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FDA Requires Black Box Warning on Sunlamp Products due to Risk for Skin Cancer

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Washington, DC: The US Food and Drug Administration (FDA) has issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices.

The order also requires that sunlamp products carry a visible black-box warning on the device that explicitly states that the sunlamp product should not be used on persons under the age of 18 years. In addition, certain marketing materials for sunlamp products and UV lamps must include additional and specific warning statements and contraindications.

Sunlamp products, which include tanning beds and tanning booths, emit UV radiation that may cause skin cancer. According to the American Academy of Dermatology, people who have been exposed to UV radiation from indoor tanning experience a 59 percent increase in the risk of melanoma, the deadliest type of skin cancer. This risk increases each time they use a sunlamp product.

In addition to a warning placed on the sunlamp product advising that the product not be used on children under 18, certain marketing materials promoting sunlamp products and UV lamps must carry additional warnings and contraindications, including "Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer."

The FDA' final order for the reclassification of sunlamp products and UV lamps follows the recommendations from a panel meeting of outside experts convened in March 2010. This panel of outside experts evaluated the risks of sunlamp products, and recommended that FDA increase regulation of these devices and certain members of the panel recommended that children and teenagers not use the products.

The FDA' action follows a public comment period after the release of the proposed order in May 2013. The FDA received comments from industry, patient groups and professional societies, which are addressed in the final order.

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