1. FDA Device Panel Meeting Tanning Bed Classification Suraj Venna, MD, FAAD Director, Melanoma Center Washington Cancer Institute Washington, DC March 25, 2010 I HAVE NO CONFLICTS OF INTEREST

3. MELANOMA IS A DEADLY DISEASE http://www.nepetimaging.com/pdf/feb_05.pdfhttp://www.nepetimaging.com/pdf/feb_05.pdf (with permission) http://www.nepetimaging.com/pdf/feb_05.pdf

4. BIOLOGY Genotype - Genodermatoses (e.g. XP, EB & albnism) - Mutations: p53, p16, BRCA2, BRAF or MC1R Phenotype - SPT I & II - Blue or Green eyes - Red or Blonde hair - # of typical &/or atypical nevi - Large Congenital Nevus - Hx of prior skin cancer or precursor lesions - Family hx of skin cancer - Immune suppressin BEHAVIOR - Sun protection - Duration of sun exposure -Ultraviolet Exposure -Natural -Artificial -Tanning Beds ENVIRONMENT UV Radiation Exposure - UV Radiation Exposure ULTRAVIOLET RADIATION Risk Factors for Melanoma

5. UV and Melanoma 1992 International Agency for Research on Cancer (IARC) classify solar radiation a human carcinogen 1992 International Agency for Research on Cancer (IARC) classify solar radiation a human carcinogen 1992 IARC classify use of sunbeds/sunlamps as Group 2A 1992 IARC classify use of sunbeds/sunlamps as Group 2A 2002 US Dept. of Health and Human Services National Toxicology Program 2002 US Dept. of Health and Human Services National Toxicology Program – broad spectrum ultraviolet radiation as emitted by solar and artificial sources as ‘reasonably anticipated’ human carcinogens

6. 2006 IARC Working Group 2006 IARC Working Group ‘…. association of the use of indoor tanning equipment with melanoma risk……. conclude that there is convincing evidence to support a causal relationship, particularly with exposure before the age of 35 years.’ 2008 World Health Organization 2008 World Health Organization – Recommended banning those younger than age 18 from commercial indoor tanning 2009 World Health Organization 2009 World Health Organization – Classified tanning bed exposure as a Class 1 carcinogen-equivalent to arsenic and tobacco use

7. A comprehensive catalogue of somatic mutations from a human cancer genome Pleasance, Cheetham, Stephens, et al. Nature December 2009. 463, 191-196 Catalogued somatic mutations from a 43yo man with metastatic melanoma Catalogued somatic mutations from a 43yo man with metastatic melanoma Identified 33,345 mutations (base substitutions) Identified 33,345 mutations (base substitutions) Dominant mutation signature reflects DNA damage secondary to UV Dominant mutation signature reflects DNA damage secondary to UV Cancer Genome Project at the Wellcome Trust Sanger Institute

8. Ultraviolet Exposure During Childhood Increases Melanoma Incidence Elwood JM, Gallagher RP, Hill GB, et al. Pigmentation and skin reaction to sun as risk factors for cutaneous melanoma: Western Canada melanoma study. Br J Med J (Clin Res Ed). 1984;288:99-102 Gandini S, Sera F, Cattaruzza MS, et al. Meta-analysis of risk factors for cutaneous melanoma, II: sun exposure. Eur J Cancer. 2005;41:45-60 Weinstock MA, Colditz GA, Willett WC, et al. Nonfamilial cutaneous melanoma incidence in women associated with sun exposure before 20 years of age. Pediatrics. 1989;84:199-204.

9. Tanning and Increased Nevus Development in Very-Light-Skinned Children Without Red Hair Aalborg J, Morelli JG, Mokrohisky ST, et al Arch Dermatol. 2009;145:989-996 Tanning is associated with an increased risk of nevus or mole counts

10. Recent Tanning Bed Use. A Risk Factor for Melanoma. Buckel T, Goldstein A, Fraser M, et al Arch Dermatol. 2006;142:484-488 Tanning bed use can increase mole counts and cause existing moles to change

11. Melanoma risk and number of common melanocytic nevi. Bauer & Garbe: Pigment Cell Res. 2003

12. Ultraviolet Radiation Is a human carcinogen Is a human carcinogen Is involved in the pathogenesis of melanoma Is involved in the pathogenesis of melanoma Only comes from 2 sources Only comes from 2 sources – Natural – Artificial

13. Tanning Inexpensive ($7-10/session, some as little as $3) Inexpensive ($7-10/session, some as little as $3) Widespread Widespread Young Women Young Women – Nearly 70 percent of users girls and women aged 16 to 29

14. Prevention Protection from UV Modify Behavior EDUCATE Indoor Tanning Intentional Sunbathing Inadequate Sun Protection SchoolsParents Healthcare Providers POLICY

15. Stronger Regulations Are Needed To protect the public health, the FDA should: To protect the public health, the FDA should: – Ban the use and sale of tanning devices in the US; or at a minimum, Reclassify tanning devices to the strongest possible category; Reclassify tanning devices to the strongest possible category; Restrict access to tanning beds by minors; Restrict access to tanning beds by minors; Require informed consent for all consumers; Require informed consent for all consumers; Require posted warning statements; Require posted warning statements; Implement and enforce labeling recommendations from the TAN Act; and, Implement and enforce labeling recommendations from the TAN Act; and, Enforce additional state regulations. Enforce additional state regulations.

16. Thank You