FDA Drug Safety Podcast for Consumers: FDA and FTC: HCG Diet Products Are Illegal

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued warning letters to firms marketing over-the-counter homeopathic HCG drug products for weight loss. These firms are violating the Federal Food, Drug, and Cosmetic Act and the Federal Trade Commission Act by selling unapproved and misbranded drugs that make unsubstantiated claims about weight loss. Unapproved homeopathic HCG drug products are sold on websites and in stores. FDA has not evaluated these products for safety or effectiveness.

Elizabeth Miller, Lead Consumer Safety Officer in FDA's Center for Drug Evaluation and Research, explains the agency's concerns.

E.M: HCG stands for human chorionic gonadotropin. It's a hormone produced by the body and a lot of people think of it as a pregnancy hormone and we measure it in the urine of pregnant women. Forms of HCG have been evaluated by the FDA and approved as an injectable prescription drug for things like female infertility and other medical conditions.

E.M.: HCG, or human chorionic gonadotropin, has been approved by FDA for things like female infertility and other medical conditions but it has not been approved by the agency for weight loss.

E.M.: FDA hasn’t received specific reports of harm about them but we are very concerned because the products instruct users to take them with a 500 calorie per day diet. This kind of diet should only be done under medical supervision. The risks of such a diet can include things like dizziness, fainting, gal stones or even heart arrhythmias.

FDA along with the Federal Trade Commission has issued seven warning letters to firms marketing these products. We're telling them that they need to stop marketing these unapproved and illegal products.

Narrator: FDA and FTC will monitor the firms’ responses to the warning letters and take further action as needed. Firms that do not correct the violations may face enforcement action, possible legal penalties, or criminal prosecution. For more information about HCG, visit w-w-w-dot-F-D-A- dot-gov-slash-H-C-G-D-I-E-T