Indoor Tanning Hazards Prompt Further Safety Proposals

FDA Seeks to Restrict Sunlamp Use to Adults, Mandate Informed Consent

December 23, 2015 02:05 pm News Staff

Generally speaking, the adage "Moderation in all things" offers sound advice. But when it comes to teens and indoor tanning, even a little is too much. That's the thinking behind the first of two proposed rules the FDA issued Dec. 18.

[Tanning bed]

Roughly 1.6 million minors tan each year, according to the latest survey data, and that boosts their risk for skin cancer and other adverse effects, including eye damage. Statistics from the American Academy of Dermatology( indicate that exposure to ultraviolet (UV) radiation from indoor tanning hikes melanoma risk by 59 percent, and the effects are cumulative.

In response to this public health threat, the FDA is proposing( to restrict the use of sunlamps and indoor tanning devices solely to individuals age 18 or older. Furthermore, the agency seeks to ensure that adults are aware of the dangers of exposure to UV radiation from indoor tanning by requiring them to sign a risk acknowledgement certification before they tan and by mandating that they, along with tanning facility operators, be provided a user manual for any sunlamp product being used if they so request.

"The FDA understands that some adults may decide to continue to use sunlamp products," said acting FDA Commissioner Stephen Ostroff, M.D., in a news release.( "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."

In a second proposed rule, FDA officials would require manufacturers of these devices and tanning facility operators to take additional actions to safeguard users. Among specific changes the agency is calling for are

  • making device warnings more prominent and easier to read;
  • requiring an emergency shut-off switch (i.e., a "panic button");
  • improving eye safety by requiring limits on the amount of light allowed through protective eyewear;
  • improving labeling on replacement bulbs to ensure tanning facility operators are using the right bulbs; and
  • prohibiting dangerous device modifications, such as installing more powerful bulbs, without recertifying the device with the FDA.

These latest proposals continue the agency's efforts to protect consumers from the potentially harmful effects of sunlamp products used in indoor tanning devices. In May 2013, for example, the FDA issued an administrative order( that sought to reclassify the products from falling under a "general controls" designation exempt from premarket review to a "special controls" designation that would require this review. Such a reclassification would permit the agency to institute stricter regulations to safeguard the public, especially minors.

The Academy supported that action,(2 page PDF) writing FDA Assistant Commissioner Leslie Kux to commend the agency for basing the change "on an assessment of new and valid scientific data related to the health benefits and risks associated with sunlamp products."

Citing the AAFP's own clinical recommendations on preventing and screening for skin cancer, (then) Board Chair Glen Stream, M.D., M.B.I., also recommended that FDA officials "produce consumer education materials on the dangers of indoor tanning."

"We encourage the agency to consider additional regulations and educational materials that further address the public health risks associated with sunlamp products," he said.

When that order was finalized in May 2014, the FDA also required all sunlamp products to carry an easy-to-read black box warning stating that they should be used only by people 18 or older.

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