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NAD Cosmetics, Anti-Aging, and Personal Care Digest
Advantice Health, LLC
Kerasal Fungal Nail Renewal
Case #6421 (October 2020)
NAD determined that Advantice Health, LLC (“Advantice”) failed to support the claim that its Kerasal
Fungal Nail Renewal product delivered visible results in two days. Competitor Arcadia Consumer
Healthcare (“Arcadia”) challenged claims made on Kerasal product packaging and in Internet and
television advertising. Advantice relied on an in-home use test (IHUT) to support the claim “VISIBLE
RESULTS START IN 2 DAYS” and other similar claims. A properly conducted consumer use survey
requires certain standards and controls to ensure that the responses are free from bias (e.g., blinding,
randomization), that there is a representative study population, and that there is proper validation of
the results. NAD had several concerns with the IHUT, including the population selected for the test and
screening questions. The screening questions included a product description that explicitly informs study
participants that the product produces visible results fast on nails damaged by fungus before they begin
the study, preconditioning them to see visible results, fast. Further, the IHUT was not blinded and had no
control group. Additionally, the study did not have dermatologists screen the study population for nail
fungus but relied upon self-reporting of nail fungus. For all of these reasons, NAD recommended that
Advantice discontinue its claims that its product delivers visible results in two days.
Advantice also failed to support the claim that its Kerasal Fungal Nail Renewal product was clinically
proven. Arcadia took issue with the Kerasal product packaging, which included the claims “Reduces
discoloration” and “Normalizes thickness” in proximity to the claim “clinically proven.” Clinically proven
claims are establishment claims that require highly reliable scientific testing that directly correlates with
the claims at issue. Advantice submitted four studies, including one test, Piraccini, on the product itself.
However, the Piraccini study lacked a control group and a lack of blinding. NAD has stated that “clinical”
means “controlled, consistent and reproducible conditions” pursuant to which NAD has repeatedly stated
the importance of blinding and a control. Advantice argued that there is a lower standard of substantiation
for products touted as improving the appearance of nails damaged by fungus. However, Advantice sets
its standard by claiming that the product is “clinically proven.” Advantice also contended that the study
results were supported by photographic analysis, and submitted some of the photographs to NAD as
confidential evidence, but it was not clear to NAD that the photographs were part of the study because
they are not mentioned in the published study, are not mentioned in the primary or secondary endpoints
of the study, and there is no statistical analysis of them. Because NAD concluded that the studies
submitted were not competent and reliable scientific evidence sucient to substantiate the “clinically
proven” claim, it recommended that Advantice discontinue claims that the product is “clinically proven.”
Advantice supported the claim that its Kerasal Fungal Nail Renewal product reduces discoloration.
“Reduces discoloration” is a qualified claim that suggests that some discoloration remains after the use
of the product. Advantice relied on three studies, one of which tested Kerasal itself, while the other two
tested similar products. There was a good fit between the evidence and the claim that Kerasal reduces
discoloration. In the testing, patients were asked to assess the dierence between what the color of the
nail should be and what it is, a subjective assessment. The data reported the percentage of patients who
saw an improvement and not a cure, and the claim “reduces discoloration” conveyed the message that a
patient can expect an improvement in discoloration, not a cure, and that some discoloration will remain.
Further, the patient-reported outcomes supplied as evidence are subjective, and “reduces discoloration,”
here, conveyed the message that the improvement was a subjective one that patients will see.
Advantice did not support the claim that its Kerasal Fungal Nail Renewal product normalizes thickness.
“Normalizes thickness” reasonably conveys the message that the thickness becomes normal after the use
of the product. Further, while discoloration is a perceived trait regarding deviance from the norm that is
arguably subjective, thickness is a trait that can be measured objectively in units of distance. Advantice
relied on three studies, one of which tested Kerasal itself, while the other two tested similar products. The
fit between the evidence and the claim that Kerasal normalizes thickness was not as good. “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. Further, thickness, while not expressly defined in
the case record, can be measured objectively in units of distance, but the data in the case record contains
no such measurements. The claim that the product “normalizes thickness” did not convey the message