HealthDay News — The FDA is proposing an order that would require a prominent label on all indoor tanning beds recommending regular cancer screening for users, and warning against use by children younger than 18 years.
If passed, the proposed order would reclassify tanning beds and sunlamp products from current Class I, low-risk medical devices, to Class II moderate-risk devices. This move would require all manufacturers to submit premarket notification to the FDA using the 510(k) process, to ensure their products meet performance standards and also to obtain FDA approval for labeling.
Promotional materials for indoor tanning facilities — including brochures, catalogs and consumer-oriented websites — would also have to include warnings about the associated risks, Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press briefing.
People exposed to ultraviolet radiation from indoor tanning have a 75% increased risk for melanoma, the deadliest type of skin cancer, according to the American Academy of Dermatology (AAD), and this risk increases with each use.
“Using indoor tanning beds can damage your skin and increase your risk of developing skin cancer,” Margaret A. Hamburg, MD, Commissioner of the FDA, said in a statement. “The FDA’s proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information.”
Mary Maloney, MD, chairperson of the AAD’s regulatory policy committee, commended the FDA proposal as “a significant first step to protect the public,” but noted the AAD would prefer a ban on tanning bed use by people younger than 18 years.
Under current Class I medical device status, sunlamp devices are exempt from any premarket FDA review. If the FDA’s proposal passes, tanning salons would have one year to add the required labels to tanning beds already installed. The FDA is accepting comments on the proposed order for 90 days (use Docket No. FDA-2013-N-0461 as identifier).