FDA Seeks Supporting Data

by Staff Writer | July 16, 2015

Unless the Food and Drug Administration (FDA) receives manufacturer-supplied data demonstrating  that antifungal nail treatments works effectively on fungal infections of the nails, proposed regulations could be approved that would force manufacturers to reformulate or relabel the antifungal treatments.

Antifungal nail treatments that claim to prevent, treat, or cure a condition are considered over-the-counter drugs by the FDA. OTC drugs must be in compliance with the FDA’s OTC drug monograph, which is a set of regulations governing the sale of non-prescription drugs.

Currently, manufacturers don’t need FDA approval to sell antifungal treatments, but new regulations are in the works. According to Debbie Lumpkins, a microbiologist with the FDA Office of OTC Drug Evaluation, tentative final regulations were published in the Federal Register on December 12, 1989. In these proposed regulations, antifungal nail treatments are not recognized by the FDA as safe and effective.

According to Lumpkins, the proposed regulations include a recommendation by the panel that would require manufacturers to print a disclaimer in the directions that says, “This product is not effective on the scalp or nails.”

Lumpkins emphasizes that the regulations are proposed, not final. Manufacturers are welcome to submit data to the FDA demonstrating that their products effectively treat, cure, or prevent fungal infections of the nails. Currently, only one manufacturer has submitted data. Lumpkins says the data did not satisfactorily demonstrate that the antifungal ingredient, in conjunction with the product’s other ingredients, was effective against fungal infections of the nails. There is no deadline for submitting data, although the proposed regulations could be made final at any time.


Illinois nail technicians have the opportunity to put in their two cents about what Illinois nail Technician regulations should contain. According to Jean Courtney, rules coordinator, the Illinois Department of Professional Regulation has issued what she calls a “very rough draft” of nail technician rules and regulations.

Courtney says the proposed regulations were based on existing regulations for cosmetologists and estheticians so that association members can see what is already in place. She says the department recognizes that some of the proposed regulations are not suited to the nail industry and emphasizes that the proposal is only a rough draft to give the department a starting point for discussion with schools and associations.

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