| By John Gever, Senior Editor, MedPage Today Published: December 06, 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 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.
If the companies do not do so voluntarily, the FDA and FTC threatened to forcibly halt their operations.
Many of these products are labeled as homeopathic remedies, but they are illegal whether the word "homeopathic" is used or not, said Richard Cleland, assistant director of the FTC's advertising practices division.
If the product is marketed or meets federal standards to qualify as a drug, but is not FDA approved, it cannot be sold legally, Cleland said.
Officials from both agencies were unable to estimate how many people have bought HCG weight-loss products, but Cleland said they were the current hot item in the lose-weight-fast category.
"Four years ago, the miracle weight-loss ingredient was Hoodia gordonii, and then it was acai berry, and now it's homeopathic HCG," he said.
"Almost more than any other, the weight-loss industry is fad-driven," he added. "Unfortunately, all too often, it is also fraud-driven."
The seven companies receiving the warning letters, in addition to HCG Diet Direct, included Nutri Fusion Systems, Natural Medical Supply (doing business as HCG Complete Diet), HCG Platinum, Theoriginalhcgdrops.com, and HCG-miracleweightloss.com.
The FDA and FTC emphasized that the letters were a "first step in halting sale" of HCG weight-loss remedies. Other companies that market such products "should also read these letters carefully and take appropriate action," Cleland said.
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 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.
If the companies do not do so voluntarily, the FDA and FTC threatened to forcibly halt their operations.
Many of these products are labeled as homeopathic remedies, but they are illegal whether the word "homeopathic" is used or not, said Richard Cleland, assistant director of the FTC's advertising practices division.
If the product is marketed or meets federal standards to qualify as a drug, but is not FDA approved, it cannot be sold legally, Cleland said.
Officials from both agencies were unable to estimate how many people have bought HCG weight-loss products, but Cleland said they were the current hot item in the lose-weight-fast category.
"Four years ago, the miracle weight-loss ingredient was Hoodia gordonii, and then it was acai berry, and now it's homeopathic HCG," he said.
"Almost more than any other, the weight-loss industry is fad-driven," he added. "Unfortunately, all too often, it is also fraud-driven."
The seven companies receiving the warning letters, in addition to HCG Diet Direct, included Nutri Fusion Systems, Natural Medical Supply (doing business as HCG Complete Diet), HCG Platinum, Theoriginalhcgdrops.com, and HCG-miracleweightloss.com.
The FDA and FTC emphasized that the letters were a "first step in halting sale" of HCG weight-loss remedies. Other companies that market such products "should also read these letters carefully and take appropriate action," Cleland said.
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