FDA to require black-box warnings on tanning beds

The Food and Drug Administration is requiring black-box warnings on tanning beds, advising the devices shouldn’t be used by those under age 18.

Noting the harm that repeated UV radiation exposure causes over time, the FDA said the strengthened warnings on indoor tanning devices are necessary in an effort to curb rising rates of skin cancer in the United States.

“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,” the FDA stated in a news release.

Tanning bed manufacturers have to comply with FDA regulations for medical devices and radiation-emitting devices. The FDA has reclassified tanning beds from low-risk Class 1 to moderate risk Class 2, allowing the regulatory agency greater control over the devices. Under Class 2, sunlamp devices must submit to a premarket review by the FDA.

The FDA will require promotional materials and certain user instructions on UV lamps and sunbed devices to include the following information and warnings:

• the product is contraindicated for use in those under age 18;

•  the product must not be used if the consumer has open wounds or skin lesions;

• the product shouldn’t be used on consumers who have skin cancer or a family history of the disease; and

• those who are repeatedly exposed to UV radiation should be checked regularly for skin cancer.

“We believe the reclassification will not only strengthen oversight of sunlamp products, but also help consumers be better informed about, and protected from, this sort of exposure,” Neil Ogden, FDA medical device expert, said in the news release.

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