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01-03-2015 | Melanomas

Teens and Indoor Tanning: Time to Act on the US Food and Drug Administration’s Black-Box Warning

Authors: Mark Gottlieb, JD, Sophie J. Balk, MD, Alan C. Geller, MPH, RN, Jeffrey E. Gershenwald, MD

Published in: Annals of Surgical Oncology | Issue 3/2015

Excerpt

On 27 May 2014, the US Food and Drug Administration (FDA) issued an order requiring that sunlamp products used in tanning salons carry a visible boxed warning that states: “Attention: This sunlamp product should not be used on persons under the age of 18 years”.1 This order, and other requirements for these products, are unprecedented, representing “an important step… to address the risk to public health from sunlamp products”.2 …

Department of Health and Human Services, Food and Drug Administration. 21 CFR Part 878. [Docket No. FDA-2013-N-0461]. General and plastic surgery devices: reclassification of ultraviolet lamps for tanning, henceforth to be known as sunlamp products and ultraviolet lamps intended for use in sunlamp products. http://www.gpo.gov/fdsys/pkg/FR-2014-06-02/pdf/2014-12546.pdf. Accessed 28 Nov 2014.

US Food and Drug Administration. FDA to require warnings on sunlamp products. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm399222.htm. Accessed 28 Nov 2014.

Department of Health and Human Services. Food and Drug Administration. Guidance for Industry. Warnings and precautions, contraindications and boxed warnings sections of labeling for human prescription drugs and biological products—content and format. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf. Accessed 28 Nov 2014.

Guy GP Jr, Berkowitz Z, Tai E, Holman DM, Jones SE, Richardson LC. Indoor tanning among high school students in the United States, 2009 and 2011. JAMA Dermatol. 2014; 150:501–511.PubMedCrossRef

Guy GP, Berkowitz Z, Watson M, Holman DM, Richardson LC. Indoor tanning among young non-Hispanic white females. JAMA Intern Med. 2013;173:1920–1922.PubMedCrossRef

Wu X, Groves FD, McLaughlin CC, Jemal A, Martin J, Chen VW. Cancer incidence patterns among adolescents and young adults in the United States. Cancer Cause Control. 2005;16(3):309–320.

US Department of Health and Human Services. The Surgeon General’s call to action to prevent skin cancer. Washington, DC: US Department of Health and Human Services, Office of the Surgeon General; 2014. http://www.surgeongeneral.gov/library/calls/prevent-skin-cancer/call-to-action-prevent-skin-cancer.pdf. Accessed 24 Nov 2014.

Guy GP, Berkowitz A, Jones SE, Olsen EO, Miyamoto HN, Michael SL, et al. State indoor tanning laws and adolescent indoor tanning. Am J Public Health. 2014;104:e69–e74.PubMedCrossRef

Obayan B, Geller AC, Resnick EA, Demierre MF. Enacting legislation to restrict youth access to tanning beds: a survey of advocates and sponsoring legislators. J Am Acad Derm. 2010;63:63–70.PubMedCrossRef

10.

US Federal Trade Commission. Indoor Tanning Association settles FTC charges that it deceived consumers about skin cancer risks from tanning. FTC File No. 0823159. (January, 2010) Available at: http://www.ftc.gov/opa/2010/01/tanning.shtm. Accessed 11 Dec 2014.

11.

US House of Representatives Committee on Energy and Commerce. New report reveals indoor tanning industry’s false and misleading practices. February 1, 2012. Available at http://democrats.energycommerce.house.gov/index.php?q=news/new-report-reveals-indoor-tanning-industry-s-false-and-misleading-practices. Accessed 28 Nov 2014.

12.

Attorney General of the State of New York Health Care Bureau. In the Matter of 750 6th Avenue Tans, LLC. Assurance No. 14-039, March 24, 2014. http://www.ag.ny.gov/sites/default/files/pdfs/bureaus/health_care/new/2014-03-24%20Hollywood%20Tans%20NYC_BC.pdf. Accessed 28 Nov 2014.

Title: Teens and Indoor Tanning: Time to Act on the US Food and Drug Administration’s Black-Box Warning
Authors: Mark Gottlieb, JD
Sophie J. Balk, MD
Alan C. Geller, MPH, RN
Jeffrey E. Gershenwald, MD
Publication date: 01-03-2015
Publisher: Springer US
Published in: Annals of Surgical Oncology / Issue 3/2015
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-014-4257-6

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Teens and Indoor Tanning: Time to Act on the US Food and Drug Administration’s Black-Box Warning

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