The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have deemed HCG diet products illegal and just issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss, the FDA announced.
Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and is found in the urine of pregnant women. HCG is and FDA-approved injectable medication drug prescribed for the treatment of some cases of female infertility and other medical conditions.
The letters warn the companies that they are violating federal law by selling unapproved drugs and making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.
The joint FDA-FTC action is the first step in helping to ensure unproven and potentially unsafe products are not marketed online and in retail outlets as oral drops, pellets, and sprays, the FDA said.
The labeling for the “homeopathic” HCG products states that each product should be taken in conjunction with a very low calorie diet. There is no substantial evidence that HCG increases weight loss beyond that resulting from the recommended caloric restriction. Meanwhile, consumers on very low-calorie diets are at increased risks for side effects, such as gallstone formation, electrolyte imbalance, and heart arrhythmias.
“These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed,” said Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “And a very low calorie diet should only be used under proper medical supervision.”
“Deceptive advertising about weight loss products is one of the most prevalent types of fraud,” said 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 Warning Letters allow the companies 15 days to notify the FDA of the steps they have taken to correct the cited violations. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.
Consumers and health care professionals are encouraged to report adverse events (side effects) that may be related to the use of these products to MedWatch, the FDA’s voluntary reporting program, by calling 1.800.FDA.1088, or electronically at www.fda.gov/medwatch/report.htm.