Tainted dietary supplements made by Globe All Wellness (Globe All), in Hollywood, Fla., were seized by U.S. Marshals acting on behalf of the Food and Drug Administration (FDA) because the products contain an undisclosed active pharmaceutical ingredient and may be unsafe.
Several of the seized products contain sibutramine hydrochloride (sibutramine), the active ingredient in the obesity drug Merida. In December 2010, the FDA pulled Meridia from the U.S. market after clinical data showed the drug increased the risk for heart attacks and strokes.
Globe All claims its products can lower blood pressure and cholesterol, as well as improve other health conditions. However, making such claims on dietary products violates the Federal Food, Drug and Cosmetic Act (FDCA). Products that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are considered drugs and thus are required to go through clinical testing for safety and efficacy, and gain FDA approval before they can be marketed in the United States.
“Companies that distribute products containing undisclosed drugs are not only breaking the law, they are putting consumers at risk,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “With these kinds of hidden dangers, consumers cannot make informed decisions about the products they are taking.”
“Two important protections for the public are that a firm may not sell new drugs unless they have been tested and approved by the FDA and a firm may not make false or unsubstantiated claims about drugs they sell,” said Melinda K. Plaisier, acting associate commissioner for regulatory affairs. “When a firm disregards these protections, it not only violates the law but also creates a risk for consumers who may rely on a bogus product and forego effective and proven treatment. The FDA must and will take aggressive enforcement action.”
Various lots of the following products were seized:
- SlimXtreme Gold
No illnesses have been associated to date with Globe All’s products, though persons experiencing any problems after taking the products should seek immediate medical attention. Any serious side effects should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.com.
Source: Pharm Pro