By Lisa Wade McCormick
ConsumerAffairs.com
November 13, 2009
A California company has recalled a weight loss supplement because it contains two undeclared ingredients that pose a health risk.
The Food and Drug Administration (FDA) on Friday announced that GMP Herbal Products, Inc. recalled all lots of its Pai You Guo weight loss supplements sold and marketed on the Internet nationwide. The products came in either a box of 30 capsules or a bag of 10 g powder.
An FDA analysis revealed the dietary supplements contained two undeclared and potentially harmful ingredients:
• Sibutramine -- an FDA-approved drug used as an appetite suppressant for weight loss;
• 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 a drug. Therefore the safety and effectiveness of this product is unknown," the FDA said in a statement issued Friday.
FDA officials warned the supplements pose a health risk because sibutramine can increase blood pressure and pulse rates in some patients. Sibutramine can also be harmful to patients with coronary artery disease, congestive heart failure, arrhythmias or stroke, the FDA said.
No illnesses or injuries, however, are linked to this weight loss product.
GMP Herbal Products said it pulled the supplements off the market because it is "committed to providing accurate information about its products and because of the concern for the health and safety of consumers."
The company apologized for any inconvenience caused by this action.
The FDA advised customers who have the recalled supplements to immediately destroy them or return them to the company.
For more information, customers can contact the company at 1-866-995-8585.
The FDA said customers who experience any adverse reactions to these supplements should report them to the agency's MedWatch Program.
