HCG Diet Products Illegal, Says FDA

January 2012 - Anyone who has ever been on a diet knows that there are sensible ways to lose weight. These include balanced diets, exercising and realistic goals. And then there are reckless ways to shed pounds—fads and diet aids that promise rapid weight loss, but often recommend potentially dangerous practices. These include HCG weight-loss products (usually drops) marketed over-the-counter (OTC) that are identified as "homeopathic" and direct users to follow a severely restrictive diet.

The Food and Drug Administration is advising consumers to steer clear of these "homeopathic" human chorionic gonadotropin (HCG) weight loss products.  They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores. 

FDA and the Federal Trade Commission have issued seven letters to companies warning them that they are selling illegal homeopathic HCG weight loss drugs that have not been approved by FDA, and that make unsupported claims. 

(For the list of manufacturers, distributors and products—and more information about FDA’s concerns about HCG—visit www.fda.gov/hcgdiet.)

HCG was first promoted for weight loss in the 1950s. “It faded in the 1970s, especially when it became apparent that there was a lack of evidence to support the use of HCG for weight loss.

The diet has become popular again and FDA and FTC are taking action on illegal HCG products. “You cannot sell products claiming to contain HCG as an OTC drug product. It’s illegal,” says Brad Pace, team leader and regulatory counsel at FDA’s Health Fraud and Consumer Outreach Branch. “If these companies don’t heed our warnings, they could face enforcement actions, legal penalties or criminal prosecution.” 

Elisabeth Walther, a pharmacist at FDA, explains that the agency does not evaluate homeopathic drug products for safety or effectiveness, and is not aware of any scientific evidence that supports homeopathy as effective. However, those that meet certain conditions set by FDA can be marketed. A reference document called the Homeopathic Pharmacopoeia of the United States lists active ingredients that may be legally included in homeopathic drug products. “HCG is not on this list and therefore cannot be legally sold as a homeopathic medication for any purpose,” Walther says.