The BBB National Programs, National Advertising Division (NAD) determined that multiple claims made by Dr. Luke Healthcare about its antifungal nail treatment, Dr. Luke’s Fungal Nail Renewal, must be discontinued. The decision underscores the importance of proper claim substantiation and shows how consumer survey evidence could support or challenge advertising representations.
Active Ingredient Claims
Dr. Luke Healthcare manufactures Dr. Luke’s Fungal Nail Renewal, a topical product marketed to treat and cure nail fungus. The product contains tolnaftate, an over-the-counter antifungal ingredient, as well as four Chinese herbal ingredients and acetic acid, a compound similar to vinegar. It is sold through Walmart, Amazon, and Dr. Luke’s website.
Advantice Health, manufacturer of Emitrix, a competing antifungal ointment, challenged several of Dr. Luke Healthcare’s claims. These included representations that the product was natural, that its active ingredient effectively treats nail fungus, that it cures and repairs the condition, and that it repairs nails more deeply than competing products. Advantice also challenged implied claims, based on packaging and messaging, that the product was doctor-recommended.
The NAD Decision on Curable Claims
The NAD concluded that the studies Dr. Luke Healthcare submitted did not substantiate the challenged claims because of differences in composition, dosage, and method of administration between the studies and the marketed product. They also found that studies submitted on tolnaftate and the Chinese herbal ingredients did not support the product’s advertised antifungal efficacy.
The NAD recommended that Dr. Luke Healthcare discontinue claims, including:
“Extra Strength Toenail Fungus Treatment for Toenail or Fingernail”
- “Repair Onychomycosis deeply.”
- “Formulated to treat Nail Damage effectively. 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 toes’ health.”
- “Repair & Renew – It can radically repair damaged nails, such as nail discoloration, nail thickening, nail splitting, and nail crumbling.”
- “Extra strong formula, repairs damaged nails faster.”
- “It also protects from further damage.”
NAD Rules and Claim Substantiation Research
Dr. Luke Healthcare voluntarily discontinued a number of its advertising claims during the proceeding. Namely, it discontinued those claims implying doctor endorsement by featuring an image of a man in a white coat with a stethoscope, along with text suggesting that doctors recommend the product for treating nail fungus. Because the company did not provide evidence to substantiate that claim, the NAD recommended it be discontinued.
They also recommended that, given the evidence that the active ingredient tolnaftate is a synthetic compound, Dr. Luke Healthcare remove all “natural” claims from its advertising and packaging.
Claims on product packaging, digital platforms, or social media must be substantiated with reliable evidence, or risk false advertising allegations or costly regulatory challenges. Had this challenge focused on consumer perception rather than scientific evidence, survey research could have been used to assess how consumers perceived the product and its advertising.
Survey Evidence and Advertising Compliance
Consumer surveys provide courts and regulators with evidence of how audiences interpret product messaging. Reliable survey design and execution help distinguish between consumer interpretation and misleading implication, before claims are brought under scrutiny. IMS Legal Strategies conducts claim substantiation and litigation survey research to support advertisers, regulators, and legal teams.
