FDA Withdraws Proposal for Tanning Bed Age Limit

In response to more than 8,000 public comments, the FDA has withdrawn a proposal to restrict the sale and use of sunlamps, including tanning beds, in minors.

In a notice to be published in the Federal Register, the FDA cited concerns raised by public comments on the proposal, which was introduced in December 2015. The agency received comments related to the dangers of UV radiation exposure from sunlamp products, various “scientific aspects” of the proposal, vulnerability of young people to the risks of sunlamp products, support for personal choice and parental decision-making, availability and relative safety of sunlamp alternatives, and the compliance burden on small businesses.

According to the notice, the agency singled out “possible unintended consequences” of certain elements of the proposal and potential alternatives as factors in the decision to withdraw the proposal for further study and consideration. The action “does not preclude the Agency from reinstituting rulemaking concerning the issues addressed in the proposal.”

The decision quickly encountered pushback from the American Academy of Dermatology Association. In a statement, Susan C. Taylor, MD, president of the American Academy of Dermatology, cited the skin cancer risk associated with UV radiation from indoor tanning devices, with particular emphasis on young people.

“Using tanning beds before age 20 can increase the risk of developing melanoma by 47%, and the risk rises with each use,” said Taylor. “Adolescents who begin indoor tanning before age 18 are also more likely to continue their behavior into adulthood.”

“Restricting teens’ access to indoor tanning and informing the public about the dangers of indoor tanning are critical to preventing skin cancer,” she added. “As medical doctors who diagnose and treat skin cancer, dermatologists are committed to reducing its incidence and saving lives. We encourage the reintroduction of the proposed rule by the FDA.”

The FDA has taken other regulatory initiatives related to sunlamps, according to the notice, which had sign-off from HHS Secretary Robert F. Kennedy Jr. For example, a reclassification order that became effective in September 2014 reclassified sunlamp products and UV lamps to make them subject to premarket notification requirements. Additionally, the action established special controls that included performance testing and labeling requirements that included a warning that “sunlamp products should not be used on persons under the age of 18 years.”

In the meantime, the FDA will continue to consider regulatory initiatives related to sunlamp products, according to the notice.