A weight loss dietary supplement is being recalled by the Food and Drug Administration (FDA) after an FDA analysis found the supplements contain the presence of undeclared drug ingredients, including a suspected cancer-causing agent. The recalled supplement is made by GMP Herbal Products and is marketed under the name Pai You Guo.
Pai You Guo was found to contain subutramine, 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 warning stated that the agency has not approved the Pai You Guo products as a drug, therefore safety and effectiveness of this product is unknown.
Pai You Guo is either sold in a box of 30 capsules or a bag of 10 g powder. The affected products were sold and distributed nationwide via the Internet.
While no illnesses or injuries have been reported to the company to date in connection with this product, the FDA advises consumers 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 affected products or return them to the company. For information or mailing instructions, contact GMP Herbal Products at 1-866-995-8585 Tuesday through Saturday between 11 a.m. and 7 p.m. Pacific time.
Adverse reactions experienced with this or any other product should be reported to the FDA’s MedWatch Program at www.fda.gov/Safety/MedWatch/default.htm.