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FDA says HCG weight-loss products are illegal
December 6th, 2011
03:11 PM ET

FDA says HCG weight-loss products are illegal

Over-the-counter HCG products being sold for weight loss are illegal and claims that the drugs work are unsubstantiated, the Food and Drug Administration warned consumers Tuesday.

HGC products are sold online and in stores as pellets, sprays or oral drops. These products are considered by the FDA to be unapproved new drugs.

Last week, the FDA, along with the Federal Trade Commission sent warning letters to seven companies manufacturing human chorionic gonadotropin, or HCG, products labeled "homeopathic." The products in question are "hCG Diet Drops Weight Loss Formula," "hCG Diet Pellets Weight Loss Formula," "Alcohol Free hCG Weight Loss Formula,""HCG Fusion 30," "HCG Fusion 43," "Homeopathic Original HCG," Homeopathic HCG," "HCG Platinum X-30," "HCG Platinum X-14" "HCG Diet Homeopathic Drops," and "HCG Extra Weight Loss Homeopathic Drops."

According to the labels, these products should be taken with a "very low calorie diet." This is a very dangerous way to use the HCG supplement, according to the FDA.

“These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed,” said Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “And a very low-calorie diet should only be used under proper medical supervision.”

The FDA says people on such diets have an increased risk of heart arrhythmia's, electrolyte imbalance and gallstones. Currently no HCG products for weight loss have been approved by the agency.

Companies have 15 days to tell the agency what corrective actions they will take, otherwise the FDA will take legal action ranging from seizure to criminal prosecution.

“Deceptive advertising about weight loss products is one of the most prevalent types of fraud,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection. “Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence, so consumers have the accurate information they need to make good decisions.”


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