FDA disclaimer for HCG and Weight loss
Government Regulation In 1976, the FTC ordered the Simeon Management Corporation, Simeon Weight Clinics Foundation, Bariatrics Management Corporation, C.M. Norcal, Inc., and HCG Weight Clinics Foundation and their officers to stop claiming that their HCG-based programs were safe, effective, and/or approved by the FDA for weight-control. Although the order did not stop the clinics from using HCG, it required that patients who contract for the treatment be informed in writing that:
THESE WEIGHT REDUCTION TREATMENTS INCLUDE THE INJECTION OF HCG, A DRUG WHICH HAS NOT BEEN APPROVED BY THE FOOD AND DRUG ADMINISTRATION AS SAFE AND EFFECTIVE IN THE TREATMENT OF OBSITY OR WEIGHT CONTROL. THERE IS NO SUBSTANTIAL EVIDENCE THAT HCG INCEASES 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-RESTRICTIVE DIETS .
Since 1975, the FDA has required labeling and advertising of HCG to state:
HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. 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.