CORRECTION: An earlier version of this story omitted one of the companies that received a warning letter.
Federal regulators said on Tuesday that they are cracking down on some illegally marketed weight-loss drugs. The Food and Drug Administration and the Federal Trade Commission have warned seven companies that market ‘homeopathic’ hormonal weight-loss schemes that their products have no proven weight-loss benefit. They also saId that these companies could be giving dangerous dieting advice.
“These products are illegal and unapproved drugs,” the FDA’s Elizabeth Miller told reporters in a conference call. “The FDA feels that it is important for consumers to understand that these products are potentially dangerous if taken as directed.”
The products claim to use human chorionic gonadotropin, or hCG, a hormone produced by the human placenta. The FDA has approved hCG for treating some cases of female infertility, but not for weight loss. It is sold as oral drops, pellets, or spray. Licensed hCG drugs must be injected.
HCG packages typically instruct consumers to follow a severely calorie-restricted diet, which can be dangerous, Miller said. She and the FTC’s Richard Cleland characterized hCG supplements as the latest weight-loss fad, heavily marketed on the Internet.
“Almost more than any other, the weight-loss industry is fad-driven. Unfortunately, all too often it’s also fraud-driven,” Cleland said. Five million Americans are taken in by weight-loss frauds each year, he said.
Warning letters were sent to Nutri Fusion Systems, Inc; Natural Medical Supply, LLC DBA HCG Complete Diet; HCG Platinum, LLC; Theoriginalhcgdrugs.com; HCG Diet Direct, LLC; Hcg-miracleweightloss.com, and hCG Drops LLC, according to the FDA’s web site.
The companies have 15 days to notify the FDA that they have taken steps to purge unsubstantiated claims from their advertising. Otherwise, they could face legal action, the FDA warned in a statement.
One of the product makers, Reset the Body, claims that its product “very well could be the safest way to LOSE WEIGHT and KEEP WEIGHT OFF!” It promotes hCG as a way to naturally break down fat.