FDA Seeks To Regulate Tanning Beds More Strictly

Posted on May 7, 2013

The Food and Drug Administration has announced a proposal that has the potential to drastically alter the tanning bed market.  Specifically, the approval process would become more strict and attempts would be made to outline the risks of UV exposure to young people.

First, the FDA wants to change tanning beds’ current designation as a Class I low risk device.  Given the threat of skin damage and the possible development of skin cancer, the Commissioner of the organization explains that it would be in the consumers’ best interest to reclassify the items as a Class II device carrying a moderate risk.

This would alter the way that sunlamp items are approved.  Right now, they do not have to go through a pre-market approval process.  With the proposed changes, though, tanning beds would have to meet certain benchmarks and labeling requirements.  A 510k pre-market notification would need to be filed.

In addition to these pending rules, the FDA also wants tanning beds to come with labels suggesting that persons under the age of 18 decline to use the devices and explaining that regular users should submit to cancer testing.

These proposed changes have been issued in order to combat skin cancer around the country.  The American Academy of Dermatology estimates that the threat of the often-fatal skin cancer known as melanoma rises by 75% in persons who use tanning beds.

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