A note on the Food and Drug Administration and the HCG Diet Protocol:

The FDA's role is to regulate drugs and drug related products on the market. As a part of this role, the FDA reviews the research done on the safety and
effectiveness of particular medications and determines if a particular medication can be prescribed in the United States, and if so what conditions the FDA believes the medication is effective in treatingAs long as a drug is safe to use, it is up to the discretion of the medical doctor to prescribe it for various conditions that they, in their training and experience, understand and attempt to safely treat.

HCG has been used by the medical community for over 25 years to treat various medical conditions including overweight conditions.

While HCG has been approved for use by the FDA, it has not been given an indication for dieting. This is because the FDA does not believe that scientific research done thus far supports the use of HCG for dieting.

The use of HCG for dieting under these conditions is known as an “off label” use of the medication. Because medical knowledge and therapeutic methods are always evolving, the “off label” use of medications to treat various medical conditions, including being overweight, is a not uncommon practice in the field of medicine.

As the government regulator of prescription medications, the FDA requires physicians to make patients aware of and understand the FDA’s position on HCG and dieting. Their position is included on the package insert of all

prescription HCG and is copied below:

“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.”