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A FDA official noted that the HCG product labels call for the pellets, liquids, and sprays to be taken in conjunction with a very low-calorie diet, but it did not appear that oral HCG weight loss products 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,cardiac arrhythmias, electrolyte imbalance, and gallstone formation, said Miller.

OTC HCG Weight Loss products Readily Available Across the Web

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." HCG weight-loss products are also becoming increasingly available in large retail supermarket chainsm, drugs stores, and health food stores too.

OTC HCG Weight-loss Products are Illegal

HCG is approved as an injectable drug for certain forms of female infertility and is therefore clearly subject to FDA regulation.

OTC HCG weight-loss products are ilegal because there is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction.

Many of these HCG weight-loss products are labeled as homeopathic remedies, but the  HCG weight-loss products are illegal whether the word "homeopathic" is used or not, said Richard Cleland, assistant director of the FTC's advertising practices division.

If the HCG weight-loss product is marketed or meets federal standards to qualify as a drug, but is not FDA-approved, the HCG weight-loss product cannot be sold legally, Cleland said.

Seven Companies Selling HCG Weight-loss Products Receive FDA Warnings

The seven companies receiving the warning letters, included HCG Diet Direct, HCG Platinum, Nutri Fusion Systems, Natural Medical Supply (doing business as HCG Complete Diet), HCG-miracleweightloss.com and Theoriginalhcgdrops.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.

The warning letters sent to manufacturers of the products note that HCG has not received FDA approval for any weight loss indication.

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. HCG Diet Direct claims on their website that you can lose 26 pounds in 26 days on the homeopathic HCG Diet without heavy exercise or without frozen or prepared foods to buy.

The companies selling the OTC HCG products 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 OTC HCG products.

If the companies selling the OTC HCG weight-loss products do not stop selling the products voluntarily, the FDA and FTC threatened to forcibly halt their operations.

OTC HCG Weight-loss  Products Very Popular

FDA and FTC Officials were unable to estimate how many people have bought HCG weight-loss products, but Cleland said HCG weight-loss product 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," Cleland added. "Unfortunately, all too often, it is also fraud-driven."