FDA and FTC warns companies selling HcG Products

FDA warns the businesses that they are violating a law by selling drugs that have not been approved, and by creating unproven claims for the substances. December 6, 2011 - The U.S. FDA (Food and Drug Administration) and the FTC (Federal Trade Commission) issued seven Warning Letters to businesses promoting over-the counter HCG or (Human chorionic gonadotropin) goods that are marked as “homeopathic” for losing weight.

Human chorionic gonadotropin is Food and Drug Administration-approved prescription drug for curing cases of female infertility and some medical conditions. HCG is a hormone produced by the human placenta and can be found in the urine of expectant women. This drug is injected to the body.

In the said letters, FDA warns the businesses that they are violating a law by selling drugs that have not been approved, and by creating unproven claims for the substances.

At this time, they said that there are no FDA-approved HCG products for losing weight or dieting. Moreover, the businesses were warned that they have fifteen days to notify the FDA of the procedures they have taken to rectify the violations cited. The joint action is the initial step in keeping the unproven and possibly dangerous products from being promoted online and in retail outlets like oral drops, pellets, and sprays. Failure to inform them with the procedures in 15 days may result in legal action or criminal prosecution.

The classification for the “homeopathic” HCG products says that every product must be taken in conjunction with a very low calorie diet. There is no significant evidence HCG increases weight loss beyond that resulting from the suggested caloric restriction. Consumers on a very low calorie diet are at increased risk for side effects which includes gallstone formation, electrolyte imbalance, and heart arrhythmias.

“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.”
“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.”

The Food and Drug Administration most recent action to remove homeopathic HCG weight loss products from the market is a defining moment in the fight against deceptive advertising of weight loss products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products

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