By Mary E. Maloney, MD, FAAD
As a Massachusetts native, I am very familiar with one of the most prestigious marathons in the world — the Boston Marathon. People from around the world train and race their hearts out just to qualify for the Boston Marathon. And once they’re in, they still have to run 26.2 miles! My daughter runs the marathon, and I am there cheering her and all the runners, cow bell ringing.
All marathons are a test of endurance. I can confidently say that the American Academy of Dermatology Association’s (AADA) recent milestone victory regarding the FDA’s actions on indoor tanning devices was no sprint, but rather part of a marathon. For years, the AADA aggressively worked to strengthen regulations around tanning devices, and the FDA’s final order represents the fruits of our labors. However, we have not reached the finish line yet.
A recap: FDA final order on indoor tanning devices
Late in the month of May — coincidentally Melanoma/SkinCancer Detection and Prevention Month — the FDA issued a final order that strengthens regulations of tanning beds by issuing a strong recommendation against the use of tanning beds by minors under 18; reclassifying indoor tanning devices from a Class I to a Class II medical device; and requiring labeling that clearly communicates the risk of skin cancer to all users.
Prior to the FDA’s final order, indoor tanning devices were categorized as Class I — the category for items that have minimal potential to cause harm to individuals, such as adhesive bandages and tongue depressors. With a Class II reclassification, tanning bed and lamp manufacturers will be required to show that their products have met certain performance testing requirements.
In addition, tanning bed and lamp manufacturers will be required to label the devices so that they:
- Clearly inform consumers about the risks of using tanning beds;
- Warn frequent users of sunlamps to be regularly screened for skin cancer; and
- Alert users that tanning lamps are not recommended for people under 18 years old.
There is no doubt: the AADA worked very hard to get this far and the FDA’s actions represent a huge win for us and for our patients. However, there is more work that needs to be done to prohibit the sale and use of indoor tanning devices.
With a Class II reclassification, tanning bed and lamp manufacturers will be required to show that their products have met certain performance testing requirements.
State youth access laws
The FDA’s actions sent a strong message to states about the real danger of indoor tanning and will hopefully serve to encourage additional states to strengthen indoor tanning restrictions — at a minimum — for minors under the age of 18. Currently, more than 24 states restrict access to indoor tanning beds by minors, and nine states outright restrict minors under the age of 18 from using indoor tanning devices. The AADA will continue to pursue state legislation that restricts minors from using indoor tanning devices. Learn more about state legislation and regulations on this issue.
Movement at other government agencies
In addition to the FDA’s actions, the CDC is also eyeing this issue and looking for ways to protect the public from the dangers of UV exposure. Last year, the AADA responded to the CDC’s request for information about ways to prevent skin cancer by reducing UV exposure. The CDC will use the information to work with the Office of the Surgeon General to formulate a plan to address this public health issue. The AADA will continue to be there to help.
The FDA final order is an incredible achievement but is only a part of a larger race. Nearly 30 million people tan indoors in the United States annually. Of these, 2.3 million are teens. As dermatologists, we have seen the devastating effects that indoor tanning has had on our patients. Now is the time to ride this wave of momentum to achieve the ultimate goal of prohibiting the use and sale of indoor tanning devices for minors.
Dr. Maloney is former chair of the American Academy of Dermatology Association Regulatory Policy Committee. She serves as chair of the Ad Hoc Task Force on State Society Relationships, and Vice Chair of the Professionalism & Ethics Committee. Dr. Maloney is chief of the division of dermatology at the University of Massachusetts in Worcester.
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