The Food & Drug Administration has just put another dark cloud over the business of tanning booths. This FDA issue is a final order which reclassifies sunlamp products and ultraviolet lamps intended for use in sunlamp products. The risk is moving up from low-risk (class I) to moderate-risk (class II) devices.
The order also requires that sunlamp products carry a visible black-box warning on the device that explicitly states that the sunlamp product should not be used on persons under the age of 18 years. Also, certain materials used in marketing of sunlamp products and UV lamps will have to include additional and specific warning statements and contraindications.
The FDA’s take is that this UV radiation may cause skin cancer. The latest FDA action also cites figures from the American Academy of Dermatology, showing that people who have been exposed to UV radiation from indoor tanning have a 59 percent increase in the risk of melanoma. The FDA also says that this risk increases each time they use a sunlamp product.
Manufacturers will now have to submit a premarket notification to the FDA, and they will have to obtain FDA clearance, before marketing the devices. The FDA’s statement included the following notes,
“The FDA’s final order for the reclassification of sunlamp products and UV lamps follows the recommendations from a panel meeting of outside experts convened in March 2010. This panel of outside experts evaluated the risks of sunlamp products, and recommended that FDA increase regulation of these devices and certain members of the panel recommended that children and teenagers not use the products. Today’s action follows a public comment period after the release of the proposed order in May 2013. The FDA received comments from industry, patient groups and professional societies, which are addressed in the final order.”
Are tanning beds worse for you than cigarettes? Probably not, but it turns out that the leathery look and feel you get in from the sun and/or from tanning booths may have more to it than nothing at all.
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