The first proposed rule would restrict use of sunlamp products to individuals 18 and older. In addition, before their first tanning session and every six months thereafter, adult users over age 18 would have to sign a risk acknowledgement certification that states that they have been informed of the risks to health that may result from use of sunlamp products.
The FDA’s second proposed rule would require that sunlamp manufacturers and tanning facilities take additional measures to improve the overall safety of these devices.
Specifically, some of the key proposed changes would include making warning easier to read and more prominent on the device; equiring 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; and prohibiting dangerous device modifications, like installing stronger bulbs, without re-certifying and re-identifying the device with the FDA.
The FDA says 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,” said acting FDA commissioner Stephen Ostroff, M.D. “Individuals under 18 years are at greatest risk of the adverse health consequences of indoor tanning.”
Ostroff added, “The FDA understands that some adults may decide to continue to use sunlamp products. 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 proposed device restriction 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. 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.
In July 2014, the Office of the Surgeon General issued a Call to Action to Prevent Skin Cancer, which included strategies for reducing indoor tanning among minors.
The proposed rules are available online at www.regulations.gov for public comment for 90 days.
The comment period closes March 21, according to FDA.