Addressing health concerns related to indoor tanning beds, the FDA is issuing two proposals that would restrict minors from using indoor tanning beds, regulated as sunlamp products, and require adults to sign documentation stating awareness of potential health risks prior to use of tanning beds; and sunlamp manufacturers and tanning facilities would be required to take additional measures to improve the overall safety of these devices. The proposed rules will be officially published in the Federal Register on December 22, 2015 and available for public comment for 90 days.
According to the Centers for Disease Control and Prevention (CDC), an average of more than 3,000 emergency department room visits occurred for injuries related to indoor tanning each year in the U.S. between 2003 and 2012. Indoor tanning is a known contributor to skin cancer, including melanoma, and other skin damage. Overall, the proposed device requirements and restrictions would apply to manufacturers and tanning facility operators. 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 in the U.S.
In an advance release of the first Proposed rule, use of sunlamp products would be restricted to individuals 18 and older. CDC data reported in the 2013 National Youth Risk Behavior Survey indicated that almost 1.6 million minors indoor tan each year, increasing their risk of skin cancer and other damage. According to the American Academy of Dermatology, those who have been exposed to radiation from indoor tanning are 59 percent more likely to develop melanoma than those who have never tanned indoors. In addition, the effects of exposure to UV radiation add up over one’s lifetime. Therefore, UV radiation exposure in children and teenagers puts them at a greater risk for skin and eye damage later in life.
In addition to the age restriction, adult users over age 18 would have to sign a risk acknowledgement certification that states that they have been informed of the risks to their health that may result from use of sunlamp products before their first tanning session and every six months thereafter.
Device safety measures
In an advance release of the second Proposed rule, sunlamp manufacturers and tanning facilities would have additional requirements imposed related to safe use of the devices. Specifically, some of the key proposed changes would include: (1) making warnings easier to read and more prominent on the device; (2) requiring an emergency shut off switch, or “panic button”; (3) improving eye safety by adding requirements that would limit the amount of light allowed through protective eyewear; (4) 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; and (5) prohibiting dangerous device modifications, like installing stronger bulbs, without re-certifying and re-identifying the device with the FDA.
The second FDA proposal would incorporate certain elements of the International Electrotechnical Commission (IEC) International Standard 60335-2-27 to harmonize the FDA standard with the current IEC standard. Harmonization would benefit sunlamp product manufacturers because many firms producing sunlamp products for sale within the United States and abroad have to follow both IEC and FDA standards. Aligning these standards would mean that such firms would need to comply with a single set of rules instead of two different ones.