FDA Hearing on UV Tanning Devices

1. FDA Hearing on UV Tanning Devices March 25th, 2010 Gaithersburg, MD Dr. Michael Zanolli representing The Photomedicine Society

2. Michael Zanolli MDDisclosures • Physician • Dermatologist • President, The Photomedicine Society • Author: Phototherapy Treatment Manual 2nd ed. • Member, American Academy of Dermatology • Board of Trustees, TN Medical Association • Board of Medical Examiners, State of TN

3. Medical Uses of UV light • Used to treat skin diseases. • Used to treat symptoms or side effects of internal disease. • Application of UV light as a therapeutic option to treat disease fulfills the definition of the practice of medicine in the State of Tennessee, because it requires an examination and diagnosis of a patient followed by determination of a treatment or remedy.

4. Snapshot of a Solo Practice • Phototherapy utilization in my private office • February, 2010 • 54 active phototherapy patients

5. Categories of Diseases Being Treated • Psoriasis (32) • Vitiligo (6) • Dermatitis (5) • Pityriasis Lichenoides (2) • Grover’s Disease (2) • Morphea (1) • Generalized Pruritus (1) • Lichen Planus (1) • Erythema Annulare Centrificum (1) • Granuloma Annulare (1) • Alopecia (1) • Cutaneous T cell Lymphoma stage 1a (1)

6. Types of UV treatment to treat medical diseases and conditions • Narrow Band UVB (311-313 nm) • PUVA (Psoralen plus UVA light) • Broad Band UVB (spectrum 290-340) • Laser produced UV at 308 nm • UVA-1 (340-400 nm)

7. Differences in Medical UV light devices and Tanning Beds • Wavelength • >90% of medical application of UVB in N.A. since 2006 is narrow band UV • Sale of new units in 2009 was >98% NBUVB • Still some PUVA but declined steadily since 1998 • Main reason: Association with increased risk of melanoma when > 250 treatments in fair skinned patients. • Tanning Bed lamps have variable percentages of UVB and UVA • 0.7% UVB to 8.5% UVB (5% UVB very common) • Some more recent tanning bed lamps all UVA • Hundreds of lamps available

8. Differences in Medical UV light devices and Tanning Beds • Dosimetry • Dose in either mj/cm2 (UVB) or J/cm2 (PUVA or UVA-1) for medical. • Exposure is rated on a range of time in minutes for tanning beds. • Dependant upon the lamp used • The number of lamps in a tanning bed • Dependant upon the ballast used to provide the current • Low/high pressure lamps • Reflectance materials in the tube • Proper measurement of the fluence of lamps needs to have a photometer which is matched to the wavelength output of the lamps being tested.

9. Differences in Medical UV light devices and Tanning Beds • Informed consent • Prior to treatment course in a medical setting. • Cumulative dosage monitoring • Easily calculated on the treatment flow sheet. • Ongoing medical examinations and monitoring • Documented in a medical office.

10. Emission spectra Narrow-band UVB Phillips TL01 Broad-band UVB Phillips TL12

12. Low Pressure Lamp

13. High Pressure Lamp

14. Tanning Bed Devices • Designed to produce a tan • Variables include • Lamp output • Fluence or power • Essentially will determine the time (min) • Wavelength ratio • UVB/UVA • Avoidance of “sunburn” reaction • UVB with a much higher UV index • High UVA output and fluence • End result • Common feature of all tanning bed lamps

15. What evidence do we have to be able to estimate the amount of UVA delivered in tanning salons? • Tanning facility use: Are we exceeding Food and Drug Administration limits? • J Am Acad Dermatol 2003;49:655-61 • A detailed study of 62 tanning facilities in North Carolina

16. Critical review • A state employed regulator visited each site • Surveyed what type of establishment offered tanning as a service • Reviewed records of patrons kept by the facility • Collected data on compliance with FDA exposure schedules • Measurements of tanning bed UV output

17. Critical review • Results • 95% of patrons exceeded recommendations of the FDA for exposure times and dose • UV output of tanning beds • mean UVA = 192 W/m2 • range for UVA 17.7 - 674.0 W/m2 • mean UVB = 0.35 W/m2 (measured as 6MED/hr) • range for UVB 0.12 W/m2 - 0.82 W/m2

18. Relative comparisons to gauge the energy • Average UVA output at noon in summer in Washington D.C. • 48 W/m2 (compare to 192 W/m2) • Photochem Photobiol 1998;68:63-70 • Average UVB output at noon in summer in Washington D.C. • 0.18 W/m2 (compare to 0.35W/m2) • Photochem Photobiol 1998;68:63-70 • A flux of UVB at 0.35 W/m2 is equal to a UV index of 14 (now 11+)

19. Ultraviolet light is used to treat skin disease and symptoms of disease. Physicians are trained to be aware of known acute and long term side effects. More specific wavelengths of UV and lowest dose is used to treat disease. Measurement of the actual dose used and cumulative dose is part of medical therapy. Tanning salons are not medical facilities and should not treat disease. Patrons of tanning facilities are not examined as part of their service. Tanning is using higher and higher doses of UVA to produce the end results. Cannot compare the time between devices because of the variables involved. Dosage is not measured or required. Summary

20. Recommendations • The Photomedicine Society recommends: • Ban or reclassify tanning bed devices • Special controls and/or premarket approval may be inadequate for the safety of the public. • If not banned • Require dosimetry on each device • Informed consent • Require a national registry which could be used to gather data on this cohort of individuals.

22. Effects of chronic excessive UVA exposure through window glass