June 6, 2012
NEW YORKThe National Advertising Division (NAD) recommended that Lunada Biomedical modify or discontinue a certain range of advertising claims for Amberen," a dietary supplement promoted to menopausal women. NAD further noted the company took necessary and appropriate steps in voluntarily discontinuing certain claims and testimonials, andNAD determined the company could support claims related to its proprietary technology, as well as the claim that Amberen could lessen various symptoms of menopause.
NAD is an investigative unit of the advertising industrys system of self-regulation and administered by the Council of Better Business Bureaus. As a part of its ongoing monitoring program and in conjunction with NADs initiative with the Council for Responsible Nutrition (CRN) designed to expand review of advertising claims for dietary supplements, NAD requested the advertiser provide substantiation for claims made in print and Internet advertising.
CRN also challenged testimonials posted on the advertisers website, as well as the advertisers use of FDA's logo on its website.
NAD noted in its decision that the advertiser had voluntarily discontinued certain claims, including claims that relief is complete" and fast," that Amberen is an all in one solution," and that Amberen can achieve balanced production and circulation of hormones throughout your body" and support the optimal function of your vital organs. Energy metabolism is soon restored. Suddenly you feel younger!" NAD determined that the advertisers discontinuation of these claims was necessary and appropriate.
NAD also noted Lunadas decision to discontinue the challenged testimonials, and to cease making its claim that the ingredients in Amberen are on FDAs GRAS (Generally Recognized as Safe) list. NAD determined the discontinuation of these claims was necessary and appropriate.
Lunadas primary claims support was a four-week, randomized, double blind, placebo-controlled study. The study was conducted on both mice and humans. NAD was satisfied that the fundamentals of the studys methodology were sufficiently reliable, and that the results tended to show that Amberen reduced many menopausal symptoms.
However, NAD had several concerns about the disconnect between the studys results and the advertising at issue. NAD recommended Lunada discontinue claims that Amberen relieves night sweats," moodiness" and inability to concentrate." Further, NAD cautioned the advertiser against suggesting or implying that the product provides complete or near-complete relief of symptoms.
While the advertisers evidence showed Amberen could improve" or lessen various menopausal symptoms, the improvements were not shown to be dramatic or cure-like. NAD recommended Lunada exercise caution and moderation in its advertising claims. Further, NAD recommended that the advertiser discontinue its claim that Amberen will last for up to three months."
NAD was satisfied that Lunadas large body of evidence supports its claim that Amberen has been clinically tested and extensively studied for over 30 years."
NAD was also satisfied with the evidence that was offered in support of the claim that its proprietary technology produces perfectly shaped smart molecules that your body can readily recognize and use. Inside your cells, these remarkable compounds rejuvenate mitochondria and rebalance hormone levels."
Lunada, in its advertisers statement, said the company supports self-regulatory process and therefore voluntarily participated in both, the Electronic Retailing Self-Regulation Program (ERSP) review, as well as the lengthier and more exhaustive review by NAD. Lunada will continue to consider ERSPs and NADs recommendations in regards to all current and future advertising for Amberen."
In 2011, ConsumerLab.com reported that the labeling of natural products that address hot flashes and other menopausal symptoms may be confusing to consumers.
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