1. FDA Sunlamp Guidance Policies: Successfully Implemented Robert M. Sayre 1,2 John C. Dowdy 2 and and James G. Shepherd 3 1 Div Dermatology, Dept Medicine, University of Tennessee, Health Sciences Center, Memphis TN. 2 Rapid Precision Testing Laboratories, Cordova TN. 3 KBD, Inc. Crescent Springs, KY.

2. FDA SUNLAMP GUIDANCE In 1985 the FDA required all indoor tanning units to have two things: 1. A timer who’s maximum was 4 MED’s 2. An exposure schedule

3. FDA SUNLAMP GUIDANCE THIS EXPOSURE SCHEDULE ALLOWS GRADUAL ACCLIMATIZATION THE SKIN ALLOWING THE 4 MED EXPOSURES TO BE ADMINISTERED WITHOUT SUNBURNS OCCURRING. ALL TANNING UNITS HAVE A TIMER WITH A MAXIMUM OF 4 MEDS. TANNING UNITS HAVE AN EXPOSURE SCHEDULE STARTING WITH FIRST 3 EXPOSURES AT ¾ MED THEN RAMPING UP EACH WEEK TO TIMER MAX THE FOURTH WEEK. FOLLOWED BY TAN MAINTENANCE EXPOSURES TWICE WEEKLY OF 4 MEDS.

4. REFERENCES: 1.Dowdy J C, Sayre R M, Shepherd J G. Indoor tanning injuries: an evaluation of FDA adverse event reporting data. Photodermatol Photoimmunol Photomed, 2009:216-220. 2.Miller S A, Beer J Z, Savalia V. Commentary on 'Indoor tanning injuries: an evaluation of FDA adverse event reporting data'. Photodermatol Photoimmunol Photomed 2009: 25: 223-224. 3.Feldman S R, Fleischer A B, Jr. Commentary on 'Indoor tanning injuries: an evaluation of FDA adverse event reporting data'. Photodermatol Photoimmunol Photomed 2009: 25: 221-222.

5. DATABASES EXAMINED FDA CDRH - MDR (1984-1997) Device Experience Network database & MAUDE Manufacturer and User Facility Device Experience database (SINCE 1995) VOLUNTARY REPORTING NOT PROJECTABLE CPSC –NEISS DATA FROM 1991 REQUIRED REPORTING FROM NATIONAL NETWORK OF HOSPITAL EMERGENCY ROOMS CPSC RESULTS CAN BE NATIONALLY PROJECTABLE

6. Summary of FDA MDR/MAUDE and CPSC NEISS UV-Injury Data

7. CONCLUSION THE FDA SUNLAMP STANDARD DEVELOPED IN 1985 AND ACCOMPANYING GUIDANCE DOCUMENTS HAVE PROTECTED THE US PUBLIC WELL AND PROVIDED THE BASIS FOR REDUCING INDOOR TANNING INJURIES NATIONALLY TO AN INSIGNIFICANT NON- PROJECTABLE LEVEL.