FDA Requires Black Box Warning on Tanning Beds Nation-Wide
In order to inform and protect consumers from the risks of sunlamp products such as tanning beds, the FDA is changing the classification and requiring a black box warning to be clearly visible on each indoor tanning device. The warning will emphasize the heighten risk for those younger than 18 or for people with a family history of skin cancer, and include language advising regular skin cancer evaluations for persons repeatedly exposed to UV radiation.
Some states have limited or banned tanning bed use for individuals under the age of 18 and it is hoped that the warning will not only inform consumers but also encourage additional states to revisit their tanning salon legislation.
Moving tanning beds from a Class I (low risk) to a Class II (moderate risk) devices affects the sunlamp production level as well. Products will now have to undergo reviews from the FDA before they are places on the market to make sure that they comply with the requirements such as timers and restricted UV-emitting levels. Manufacturers are also required to provide skin cancer warnings on advertising materials such as pamphlets or web pages.
In their report, the FDA cited research linking tanning bed use to a 59% risk increase for melanoma, the deadliest form of skin cancer. The risk increases to 75% for consumers under the age of 18, making restrictions and label warnings for this population essential.