"Homeopathic" weight-loss products containing human chorionic gonadotropin (HCG) are illegal and mislead consumers, federal agencies said Tuesday after issuing warning letters to seven companies that market the popular pellets, powders and sprays.
In a joint effort to yank the unproven weight-loss agents from the market, the Food and Drug Administration and the Federal Trade Commission ordered the businesses to review "unsubstantiated health claims" and correct a host of other violations — several companies used the FDA logo on their sites — by month's end. Companies that do not comply could face legal action, according to the warning letters.
HCG is a hormone taken from pregnant women that has been used by dieters since the 1970s despite scant scientific evidence showing that it contributes to weight loss. The near-starvation regimen restricts followers to 500 calories a day for six weeks. At the same time, dieters regularly inject, swallow or inhale HCG because they believe it will curb hunger pangs, making it easier to stay on a low-calorie diet.
Companies also routinely claim HCG can pull fat from the hips, thighs, buttocks and chin, "reset" the hypothalamus gland so the weight doesn't come back and mobilize excess fat for energy while eliminating the fat that remains.
An injectable, prescription form of HCG has been approved by the FDA for female infertility and other medical issues; thus it can be used legally off label for other purposes. But the agency has not cleared any HCG injections, pellets, sprays or pills for weight loss. Since the 1970s, the FDA has required labels to state that the hormone "is not an effective adjunctive therapy" for obesity.
Though men and women lose weight on the diet — as would anyone who eats 500 calories a day — the bulk of research has found no evidence that taking HCG brings about weight loss or fat redistribution, reduces hunger or improves mood. Most studies have concluded the HCG is a placebo.
"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."
The letters warn the companies they are violating federal law by selling drugs that have not been approved and by making unsupported claims for the substances.
The products are technically classified as drugs because they are intended to alter the body's structure or function. But a new drug must be approved by the FDA; the companies that received the warning letters have not submitted applications for approval.
Many of the products are problematic because their websites and packaging contain false claims, according to the FDA and the FTC.
Warning letters were sent Nov. 28 to Greg Grimshaw (hcg-miracleweightloss.com); Richard Marmer, of Nutri Fusion Systems (hcgfusion.com); Tom Hall, of Natural Medical Supply (hcgcompletediet.com); Gary Arbuckle and Amy Freeze (theoriginalhcgdrops.com and resetthebody.com); Clint Ethington, of HCG Diet Direct LLC (hcgdietdirect.com); and Kevin Wright of HCG Platinum LLC (hcgplatinum.com).
The companies have 15 days to tell the FDA how they will correct the violations. It's possible they could seek FDA approval for the weight-loss claims, but the agencies expect they will stop selling the products. None of the companies that received letters returned calls for comment.Copyright © 2015, The Baltimore Sun