FDA Orders Tougher Rules On Tanning Beds

Issue 24 Winter/Spring 2015

All sunlamp products must now carry 'Black Box' warning label warning against use by those under 18

Picture of a tanning bed

Stopping short of a full ban on tanning bed use by minors, the U.S. Food and Drug Administration earlier this year tightened its regulatory control of a major culprit behind skin cancers: tanning beds.

All sunlamp products — which include tanning beds and tanning booths — must now carry the FDA's strictest "Black Box" warning stating that the product should not be used by people under the age of 18.

These products have also been moved from "low-risk" (class I) device status to the "moderate-risk" (class II) category in terms of their impact on human health, the FDA said.

In an agency statement, Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, called the move "an important step" in reducing the risk to the public.

"Repeated UV exposure from sunlamp products poses a risk of skin cancer for all users — but the highest risk for skin cancer is in young persons under the age of 18 and people with a family history of skin cancer," he noted.

Besides adding the new warning label to sunlamp products, the FDA is mandating that certain sunlamp marketing materials also carry messages such as, "Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer."

Many studies have shown that the regular use of indoor tanning raises skin cancer risk. According to the American Academy of Dermatology (AAD), regular visits to tanning booths or salons boost a person's odds for melanoma, the deadliest skin cancer, by 59 percent.

Dr. Mary Maloney, former chairwoman of the AAD's regulatory policy committee, said the new warning label sends a powerful message to tanning salons, many of which claim their products are safe.

"Now [salons] won't be able to deny that there's any risk to indoor tanning because there will be a label and warnings," she told the The New York Times.

Bumping sunlamp products from class I to class II status also gives the FDA more control over the devices.

According to the Times, manufacturers who hope to have their products approved for use will now have to make sure that the devices don't emit so much UV radiation that they could cause burns, and they must ensure that timers or alarms on tanning beds work properly, to cut down on overuse.

The FDA will require models that do not meet the new standards to be pulled from the market by 2015.

Of course, many cancer-prevention advocates had hoped that the FDA would implement a full ban on use of tanning beds by minors. Nancy Stade, deputy director for policy at the FDA's Center for Devices and Radiological Health, told the Times that such a move might still be possible in the future.

According to the AAD, nearly 30 million Americans patronize tanning salons each year — including almost 30 percent of white girls in high school. That's an especially troubling statistic, experts say, because high exposure to UV rays in childhood is a key factor in risk for melanoma later in life.

However, advocates in the fight against skin cancer called the FDA move a healthy step forward.

"It's huge," Dr. Eleni Linos, an assistant professor of dermatology at the University of California, San Francisco, told the Times. "We've been trying to get the FDA to change its rules both on labeling and classification of tanning beds for a really long time. It indicates the FDA is finally taking into account the evidence that tanning beds are dangerous."