Is hCG Legal? Is hCG FDA Approved?

Many people wonder Is hCG legal in my state? Or they wonder is it legal without a prescription, or legal or buy (or purchase online) and bring into the country. Let's take these questions one at a time.

Is hCG Legal in my state(or province)

hCG for weight loss is legal in the United States, Europe, Canada and many other countries, where it is available as prescription medicine and also available as homeopathic medicine. hCG is also available in higher doses as a prescription medicine for certain specific metabolic and reproductive medical conditions.

These various medical uses have important distinctions.

In order to legally purchase prescription HCG, you need to have a prescription written by a medical doctor (or a Nurse Practitioner) and filled at a pharmacy. Some doctors may be reluctant to write a prescription for HCG for weight loss since the FDA has not approved it for this purpose yet. Nonetheless, it is legal for doctors to write these prescriptions and many do. There are hCG weigh loss clinics in many countries, and you can refer to our Directory of hCG Programs and Providers if you are looking for one near you, or if you have a review of a clinic or provider to share with us.

is hCG legal to buy without a prescription?

The only form of hCG that is legal to buy without a prescription in the USA, Canada and Europe is homeopathic hCG. Homeopathic Medicine is not subject to the same control as traditional medical prescription medications because in the science of homeopathic medicine the medication is administered (usually orally) in diluted concentrations, which is believed to be more effective for cell use.

Is hCG Legal to buy (or purchase online) and Bring into the country

While hCG is legal here by prescription and it is generally believed to be legal to import from other countries, in order to take advantage of cheaper prices or because no Rx is asked for during online ordering, ordering offshore presents many unexpected hazards. Please read our important hCG Consumer Beware post to learn more about these hazards.

Is hCG legal to import? As of January 2007, it was legal to import prescription drugs from other countries as long as you provide them with a legal US prescription, which the offshore pharmacy will keep on file, and you are ordering it for personal use.

Usually, you can order up to a three month supply and still have it looked upon as for personal use. Again, laws do change, so it is always a good idea to find the most current information before ordering prescription drugs from overseas.

Is hCG legal to import for resale? It is important to note that reselling prescription drugs is a federal offense. Therefore, be certain you are only ordering the drugs for yourself.

Additionally, you will want to check with your local postal laws, or customs, just to make sure it is legal to ship supplies such as hypodermic needles, and "human material" even though it is a prescription medicine compound, through mail or delivery services.

Another common question asked about the legalities of hCG is -

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 Homeopathic hCG Approved by the FDA?

The FDA considers homeopathic medicine to be in the same classification as "over the counter" medicines and as such does not regulate them in the same way it regulates prescription medicines.

The FDA does however require that homeopathic remedies meet certain legal standards for strength, purity, and packaging information.

Homeopathic hCG is made using "real" human hCG, or bio-identical hCG, that is diluted in a solution to create sublingual drops in standardized homeopathic ratios according to the Homeopathic Pharmacopoeia of the United States (HPUS), the guidelines of which are included in the Federal Food, Drug and Cosmetic Act of 1938.

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.

Is hCG legal? Yes, even though some of the bureaucracy around it is confounding. Is it effective for weight loss? Yes, but the best (least confusing) way to answer this question is to answer it for yourself.

Is hCG legal in the USA?
More good questions about hCG anwered here