"FDA and the Federal Trade Commission (FTC) 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.
HCG is a hormone that is produced by the human placenta during pregnancy. Products that claim to contain HCG are typically marketed in connection with fad diets with promises that it can "reset your metabolism," change "abnormal eating patterns," and can shave off 20-30 pounds in a month when used in conjunction with low-calorie diets.
“These products are marketed with incredible claims and people think that if they're losing weight, HCG must be working,” says Elizabeth Miller, acting director of FDA’s Division of Non-Prescription Drugs and Health Fraud. “But the data simply does not support this; any loss is from severe calorie restriction. Not from the HCG.”
According to the FDA, HCG is approved as a prescription drug for the treatment of female infertility, and other medical conditions. It is not approved for weight loss. In fact, the prescription drug label notes there “is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”
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,” Miller says.
But the diet became 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. Even though they are not known to be effective, homeopathic drugs that meet certain conditions set by the FDA can be marketed only because they are said to contain active ingredients that are safe and legal.
“HCG is not on this list [of legal ingredients] and therefore cannot be legally sold as a homeopathic medication for any purpose,” Walther says.
FDA advises consumers who have purchased homeopathic HCG for weight loss to stop using it, throw it out, and stop following the dieting instructions. Harmful effects should be reported online to FDA’s MedWatch program or by phone at 800-FDA-1088 (800-332-1088) and to the consumer’s health care professional.
Click here for a list of manufacturers, distributors and products—and more information about FDA’s concerns about HCG.
