SILVER SPRING, Md., Dec. 6, 2011 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.
Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved as an injectable prescription drug 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 drugs that have not been approved, and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.
The joint action is the first step in keeping the unproven and potentially unsafe products from being marketed online and in retail outlets as oral drops, pellets, and sprays.
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 HCG increases weight loss beyond that resulting from the recommended caloric restriction. Consumers on a very low calorie diet are at increased risk for side effects including 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