The makers of a dietary supplement touted to help users lose weight and aid with the symptoms of menopause settled with the Federal Trade Commission over charges that their claims were unsubstantiated and violated Section 5 of the Federal Trade Commission Act.

According to the agency, Lunada Biomedical and three principals promised that Amberen was "clinically proven" to cause substantial and sustained weight loss, loss of belly fat, and an increase in metabolism for women over 40 who were perimenopausal or menopausal. They also asserted that Amberen provided relief from symptoms such as hot flashes, night sweats, fatigue, and irritability.

The defendants marketed the dietary supplement commercials via websites, e-mails, and radio and television commercials with female announcers making claims such as "Amberen restores hormonal balance naturally, so the weight can just fall right off. Even that stubborn belly fat," and that Amberen is "the ONLY product on the market today clinically proven to cause substantial weight loss for women over 40." Almost $65 million worth of Amberen was sold nationwide between 2010 and 2013, the FTC said, with the defendants charging up to $150 for a three-month supply.

However, according to the complaint, the only science backing the claims was a 2001 Russian clinical trial conducted by the scientists who developed the Amberen formula, who used a double dose of the dietary supplement and did not specifically measure weight loss. A later clinical study failed to demonstrate a statistically significant difference in weight loss between the test and control groups, the agency added.

The defendants also neglected to disclose their relationship with consumer endorsers (including a registered nurse who blogged about the benefits of the supplement, but was paid for her work). They also falsely promised customer satisfaction with "success rates" of nearly 93 percent, and offered a "risk-free" 30-day trial where they charged consumers up front, provided them with a 90-day supply, and instructed them to return two unopened boxes at their own expense within a certain time period to receive a refund for the 30 days.

To settle the charges, the defendants agreed to a consent order in California federal court with a host of advertising prohibitions. Pursuant to the deal, the defendants may not claim that any dietary supplement, food, or drug 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, unless they have human clinical testing that meets certain requirements and is sufficient to substantiate the truth of the claims.

In addition, the order prohibits defendants from making any misleading or unsubstantiated claims about the health benefits or efficacy of any dietary supplement, food, or drug and bans misrepresentations about the results of any product test. Further, the defendants may not misrepresent any material fact about the product or any material terms and conditions of any offer, or fail to disclose any material connections—financial relationships, for example—they have with endorsers.

A $40 million judgment will be suspended upon a payment of $250,000.

To read the complaint and the stipulated final order in FTC v. Lunada Biomedical, click here.

Why it matters: This case serves as a reminder that the FTC will closely scrutinize weight loss and health claims. Furthermore, once the FTC begins investigating false advertising cases, the scope of the investigation can expand. In this case, the FTC amended its complaint to add two additional allegations: (1) that the advertisers failed to disclose material connections with consumer endorsers, and (2) that the advertisers falsely claimed to offer a "Risk Free Clinical Trial" for 30 days while also requiring consumers, at their own expense, to return unopened boxes of Amberen within 30 days of placing their orders.