New York, NY – Aug.13,  2012 – The National Advertising Division has recommended that Interceuticals, Inc., discontinue a wide range of advertising claims for the company’s BetterWOMAN dietary supplement, which is promoted as improving urinary control.

NAD is an investigative unit of the advertising industry system of self-regulation and administered by the Council of Better Business Bureaus.

As part of its ongoing monitoring program and in conjunction with an initiative with the Council for Responsible Nutrition to expand the  review of advertising claims made for dietary supplements, NAD requested substantiation for claims made in print, broadcast and Internet advertising, including:
• “Clinically Tested Chinese Herbal Supplement”
• “Reduced Urinary Frequency”
• “Reduced Urine Leakage”
• “Sleep Better Through a Night”
• “Improves Urinary Control”

According to the advertiser, BetterWOMAN is an all-natural supplement containing a proprietary blend of 20 Chinese herbs specifically formulated to help women improve urinary control.

As substantiation for its claims, the advertiser relied on the results of one study, the BetterWOMAN Study, published in “Menopause,” the Journal of the North American Menopause Society in 2003.

NAD noted in its decision that the BetterWOMAN Study “was not a randomized, controlled trial, nor did it have many of the controls used in reliable scientific research.  It was not placebo-controlled, and therefore could not distinguish between the positive results attributable to BetterWOMAN supplements and any placebo effect.  The BetterWOMAN Study did not use objective measures to evaluate participants’ symptoms.  Instead participants completed a self-evaluation questionnaire before beginning treatment and after a 60-day treatment period.  The self-evaluation questionnaire asked participants to score symptoms subjectively using a scoring system with numbers 0 through 4 to describe frequency of symptoms increasing from never, rarely, occasionally, frequently, and always.

NAD noted additional concerns regarding the study’s design, including the small sample size: There were 45 participants in an initial self-assessment questionnaire, and only 38 responses to the second self-assessment questionnaire after the 60-day treatment period – a less than 90% response.   Of the 45 total participants, fewer than half qualified to be evaluated for the product’s effect on their urinary incontinence symptoms.

Following its review of the evidence in the record, NAD determined that the advertiser’s evidence did not support the claims at issue. Further, NAD noted testimonials and letters from customers may not be used to support claims that are not adequately supported by scientific evidence.

NAD recommended the advertiser discontinue all claims at issue.

Although Interceuticals took issue with NAD’s decision, the company said it would take NAD’s recommendations into consideration “in modifying future advertising for the BetterWOMAN dietary supplement product.”