On May 29, the Food and Drug Administration (FDA) announced that it is beefing up its regulation of sunlamp products such as tanning beds or tanning booths. Studies have found that these devices increase the risk of skin cancer, including deadly melanomas. In addition, sunlamp products can cause permanent or temporary eye damage.
According to the American Academy of Dermatology (AAD) and the World Health Organization (WHO), indoor tanning increase the risk of developing a melanoma by 59%; furthermore, the risk increases with each use. The American Cancer Society (ACS) notes that, despite these risks, thousands of Americans undergo indoor tanning. The ACS estimates that almost 13,000 individuals die each year from skin cancers; the majority (approximately 9,700) are melanoma. The ACS predicts that 76,100 cases of melanoma will occur in 2014.
In view of the risks of the use of sunlamp products and to increase consumer awareness, the FDA is changing its regulation of sunlamp products and UV lamps intended for use in sunlamp products. The changes strengthen the regulation of these devices, and require that they carry a visible, black-box warning stating that they should not be used on individuals under the age of 18. This increased regulation is due to concerns that the effects of ultraviolet radiation add up over time; thus, children and teens who are exposed to indoor ultraviolet radiation are at increased 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,” explained FDA dermatologist Markham Luke, MD, PhD. He added that, according to an overview of studies published in the journal Pediatrics, melanoma is the second most common cancer in women in their twenties and the third most common cancer in men in their twenties in the U. Many healthcare experts believe that at least one reason is the increased use of sunlamp products by US teenagers and young adults.
A review by the American Academy of Pediatrics suggests that doses of ultraviolet radiation produced by high pressure sunlamp products may be up to 10 to 15 times greater than that of the midday sun; thus, the intensity is far greater than that present in nature. Ultraviolet-A radiation penetrates to the deeper layers of the skin; it is often associated with allergic reactions, such as a rash. The World Health Organization has classified all ultraviolet radiation as a carcinogenic (cancer-causing).
The beefed-up FDA regulations require that manufacturers of sunlamp products, including tanning beds and booths, must comply with applicable FDA regulations for both medical devices and radiation-emitting products. Based partially on risk information derived from clinical studies and recommendations from experts at an earlier FDA Medical Device Advisory Committee meeting, the FDA is reclassifying these devices from Class I (low risk) to Class II (moderate risk). FDA medical device expert Neil Ogden notes that the agency can apply more regulatory control over Class II devices. After the reclassification becomes effective, sunlamp products will have to submit to a premarket review by the FDA and comply with requirements relating to performance testing, software validation, and biocompatibility. The agency is also mandating that certain user instructions and promotional materials for sunlamp products and ultraviolet lamps intended for use in sunlamp products include the following warnings and contraindications (a contraindication is a reason that a drug or medical product has greater risk than benefit):
- The product is contraindicated for use on individuals under the age of 18 years
- The product must not be used if skin lesions or open wounds are present
- The product should not be used on individuals who have had skin cancer or a family history of skin cancer
- Individuals repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.
The FDA notes that certain practices involving sunlamp products are particularly 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, a person may not realize that his or her skin is burned until it is too late
- Failing to follow manufacturer-recommended exposure times on the label for one’s skin type (some skin types should not tan with ultraviolet radiation at all; for example, those with skin that burns easily and does not readily tan)
- Tanning while using certain medications or cosmetics that may make one more sensitive to UV rays. Before using a sunlamp product, one should discuss medications with a physician or pharmacist.