FDA: HCG weight-loss products are illegal and may be unsafe
They are tremendously popular—a Google search pulls up over 27 million results.
They claim to be all-natural, and promise consumers using it that they will lose one to two pounds a day, while feeling “healthy and energetic” all the while.
Its sellers claim that “very small amounts” of it can “disconnect the mobile fat of people’s body” and “burn and discharge the unwanted fat through the kidneys.”
There are over-the-counter “homeopathic” human chorionic gonadotropin (HCG) weight-loss products — and the United States Food and Drug Administration (FDA) is advising consumers to steer clear of them.
“Over-the-counter HCG products being sold for weight loss are illegal and claims that the drugs work are unsubstantiated,” FDA warned consumers early last December (2011). The warning can be found in the agency’s Consumer Updates page, which features the latest on all FDA-regulated products.
The products in question are sold in the form of oral drops, pellets and sprays and can be found online in some retail stores.
Some of these products are: “hCG Diet Drops Weight Loss Formula,” “hCG Diet Pellets Weight Loss Formula,” “Alcohol Free hCG Weight Loss Formula,”“HCG Fusion 30,” “HCG Fusion 43,” “Homeopathic Original HCG,” Homeopathic HCG,” “HCG Platinum X-30,” “HCG Platinum X-14” “HCG Diet Homeopathic Drops,” and “HCG Extra Weight Loss Homeopathic Drops.”
These and other homeopathic HCG drug products are sold on websites and in stores even when FDA has not evaluated these products for safety or effectiveness. Today, these products remain FDA-unapproved.
On Dec. 6, 2011, FDA and the Federal Trade Commission (FTC) also issued letters to companies warning them that they are selling illegal homeopathic HCG weight-loss drugs that have not been approved by the FDA, as well as making unsupported claims.
The joint action is the first step in keeping the unproven and potentially unsafe products from being marketed online and in retail outlets, FDA says in an advisory in its site.
The two agencies say HCG marketers 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.
“It’s unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made,” FDA told sellers of HGC weight-loss products in one of its letters.
“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,” notes David Vladeck, FTC’s Bureau of Consumer Protection director in another FDA advisory.
After receiving the letters, the companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.
“If these companies don’t heed our warnings, they could face enforcement actions, legal penalties or criminal prosecution,” says Brad Pace, team leader and regulatory counsel at FDA’s Health Fraud and Consumer Outreach Branch.
“Deceptive advertising about weight loss products is one of the most prevalent types of fraud,” Vladeck notes.
Big claims, but lies
Most HCG weight-loss products in the market claim to “reset your metabolism,” change “abnormal eating patterns,” and “shave 20-30 pounds in 30-40 days.” Worse, sellers of these products market these products together with a very low calorie diet regimen—usually one that limits calories to 500 per day.
“These products are marketed with incredible claims and people think that if they’re losing weight, HCG must be working,” says Elizabeth Miller, acting director of FDA’s Division of Non-Prescription Drugs and Health Fraud. “But the data simply does not support this; any loss is from severe calorie restriction. Not from the HCG.”
HCG, which stands for human chorionic gonadotropin, is a hormone that is produced by the human placenta during pregnancy, Miller explains, and measured in the urine of women to check for pregnancy.
Miller also says that forms of HCG have been evaluated by the FDA and approved as an injectable prescription drug for things like female infertility and some hormonal treatment in males—but it’s never been approved for weight loss.
In fact, FDA labeling for the approved HCG drug products requires the following statement about the use of HCG for weight loss:
“HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There’s no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”
HCG is also not approved for OTC sale for any purpose. “You cannot sell products claiming to contain HCG as an OTC drug product. It’s illegal,” FDA’s regulatory counsel Pace says explicitly.