Sunlamps: Scientific Issues and Proposed Regulatory

Revisions

W. Howard Cyr, Ph.D.Senior Science AssociateAEGIS Regulatory, P.A.

Briefing for FDA, CDRH, March 25th, 2010

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AEGIS

• Scientific and legal research consultancy

• Serves both government and private industry

• Deals with regulatory impact Devices,

Cosmetics Drugs 28 Foreign AHJ’s.

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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 sunbedsAADA, Skin Cancer FoundationNIH, CDC, NTP

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Purpose

• Assistance in negotiations with FDA and the dermatology community

• Re-exam the issuesRecent Congressional Bill IARC reclassificationNew published epidemiology reports

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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 labelingLocation of labelsEducation of consumers and tanning industry employees

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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.

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IARC reclassification

• Sunbeds versus Cigarettes

Relative risksCigarettes – Odds ratios or RR as high as 20.0Sunlamps – Odds ratios or RR as high as 1.75

Absolute risks3X more cases of lung cancer than cases of melanoma10X to 20X more deaths from lung cancer than melanomaCigarettes – 5 year survival rate for lung cancer – 15%Sunlamps (and sun) – 5 yr. survival rate for melanoma – 85%

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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

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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

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FDA, Industry, and Public Health Community Cooperation

• We offer our services to you in helping to debate and resolve these

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Summary

Thank you