The Food and Drug Administration and the Federal Trade Commission announced today that they have sent seven warning letters to companies that make the products, notifying them that they are violating federal law by selling drugs that have not been approved and by making unsupported claims for the substances.
There are no FDA-approved HCG products for weight loss, says Elizabeth Miller, the FDA's acting director of the division of non-prescription products and health fraud.
HCG weight-loss products, which promise dramatic results and claim to be homeopathic, are sold as drops, pellets and sprays in retail stores and on the Web, including GNC.
The homeopathic HCG products contain HCG, or human chorionic gonadotropin, which is a hormone made by the placenta during pregnancy. The hormone itself is approved as a prescription treatment for infertility and other conditions, the FDA says.
Many of these products claim to "reset your metabolism," change "abnormal eating patterns" and shave 20 to 30 pounds in 30 to 40 days, the FDA says.
"These products are marketed with incredible claims, and people think that if they're losing weight, HCG must be working," Miller says. "But the data simply does not support this — any loss is from severe calorie restriction, not from the HCG."
The products are supposed to be used in combination with a very low-calorie diet of 500 calories a day so they are potentially dangerous and could lead to gallstone formation, electrolyte imbalance and heart arrhythmia, she says.
Miller says the FDA doesn't know how many consumers are using the products, "but we understand they are very popular." The products are mostly sold on the Internet, so it's difficult to track sales.
HCG began being used for weight loss in the 1950s when a British physician had a theory that it could help people on a near-starvation diet not feel hungry. Since then, there have been a number of clinical trials debunking that theory.
Duffy MacKay, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, an industry group, says the HCG weight-loss products "are totally illegal," because they don't meet the criteria for either a dietary supplement ingredient or a homeopathic product.
"I am not aware of any scientific evidence that supports its use when taken orally for weight loss," he says.
Homeopathy is an alternative medicine practice of using very small or diluted preparations of medicines or remedies to treat a condition.
Donna Ryan, an obesity researcher with the Pennington Biomedical Research Center in Baton Rouge, says she is "delighted" by the government's actions.
"There is not a shred of evidence that HCG has any more than a placebo effect in promoting weight loss. It's yet one more unproven treatment for obesity that is unscrupulously marketed to patients," she says.
The companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.
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