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Warning Letters Cite Lack of Approval, Potential for Harm

Dec. 6, 2011 -- 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.”

7 Companies Warned

Below is a list of the companies that received the warning letters as well as the products they sell:

Manufacturer/Distributor Name

Product Name

1. HCG Diet Direct LLC

HCG Diet Homeopathic Drops

2. The hCG Drops LLC

Homeopathic HCG

3. HCG Platinum LLC; RightWay Nutrition

HCG Platinum

HCG Platinum X-30

HCG Platinum X-14

4. Nutri Fusion Systems LLC

HCG Fusion 30

HCG Fusion 43


Homeopathic Original HCG

Homeopathic HCG


HCG Extra Weight Loss Homeopathic Drops

7. Natural Medical Supply

Alcohol Free hCG Weight Loss Formula

The companies have 15 days to correct the violations or face seizure, injunctions, criminal prosecution, or other legal actions.

“We’re telling them that they need to stop marketing these unapproved and illegal products,” Elizabeth Miller, acting director of the FDA's fraud unit for OTC products, said in a videotaped statement posted on the FDA's web site.

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