December 7, 2011
WASHINGTONFDA and FTC sent warning letters to seven companies that market HCG weight-loss products as over-the-counter (OTC) "homeopathic" drugs and direct users to follow a severely restrictive diet. The letters warned these companies that they are selling illegal homeopathic HCG weight-loss drugs that have not been approved by FDA, and that they are making unsupported claims.
This action comes almost a year after Elizabeth Miller, acting director of FDAs Division of Non-Prescription Drugs and Health Fraud, told USA Today, that HCG are illegal and fraudulent. In January 2011, she said no evidence shows the oral OTC products are effective for weight loss, according to.
Following up on Miller's statement and acting in line with increased enforcement measures, FDA and FTC sent the companiesNutri Fusion Systems Inc ., Natural Medical Supply LLC DBA HCG Complete Diet, HCG Platinum LLC , Theoriginalhcgdrogs.com, HCG Diet Direct LLC and Hcg-miracleweightloss.comwarning letters on Nov. 28 warning them that HCG is not a dietary supplement or food. Instead, the agency said these products are approved new drugs.
FDA also issued a alert advising consumers to steer clear of these products because living on so few calories a day is hazardous. Consumers on such restrictive diets are at increased risk for side effects that include gallstone formation, an imbalance of the electrolytes that keep the bodys muscles and nerves functioning properly and an irregular heartbeat. Without medical oversight, FDA said consumers on very low calorie diets may not be getting enough vitamins, minerals andmost criticallyprotein.
These "homeopathic" human chorionic gonadotropin (HCG) weight-loss products are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores. HCG is a hormone that is produced by the human placenta during pregnancy. Products that claim to contain HCG are typically marketed in connection with a very low-calorie diet, usually one that limits calories to 500 per day. Many of these popular HCG products claim to reset your metabolism," change abnormal eating patterns," and shave 20 to 30 pounds in 30 to 40 days.
In the recently released consumer alert, Miller said These products are marketed with incredible claims, and people think that if they're losing weight, HCG must be working. But the data simply does not support this; any loss is from severe calorie restriction. Not from the HCG."
HCG is approved by FDA as a prescription drug for the treatment of female infertility, and other medical conditions. It is not approved for weight loss. In fact, the prescription drug label notes there, is 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."
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