The FDA is warning consumers to avoid using or purchasing the herbal weight loss product New You after a laboratory analysis discovered undeclared sibutramine and phenolphthalein.

Sibutramine, a Schedule IV substance, was voluntarily withdrawn from the market in October 2010 following evidence supporting potentially serious cardiovascular adverse effects. Sibutramine may pose a significant risk for patients with prior coronary artery disease, congestive heart failure, arrhythmias, or stroke. Phenolphthalein, a compound previously found in many over-the-counter (OTC) laxatives, is no longer approved for use after concerns of carcinogenicity arose. Currently, phenolphthalein is classified by the FDA as “not generally recognized as safe and effective.”

RELATED: Nutrition Resource Center

New You has been sold on various websites and in some retail stores.


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For more information call (855) 543-3784 or read the FDA Safety Alert.