FDA to Require Warnings on Sunlamp Products

The FDA 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.

“The FDA has taken an important step today to address the risk to public health from sunlamp products,” said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. “Repeated UV exposure from sunlamp products poses a risk of skin cancer for all users—but the highest risk for skin cancer is in young persons under the age of 18 and people with a family history of skin cancer.”

As part of today's action, manufacturers will now have to submit a premarket notification (also called a “510(k)”) to the FDA – and obtain FDA clearance – prior to marketing these devices, which until now were exempt from premarket review. Manufacturers also will now have to show that their products meet certain performance testing requirements and address certain product design characteristics, and will have to include certain warnings and contraindications on sunlamp products and in certain marketing materials for sunlamp products and UV lamps that present consumers with clear information on the risks of use.

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's 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.

Today's 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.

In response, the American Academy of Dermatology Association (AADA) announced that it is extremely pleased with the FDA's decision.

“Restricting teens' access to indoor tanning is critical to preventing skin cancer. As medical doctors who diagnose and treat skin cancer, dermatologists are committed to reducing its incidence and saving lives,” said board-certified dermatologist Brett M. Coldiron, MD, FAAD, president of the AADA. “Therefore, we will continue to communicate to the FDA the need for stricter regulations on the use and sale of indoor tanning devices for minors under the age of 18.”

In 2010, the FDA convened an Advisory Panel hearing to examine the current classification and regulations of tanning beds. Representatives from the AADA, leading dermatologists, researchers and patients testified before the panel highlighting the risks associated with indoor tanning and the need to protect the public from these dangers. Following the hearing, the AADA has been working closely with the FDA, and both state and federal legislatures to protect minors from the dangers of indoor tanning.

“The AADA has been working aggressively with the FDA, congressional leaders and policy makers to help make today's reclassification of indoor tanning devices and the placement of additional restrictions on indoor tanning possible. We applaud the FDA for taking this important first step,” said Dr. Coldiron. “However, we recognize that there is still more work to be done to protect the public from these dangerous devices.”