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Author Topic: FDA Removes HCG Weight Loss Agents From Market  (Read 2562 times)
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MuffyBee
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« on: December 06, 2011, 01:54:18 PM »

http://www.medpagetoday.com/ProductAlert/OTC/30042
FDA Yanks HCG Weight Loss Agents from Market
December 6, 2011

The FDA and the Federal Trade Commission said over-the-counter weight loss products containing human chorionic gonadotropin (HCG) are fraudulent and illegal, and the agencies have told seven manufacturers to stop selling them.

Noting that the product labels call for the pellets, liquids, and sprays to be taken in conjunction with a very low-calorie diet, an FDA official said it did not appear that oral HCG offers any extra benefit.

"There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction," said Elizabeth Miller, acting director of the FDA's fraud unit for OTC products, during a conference call with reporters.

The recommended diets call for daily calorie intake as low as 500 calories, low enough to create a risk of malnutrition, electrolyte imbalance, cardiac arrhythmias, and gallstone formation, Miller said.

The warning letters sent to manufacturers of the products note that HCG has not received FDA approval for any weight loss indication. The substance is approved as an injectable drug for certain forms of female infertility and is therefore clearly subject to FDA regulation.

HCG weight-loss products are typically sold over the Internet, often promoted with unsolicited "spam" emails, with such claims as "Lose 26 pounds in 26 days" and "Resets your metabolism."

According to one of the letters, sent to HCG Diet Direct LLC of Tucson, Ariz., "The claims made on your product labeling and website ... clearly demonstrate that this product is a drug as defined" by federal law.

The companies have 15 days to inform the FDA of the steps they have taken to correct the violations. Theoretically, the firms could seek FDA approval for the weight-loss claims, but the agencies expect that they will simply stop selling the products.
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MuffyBee
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« Reply #1 on: December 08, 2011, 07:04:56 PM »

http://www.cbsnews.com/8301-500368_162-57338043/federal-agencies-act-to-remove-hcg-weight-loss-products/
Federal agencies act to remove hCG weight loss products
December 8, 2011

(WebMD)

The FDA and the Federal Trade Commission today took joint action against several companies selling over-the-counter hCG products that falsely and illegally claim to promote weight loss.

Labeled "homeopathic" by the seven companies who received the letters, the products contain human chorionic gonadotropin (hCG), a hormone produced during pregnancy by cells that form the placenta.

An injectable drug containing hCG has been approved by the FDA to treat female infertility and other medical conditions. No form of hCG has been approved for weight loss. Making such claims, the letters inform the recipients, is a violation of federal law.

"The joint action is the first step in keeping the unproven and potentially unsafe products from being marketed online and in retail outlets," reads a news release announcing the ban of hCG weight loss products.

The over-the-counter products' labels advise consumers to take the "homeopathic" hCG oral drops, pellets, and sprays while adhering to a very low-calorie diet, as low as 500 calories a day. According to the FDA/FTC news release, there is no evidence that anything but the potentially dangerous diet promotes weight loss.

"These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed," Ilisa Bernstein, acting director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, says in a news release. "And a very low calorie diet should only be used under proper medical supervision."
List of 7 companies warned in article at above link.
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  " Everyone is entitled to his own opinion, but not his own facts."  - Daniel Moynihan
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