The Food and Drug Administration announced on Thursday that the regulatory agency is reclassifying sunlamp products and ultraviolet lamps, and they must also now come with a skin cancer warning.
Sunlamp products will now be classified as moderate-risk devices instead of low-risk and all products must come with a visible warning against people under 18 from using them.
Marketing must also carry warnings, contraindications and other information as well, including the warning: “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.” Before devices can be sold, manufacturers must obtain a premarket notification and get clearance from the FDA.
Dr. Jeffrey Shuren, FDA’s Center for Devices and Radiological Health director, said, “The FDA has taken an important step today to address the risk to public health from sunlamp products.” He added, “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 family history of skin cancer.”
Sunlamp products expose users to ultraviolet radiation and the American Academy of Dermatology says that these products can increase the chance of developing melanoma by 59 percent.
The FDA is following a recommendation made by a panel of experts who said there should be more regulation and advised against under-18s using these products.