New York, NY - The National Advertising Division of the Council of Better Business Bureaus has recommended that Natrol, Inc., which distributes "Promensil," a dietary supplement marketed for the relief of the symptoms of menopause, modify or discontinue certain claims for the supplement. NAD did find that the advertiser had provided adequate support for certain claims.
NAD, the advertising industry’s self-regulatory forum, has expanded its review of dietary supplements, pursuant to a series of grants from the Council for Responsible Nutrition. NAD inquired about print, Internet and labeling advertising claims for Promensil.
The print advertisement featured the following claim:
"Why Promensil ... 22 clinical studies can’t be wrong"
The body copy then states:
"Promensil provides more than relief from hot flashes! Promensil is a natural alternative for menopause that is clinically proven to safely relieve hot flashes, night sweats, sleep disturbances and mood swings while promoting breast health, heart health and emotional well-being."
"Promensil tablets are standardized to contain 40mg of isoflavones extracted from red clover, one of the richest natural sources of isoflavones, in a unique ratio to maximize its effectiveness.
"If you are experiencing menopause symptoms, don’t suffer any longer, get Promensil today and get back in control of your days and your nights."
In addition, the label includes a burst stating:
"Clinically Proven & Doctor Recommended."
The Website www.Promensil.com included many similar claims.
At the outset of the NAD inquiry, Natrol explained that Promensil is a brand of dietary supplement for the relief of menopausal symptoms. The supplement contains an extract of red clover, standardized to provide four naturally occurring isoflavones, biochanin A, formononetin, genistein and daidzein.
Following a review of each of the 22 cited studies, NAD found that while there is significant research that Promensil may provide certain benefits for menopausal women, the challenged advertising overstates the results of such research.
Specifically, NAD determined that there was insufficient evidence to support the message conveyed by the advertiser’s claim that "22 clinical studies can’t be wrong." NAD determined, as well, that because of conflicting efficacy research, as well as deficiencies in many of the studies, the evidence was not sufficiently reliable to support the advertiser’s unqualified "clinically proven" claims and recommended that such claims be discontinued or modified.
NAD further recommended that the advertiser’s "Doctor Recommended" claim be modified to clearly and conspicuously disclose that the doctors surveyed were Australian and Canadian.
With respect to claims concerning hot flashes, NAD found that, based on the current research, the advertiser can make qualified claims that more accurately reflect the current state of the science, i.e., that Promensil may help reduce the frequency and/or the severity of hot flashes.
NAD found that Natrol provided a reasonable basis to make certain limited claims that Promensil can help relieve the frequency and/or severity of hot flashes, increase testosterone which may alleviate certain mood swings, promote breast health, promote heart health, and promote emotional well-being.
NAD found also the "uniqueness" claim was adequately supported by the relevant patents and the research.
The company said in its advertiser’s statement that it would modify its advertising to conform to NAD’s findings.
"Natrol, Inc. thanks the NAD for its consideration and review of the evidence submitted to it by Natrol. Although Natrol respectfully disagrees with the decision reached by the NAD, it voluntarily accepts the NAD’s recommendations and suggestions on the claims in question," the company said.
NAD's inquiry was conducted under NAD/CARU/NARB Procedures for the Voluntary Self-Regulation of National Advertising. Details of the initial inquiry, NAD's decision, and the advertiser's response will be included in the next NAD Case Report.