Between 2010 and 2013, FTC says the company sold almost $65 million worth of Amberen nationwide. The company claimed the supplement, which is based on Konjac fiber, was ‘clincally proven’ to cause substantial weight loss. The marketing is aimed at women over 40 and claims the product will help consumers deal with the weight gain that sometimes comes with menopause.
“But their own studies didn’t support those claims. The best way to lose weight is still diet and exercise,” said Jessica Rich, director of the FTC’s Bureau of Consumer Protection.
According to the FTC’s complaint, which was filed in US District Court in the Central District of California, the defendants have marketed Amberen nationwide using radio and TV commercials, websites, email, and other promotional materials. In their ads, the defendants touted Amberen capsules, through direct product claims and consumer endorsements, as able to cause significant weight loss and loss of belly fat, and to increase the metabolism of perimenopausal or menopausal women over 40.
Lunada’s websites and other advertisements pitched the capsules using female announcers saying things like: “Amberen restores hormonal balance naturally, so the weight can just fall right off. Even that stubborn belly fat.” They also claimed that Amberen is “the ONLY product on the market today clinically proven to cause sustained weight loss for women over 40.”
Data doesn’t support conclusions
According to the FTC’s complaint, however, a clinical trial conducted in 2001 by the Russian scientists who developed the Amberen formula, used a double dose of Amberen and did not specifically measure weight loss. Additionally, a 2011 study paid for by Luanda and conducted by Medicus Research of Los Angeles on 64 women did not find a statistical difference in weight loss between the Amberen group and a placebo group, according to the FTC complaint. Over 12 weeks the Amberen group lost an average of 1.48 pounds while the placebo group gained 0.28 pounds.
The FTC complaint also takes the company to task over the details of its “risk free” offer. Under the arrangement, to receive a refund of the purchase price the consumer had to buy a three months supply and send back unopened the additional two months worth of product within 30 days of receiving the shipment and to bear the shipping costs both ways. The FTC complaint deemed this arrangement to be fraudulent.
Company fights back
After being contacted by NutraIngredients-USA, Luanda issued the following statement on how it views the research backing of its products. The statement does not address the equivocal outcome of the Medicus study nor does it discuss FTC’s criticism of the “risk free” offer.
“The principal basis underlying the FTC’s suit is its contention that Amberen, a product marketed by Lunada Biomedical, fails to bring about weight loss in menopausal women. Scientific evidence, including a recent randomized, double blind, placebo controlled clinical trial, involving 102 test subjects, just released by the world renowned First Moscow State Medical University (the premier educational, scientific and medical institution in Russia since 1758) supports the conclusion that Amberen achieves weight loss in menopausal women. The data obtained during the study was evaluated independently by the prestigious Institute of Mathematical Problems in Biology, a division of the Russian Academy of Sciences. Additional peer reviewed scientific evidence supports the conclusion that Amberen also reduces many menopausal symptoms.
“Confident in the strength of its supporting science and the integrity of its product, Lunada rejected FTC demands for a large pay-out to settle the FTC’s claims. Lunada prefers instead to litigate this matter before an impartial judge,” the company said.