FDA Strengthens Warnings for Indoor Tanning Products
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FDA Strengthens Warnings for Indoor Tanning Products

June 3, 2014

Using sunlamp products such as tanning beds or tanning booths increases the risk of skin damage, skin cancer and eye injury, according to the Food and Drug Administration (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, indoor tanning heightens the risk of developing melanoma by 59 percent, and the risk goes up with each use. 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.

To help protect consumers and inform them about the risks of indoor tanning, the FDA is changing its regulation of sunlamp products and UV lamps intended for use in sunlamp products. The changes strengthen the oversight of these devices, and require that sunlamp products carry a visible, black-box warning stating that they should not be used on people under the age of 18.

This change is due to concerns that the effects of UV radiation add up over time, and children and teenagers who are exposed to indoor UV radiation are at greater risk for skin and eye damage.

"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 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).

Manufacturers of sunlamp products (including tanning beds and booths) must comply with applicable FDA regulations for both medical devices and radiation-emitting products. Based in part on risk information and recommendations from experts at an earlier FDA Medical Device Advisory Committee meeting, the agency is reclassifying these devices from Class I (low risk) to Class II (moderate risk). The FDA can exert more regulatory control over Class II devices.

For example, once the reclassification is effective, sunlamp products will have to undergo a premarket review by the FDA and comply with requirements relating to performance testing, software validation, and biocompatibility.