Makers of a controversial weight loss formula got the plug pulled on them by the FDA this week in what is becoming a trend of the federal government to ban homeopathic medicines. Supplements made from the placenta known as HCG were pulled from shelves and internet Websites after the FDA banned their use, citing that there is no factual proof that the supplements work to reduce weight gain as they are advertised. The FDA also said there could be health risks involved if these supplements are taken as suggested by their manufacturers.
The products in question contain human chorionic gonatropin, a protein produced by the placenta and synthesized from the urine of women who are pregnant. The brand names of the banned products are: HCG Diet Homeopathic Drops, Homeopathic HCG, HCG Platinum, HCG Platinum X14, HCG Fusion and HCG Extra Weight Loss Drops.
Basically HGC is sold as an injectable, drop or pill. The injectable version is used widely for the treatment of infertility, also in organ transplants, AIDS related muscle wasting and in people with hormone deficiency growth. Also this injectable form is banned by the Olympic Committee and the Major League Baseball Association because of its performance enhancing qualities. HGC also comes in powder, pill form and drop solution but these do not present a safety problem.
The original HGC diet was brought to the masses by Dr. A.T.W. Simeons an endocrinologist from England. He noticed that calorie deficient pregnant woman in India had higher HGC secretions which seemed to cause a loss of stored fat while keeping the muscles preserved in the pregnant woman. In pregnant woman HGC triggers the uterus into accepting the embryo but most importantly for those seeking to lose weight it causes the metabolizing of fat to be used as fuel. Thus one could lose the fat but still preserve the muscles.
FDA NEWS RELEASE
FDA, FTC act to remove “homeopathic” HCG weight loss products from the market
Joint action is first step in halting sale of the products
The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.
Human chorionic gonadotropin (HCG) is a hormone produced 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.
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 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.
“These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed,” said Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “And a very low calorie diet should only be used under proper medical supervision.”
“Deceptive advertising about weight loss products is one of the most prevalent types of fraud,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection. “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.”
According to the Warning 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.
Consumers and health care professionals are encouraged to report adverse events (side effects) that may be related to the use of these products to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.