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FDA and FTC Act to Remove 'Homeopathic' HCG Weight-Loss Products from the Market
Four statements from Elizabeth Miller--the acting director of FDA's
"Division of Non-Prescription Drugs and Health Fraud"--in:
mp3PRO format
QuickTime
(MPEG-4/AAC) format
Windows Media Audio
9.2 format
(86 seconds total)
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The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued seven "Warning Letters" to companies marketing over-the-counter HCG products that are labeled as "homeopathic" for weight loss.
"Human chorionic gonadotropin" (HCG) is a hormone that is produced by the human placenta and is 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 that 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.
According to the "Warning Letters", the companies have 15 days (as of Tuesday, December 6th) to notify FDA of the steps that they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.
Consumers and healthcare professionals are encouraged to report adverse events (side effects) that may be related to the use of these products to "MedWatch"--FDA's voluntary-reporting program--by calling 1-800-FDA-1088 or visiting www.fda.gov/medwatch/report.htm.
