National Advertising Division Recommends Dr. Luke Healthcare Discontinue Treatment Claims for its Fungal Nail Renewal Product

New York, NY – July 24, 2024 – In a challenge brought by Advantice Health, BBB National Programs’ National Advertising Division recommended that Dr. Luke Healthcare discontinue certain claims for Dr. Luke’s Fungal Nail Renewal product, including health-related claims that the product treats nail fungus, natural claims, and claims that a doctor recommends the product or that it treats a medical condition.

The challenged claims, which appeared on various channels including Amazon, Walmart, and Dr. Luke’s website, position Fungal Nail Renewal as an effective treatment for nail fungus (onychomycosis).  

Treatment Claims

The National Advertising Division (NAD) determined that Dr. Luke’s claims that its product treats nail fungus are not supported by competent and reliable scientific evidence.

NAD determined that the studies on products with acetic acid were not a good fit for the challenged claims because the composition of the products tested, the dosage, and the mode of administration differed from the Dr. Luke product. 

NAD also found that the Food and Drug Administration’s Over the Counter (OTC) monograph regarding 1% Tolnaftate does not support nail fungus treatment claims. Further, NAD concluded that the evidence provided by Dr. Luke regarding the efficacy of the Chinese herb ingredients and the benefit they provide did not support the challenged treatment claims.

NAD recommended that Dr. Luke discontinue the following claims: 

• "Extra Strength Toenail Fungus Treatment for Toenail or Fingernail"
• "Repair Onychomycosis deeply"
• "Formulated to effectively treat Nail Damage. Nail Fungus. Based on Chinese Traditional Treatment Research"
• “Doctor Recommended”
• “Dr. Luke’s Toenail Fungus Treatment cures nail fungus”
• “Kills fungus, stops itching and burning, restores your skin and toe's health”
• "Repair & Renew – It can radically repair damaged nails, such as nail discoloration, nail thickening, nail splitting, nail crumbling"
• "Extra strong formula, renew damaged nail faster "
• “It also protects from further damage”

Natural Claims

The National Advertising Division (NAD) determined that Dr. Luke’s "natural formula" claims reasonably convey the message that the product is formulated without artificial ingredients and treats nail fungus through natural ingredients. As the active ingredient in Fungal Nail Renewal is a synthetic compound, NAD found the natural claims to be unsupported and recommended they be discontinued.   

Doctor Recommended/Treatment Claims

The National Advertising Division (NAD) found that Dr. Luke’s imagery of a man in a white coat with a stethoscope conveys the messages that a doctor recommends the product or that the product treats a medical condition. Although Dr. Luke voluntarily discontinued its doctor-recommended claims, in the absence of supporting evidence, NAD recommended that Dr. Luke modify its advertising to avoid conveying these messages.

During the proceeding, Dr. Luke permanently discontinued a number of claims. Therefore, NAD did not review these claims on their merits and will treat the claims, for compliance purposes, as though NAD recommended they be discontinued.

In its advertiser statement, Dr. Luke stated that although it disagrees with the decision, it will “comply with NAD’s recommendations.”

All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive. Per NAD/NARB procedures, this release shall not be used for advertising or promotional purposes.