Clarion Brands, LLC recently received an earful from the National Advertising Division (“NAD”) about its marketing of the dietary supplement Lipo-Flavonoid Plus. Clarion had been marketing Lipo-Flavonoid Plus with advertising that the NAD found reasonably conveys the message that the supplement substantially reduces or eliminates tinnitus and the symptoms of Ménière’s disease—conditions that affect an individual’s hearing and can cause discomfort in the ears. NAD initiated the inquiry into Clarion’s advertising claims as part of its initiative to expand its review of advertising claims for dietary supplements, and ultimately found this message to be unsubstantiated and recommended that Clarion discontinue certain claims that convey this message.

Clarion presented various studies and articles spanning over five decades to attempt to support the efficacy of Lipo-Flavonoid in treating Ménière’s disease and/or tinnitus. This evidence fell on deaf ears: NAD expressed concerns about the reliability of some of the studies because they were not double-blind or placebo controlled, they did not define what would constitute a clinically relevant improvement in the test subjects’ symptoms, and their results were not statistically significant. NAD also found that the other articles and studies cited by Clarion demonstrate mixed opinions on the efficacy of Lipo-Flavonoid in treating Ménière’s disease and/or tinnitus in a clinically meaningful way. Based on these studies, NAD permitted Clarion to continue making the claim that “Lipo-Flavonoid Plus has been used and evaluated in clinical settings for over 50 years,” but recommended Clarion discontinue advertising, including use of customer testimonials, that reasonably conveys the message that the product substantially reduces or eliminates tinnitus and the symptoms of Ménière’s disease.

Clarion also advertised on the Lipo-Flavonoid product packaging that it is “#1 Ear Doctor Recommended,” and on the product website that it is the “#1 recommendation of doctors for relief of ringing in the ears* (Source: December 2014 survey)”. To support these claims, Clarion referred to the results of two independent surveys of ENTs. While NAD found the ringing endorsements of the first survey not sufficiently reliable due to a lack of information about the survey methodology, NAD lent an ear to the results of the second survey, which it commended for being independent, geographically representative, with a robust sample size, and blinded and randomized. Based on this second survey, NAD determined that the claim “#1 Ear Doctor Recommended” was supported. However, this second survey did not ask ENTs whether Lipo-Flavonoid Plus was doctor-recommended specifically because it substantially reduces or eliminates tinnitus and the symptoms of Ménière’s disease—the message NAD found was reasonably conveyed by the claim on the product website. NAD therefore also recommended that Clarion discontinue the reference to “for relief of ringing in the ears” in connection with the “#1 Ear Doctor Recommended” claim, or at least make clearer that the product is recommended as an adjunct therapy for tinnitus and Ménière’s disease.

Clarion intends to appeal NAD’s adverse findings to the NARB—stay tuned for further developments.