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FDA Updates Previously Recalled Weight Loss Supplement

Tim Boyer's picture
weight loss tools

Here is an important update made by the FDA recently on a voluntarily recalled weight loss supplement to help protect consumers from a popular, but potentially dangerous weight loss pill.


Last June, the FDA announced a recall of the popular weight loss supplement Smart Lipo that was limited to specific lots sold in 800, 900, and 950 mg capsules. Today, however, the public is alerted to a new update that extends the recall to ALL Smart Lipo dietary supplements packaged in bottles of 30 capsules in 800mg, 900mg, and 950mg doses per capsule. Purchase areas identified include sales of the product in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet, at SmartLipo365.com.

According to the update, scientists at the FDA continue to detect the undeclared ingredients sibutramine, desmethylsibutramine, and phenolphthalein in the Smart Lipo product line, which are unapproved for safety and efficacy and could interact in life-threatening ways with other medications. Smart Lipo 365, however, to this date has not received any complaints associated with their product.

Why Sibutramine, Desmethylsibutramine, and Phenolphthalein Pose a Health Risk

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to that it was found to substantially increase blood pressure and/or pulse rate in some patients, which presents a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Desmethylsibutramine―an analogue of sibutramine―is banned as well due to it could possess similar effects as sibutramine.

The third worrisome ingredient detected in Smart Lipo products―phenolphthalein―which was previously used in over-the-counter laxatives, is now also banned because of concerns of carcinogenicity, and is not currently approved for marketing in the United States. Health risks associated with phenolphthalein include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

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Consumers who have bought Smart Lipo are advised to immediately discontinue the use of these products and contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

If you have experienced any adverse reactions with the product you can file a report with the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm

• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more about recalls of diet supplements, here is a recent nationwide recall alert of an herbal appetite suppressant.

Reference: FDA press release “SmartLipo365 Issues Voluntary Nationwide Recall of Smart Lipo Due to Undeclared Sibutramine, Desmethylsibutramine and Phenolphthalein”