FDA Proposes Raising Tanning Beds to a Higher Risk Classification

It is well established that the ultraviolet (UV) rays emitted by tanning beds can cause skin cancer. Despite this, the US Food and Drug Administration (FDA) classifies UV tanning machines as “low to moderate risk” Class I medical devices, in the same category as elastic bandages and tongue depressors. However, it is taking strides to correct this. In 2010, after hearing public testimony, including skin cancer survivors and physicians representing The Skin Cancer Foundation, its Advisory Committee unanimously recommended raising tanning machines’ medical device classification. Now the FDA has taken the next step, officially proposing to upgrade sunlamp products to Class II, “moderate to high risk” medical devices — a category including powered wheelchairs and infusion pumps.

HOW THE PUBLIC WOULD BENEFIT

If the proposal is adopted, the machines would be required to bear a product label warning people under age 18 to avoid them. “Salons would be expected to display the new labeling within one year… of the final order,” notes FDA spokesperson Morgan Liscinsky.

Reclassification would also permit more oversight. Class II devices mandate that manufacturers provide reasonable assurance of safety and effectiveness prior to marketing.

The FDA additionally proposes informational materials advising people with skin lesions, open wounds, or a personal or family history of skin cancer to avoid sunlamp products. “The FDA’s proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information,” says Margaret A. Hamburg, MD, FDA Commissioner.

Public comments on the proposal were accepted through the beginning of August. Now the FDA will review the comments and decide what steps it will take to change the classification.

The Skin Cancer Foundation Made Your Voices Heard

When the FDA issued its proposal to reclassify tanning beds from Class I (low–moderate risk) to Class II (moderate–high risk) medical devices, The Skin Cancer Foundation sprang into action.

The Foundation asked its supporters to send letters through its website, SkinCancer.org, urging their senators to show support for the increased tanning bed regulations. In addition, community members could compose their own letters directly to the FDA, petitioning it to finalize its proposed order and supporting even stronger regulation: banning minors from using indoor tanning beds.

The results of the Foundation’s online efforts included 1,000 letters of support sent to senators and more than 400 letters sent directly to the FDA, all encouraging the reclassification; many of the letter writers shared their own personal experiences with skin cancer.