Upholding a determination by the National Advertising Division, a panel of the National Advertising Review Board recommended that Clarion Brands, LLC modify or discontinue certain claims for a dietary supplement that stated or implied it could substantially reduce or eliminate tinnitus.

Clarion's ads for its Lipo-Flavonoid Plus claimed that the dietary supplement "can help provide tinnitus relief" and "Helps ease the ear ringing that characterizes tinnitus." The advertiser also relied on a consumer testimonial video called "Debby's Store of Hope," where a customer spoke about the ringing in her ears. Diagnosed with Meniere's disease (a disorder of the inner ear that causes vertigo, tinnitus, and hearing loss), Debby was told by her doctor that she would eventually go deaf as a result of the disease. But after a friend recommended Lipo-Flavonoid, she has had no tinnitus, vertigo, or hearing loss for two years. The video featured a disclaimer stating, "Individual results may vary."

After considering the advertising, the NAD recommended that the claims and the consumer testimonial be discontinued, as they reasonably conveyed a message that Lipo-Flavonoid can substantially reduce or eliminate tinnitus.

Clarion appealed.

The NARB panel agreed with the NAD, finding that the consumer testimonial "reasonably conveys a message that Lipo-Flavonoid Plus provides significant or complete relief from tinnitus and other symptoms of Meniere's Disease." It cited the Federal Trade Commission's Guides Concerning the Use of Endorsements and Testimonials in Advertising, which states that "consumer statements about their experience with a product will likely be interpreted as representing that the consumer's experience is representative of what consumers will generally achieve with the product." As for the disclaimer, the panel "does not believe that the … disclaimer is sufficient to change this message."

Clarion's efficacy claims for Lipo-Flavonoid met a similar fate. "[I]n the context of the advertising," the panel wrote, the advertising "also reasonably conveys the message that Lipo-Flavonoid Plus provides significant or complete relief from tinnitus." The advertiser offered a number of scientific studies, case reports, and medical articles in support of its claims. But the NARB panel noted that the studies most heavily relied upon by Clarion were not double-blinded, were not placebo-controlled, and were not subject to a statistical analysis.

"For health claims, the reasonable basis must be established by competent and reliable scientific evidence," the panel explained, noting its methodological concerns with Clarion's studies. "While the panel recognized that the FTC and [the Food and Drug Administration] have established a flexible standard for substantiation of dietary supplement claims, studies should use procedures that are generally accepted in the profession to yield accurate and reliable results. At the very least, [the] failure to use a placebo control group or to conduct a statistical analysis raises questions about the reliability of [the] findings."

After considering the totality of the evidence in the record, "the panel finds there is sufficient support for a claim that Lipo-Flavonoid Plus may provide relief for some consumers who suffer from tinnitus." Lacking sufficient support, Clarion's stronger claims should be discontinued.

"This decision does not preclude Clarion from truthfully advertising that Lipo-Flavonoid Plus may provide relief for some people who suffer from tinnitus," the panel added.

To read the NARB's press release about the decision, click here.

Why it matters: While the NARB recognized that the FTC and FDA have established a "flexible standard" for determining whether the competent and reliable scientific standard has been met in substantiating advertising claims for dietary supplements, the panel expressed concern that the studies relied upon by the advertiser had methodological problems because they were not double-blinded, placebo-controlled, or subject to a statistical analysis. "[S]tudies should use procedures that are generally accepted in the profession to yield accurate and reliable results," the panel wrote, noting that both of the federal agencies "generally recognize that the standard may be met by tests, analyses, research, studies or other evidence based on the expertise of professionals using procedures generally accepted in the profession to yield accurate and reliable results."