The U.S. Food and Drug Administration (FDA) has heightened its warnings for the use of tanning beds and booths. Under new regulations, the agency will require them to undergo premarket testing and carry warnings that they’re not safe for people younger than 18. Under the new regulations, the FDA is changing its regulation of sunlamp products and UV lamps intended for use in sunlamp products by reclassifying these devices from Class I, or low risk, to Class II, or moderate risk. The change was based in part on risk information and recommendations from experts at an FDA Medical Device Advisory Committee meeting, according to the agency.
Sunlamp products, which include tanning beds and tanning booths, emit ultraviolet radiation that may cause skin cancer, the FDA said. It said that according to the American Academy of Dermatology, 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, and the risk increases each time they use a sunlamp product. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, stated:
The FDA has taken an important step today to address the risk to public health from sunlamp products. 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.
Manufacturers of sunlamp products must comply with the regulations for medical devices and radiation-emitting products, the FDA said. Because the FDA can exert more regulatory control over Class II devices, 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.
User instructions and promotional materials for sunlamp products and UV lamps intended for use in sunlamp products will include the warnings that the product is contraindicated for use on persons younger than 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 people who have had skin cancer or a family history of skin cancer; and people repeatedly exposed to UV radiation should be regularly evaluated for skin cancer. Ogden says:
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.
This is another industry where regulation must be both stronger and more effective. So far neither appears to be happening.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.