FDA warns against HCG weight-loss products

Anyone who has ever been on a diet knows there are sensible ways to lose weight, including eating a balanced diet and exercising.

There are also reckless ways to shed pounds, such as fads and diet aids that promise rapid weight loss but often recommend potentially dangerous practices. Those include human chorionic gonadotropin weight-loss products that are marketed along with advice for users to follow a severely restrictive diet.

The Food and Drug Administration is advising consumers to avoid HCG weight-loss products. These products are typically sold in the form of oral drops, pellets and sprays, and can be found online, at weight loss clinics and in some retail stores.

HCG is not approved without a prescription and is not approved for weight loss

HCG is a hormone produced by the placenta during pregnancy.

Products marketed for weight loss that claim to contain HCG are typically marketed in connection with a very low-calorie diet, usually one that limits calories to 500 per day. Many of these popular HCG products claim to "reset your metabolism," change "abnormal eating patterns," and shave 20 to 30 pounds in 30 to 40 days.

These products are marketed with incredible claims, and people think that if they're losing weight, HCG must be working. But the data simply do not support this; any loss is from severe calorie restriction. Not from the HCG."

Carolyn Becker, Director of the Office of Unapproved Drugs and Labeling Compliance, FDA's Center for Drug Evaluation and Research

The FDA has approved HCG as a prescription drug for the treatment of female infertility and for other medical conditions. HCG is not approved for use without a prescription for any purpose. It is not approved for weight loss.

In fact, the prescription drug label notes 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."

Very low-calorie diets are unhealthy

Living on 500 calories a day is not only unhealthy but also dangerous. People on such restrictive diets are at increased risk for side effects, including gallstone formation, an imbalance of the electrolytes that keep the body's muscles and nerves functioning properly, and an irregular heartbeat. Such restrictive diets can be dangerous, even potentially fatal.

Very low-calorie diets are sometimes prescribed by health care professionals for people who are moderately to extremely obese as part of medical treatment to lessen health conditions caused by obesity, such as high blood pressure. But even then, strict and constant medical supervision is needed to ensure that side effects are not life-threatening.
Without medical oversight, people on very low-calorie diets may not be getting enough vitamins, minerals and — most important — protein. If you want to lose weight, do it gradually and reduce the calories you eat every day.

If you have HCG products for weight loss, quit using it, throw it out, and stop following the dieting instructions. Talk to your health care professional about a safe and healthy weight loss plan for you.

Health care professionals and patients should report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.