Last year, the Federal Trade Commission sued Lunada, the makers of the supplement Amberen, alleging that the company did not have the science to back up claims that Amberen was “clinically proven” to cause substantial weight loss, and to alleviate just about every symptom associated with menopause: hot flashes, night sweats, sleep problems, fatigue, and irritability. Now Lunada has agreed to stop making these claims to settle the complaint.

Radio ads for the supplement said Amberen is “the ONLY product on the market today clinically proven to cause sustained weight loss for women over forty,” and that it is “clinically shown to cause sustained weight loss in women over forty – with no big changes in lifestyle.”

However, footnotes on its advertising revealed that “weight loss was not clinically evaluated in Amberen clinical trials” and that the claims of weight loss were based solely on anecdotal reporting from “some women” who referenced “varying degrees of weight loss.”

The weight loss claims were based solely on a 2001 study done in Russia by the creators of the supplement. That study asked trial subjects — some of whom received a placebo — to write about their menopause-related symptoms in a journal for 21 days. Weight loss was not one of those symptoms and was not measured in any way.

Subsequent reviews of that study also noted that there was no statistical proof that Amberen has positive effect in treating hot flashes or insomnia, where were symptoms monitored in the diaries.

Then a 2012 independent study on Amberen — commissioned by Lunada — found that the average weight loss was only 1.48 pounds over the course of 12 weeks, statistically insignificant compared to the .28 pound average weight gain among the placebo group.

Yet the company continued to market the product as a proven weight loss supplement. Additionally, Lunada claimed a weight loss success rate of 92% and that 93% of women who tried Amberen through the company’s 30-day risk-free trial offer ended up purchasing it.

Speaking of which, those trials weren’t so risk-free, says the FTC, because the company failed to reimburse customers for the return shipping.

As part of the proposed settlement [PDF], Lunada is barred from claiming — without sufficient evidence to substantiate the claims — that any dietary supplement or other product causes weight loss, sustained weight loss, or loss of belly fat; boosts metabolism; relieves hot flashes, night sweats, and other specific symptoms of menopause; or cures, mitigates, or treats any disease.

The Amberen website now claims that there is new scientific research (which it does not make available, other than to name it) to bolster claims regarding hot flashes and other symptoms. While it doesn’t mention weight loss, it makes vague reference to physical changes.

On the website for the Russian medical school where the study was done, we could only find a mention of a 2014 call for test subjects.

The $40 million judgment against Lunada and its principals has been suspended — based on a purported inability to pay — in lieu of a $250,000 payment. If the defendants are later found to have misstated anything about their financial situations, they could face having to pay the full amount.

We attempted to contact Lunada regarding the new research and to find out what happened to all the money it earned from a decade of selling Amberen, but have thus far been unsuccessful.

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