FDA warns that over the counter HCG products marketed for weight loss are illegal

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued Warning Letters in December 2011 to seven companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.

The letters warn the companies that they are violating federal law by selling unapproved new drugs, and by making unsupported claims for the substances. The FDA is advising that there are no FDA-approved HCG drug products for weight loss.

This joint action between the FDA and FTC is an initial step in halting sale of HCG products, keeping them from being marketed online and in retail outlets as oral drops, pellets, and sprays.

“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.”

For more information on ensuring compliance with the rules and regulations enforced by the FDA and FTC, please contact Ann Marie Gaitan, Esq.