March 21, 2016
Comments on Proposed Rule
Proposed Amendment to Performance Standard
[Docket No. FDA-1998-N-0880]
Since there are virtually no medical benefits to using commercial sunlamp products (tanning beds) and the World Health Organization’s (WHO) International Agency for Research on Cancer (IARC) classified indoor tanning devices as carcinogenic to humans, 1 we are writing as members of the Patient, Consumer, and Public Health Coalition to recommend that the Food and Drug Administration (FDA) ban the devices entirely (see our comments on the proposed rule regarding Restricted Sale, Distribution, and Use of Sunlamp Products, Docket No. FDA-2015-N-1765).
In the meantime, however, we support the proposed rule to update the performance standard for sunlamp products to “improve consumer safety.”2
We agree with the FDA that the adverse effects of ultraviolet radiation are well known and that sunlamp products emit UV radiation. In addition to long-term exposure causing skin cancer (including squamous cell carcinoma, basal cell carcinoma, and melanoma), the adverse effects from UV radiation include sunburns and ocular melanoma.2
FDA’s performance standards for sunlamp products have not been updated in more than 30 years. Since then, there have been changes in the FDA’s understanding of how UV radiation interacts with human skin, and there have been many changes in indoor tanning equipment.2
Below are our specific comments on the proposed updated standards:
We strongly support the requirement that the emergency stop button (sometimes referred to as the ‘panic button) “be easily accessible and readily identifiable to the user.”2
We strongly support FDA’s proposal to modify the warning statements on sunlamp products to make them shorter and more user-friendly so that they “more effectively communicate the risks of indoor tanning to users.”2 We support retaining the requirement that label information must be “legible and readily accessible to view by a sunlamp product user immediately prior to use” (emphasis added).2 We also support the added requirement that the warning statement be in all catalogs, specification sheets, brochures, and websites.
We strongly support FDA’s efforts to require that manufacturers of protective eyewear maintain test records that show their products comply with UV requirements.
We strongly support the proposed rule to use the International Electrotechnical Commission’s (IEC) “equivalency code” system to make sure that the correct replacement UV lamp bulbs are used. Currently, there is confusion over the compatibility requirement for lamp replacements, which could lead to a lamp being used that puts out more UV radiation than it is supposed to.
An estimated 77.000 new cases of melanoma are diagnosed in the United States every year, resulting in approximately 9,500 deaths.3 And, every year in the U.S. approximately 400,000 cases of skin cancer (including melanoma) are caused by indoor tanning, according to the American Academy of Dermatology.4
We strongly support the FDA’s proposed rule to update the performance standards for sunlamp products because much stronger standards are necessary to reduce “sunburn, photokeratitis, skin cancer, cataracts, and ocular melanoma” by limiting exposure to UV radiation.2 However, those standards should be merely a first step. The FDA should go even further to protect the public health by banning commercial sunlamp products entirely.
American Medical Women’s Association
Cancer Prevention and Treatment Fund
MRSA Survivors Network
National Physicians Alliance
Our Bodies Ourselves
Washington Advocates for Patient Safety
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at firstname.lastname@example.org
- BMJ (2012). Boniol M, et al. Cutaneous melanoma attributable to sunbed use: systematic review and meta-analysis. href=”http://www.bmj.com/content/345/bmj.e4757″>http://www.bmj.com/content/345/bmj.e4757 ▲
- Federal Register (December 22, 2015). Proposed rule: Sunlamp Products; Proposed Amendment to Performance Standard. ▲
- National Conference of State Legislatures. Web page: Indoor Tanning Restrictions For Minors – A State-By-State Comparison. href=”http://www.ncsl.org/research/health/indoor-tanning-restrictions.aspx”>http://www.ncsl.org/research/health/indoor-tanning-restrictions.aspx ▲
- American Academy of Dermatology web page. href=”https://www.aad.org/advocacy/skin-cancer-and-indoor-tanning/stop-skin-cancer”>https://www.aad.org/advocacy/skin-cancer-and-indoor-tanning/stop-skin-cancer ▲