New York, NY – February 25, 2012 – The Electronic Retailing Self-Regulation Program (ERSP) recommended that Lunada Biomedical discontinue weight-loss and other claims made for Amberen, a dietary supplement marketed to menopausal women. ERSP found, however, the company could support claims related to hot flashes, irritability, sleeplessness, and “low libido.”

ERSP is an investigative unit of the advertising industry’s system of self-regulation and is administered by the Council of Better Business Bureaus. The marketer’s advertising came to the attention of ERSP pursuant to an anonymous competitive challenge.

Certain advertising claims for Amberen were reviewed by ERSP in 2010 and by the National Advertising Division (NAD) in 2012. In this case, ERSP examined more recent weight-loss claims made primarily through testimonials, including:

• “If you want to finally lose weight – including that stubborn belly fat – without additional exercise or difficult diets – there’s no alternative to Amberen.”
• “I lost 12 pounds!”; “I lost 7 pounds!”; and “I lost 9 pounds!”

Lunada provided ERSP with preliminary data from a recent clinical study, but did not provide ERSP with raw data that would allow ERSP to evaluate the statistical significance and reliability of the study. Given the omission of raw data, comprehensive findings, and details about the testing protocol, ERSP recommended that the marketer discontinue its use of weight-loss claims.

During the course of ERSP’s inquiry, Lunada asserted that it had voluntarily discontinued all of the consumer testimonials and voluntarily modified the claim that “Amberen is the only product clinically proven to promote weight loss during menopause without additional exercise or restrictive dieting.”

ERSP determined that certain claims, including the claim that “Amberen contains patented smart molecules that support the body’s hormonal function. These breakthrough ingredients are available only from Lunada” were consistent with previous self-regulatory decisions. ERSP further found that the advertiser provided adequate support for claims regarding hot flashes, irritability, sleeplessness, and “low libido.”

However, ERSP also determined that claims that “Amberen… balances your hormones,” “Amberen balances hormones naturally” and that Amberen relieves “night sweats,” and “moodiness” were inconsistent with previous self-regulatory decisions. ERSP recommended the advertiser modify or discontinue such claims.

ERSP recommended the marketer discontinue the claim that the “leading cause of weight gain in women over 40 is hormonal imbalance.” Further, ERSP recommended that the marketer modify its “guarantee” claim by expressly stating that the guarantee is a “money-back” guarantee.

The company, in its marketer’s statement, said “Lunada is pleased by ERSP’s determination that Amberen’s core performance claims regarding most common menopausal symptoms … are adequately substantiated. Out of deference to the forum and in the spirit of cooperation, future advertising will take into consideration ERSP recommendations.”