Summary of FDA meeting, September 14, 2016

In September, American Suntanning Association Research Director Allen Miller led a scientific meeting with the U.S. Food and Drug Administration regarding their indoor tanning proposed rules. Miller and the ASA scientific team presented scientific evidence that shows how the proposed rule changes could have adverse affects on the consumers the FDA is trying to protect. ASA has invested considerable resources to constructively work with the FDA and support a better plan for consumers and our market.

Here is Miller’s summary of the meeting:

By Allen Miller, ASA Research Director

The FDA attendees were:

• Richard P. Felten, Expert Reviewer, Division of Surgical, Orthopedic, and Restorative Devices, Office of Device Evaluation. CDRH
• Steve Nager, a doctor
• Sharon Miller, CDRH/OIR/Division of Radiological Health/Magnetic Resonance & Electronic Products Branch
• Neil Ogden, CDRH/ODE/Division of Surgical Devices — Chief, General Surgery Devices Branch 1
• Ian Ostermiller, CDRH Regulatory Counsel
• Vasum Peiris, CDRH, pediatrics medical officer

The tanning industry group was myself, Dr. David Hoel, John Overstreet, Jim Shepherd and Ellen Flannery and Christopher Hanson of Covington and Burling, our FDA counsel.

Ellen Flannery began the meeting by stating that the FDA convened an Advisory Panel Meeting in March 2010 to consider scientific information about UV radiation and tanning. That was six years ago. Since that time, there have been significant changes in the understanding of the benefits and risks related to sunlamp products. The purpose of our meeting was to ask that the FDA undertake a thorough review of all the new science published since the 2010 meeting. The point being that without considering new developments, the FDA could be doing more harm than good with this approach.

In particular, more recent scientific articles do not support FDA’s assertion in the proposed rule that children and adolescents who are exposed to UV radiation (including from tanning salons) may be at higher risk of developing certain types of skin cancer than persons who begin exposure later in life as adults. We told the FDA that this ban could push teens to more risky behavior through unsupervised sun tanning either outside or at home.

Science related to mandating an under 18 ban – I began by talking about the infamous 2009 WHO/IARC fiasco. I explained Dr. Hoel’s role in that working group, how the “75% more likely to develop melanoma” statistic was actually generated by staff and had been originally published in 2006 and ignored. Dr. Hoel explained how the IARC working group really didn’t discuss sunbeds but simply reclassified UV light from a sunbed to human carcinogen, the same category as the sun. This is important because the FDA that in the preamble to the proposed rule, relies upon the 2006 International Agency for Research in Cancer (IARC) report and the follow-up 2012 Boniol study done by the same people as the 2006 IARC report (who by 2012 had left IARC and worked for the private organization, International Prevention Research Institute (IPRI).

Dr. Hoel and I told the FDA that these studies have been discredited and superseded by the 2014 Colantonio study which found that there is no statistically significant correlation between indoor tanning before age 25 versus after age 25 and increased risk of melanoma. In addition, I pointed out that the FDA fails to acknowledge that the 2010 Lazovich study published after the meeting of the March 2010 Panel, found that younger individuals are not at increased susceptibility to the effects of UV radiation. We concluded that a careful review of our previous scientific submission shows that the totality of the current scientific evidence does not support the restrictions on use of sunlamp products (including the under-18 ban) being proposed by FDA.

We also talked about how the studies often group home tanning with salon tanning and if you separate out the home tanning data, there is no increased risk for melanoma from tanning in a salon and a 50% increased risk of melanoma from home tanning. We gave them a copy of Dr. Hoel’s meta-analysis showing this.

Science relating to proposed limitations on tanning exposure – Dr. Hoel and I pointed out that FDA’s suggestions of limiting indoor tanning in a tanning salon 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 bad for a person’s risk of skin cancer or is otherwise unhealthy and should be limited.

We told the FDA that current science does not support any of these limitations, other than a separation of 48 hours between each of tanning session in the first two week of a tanning course. To the contrary, there is significant science indicating that insufficient UV exposure is one of the nation’s leading public health problems. The current state of the science shows that there is no harm in a person staying tan year-round by using a commercial tanning salon, assuming there is no UV burning, and lots of benefits (whether we can promote these potential benefits or not). FDA’s current exposure guidelines as set forth in the 1986 policy are designed to prevent burning.

The proposed twice-a-week spacing and 48-hour spacing (except as stated above) is contraindicated by science that has been established for 30 years that, for a given dose of UV, skin cancer risk is minimized by getting that dose as quickly as possible without burning. Dr. Hoel argued that melanoma risk is reduced by having chronic year-round UV exposure, so an annual limit is also contraindicated by science.

The notion of limiting persons with Skin Type III and Type IV to the UV doses appropriate for persons with Skin Type II also is a consequence of a view that less UV exposure is always better than more.  This view is contraindicated by the science.

We also discussed the adoption of some of the Intermittent Exposure Chart (IEC) regulations. We understand that the FDA’s proposed recommendation of an annual limit is based on an assumption by the IEC many years ago that indoor tanning should not provide more UV exposure per year than a Dutch indoor worker receives annually from the sun. This arbitrary assumption of the IEC provides no scientific basis for the proposed rule. The Sharon Miller studies cited by FDA as supporting FDA’s notion that a tan can be maintained on a year-round basis with an annual dose of 15 kJ/m2 examined only colorization and made no investigation of epidermal thickening, an essential element of a tan, and thus also does not provide any scientific basis for the proposed rule. We pointed out that tanning equipment is approved by the FDA “for tanning purposes” and a tan includes colorization of existing melanin by UVA, production of melanin by UVB, and epidermal thickening, all of which contribute to protection against subsequent sunburn.

We also discussed efforts we have undertaken to get the CDC to back off its hard line on UV exposure using these same arguments.

If you have any question about the FDA’s proposed indoor tanning rules, email info@americansuntanning.org or call 855-879-7678.