FDA Nixes Potentially Dangerous HCG

Silver Spring, MD—The U.S. Food and Drug Administration (FDA) is cracking down on companies selling over-the-counter (OTC) HCG as weight-loss aids by making the product illegal, citing that fads and diets promising fast weight-loss often do so with unsupported claims and potentially unhealthy ways.

According to FDA, human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. As a diet aid, companies promise fast results, some saying as much as 30 pounds in 30 days. The supplements, however, must be paired with a low-calorie diet with most providers suggesting as low as 500 calories a day to “reset your metabolism” and change “abnormal eating patterns,” but such a restrictive diet can be hazardous, says the agency. “In general, the reference (average) calorie level is 2,000,” says Shirley Blakely, a nutritionist at FDA’s Center for Food Safety and Applied Nutrition. “If you want to lose weight, reduce your daily intake by 500 calories. Over the course of a week, that equals 3,500 calories, which is the loss of a pound. Gradual weight loss is the way to do it.”

As of December 2011, seven companies offering HCG as a weight-loss product were given warning letters for selling FDA-unapproved drugs along with unsupported claims that violated federal law. “Deceptive advertising about weight-loss products is one of the most prevalent types of fraud,” says David Vladeck, director of the FTC’s Bureau of Consumer Protection. “Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence, so consumers have the accurate information they need to make good decisions.”

The companies had 15 days to comply with FDA and report on the changes they’ve made to clear up any violations. After the grace period, these companies risked legal action and possible criminal prosecution if changes had not been made to their products. HCG is not to be sold OTC for any purpose, especially for weight-loss as FDA has not approved any OTC weight-loss product. HCG is only legal as a prescription to help female infertility. Although the FDA does not evaluate the efficacy of homeopathic products, certain ingredients are approved to be legally sold with accordance to the Homeopathic Pharmacopoeia of the United States. HCG is not on the list.

Side effects of a very low-calorie diet include the possibility of gallstone formation, electrolyte imbalance, heart arrhythmias and possible death, according to FDA, not to mention the dieter’s lack of vitamin, mineral and protein intake. Any weight-loss resulting from the HCG diet is most likely to be from the severe calorie reduction and not from the HCG itself, says the agency.

HCG diets were popular in the 1950s, but faded in the 1970s due to low results and lack of evidence that HCG had an effect on weight loss, according to FDA. Their suggestions for the healthiest weight-loss are through good-old-fashioned balanced diet and exercise, and leave the hormones out of it.

Published in WholeFoods Magazine, February 2012