FDA, FTC Target “Potentially Dangerous” HCG Weight-Loss Products

December 7, 2011

HCG is FDA-approved as an injectable prescription drug for female infertility.

FDA and the FTC yesterday jointly issued seven warning letters to companies marketing products containing human chorionic gonadotropin (HCG) and labeled as over-the-counter “homeopathic” products for weight loss.

The agencies describe HCG as a hormone produced by the human placenta and found in the urine of pregnant woman. HCG is FDA-approved as an injectable prescription drug for female infertility. However, the companies receiving the warning letters are being cited for making unapproved drug claims.

The agencies say that the “homeopathic” products under question state that products should be taken with a very low-calorie diet. However, “There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction.”

“These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even taken as directed,” stated Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in a press statement.