COMPANY WARNED FOR MARKETING UNAPPROVED WEIGHT-LOSS DRUG

Information on GSCM Ventures' website, including the name of a product it sells, wrongly promotes it as a treatment for obesity, an FDA warning letter said.

The product name, "Herbal Phentermine," implies the drug is intended to treat disease because it suggests the product is an alternative to the approved prescription obesity treatment phentermine, the Dec. 12 warning letter said.

Claims on the company website indicating the product is for the treatment of disease mean the FDA considers it a new drug. Because the product is not recognized as safe and effective, and the company lacks an approved new drug application, Herbal Phentermine cannot be legally marketed in the U.S., the letter said.

According to the agency, the company claimed that L-Carnitine, an ingredient in Herbal Phentermine, decreases symptoms of depression and helps prevent cataracts. The letter also said GSCM promoted another ingredient, green tea, as helping to treat cancer, rheumatoid arthritis, high cholesterol, cardiovascular disease, infection and impaired immune system function.

The agency also said GSCM Ventures' product is misbranded because its labeling does not have adequate directions for its use.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6174d.pdf (http://www.fda.gov/foi/warning_letters/g6174d.pdf).