. Under the Federal Food, Drug and Cosmetic Act, products offered for such use are considered to be drugs, since they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, Sklamberg said.
The company's products are drugs that have not been approved by the FDA for their claimed uses, the FDA said.
"Companies that distribute products containing undisclosed drugs are not only breaking the law, they are putting consumers at risk," Sklamberg said in a statement. "With these kinds of hidden dangers, consumers cannot make informed decisions about the products they are taking."
The FDA seized various lots of the following products:
-- SlimXtreme Gold
No illnesses were associated to date with Globe All's products. Illnesses or serious side effects related to the use of these products should be reported to the FDA viaMedWatch's online form or by calling 1-800-FDA-1088.