FDA GPSD Advisory Panel Mtg on Sunbed Safety Manny Karos B.S.UMD USC MS. Systems MgtSafety Retired FDA, CSO, Sunlamps Formerly Adjunct Faculty UMD, Systems Mgt Safety, President, Allied Quality Services LLC Comparison of Class I General Controls & Class II Special Controls US CPSC NEISS Data Current Scientific Reviews Recommendations

Controls used to provide a Reasonable Assurance of Safety and Effectiveness Class I General Controls 501 Adulteration charges 502 Misbranding charges 510 Registration 518 Notification& Remedies 519 Records/Reports 520 General provisions of FDCA CFR 801 Package Labeling CFR 820 Quality Systems Regulations CFR 1040 FDA Sunlamp Performance Std CFR 803 Medical Device Reporting Accidental Radiation Occurences Product/Supplement reports of Electronic Product Radiation Control provisions of FDCA Max Timer Interval/Exposure schedule Lamp Compatibility Warning Label Policies/GGP’s Defects/Noncompliance Notifications Corrective action plans Warning Statement on lamps and Sunbeds Class II Special Controls Promulgation of Performance Standards Postmarket Surveillance Patient Registries Development and Dissemination of Guidance Documents Recommendations/other actions recommended

CPSC NEISS INJURY DATA SUNLAMPS / SUNTAN BOOTHS YearActual InjuriesEstimated Injuries

CPSC NEISS INJURY DATA SUNLAMPS / SUNTAN BOOTHS YearActual InjuriesEstimated Injuries NR 1994NR H cv= H 1294A cv= H 1885 A

All Consumer Products with exception of most Medical Devices YearActual InjuriesAdjusted Estimate ,26613,456,353-H

Article in 30 th Anniversary Skin Cancer Journal in 2009 Marianne Berwick PhD stated in her article Nature or Nurture Who is Responsible for Melanoma “There is no doubt that intermittent, intense sun exposure-the kind that frequently leads to sunburn,for example on tropical vacations-is associated with development of many melanomas, while more long-term daily daily solar uv exposure is not.” “Something about consistent less intense exposure seems to "prime" the defense mechanisms against melanoma… whether by increasing serum Vit D levels, DNA repair capacity or some other mechanism not yet known" Dr. Berwick indicated that the role of UV from the sun or tanning salons and it's interaction with genetic factors in melanoma remains to be elucidated.....

Research at Dana-Farber Cancer Institute at Harvard Medical School March of 2007 an article was published in the Journal Cell by David E. Fisher, MD, PhD. Director of the Melanoma Program at the Dana-Farber Cancer Institute and Rutao Cui, MD, PhD. Principal Investigator. In the study they report “the protein P53, is not only linked to skin tanning, but also may play a role in people’s seemingly universal desire to be in the sun.---an activity that, by promoting tanning, can reduce one’s risk of melanoma. This protein known as the “master watchman of the genome” for it’s ability to guard against cancer causing DNA damage has been found to provide and entirely different level of cancer protection: By prompting the skin to tan in response to ultraviolet light from the sun, it deters the development of melanoma skin cancer…”

From 1996 to 2006 only an average of 4.9 injuries per year. This validates a significant decrease in injuries since It indicates sophisticated computer monitored electronic timer control systems and more professional training of salon operators has effected this improvement. Based on my experience the industry makes an exceptional effort to inform consumers about risks of these products. Recommendations Class I General Controls are more than adequate to provide a reasonable assurance of safety and effectiveness for Sunbed products. Suggest to the advisory panel to encourage FDA to allow more active public involvement in the amendment/ harmonization process using the Technical Electronic Product Radiation Safety Standard Committee (TEPRSSC) processes. This would provide another positive forum for regulatory/scientific issues related to sunbeds usage.

"Sunlamp--DANGER--Ultraviolet radiation. Follow instructions.Use ONLY in fixture equipped with a timer." "DANGER--Ultraviolet radiation. Follow instructions. Avoid overexposure. As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from the use of this product."