FDA Targets Homeopathic Weight Loss Products
December 9, 2011
U.S. officials on Tuesday said that they are taking action to remove controversial, unapproved and illegally labeled HCG weight loss products from the market.
HCG stands for human chorionic gonadotropin, a hormone made by the human placenta and found in the urine of pregnant women. The products are typically given in conjunction with an extremely low-calorie diet -- as low as 500 calories per day -- which has some experts worried about possible health effects.
According to the U.S. Food and Drug Administration, companies marketing over-the-counter HCG weight loss products labeled as "homeopathic" were sent warning letters on Tuesday by the FDA and the U.S. Federal Trade Commission. The letters cautioned that the companies are violating federal law by selling the unapproved drugs, and by making unsupported claims for their products.
HCG is approved in the United States as an injectable drug for treating some cases of female infertility and other medical conditions, but is not approved as a weight loss aid.
The FDA said that HCG weight loss products are sold online and in stores as oral drops, pellets and sprays, despite no proof as to either their effectiveness or safety.
Visitors to the website for one maker included in the FDA action, The Original HCG Drops, are told they can "lose 20-30 pounds in 30-40 days," as they take the product. The company also claims that HCG "tells the body to release abnormal fat" and "hold on to lean muscle. All this is designed to establish a new body weight and reset your metabolism."
The FDA is especially concerned, however, because labeling on homeopathic HCG weight loss products typically advises consumers to take the products in conjunction with a very low calorie diet. However, there is no substantial evidence that the HCG products help people lose weight, the agency said, and people on these types of severely restricted diets put themselves at heightened risk for problems such as gallstones, electrolyte imbalances and heartbeat disorders called arrhythmias.
"These products are marketed over-the-counter on websites and in some retail stores, and can be found in the form of oral drops, pellets and sprays," Elizabeth Miller, acting director of the Division of Non-Prescription Products and Health Fraud in the FDA's Office of Compliance, Center for Drug Evaluation and Research, said during a late morning news conference.

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Posted by Ken at 12:00 AM