FDA action on indoor tanning: What is a 'proposed order' anyway?


By Mary E. Maloney, MD, FAAD

On May 6 this year, we dermatologists all awoke ready to paint the nation orange for Melanoma Monday®.  Perhaps what we were not expecting, however, was that the U.S. Food and Drug Administration (FDA) would chose this very important day to propose to strengthen its regulation of indoor tanning devices to a Class II designation, and proposed a recommendation against the use of tanning beds by minors under the age of 18.

Although the American Academy of Dermatology Association (AADA) recognizes that there is more work to be done, this is a very important first step in protecting the public from these dangerous devices.

However, I can imagine that many of us in orange were thinking, “What is a proposed order? Why would the FDA only recommend against the use of indoor tanning bed by minors under the age of 18?”

Unlike the efforts to reclassify tanning beds in the past, the FDA is using a new process to put this effort forward known as a proposed order. This is a much faster regulatory process and could mean that this reclassification could be a full-fledged rule by November this year. However, because it is a proposed order — and not a traditional rulemaking process, which we’ve seen before with the FDA — the agency does not have the authority to restrict a specific population from using a device, including age restrictions. However, this is not to say that the FDA won’t decide to seek complete restriction of tanning beds in the future – especially if this proposed order receives strong support and  is finalized.

It is for this reason that it is absolutely imperative that every dermatologist makes their voice heard and shares their support for this proposed order with the FDA before the 90-day comment period closes on Aug. 7. This proposal faces significant opposition from the indoor tanning industry, and the FDA needs to hear from the physicians who treat the victims of these dangerous devices. To make it easy, the AADA has developed a template letter for dermatologists to copy and submit to the FDA before the deadline.

The FDA’s proposal is an incredible step in the right direction. As dermatologists, we see first-hand the consequences of indoor tanning. We have diagnosed too many young people with melanoma. And while we recognize that there is still more work to be done, we need to step up as a specialty and support this life-saving initiative.

Dr. Maloney is chair of the American Academy of Dermatology Association Regulatory Policy Committee. She serves as chair of the Leadership Development Steering Committee and chief of the division of dermatology at the University of Massachusetts in Worcester.

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