NAD Finds Kerasal Fungal Nail Discoloration Reduction Claim Supported, Recommends Discontinuation of Several Challenged Claims; Advertiser to Appeal
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New York, NY – November 4, 2020 – The National Advertising Division (NAD) of BBB National Programs determined that Advantice Health, LLC (Advantice) provided a reasonable basis for the claim that its Kerasal Fungal Nail Renewal product “reduces discoloration.” However, NAD recommended that the advertiser discontinue claims that its product:
- Delivers visible results in two days
- Is “clinically proven”
- Normalizes thickness (or modify the claim to better fit the evidence)
- Is “new and improved” (or modify its claim to avoid conveying the message that its product is “new & improved”)
NAD further recommended that Advantice discontinue or modify certain challenged product demonstrations.
This challenge involved claims for the advertiser’s OTC product, which is touted as improving the appearance of nails damaged by nail fungus. The claims at issue, which appeared on the advertiser’s product packaging and in internet and television advertising, were challenged by Arcadia Consumer Healthcare.
NAD recommended that the advertiser discontinue its claims that Kersasal delivers visible results in two days (“Starts improving Nail Appearance in Just 2 Days” and “Visible Results Start in 2 Days”) because it had several concerns about the methodology of the in-home use test (IHUT) relied on by the advertiser as support for these claims. NAD’s concerns about Advantice’s IHUT included, for example, potential bias of the study population as it was exposed to the product concept before the performance test, as well as lack of blinding and control group.
NAD also recommended that the advertiser discontinue claims that Kerasal is “clinically proven.” In support of this claim, the advertiser submitted four studies, including one on the product itself. However, NAD concluded, for various reasons, that the studies were not competent and reliable scientific evidence sufficient to substantiate the “clinically proven” claim.
The challenger also took issue with express claims that Kerasal “reduces discoloration” and “normalizes thickness,” which NAD proceeded to evaluate under the “reasonable basis” standard. In support of these claims, the advertiser relied on three studies in which patients were asked to assess the difference between what the color of the nail should be and what it is, a subjective assessment. NAD determined that there was a good fit between the evidence provided by the advertiser and the claim that Kerasal reduces discoloration which conveys the message that the improvement is a subjective one that patients will see. However, NAD noted that “normalizes” reasonably conveys a message of cure, not just improvement, while the data shows that panelists reported improvements, not that nail thickness returned to normal—and that thickness can be measured but only subjective data was supplied. Therefore, NAD recommended that Advantice discontinue its claim that its product normalizes thickness, or modify the claim to better fit the evidence.
NAD also considered “before” and “after” product demonstrations which show a toe progressing from damaged to near normal, including website photos labeled “Clinical Study Images” that show a big toe at the following times: “Before,” “Week 1,” “Week 4,” and “Week 8.” Because NAD concluded that the advertiser did not substantiate its “clinically proven” claim, NAD recommended that it modify its advertising to avoid conveying the message reasonably conveyed by these photographs – i.e., that clinical studies show that users can generally expect to achieve healthy-looking nails after eight weeks of treatment. In addition, NAD recommended that the challenged demonstration in a television advertisement be discontinued or modified to demonstrate the results that consumers can typically expect.
Finally, in support of the challenged claim “New* & Improved” “*See directions on back” and, in the television advertisement, “new & improved dosing directions,” NAD noted that the claim as it appears on product packaging could reasonably convey the message to consumers that something intrinsic to the product is different. However, Advantice explained that although the ingredients have not changed, the directions for use have changed from once per day to twice per day, and thus, the new dosing instructions make it new and improved. Therefore, NAD recommended that the advertiser discontinue the claim that its product is “new and improved” or modify it to avoid conveying the message that the product is “new & improved” (e.g., “new & improved dosing directions”).
In its advertiser’s statement, Advantice stated that it will appeal all aspects of NAD’s decision, except for the finding as to “New & Improved.”
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About the National Advertising Division: The National Advertising Division (NAD), a division of BBB National Programs, provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and leveling the playing field for business.
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