FDA Acts to Remove “Homeopathic” HCG Weight Loss Products from the Market

Kevin Wright, a marketer of HCG (human chorionic gonadotropin) Platinum diet products, has been charged by the Federal Trade Commission (FTC) with falsely claiming his products will result in substantial weight loss. The FTC complaint alleges that Wright and his companies, HCG Platinum and Right Way Nutrition, LLC, have deceptively sold more than $13 million of HCG Platinum since 2010. The FTC has asked the U.S. District Court for the District of Arizona to order Wright, his two marketing companies, four holding companies, and three other individuals to surrender the proceeds of these sales. The holding companies and the three individuals named in the complaint are not charged with participation in alleged deceptive advertising. The FTC vote authorizing the complaint was 4-0.

Human Chorionic Gonadotropin (HCG)

HCG is a hormone produced during pregnancy 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. According to the FDA, HCG is not approved over-the-counter (OTC) for any use, nor has it been approved for use in weight loss. HCG was first promoted for weight loss in the 1950s, but its use faded in the 1970s, especially when it became apparent that there was a lack of evidence to support its use for weight loss. The diet has become popular again and the FDA and FTC are now taking action on illegal HCG products. The FDA has advised consumers to avoid OTCweight-loss products containing HCG and has issued warning letters to HCG marketers.

Warning Letters

In November 2011, Wright and six other HCG marketers received warning letters issued jointly by the FDA and FTC, informing them that their HCG products are considered mislabeled drugs under the Federal Food, Drug & Cosmetic Act and that it is unlawful to make weight-loss claims that are not supported by competent and reliable scientific evidence. The warning letters gave the companies 15 days to notify the FDA of the steps they have taken to correct the violations cited. The letters indicated that a failure to notify the FDA of corrective action could result in legal action, including seizure and injunction, or criminal prosecution.

Specific Complaint Allegations

The FTC complaint alleges that Wright and his companies, marketing through retail outlets such as GNC, Rite Aid, and Walgreens, and through their ownwebsites, on Facebook, on product packaging, and in Internet pop-up ads and magazines, promise that HCG Platinum liquid drops will cause rapid and substantial weight loss, and that consumers will likely lose as much weight as the endorsers in their advertisements.

The alleged illegal advertisements direct consumers to place the HCG products under their tongues before meals and adhere to a very low calorie diet of 500 to 800 calories per day. Wright’s companies typically charge between $60 and $149 for a 30-day supply of one of their three HCG Platinum formulations.

The defendants market two of their three formulations as “homeopathic,” which means the listed ingredients are diluted to the point they are undetectable.On product packaging and in other advertising, they claim that the products cause consumers to lose a pound a day, are safe to use, and are clinically proven to burn fat, reduce weight, and lower cholesterol.

FDA Health Concerns

According to the FDA, there is no substantial evidence that HCG increases weight loss beyond that resulting from the recommended caloric restriction.In addition, the FDA warns that consumers on a very low calorie diet are at increased risk for side effects including gallstone formation, electrolyte imbalance, and heart arrhythmias.