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. Using sunlamp products such as tanning beds or tanning booths increases the risk of skin damage, skin cancer and eye injury, according to the FDA and numerous other health organizations. A particularly dangerous result is melanoma, the deadliest type of skin cancer. According to the American Academy of Dermatology and the World Health Organization, 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.
Despite these risks, according to the American Cancer Society (ACS), thousands of Americans will opt for an indoor tan. The ACS estimates that nearly 13,000 people die each year from skin cancers—approximately 9,700 of which are from melanoma. The ACS predicts that in 2014, melanoma will account for 76,100 cases of skin cancer.
“There is increasing evidence that tanning in childhood to early adult life increases the risk of skin cancer, including melanoma,” says FDA dermatologist Markham Luke, M.D., Ph.D. In fact, according to an overview of studies published in the journal Pediatrics, melanoma is the second most common cancer in women in their 20s and the third most common cancer in men in their 20s in the U.S. Luke adds that many experts believe that at least one reason is the increased use of sunlamp products by U.S. teenagers and young adults.
The overview in journal Pediatrics suggests that doses of UV radiation emitted by high pressure sunlamp products may be up to 10 to 15 times higher than that of the midday sun, an intensity not found in nature. UV-A radiation penetrates to the deeper layers of the skin and is often associated with allergic reactions, such as a rash. This is not to say that outdoor tanning is safe. In fact, the World Health Organization has classified all UV radiation as a carcinogenic (cancer causing).
“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 this 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.
Certain practices involving sunlamp products are especially dangerous. These include:
- failing to wear appropriate protective eye wear, such as goggles—this can lead to short- and long-term eye injury;
- starting with long exposures (close to the maximum time for the specific sunlamp product), which can lead to burning (because sunburn takes 6 to 48 hours to develop, you may not realize your skin is burned until it’s too late);
- failing to follow manufacturer-recommended exposure times on the label for your skin type (some skin types should not tan with UV radiation at all, for example, those with skin that burns easily and doesn’t readily tan); and
- tanning while using certain medications or cosmetics that may make you more sensitive to UV rays. Talk to your doctor or pharmacist first.
See the FDA Announcement
Also see the FDA Consumer Update