1. Sunlamps: Scientific Issues and Proposed Regulatory Revisions W. Howard Cyr, Ph.D. Senior Science Associate AEGIS Regulatory, P.A. Briefing for FDA, CDRH, March 25th, 2010

2. 2 AEGIS Scientific and legal research consultancy Serves both government and private industry Deals with regulatory impact Devices, Cosmetics Drugs 28 Foreign AHJ’s.

3. 3 My Background Acting Branch Chief, Radiation Biology Senior Research Biophysicist, OSEL AEGIS, Senior Science Associate Application of my experience: FDA and FTC (regulators) Industry – lamps and sunbeds AADA, Skin Cancer Foundation NIH, CDC, NTP

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5. 5 Purpose Assistance in negotiations with FDA and the dermatology community Re-exam the issues Recent Congressional Bill IARC reclassification New published epidemiology reports

6. 6 Tanning Accountability and Notification Act “TAN Act” FDA was asked to assess whether the present warning labels were adequate. FDA’s response Changes that might help to warn customers of risks Revisions to the labeling Location of labels Education of consumers and tanning industry employees

7. 7 IARC Reclassification IARC changed sunbeds from Group 2A “probably carcinogenic to humans” to Group 1 “carcinogenic to humans” Reclassification should not change warning label. Label already warns about skin cancer.

8. 8 IARC reclassification Sunbeds versus Cigarettes Relative risks Cigarettes – Odds ratios or RR as high as 20.0 Sunlamps – Odds ratios or RR as high as 1.75 Absolute risks 3X more cases of lung cancer than cases of melanoma 10X to 20X more deaths from lung cancer than melanoma Cigarettes – 5 year survival rate for lung cancer – 15% Sunlamps (and sun) – 5 yr. survival rate for melanoma – 85%

9. 9 Reclassification of Sunlamps / Equipment as Class II Devices - Discussion Prior to December 7th, 1994 - originally Class II devices “Sunlamps in same category as tongue depressors” Sunlamps are NOT un-regulated. Regulated by the Radiation Control for Health and Safety Act. Performance standard, 21CFR1040.20 Much more oversight than most Prescript. Class II Devices

10. 10 FDA, Industry, and Public Health Community Cooperation AEGIS Regulatory has worked with both FDA and the indoor tanning industry Decades of experience in helping to develop controls that enhance public safety while satisfying regulatory requirements. Real-world guidance to both Government and the health services communities

11. 11 FDA, Industry, and Public Health Community Cooperation We offer our services to you in helping to debate and resolve these

12. 12 Summary Thank you