Normally the Food and Drug Administration doesn’t handle herbal supplements, but laboratory tests have shown the presence of unlisted ingredients or increased dosage in twenty-eight weight loss drugs sold as herbal or dietary supplements, thus avoiding FDA approval.
The FDA is warning that the undeclared ingredients are potentially dangerous. The agency is seeking a recall on the products and a crackdown on illegal sales.
The weight loss products are: Fatloss Slimming, 2 Day Diet, 3x Slimming Power, Japan Lingzhi 24 Hour Diet, 5x Imelda Perfect Slimming, 3 Day Diet, 7 Day Herbal Slim, 8 Factor Diet, 7 Diet Day/Night Formula, 999 Fitness Essence, Extrim Plus, GMP, Imelda Perfect Slim, Lida DaiDaihua, Miaozi Slim Capsules, Perfect Slim, Perfect Slim 5x, Phyto Shape, ProSlim Plus, Royal Slimming Formula, Slim 3 in 1, Slim Express 360, Slimtech, Somotrim, Superslim, TripleSlim, Zhen de Shou, and Venom Hyperdrive 3.0. Most of these products are manufactured in China.
Twenty-seven of the products were found to contain sibutramine, a Schedule IV controlled substance used in prescription obesity drugs that can result in high blood pressure, seizures, palpitations and heart beat irregularities, heart attack, or stroke. Some of the products contain 3x the recommended dose in prescription medications.
Phytoshape contained rimonabant, which has not been approved for use in the United States due to concerns about increased depression and suicide risks and other adverse neurological effects. It is known as Acomplia in Europe and sales were suspended in October. Rimonabant was linked with 5 deaths in June 2008 of the 720 adverse reactions over the previous 2 years.
Phenytoin, an anti-seizure medication, was found in trace amounts in 3x slimming power and Extrim Plus.
Phenolphthalein was found in eight of the products; it is a suspected carcinogen. It is also suspected of being genotoxic, meaning that it damages DNA. It was used in laxatives until 1999.
If you have used these products and experienced side effects, report them to the FDA’s MedWatch Adverse Event Reporting Program at http://www.fda.gov/medwatch/
For more information on these products and ingredients visit http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html