Weight-loss fad human chorionic gonadotropin, or HCG, is the latest unapproved ingredient to draw FDA and Federal Trade Commission scrutiny.

The agencies Dec. 6 said they sent warning letters to seven firms marketing “homeopathic” HCG products for weight loss, stating that the products are unapproved new drugs and make unsubstantiated claims. The products were sold OTC in stores and online as pellets, sprays and oral drops.

During a same-day media briefing, FTC official Rich Cleland said HCG is the latest weight-loss ingredient advertised with unsubstantiated claims.

“Four years ago, the miracle weight-loss ingredient was hoodia gordonii, and then it was acai berry. And now it’s homeopathic HCG. Almost more than any other, the weight loss industry is fad-driven. Unfortunately, all too often, it’s also fraud-driven,” said Cleland, assistant director of FTC’s Division of Advertising Practices.

In a previous joint action, FDA and FTC targeted products containing hoodia for weight-loss claims Also see "FTC Trouble Brews For Hoodia Ads As Coffee Firm Settles False Claim Charges" - Pink Sheet, 21 January, 2008.. FTC also has enforced against firms selling acai-containing weight-loss products with charges of unsubstantiated claims and fraudulent marketing practices Also see "$100 Million Acai Case Could Be Tip Of FTC's Enforcement Iceberg" - Pink Sheet, 23 August, 2010..

Center for Drug Evaluation and Research official Elizabeth Miller said while labeling for the HCG products indicates they should be used in conjunction with a “very low-calorie diet,” there is no evidence the ingredient promotes weight loss beyond that caused by the diet.

Miller, acting director of CDER’s Division of Nonprescription Products and Health Fraud, added that FDA considers the HCG products “potentially dangerous” if taken as directed, partly because very low-calorie diets can increase the risk of conditions including gallstones and heart arrhythmias.

On Nov. 28, FDA district offices in Denver, Los Angeles, New York and Seattle sent letters to the following firms:

HCG Platinum , Bluffdale, Utah
HCG Diet Direct , Tucson, Ariz.
theoriginalhcgdrops.com , New York
Natural Medical Supply , doing business as HCG Complete Diet, American Fork, Utah
Nutrifusion Systems , Sandy, Utah
hcg-miracleweightloss.com , Orofino, Idaho
HCG Drops, St. George, Utah

The chorionic gonadotropin hormone is produced naturally by the human placenta and is approved by FDA as an injectable Rx treatment for infertility. HCG is not recognized in the U.S. Homeopathic Pharmacopoeia, according to the warning letters.

Miller said there are no FDA-approved HCG products for weight loss, and other firms making similar claims should note the warnings.

The products were uncovered in the agency’s ongoing initiative on weight-loss products and do not reflect increased agency scrutiny on homeopathics, Ilisa Bernstein, acting director of the CDER Office of Compliance, said Dec. 6 at a Food and Drug Law Institute conference.

FTC’s enforcement does not address whether a health care product contains an unapproved ingredient, but focuses on whether a firm has competent and reliable evidence to support ad claims, Cleland said.

“Taking homeopathic off the label when you don’t have evidence to show that your product actually is effective isn’t going to cure the problem,” he added.

Agencies Target “Fraud-Driven” HCG Weight-Loss Ingredient

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