FDA Disclaimers and Required Communication to Patients
“The FDA has not approved hCG Therapy to lose weight. “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.
This diet protocol includes “off-label” use of the FDA approved medication hCG Human Chorionic Gonadotropin. This medication has not been approved for the purpose of weight loss but is approved by the FDA for other medical treatments. These treatments are approved for young boys with a condition of Hyper-Gonadism and in women as an aid in achieving pregnancy.
FDA understands that sometimes approved products are used to treat conditions that the products were not approved for (i.e., “off-label” uses). The “off-label” use of products usually presents greater uncertainty about both the risks or benefits because less information is available on safety and effectiveness. Unexpected adverse events may occur in this context. . (“Off-label” use means the use of FDA approved drugs for purposes other than those for which the FDA has approved them.) “Off-label” prescribing is a legal and common practice by physicians in the United States.