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FDA Looks at Homeopathic Products for Weight Loss

UU. Said Tuesday they will take steps to remove GCH products from the market, which are controversial, unapproved and carry illegal labels.

GCH is the acronym for human chorionic gonadotropin, a hormone produced by the human placenta and found in the urine of pregnant women. The products are usually given in sets with extremely low calorie diets, up to 500 calories a day, which worries some experts because of possible health effects.

According to the US Food and Drug Administration (FDA) The companies that market the over-the-counter GCH weight loss products labeled “homeopathic” received Tuesday warning letters from the FDA and the US Federal Trade Commission. UU. The letters warned companies that they are violating federal law by selling unapproved drugs, and by making unconfirmed claims about the products.

In the USA GCH is approved as an injectable drug to treat some cases of female infertility and other medical conditions but is not approved as an adjunct to weight loss.

The FDA noted that GCH weight loss products are sold online and in stores like drops, pills and oral sprays, even though there is no evidence of its efficacy or safety.

Visitors to a manufacturer’s website included in FDA measures called The Original hcg drops are informed that they can “lose 20 to 30 pounds (9 to 13 kilos) in 30 to 40 days” by taking the product. The company also claims that GCH “tells the body to release abnormal fat” and “conserve lean muscle, all designed to establish a new body weight and reprogram the metabolism.”

However, the FDA is particularly concerned, because the labels of homeopathic GCH products for weight loss usually advise consumers to take the product in conjunction with a very low calorie diet. But there is no substantial evidence that GCH products help people lose weight, according to the agency, and people who follow these severely restricted diets are at increased risk for problems such as gallstones, electrolyte imbalances And disorders of the heartbeat known as arrhythmias.

“These products are sold over-the-counter on websites and in some retail stores, and can be found in drops, pills and oral sprays,” Elizabeth Miller, acting director of The Division of Non-Prescription Products and Health Frauds of the Compliance Office of the FDA’s Drug Evaluation and Research Center.

“Currently, there are no GCH products to lose weight approved by the FDA,” he said. “The FDA believes that it is important for consumers to understand that these products are potentially hazardous if they are taken as directed.”

Neither the FDA nor the Federal Trade Commission know how many people use these products.

“The indication is that they are marketing a lot on the internet, and that suggests there are buyers,” Richard Cleland, an assistant director of the FTC’s Advertising Practices Division, told the press conference. “A survey that we conducted several years ago on all kinds of diet products indicated that nearly five million Americans a year are victims of weight loss scams.”

One expert agreed with the FDA’s measure.

“The HCG diet is a typical fad diet that abuses people’s despair at losing weight,” said Samantha Heller, a dietitian, nutritionist, exercise physiologist, and clinical nutrition coordinator at the Hospital’s Cancer Care Center Griffin in Derby, Connecticut. “Not only is it dangerous for people to consume only 500 calories a day over time, but the safety and efficacy of taking GCH to lose weight has not been established. A starvation diet can result in emotional, psychological, and physiological damage.” .

The companies have 15 days to notify the FDA of the steps they have taken to correct the violations described in the warning letters. If they do not respond, companies could face legal action, which includes confiscation and judicial restraint, or prosecution, the FDA said.

“Misleading advertising of weight loss products is one of the most prevalent types of fraud,” said David Vladek, director of the FTC’s Office 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.”

The companies that received the warning letters are: HCG Platinum, LLC manufacturers of “HCG Platinum”, “HCG Platinum X-30” and “HCG Platinum X-14”; HCG Diet Direct, LLC, HCG Diet Homeopathic Drops Manufacturers; Theoriginalhcgdrops.com and resetthebody.com, which market “Homeopathic Original HCG” and “Homeopathic HCG”; Natural Medical Supply, whose products include “Alcohol Free hCG Weight Loss Formula”, “hCG Diet Pellets Weight Loss Formula”, and “hCG Diet Drops Weight Loss Formula”; Nutri Fusion Systems LLC, manufacturers of “HCG Fusion 30” and “HCG Fusion 43”; And hcg-miracleweightloss.com, who market “HCG Extra Weight Loss Homeopathic Drops.”