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FDA: BRAZILIAN DIET PILLS CONTAIN ACTIVE DRUG INGREDIENTS

January 24, 2006

The FDA has issued a warning about two unapproved drug products manufactured in Brazil that are being marketed as dietary supplements for weight loss.

The products, Herbathin and Emagrece Sim, also known as the Brazilian Diet Pill, are labeled as "dietary supplements," but contain prescription drugs, including several controlled substances that, if not used properly as prescribed by a physician, can be harmful, the FDA said recently.

The products contain chlordiazepoxide HCl (the active ingredient in the anxiety drug Librium), and fluoxetine HCl (the active ingredient in the antidepressant Prozac). Emagrece Sim and Herbathin also were found to contain Fenproporex, a stimulant that is not approved for marketing in the U.S., the FDA said.

Both products are made in Brazil by Fitoterapicos and Phytotherm Sim. They are offered for sale on the Internet. The FDA said it is aware of commercial imports of these products and individuals importing them for personal use. The agency has increased its efforts to prevent the importation of these products by issuing an alert to its field personnel.

For more information, go to http://www.fda.gov/bbs/topics/news/2006/NEW01298.html (http://www.fda.gov/bbs/topics/news/2006/NEW01298.html).