Any company that says it has the only proven product for helping middle-aged women lose weight better be able to back that claim up with hard science.
That's the message the Federal Trade Commission wants to convey in saying Tuesday that it has filed suit in federal court against Lunada Biomedical and its leadership over a supplement called Amberen.
In marketing Amberen through TV, radio and online ads, as wells in emails, Lunada has claimed that Amberen "restores hormonal balance naturally, so the weight can just fall right off. Even that stubborn belly fat." The company also touts the supplement as "the ONLY product on the market today clinically proven to cause sustained weight loss for women over 40."
Amberen generated an estimated $65 million in sales between 2010 and 2013 alone, according to the FTC.
"Lunada marketed Amberen to women over 40 as 'clinically proven' to cause weight loss," Jessica Rich, director of the FTC's Bureau of Consumer Protection, said in a statement. "But their own studies didn't support those claims."
The agency suit alleges that a clinical trial conducted in 2001 did not focus on weight loss and that a later study found no significant different in weight loss between those using Amberen and those in a control group.
Also drawing fire was Lunada's promise that consumers could use Amberen for 30 days "risk-free." To get a refund, the FTC said, a consumer would have to first buy a three-month supply and then, at their own expense, ship back two unopened boxes within a month.
In a statement released on Wednesday, a Lunada spokesman defended the product and said the company is ready to fight the government in court.
"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," the statement said. "Lunada prefers instead to litigate this matter before an impartial judge."
The FTC has long warned consumers to be skeptical of over-the-counter weight-loss products. Supplements remain largely unregulated, with the FTC and U.S. Food and Drug Administration taking action on questionable product claims. Here's the FDA's database of supplements it considers potentially dangerous.