FDA proposes new tanning bed requirements, including skin cancer warnings

Issue: June 25, 2013

The FDA issued a proposal on Monday that would reclassify sunlamp products from a low-risk device (class I) to a moderate-risk device (class II) and would require labeling to include a recommendation warning young people not to use the devices.

The proposal, if finalized, would not prohibit sunlamp product use by those under 18 years old, but provides a consequential warning, according to a press release.

There is a 75% increase in the risk of melanoma in those who have been exposed to ultraviolet radiation from indoor tanning, with the risk increasing with each use, according the American Academy of Dermatology.

The FDA will take comments on the proposal for 90 days. If finalized, manufacturers of tanning beds and sunlamp products would have to submit a pre-market notification [510(k)] to the FDA for the devices, which are currently exempt from any pre-market review, according to the release.

Besides warning of “contraindication against use” for those under 18 years old, the labeling “would have to include a warning that frequent users of sunlamp products should be regularly screened for skin cancer.”

“Using indoor tanning beds can damage your skin and increase your risk of developing skin cancer,” Margaret A. Hamburg, MD, FDA commissioner, said in the release. “The FDA’s proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information.”

Dirk M. Elston

“The [American Academy of Dermatology Association] supports the reclassification of indoor tanning devices and the placement of additional restrictions on indoor tanning,” AADA president Dirk M. Elston, MD, FAAD, said in an association news release. “We applaud the FDA … however, we recognize that there is still more work to be done to protect the public … . The AADA urges the FDA to prohibit the use and sale of indoor tanning devices for minors under the age of 18.”