HCG FDA Legal Disclaimer

Is hCG Approved by the FDA

 To answer that question we need know that The U.S. Food and Drug Administration (USFDA or more commonly just FDA), is an agency of the U.S.A.’s Department of Health and Human Services, responsible for protecting and promoting public health through regulation, supervision and enforcing laws. We’ll look at the FDA’s different roles with the various forms of hCG available – homeopathic hCG, prescription hCG for other medical conditions, and prescription hCG for weight loss.

Is HCG Legal for Specific FDA Approved Medical Treatments?

HCG is legal and FDA approved to treat many various reproductive and metabolic health issues and has been in existence to do so for over 45 years by the medical community. It is considered safe and has few side effects.

HCG is used to cause ovulation and to treat infertility in women, and to increase sperm count in men. HCG is also used in young boys with underdeveloped genitals, often with undescended testicles, which can be caused by a pituitary gland disorder.

Is hCG Legal and FDA Approved for Weight Loss

While hCG is legal, the FDA does has not approved hCG specifically use as a weight loss treatment.

Remember also that the FDA’s role is to set-up tests and recommend safety parameters of drug related products on the market. As an agency it is not in the medical business, but rather is a food and drug product governing body.

So, generally speaking, as long as a drug is safe to use then it is up to the discretion of the medical doctor to prescribe it for various conditions that they are medically “trained to understand and know the application for”.

The doses used for weight loss are minuscule compared to doses used for the other medical conditions (already mentioned) that it is approved for. It has been used “off label” (meaning not strictly in accordance with the use for which it was approved) in the U.S. for weight loss since the 1970s when it was introduced from Europe, where it was, and still is still is, in wider use today than it is in the USA.

Although at one time hCG was the mostly widely used weight loss treatment in America, it came under heavy criticism from the medical profession. Despite numerous studies that demonstrate significant weight loss including prodigious long term studies from Dr. Simeons’ famous hCG Wieght Loss Clinics, and countless thousands of case reports regarding weight loss, body contouring with HCG, here is the FDA’s stated position:

Indications and Usage: 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 decrease the hunger and discomfort associated with calorie-restricted diets.

 

The Official Legal FDA Disclaimer

Legal Disclaimer: The FDA has not approved HCG for 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.

 
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