NEW YORK (Reuters) - Regulators have taken first steps to remove from the market over-the-counter products containing HCG hormone, saying the homeopathic formulations fraudulently claim to produce weight loss and may pose serious health risks.
The U.S. Food and Drug Administration and the Federal Trade Commission issued seven warning letters on Tuesday to companies that sell the over-the-counter products, noting they have not been approved by the FDA for weight loss.
The FDA and FTC said the products, taken as oral drops, pellets or sprays, instruct buyers to use them in conjunction with a very low-calorie diet that the agencies consider potentially dangerous.
“Consumers on a very low calorie diet are at increased risk for side effects including gallstone formation, electrolyte imbalance and heart arrhythmias,” a type of dangerous irregular heartbeat, the agencies said in a press release.
HCG (human chorionic gonadotropin) is a hormone produced by the human placenta and found in the urine of pregnant women. Although not approved for weight loss, an injectable form of the hormone is approved by the FDA to treat some cases of female infertility and other medical conditions.
The letters warned the companies that they are violating federal law by selling drugs that have not been approved and by 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,” the agencies said.
Warning letters were sent to Nutri-Fusion Systems of Sandy, Utah; Natural Medical Supply LLC, dba HCG Complete Diet; HCG Platinum LLC; Theoriginalhcgdrops.com; HCG Diet Direct LLC and Hcg-miracleweightloss.com.
The companies have 15 days to notify the FDA of corrective action.