We Are Sunshine

FDA Panel Weighs Tanning Regs

Friday, March 26th, 2010

2010-03-26 FDA Panel Weighs Tanning RegsA U.S. Food and Drug Administration advisory panel on Thursday gave loose recommendations to the agency to begin the process of exploring tougher regulations for indoor tanning equipment.

After a day-long public hearing the FDA’s General & Plastic Surgery Devices Panel of the agency’s Medical Devices Advisory Committee — a panel of mostly dermatology industry representatives, including two past presidents of the American Academy of Dermatology — FDA was advised to:

  • Consider re-classifying indoor tanning equipment into stricter Class II or Class III categories for medical devices — categories that would enable FDA to potentially introduce stricter regulations, including warning label language.
  • Consider ways to restrict tanning bed access to those under 18 — although it isn’t clear that FDA, which regulates manufacturing standards but not retail application, even has the authority or the ability to enact such a measure.

It typically takes years for FDA to develop proposals for changes — a process that would involve industry input and many more steps before any suggestions become real proposals.

“It is likely that media reports this weekend will make changes sound more imminent than they are, and that’s because very few people understand the non-binding charge of these advisory committees,” Smart Tan Vice President Joseph Levy said. “In fact, this committee understood very little about the indoor tanning industry and is only charged with giving FDA advice that it can heed or totally ignore in taking the first step to developing new regulatory proposals.”

The panel was lobbied heavily by the American Academy of Dermatology Association, the Skin Cancer Foundation, the American Cancer Society, the American Society of Pediatrics and several melanoma patients in what appeared to be a coordinated single effort — with each of about 30 speakers asking the agency to consider banning indoor tanning altogether or to enact tougher standards.

The Indoor Tanning Association led a group from the industry at the meeting — with an ITA White Paper refuting last year’s World Health Organization report placing tanning as a class I carcinogen in the same category as cigarettes and arsenic. The WHO report was the center of evidence the anti-tanning lobby used to suggest stronger regulations were necessary.

FDA used to run tanning regulatory proposal questions by a different advisory committee — the Technical Electronic Products Radiation Safety Committee — which did not include dermatologists. FDA runs proposals by lay advisory committees in most of its divisions.

“But putting this discussion in front of a committee of dermatologists, including two former lobbyists for the dermatology industry, was like asking Coke if Pepsi should be regulated. It wasn’t an objective hearing,” said Levy, who presented material contesting the validity of AAD’s assertions on melanoma. “But this is just the beginning of a long process — no decisions were made at this meeting and we will have further opportunity to state our case.”

The ITA argued that current FDA regulations give the agency the ability to work with industry to enact any necessary safety improvements, and that the industry has worked with FDA to do so in the past.

But the dermatology-heavy panel seemed set on making a statement, asking questions and making suggestions that seemed outside of FDA’s jurisdiction. “This meeting seemed more about dermatology making a statement that its overstatement through the years of the risks of any and all UV exposure are justified,” Levy said. “This was their day in the sun. But the whole game won’t be played on their court.”