The National Advertising Division has recommended Lunada Biomedical modify or discontinue a certain range of advertising claims for Amberen, a dietary supplement promoted to menopausal women. NAD further noted that the company took necessary and appropriate steps in voluntarily discontinuing certain claims and testimonials. NAD 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 industry’s 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 NAD’s initiative with the Council for Responsible Nutrition designed to expand review of advertising claims for dietary supplements, NAD requested the advertiser provide substantiation for claims made in print and Internet advertising.
Challenged claims included:
· “Hot flashes, night sweats, irritability, mood swings, inability to concentrate, sleeplessness, lack of energy, and, yes, decreased libido. Amberen provides an effective all-in-one solution for common symptoms of menopause. Most women begin experiencing relief in just a few days.”
· “With Amberen you take just 2 capsules a day for 90 days. The capsules are very small and easy to swallow. Relief is fast and lasting. On average, you can expect the effects of Amberen to last for up to 3 months after you’ve completed your course.”
· “Amberen has been clinically tested and extensively studied for over 30 years. Ingredients in Amberen are on FDA’s Generally Recognized as Safe (GRAS) list.”
· “Amberen has the unique ability to rejuvenate your hypothalamus—the master gland that controls your body’s hormone production. This, in turn, promotes balanced production and circulation of hormones throughout your body, supporting the optimal function of your vital organs. Energy metabolism is soon restored. Suddenly you feel younger! And it’s completely natural; Amberen contains no artificial hormones or harmful ingredients, and is clinically proven to rejuvenate your natural neuroendocrine mechanisms. This means better hormonal balance. And better hormonal balance means less symptoms.”
· “Our 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. The rejuvenating effects are natural, healthy and profound.”
· “We are the only company in the world that has the technology to produce “smart molecules” of succinates and fumarates (key ingredients in Amberen) with specific shapes that are bio-identical to the human body. Which means our compounds are shaped for optimal performance.”
CRN also challenged testimonials posted on the advertiser’s website, as well as the advertiser’s use of the logo of the U.S. Food and Drug Administration (FDA) on its website.
NAD noted in its decision that the advertiser had voluntarily discontinued certain claims, including claims that relief is “complete,” “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 advertiser’s discontinuation of these claims was necessary and appropriate.
NAD also noted Lunada’s decision to discontinue the challenged testimonials, and to cease making its claim that the ingredients in Amberen are on FDA’s Generally Recognized as Safe (GRAS) list. NAD determined that the discontinuation of these claims was necessary and appropriate.
Lunada’s 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 study’s 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 study’s results and the advertising at issue. NAD recommended that 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 advertiser’s evidence showed Amberen could “improve” or lessen various menopausal symptoms, the improvements were not shown to be dramatic or cure-like. NAD recommended that 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 3 months.”
NAD was satisfied that Lunada’s 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 advertiser’s statement, said the company “enthusiastically 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 ERSP’s and NAD’s recommendations in regards to all current and future advertising for Amberen.”