On December 18, citing the risk of skin cancer, the Food and Drug Administration (FDA) announced that it was proposing restricting the use of sunlamp products (i.e., indoor tanning beds) by minors and reducing the risk of using these devices for adults. The FDA noted that it is committed to protecting public health by informing consumers of the risks of indoor tanning.
“Today’s action is intended to help protect young people from a known and preventable cause of skin cancer and other harms,” explained acting FDA Commissioner Stephen Ostroff, M.D. He added, “Individuals under 18 years are at greatest risk of the adverse health consequences of indoor tanning.” Tanning beds are a known contributor to skin cancer, including deadly melanomas; however, 1.6 million minors use them each year; thus, increasing their risk of skin cancer and other damage. The FDA notes that the foregoing is based on data from the 2013 National Youth Risk Behavior Survey.
The American Academy of Dermatology claims that individuals who have been exposed to radiation from indoor tanning are 59% more likely to develop melanoma than those who have never tanned indoors. Furthermore, the effects of exposure to ultraviolet (UV) radiation add up over one’s lifetime. Thus, UV radiation exposure in children and teenagers places them at a greater risk for skin and eye damage later in life.
The FDA issued two proposed rules. The first proposed rule would restrict use of sunlamp products to individuals 18 and older. Furthermore, before their first tanning session and every six months thereafter, adult users over age 18 would have to sign a risk acknowledgement certification, which states that they have been informed of the risks to health that may result from use of sunlamp products. According to the Centers for Disease Control and Prevention (CDC), an average of more than 3,000 emergency department room visits occur for injuries related to indoor tanning each year in the United States, based on 2003-2012 data.
The second proposed rule issued by the FDA would require sunlamp manufacturers and tanning facilities to take additional measures to improve the overall safety of these devices. Specifically, some of the key proposed changes would include:
- Making warnings easier to read and more prominent on the device
- Requiring an emergency shut off switch, or “panic button”
- Improving eye safety by adding requirements that would limit the amount of light allowed through protective eyewear
- Improving labeling on replacement bulbs so tanning facility operators can make sure they are using the proper replacement bulbs, reducing the risk of accidental burns
- Prohibiting dangerous device modifications, such as installing stronger bulbs, without re-certifying and re-identifying the device with the FDA
“The FDA understands that some adults may decide to continue to use sunlamp products,” explained Dr. Ostroff. He added, “These proposed rules are meant to help adults make their decisions based on truthful information and to ensure manufacturers and tanning facilities take additional steps to improve the safety of these devices.”
The FDA notes that the proposed device restriction would apply to manufacturers and tanning facility operators. In the US, there are approximately 18,000 to 19,000 indoor tanning salons and 15,000 to 20,000 other facilities, such as health clubs, spas, and other commercial establishments, that offer tanning services. The FDA has information for consumers and businesses via the Division of Industry and Consumer Education (DICE). Also, additional guidance and information for industry is included in the proposed rules.
The proposed rules are available online at www.regulations.gov for public comment for 90 days.