The U.S. Food and Drug Administration (FDA) informed GMP Herbal Products, Inc. that its weight loss dietary supplement, sold and marketed as Pai You Guo, contains undeclared ingredients.
An FDA lab analyses of dietary supplements distributed by GMP Herbal Products found them to contain two undeclared ingredients:
Undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss, and
Phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.
The FDA has not approved the Pai You Guo products as drug; therefore, the safety and efficacy of Pai You Guo is unknown.
All lots of the Pai You Guo product are being recalled. The product is sold either in a box of 30 capsules or a bag of 10 g powder. The recalled products were sold and distributed nationwide via the internet.
Although no illnesses or injuries have been reported to the company in connection with this product, FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Consumers are advised to destroy the recalled Pai You Guo products or return them to the company’s address in Westminster, California. Consumers with questions may contact GMP Herbal Products, Inc Tuesday through Saturday 11:00 a.m. to 7:00 p.m., toll-free at 1-866-995-8585.
Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/Safety/MedWatch/default.htm.
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