General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products

To Whom It May Concern: Attached please find comments from the President of the American Academy of Pediatrics, Benard Dreyer, MD, FAAP, concerning Docket No. FDA-2015-N-1765. Thank you for your work on this important issue. Sincerely, Ethan Jorgensen-Earp

Please see the attached letter from the New York State American Academy of Pediatrics (NYS AAP) in support of the proposal to Prohibit Tanning Bed Use by Children Under 18.

See attached file(s) To The Federal Drug Administration: As pediatricians and a member of the American Academy of Pediatrics, we applaud the U.S. Food and Drug Administration (FDA) for publishing its proposed rule to prohibit the use of tanning beds by children under age 18. We see firsthand how exposure to UV radiation, especially through intentional tanning, negatively impacts the health of children both now and as they age into adulthood. We urge FDA to adopt a final rule implementing this measure as soon as possible. Even infrequent tanning using tanning beds can lead to an increased risk of skin damage and cancer, especially if the initiation of tanning bed use occurs earlier in life. A large cohort study conducted in 2011 indicated a significantly higher increased risk of basal cell carcinoma for those who used tanning beds during high school and college as compared with use between the ages of 25 and 35, and that individuals who participated in only four tanning sessions per year were still at an increased risk of melanoma by 11% and basal cell and squamous cell carcinoma by 15%. FDA must publish a final rule prohibiting indoor tanning for children under 18 as soon as possible. As scientific evidence indicates, tanning beds cause numerous adverse health risks, including cancer, and the aforementioned psycho-social and environmental factors that influence adolescent use of sunlamp products make this population particularly vulnerable to harm from these products. Further, given their developmental vulnerability, many adolescents are not able to make completely informed decisions regarding the use of these devices. A 2011 nationwide survey indicated that nearly 90% of adolescent respondents used tanning beds despite knowing that they increase the risk of skin cancer, and adolescent respondents were twice as likely to be unaware of any warning labels on tanning beds compared with adult users. Currently, state and local laws do not adequately protect children from the harms of indoor tanning and must be supplemented with a federal prohibition on their use under age 18. Parental consent/accompaniment laws are inconsistent with the protection of children from tanning beds. Data have shown that state laws requiring parental consent and/or accompaniment are not effective in preventing adolescent use of indoor tanning services. The FDA should not allow any loopholes to this rule that would allow adolescents to use tanning beds with parental consent. Sincerely, Janice L. Pelletier, MD, FAAP President, Maine Chapter of the American Academy of Pediatrics Member, AAP Section on Dermatology Member, Society of Pediatric Dermatology Head, Pediatric Dermatology, Eastern Maine Medical Center Stephen Meister, MD, FAAP Vice-President, President Elect, Maine Chapter of the American Academy of Pediatrics Submitted on behalf of the Maine Chapter of the American Academy of Pediatrics Maine is proud to receive the 2015 and 2011 national AAP Outstanding Small Chapter Award