You have probably heard that on May 6, 2013, FDA issued a proposed rule requiring warning labels to be affixed to tanning beds. It has been all over the news – FDA’s Center for Device and Radiological Health (CDRH) was like a moth to a tanning bed light bulb, touting its latest warning requirement to the media.
A more important point that the media largely did not focus on is that the proposed rule would also reclassify tanning beds, in addition to the warning requirement. Currently, tanning beds are class I devices that are exempt from the premarket review process. Originally, these devices were classified as class II devices. Slowly, over the years, FDA loosened restrictions. In 1988, UV tanning lamps were classified as class I; then, in 1994, they were exempt from premarket clearance. Now, FDA is now planning to take it all back, and proposes to make tanning beds class II devices, subject to a 510(k) application and clearance.
FDA’s proposal to ratchet up tanning bed regulation is due to safety concerns. The media quoted various parts of FDA’s two-page discussion of safety concerns contained in the proposed rule. See 78 Fed. Reg. 27119-20. Based on these safety concerns and the level of safety focus on FDA’s consumer webpage, “Indoor Tanning: The Risks of Ultraviolet Rays,” one could speculate that there will be more regulation in the future for these products.
During a conference call with reporters, CDRH Director, Jeffrey Shuren, made a statement that confirms FDA may well intend to provide additional regulation in the future. Dr. Shuren stated that “we view this as a first step,” and “nothing is off the table.” While he did not state what the next steps would be, there has been pressure on FDA from numerous trade and professional associations to restrict use of tanning beds to those 18 years or older (e.g. American Academy of Pediatrics, American Academy of Dermatology, Skin Cancer Foundation). Interestingly, Dr. Mary Maloney, who chairs the American Academy of Dermatology Association’s regulatory policy committee, was on the conference call with Dr. Shuren. She agreed that this rulemaking is an important first step, but that her group would continue to push for a ban on the sale and use of tanning beds for people under age 18. While FDA has not, at least 7 states restrict minors from use of tanning beds, and many others have the ban in their legislative or regulatory pipeline.
The proposed rule would allow industry time to plan as the rule, if finalized, would not be effective for another 15 months. The industry will likely lobby and attempt to influence the proposed rulemaking. To influence this rulemaking, industry will need to beef up arguments regarding safety and suggest alternative ways to ensure safe products are on the market. As always with the rulemaking process, the final outcome is tough to predict so we will have to wait and see.
