Nail & Skin Disorders

FDA Regulates Antifungal Nail Product Claims

The new ruling is intended to standardize label claims for all OTC antifungal products, eliminate products that contain ingredients deemed unsafe or ineffective and prevent the sale of any antifungal products for the nails and scalp that are not FDA-approved.

On September 2, 1993, the Food and Drug Administration (FDA) released its long-anticipated final ruling on over-the-counter (OTC) antifungal products. The new ruling is intended to standardize label claims for all OTC antifungal products, eliminate products that contain ingredients deemed unsafe or ineffective and prevent the sale of any antifungal products for the nails and scalp that are not FDA-approved.

According to the final ruling, “Any claims or directions for using an OTC topical antifungal drug product on the scalp or on the nails should be eliminated from OTC drug products by March 2, 1994, regardless of whether further testing is undertaken to justify further use. Thereafter, any OTC drug product containing any topical antifungal active ingredient and labelled or intended for use on the scalp or on the nails will be considered not incompliance with FDA regulations and misbranded under section 502 of the Federal Food, Drug and Cosmetic Act.”

The FDA concluded that “there is no basis for the continued marketing of any OTC topical antifungal drug products with claims or directions for use on the scalp or the nails.”

After March 2, 1994, nail product manufacturers will not be allowed to sell any professional or retail products designed to eliminate, control, or prevent fungal infections of the nails, unless these products have been approved by the FDA. Nor may these products be imported into the United States and distributed for sale.

Since the ruling clearly states that products labelled or intended for use on the nails are considered “misbranded” manufacturers may not be able to simply re-label the products. The FDA is also formulating a final rule on antifungal active ingredients and may not allow them to be used at all in OTC nail product, even if the manufacturer makes no claims about the antifungal ingredients properties.

North Carolina Pledges to Keep Licensing Bill Alive

Although House Bill 997, which would establish esthetician licensing and increase education hours for nail technicians (among other things), was not voted on in the 1993 North Carolina legislative session. Mary Quaintance of the North Carolina State Board of Cosmetic Arts speculates that the bill will be voted on in the 1994 summer session. “We’ll keep trying until it passes,” says Quaintance.

House bill 997 would include artificial nail providers in the definition of manicurist, increase the course hours for manicurists to 300, and remove the licensing exemption for manicurists practicing outside “cosmetic art shops”(full-service salons that do hair.)

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