Metabolism Apple Cider Vinegar Contains Undeclared Drug, FDA Warns

The U. S. Food and Drug Administration (FDA) has warned Confidence Inc. of Port Washington, NY, manufacturer of METABOSLIM Apple Cider Vinegar brand dietary supplement about the presence of the undeclared drug ingredient, sibutramine, in their product.

FDA notified the company that FDA lab analysis of METABOSLIM samples found that the product contains undeclared sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. Since FDA has not approved Metaboslim as a drug in cannot contain sibutramine as an ingredient. The FDA has not evaluated the safety and effectiveness of Metaboslim as a drug.

Sibutramine, marketed as Meridia in the USA and Reductil in Europe and other countries, is usually administered, orally, for the treatment of obesity. In the US, sibutramine is classified as a controlled substance since it is related to the drug family of amphetamines. Abbott Laboratories manufacture Sibutramine

According to the FDA, the agency is posting this WARNING because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Thus, sibutramine poses a substantial risk for the health and well being of unaware consumers. However, no illnesses or injuries have been reported to the company to date in connection with this product.

The product being recalled was sold in plastic bottles with white and red labeling and contained 60 gelatin capsules. Confidence, Inc has initiated a voluntary recall of its products after the FDA notified the company of the lab results regarding the presence of an unapproved drug in its product.

Sibutramine was approved by the U.S. Food and Drug Administration (FDA) in November 1997for the treatment of obesity. Sibutramine acts by increasing the patient's levels serotonin and norepinephrine levels in the brain, known appetite and mood modifiers.