FDA, FTC Crack Down on Illegal HCG Weight Loss Products
Agencies issue warning to companies marketing and selling unapproved drugs.
Dec. 6, 2011 — -- The Food and Drug Administration and the Federal Trade Commission issued warning letters today to seven companies that market over-the-counter weight loss products containing the hormone HCG, calling for these companies to stop selling and marketing these unapproved drugs.
Human chorionic gonadotrpin (HCG), otherwise known as a fertility hormone, is produced in women's placentas and is also found in pregnant women's urine. The hormone is FDA-approved only as a prescription injection drug to treat some cases of infertility and for select male hormone imbalances.
Some studies suggest that HCG can also absorb excessive fat tissue. Many companies also claim the hormone can curb appetite and speed metabolism.
HCG products sold online or in stores are not approved for weight loss. Still, so-called homeopathic versions of the hormone -- found as oral drops, sprays, and pellets -- are marketed by many companies as a weight loss supplement.
"Almost more than any other [market], the weight loss industry is fad driven," Richard Cleland, assistant director of the division of advertising practices at the Federal Trade Commission said today. "Also, unfortunately it is fraud driven."
It's unclear how much HCG is contained in the homeopathic products -- some suggest only trace amounts -- or whether the products truly contain HCG at all, even if labeled as such, said Elizabeth Miller, acting director of the Division of Non Prescription Products and Health Fraud at the FDA.
"Whether they contain it or not, they are illegal and unapproved drugs," Miller said.
Advertisements claim dramatic weight loss results of the HCG Diet, asserting that the diet program, which combines a 500-calorie diet while taking an HCG product, can produce fast results.
But there are no studies that show taking any product containing HCG as part of a low calorie diet has additional weight loss benefits, Miller said.
Women need to consume on average 1600 to 2400 calories a day and men need to consume 2000 to 3000 calories a day to maintain a healthy weight.
The FDA says a very low calorie diet can cause gall stone formation, electrolyte imbalances, and even heart arrhythmia, regardless of whether the hormone is also taken.
Companies that have been issued warning letters include Nutri-Fusion Systems LLC; Natural Medical Supply; HCG Platinum, LLC; theorginalhcgdrops.com; HCG Diet Direct, LLC; and Hcg-miracleweightloss.com.
Gary Arbuckle, co-founder of theorginalhcgdrops.com said even though the company solely sells HCG drops, it has no plans to shut down.