FDA panel urges tanning bed restrictions

May 1, 2010

A Food and Drug Administration advisory panel has recommended reclassifying tanning beds and setting stricter limits for their use by minors. But whether the FDA will adopt these changes remains unclear, say sources who attended a March 25 General and Plastic Surgery Devices Panel meeting at which these and related manners were discussed.

Key Points

Washington - A Food and Drug Administration (FDA) advisory panel has recommended reclassifying tanning beds and setting stricter limits for their use by minors. But whether the FDA will adopt these changes remains unclear, say sources who attended a March 25 General and Plastic Surgery Devices Panel meeting at which these and related matters were discussed.

"The American Academy of Dermatology Association (AADA) supports a ban on the production and sale of indoor tanning equipment for nonmedical purposes," says William D. James, M.D., AAD president. "However, until this action occurs, the AADA supports shifting the classification of indoor tanning devices to the strongest possible category and placing additional restrictions on indoor tanning to protect the health and safety of Americans."

"The ACS believes there was ample testimony at the meeting to warrant the FDA's taking action to impose new regulations on tanning bed use, and perhaps manufacture. Ultimately, it depends on what the FDA decides to do," Dr. Lichtenfeld says.

FDA to review comments

However, in a posted summary of the meeting, the agency's Web site states: "The Panel's unanimous conclusion was that tanning lamps/beds should not be Class I devices," their current FDA regulation category.

"The science shows that these devices can potentially induce changes - DNA damage and tanning - that can result in skin cancer," he says.

Still, the FDA's summary states that some panelists recommended placing tanning beds in Class II, with additional controls based on the user's age, skin type and other factors.

Limiting UV

Attendees also discussed revising FDA performance standards to limit the amount of UV delivered by tanning beds. In this regard, says Allan C. Halpern, M.D., vice president of the Skin Cancer Foundation (SCF), "The highest priorities in the original set of standards related primarily to the risk of being exposed to electricity, direct skin burning and eye damage. Although there have been concerns raised by the FDA dating back to 1977 about the risk of skin cancer associated with these beds, that has never entered the standards."

Additional arguments against indoor tanning include the fact that "There is no known health benefit from exposing oneself to tanning lamps," Dr. Lim says. In fact, in 2009 the World Health Organization's International Agency for Research on Cancer (IARC) declared UV rays a Class I carcinogen, the same class as tobacco.