In September, members of the ITA and ASA conducted a second meeting with officials at the Food and Drug Administration. This meeting focused exclusively on recent developments related to the science of exposure to ultraviolet light.
The purpose of this meeting was to ask the FDA to carefully consider new science as the Agency reviews its two rules concerning our industry that were proposed in December, 2015. You may remember that the FDA last convened an Advisory Panel meeting to consider scientific information about ultraviolet (UV) radiation and tanning in March, 2010. That was six years ago and turned out to be extremely one-sided – not in our favor. Since that time, there have been significant changes in the understanding of the benefits and risks related to sunlamp products.
With regard to the restricted device proposal which includes the ban on use by people under the age of 18, our team presented data to demonstrate that there is no scientific basis for such a ban. Because the introduction to the proposed rule relies on the flawed 2006 IARC report, we pointed out that the IARC report has been discredited and superseded by other studies. Those studies found there is no statistically significant correlation between indoor tanning before age 25 (versus after age 25) and increased risk of melanoma. We told the FDA that a ban could push teens to seek suntanning in environments where they may be more likely to sunburn, either outside or in tanning systems made for home use.
In the other proposed rule (amendments to the Performance Standard), the FDA’s recommendations of limiting tanning salon sessions to: (1) two times per week, (2) once every 48 hours and (3) 15 kJ/m2 per year, all appear to be based on a view that non-burning UV is somehow unhealthy. We called to the FDA’s attention a number of studies that challenge the reasoning behind this thinking. While acknowledging that sunburns do increase risk of developing melanoma, we pointed out there are no studies showing that UV exposure without burning does so.
Unfortunately, the clear intent of both the proposed rules is to reduce UV exposure.We told the FDA that since 2010, significant science has demonstrated that there are benefits to UV exposure and that insufficient UV exposure is the second leading cause of death in the United States. Further, avoidance of sun exposure is a risk factor for all-cause death at the same magnitude as tobacco smoking.
While everyone on our team agreed that the meeting was productive and that the regulators seemed to listen to our views, it is not at all clear if we made any progress or where this will lead us. There is no set time in which the Agency must act on finalizing the two rules. Other than setting a target of December, the government’s plans remain a well-kept secret.
Until the FDA acts, we will continue to press our case. In the meantime, your industry organizations can use your support. We are fighting for you!
