According to the American Cancer Society, melanoma—the deadliest form of skin cancer—accounted for 75,000 cases of skin cancer in 2012. According to the American Academy of Dermatology, indoor tanners are 75 percent more likely to develop melanoma than those who have never tanned indoors, and the risk increases with use.
To help protect consumers from the risks of indoor tanning, FDA is proposing changes in its regulation of sunlamps. The proposals are to enhance oversight of these devices, and to require labeling to include a recommendation designed to warn young people under the age of 18 not to use these devices.
This is due to concerns about long-term effects of exposure to dangerous UV rays. Because the effects add up over a lifetime, UV exposure in children and teenagers puts them at greater risk for skin and eye damage later in life.
Proposed Changes
FDA regulates sunlamp products (including tanning beds and booths) both as medical devices and radiation-emitting products. Manufacturers of sunlamps must comply with FDA regulations regarding these devices.Based on new risk information and recommendations from experts at an earlier FDA Medical Device Advisory Committee meeting, the agency is proposing to reclassify these devices from Class I to Class II. FDA can exert more regulatory control over Class II devices, notes FDA medical device expert Neil Ogden.
For example, sunlamps would have to undergo premarket review and comply with requirements relating to performance testing, software validation and biocompatibility. "We believe the reclassification will not only strengthen oversight of sunlamp products, but also will ensure that consumers are better informed about and protected from this sort of exposure," he explains.
In addition, FDA is proposing that manufacturers add a label to the sunlamp warning young people not to use these devices. The World Health Organization, the American Academy of Pediatrics, the American Academy of Dermatology, the American Medical Association and other organizations have previously supported what the FDA is now proposing: a recommendation that minors refrain from indoor tanning.
The proposed order will be published in the Federal Register at www.regulations.gov and FDA will take public comments for 90 days.
FDA also is proposing that sunlamp product labeling include a warning that people who are repeatedly exposed to sunlamp products see their health care professional on a regular basis to check for possible skin cancer.
Skin Cancer Risk
"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. In fact, according to an overview of studies recently 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 cause is the increased use of sunlamp products by U.S. teenagers and young adults.The overview in Pediatrics suggests that doses of UV-A ultraviolet radiation emitted by high pressure tanning units may be up to 10 to 15 times higher than that of the midday sun, an intense exposure not found in nature. UV-A rays penetrate to the deeper layers of the skin and are often associated with allergic reactions, such as a rash. This is not to say that tanning outdoors is a safe activity. WHO has classified all UV radiation as carcinogenic (cancer causing).
Practices to Avoid
FDA's proposal seeks to provide a reasonable assurance of safety and to make prospective users of sunlamps aware of the risks they face. Certain practices involving sunlamps are especially dangerous. These include:- failing to wear goggles—this can lead to short- and long-term eye injury.
- starting with long exposures (close to the maximum time for the particular sunlamp), 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).
- tanning while using certain medications or cosmetics that may make you more sensitive to UV rays. Talk to your doctor or pharmacist first.
