FDA considers revision of tanning bed warning

Skin & Allergy News, Jan, 2009 by Alicia Ault

The Food and Drug Administration is considering changing the warning label on indoor tanning beds to be shorter and more forceful, according to a report that the agency submitted to Congress and posted on its Web site in early December.

Congress required the FDA to take a closer look at the warning label as part of the FDA Amendments Act of 2007. Legislators were concerned that the current labeling does not effectively communicate the risks of skin and eye damage and skin cancer. The FDA missed the statutorily imposed September deadline, but did fulfill Congress' request to study the issue.

Currently, every "sunlamp product" is required to carry the warning established by the FDA in 1985. It is a para graph long, with various statements about the potential for damage, the need to wear protective eyewear (which is bolded), and a caution that a physician should be consulted if the tanner is using medications or has a history of skin problems. It also states, "Repeated exposure may cause premature aging of the skin and skin cancer."

The agency was directed to use consumer testing to determine whether these statements have had any impact.

The FDA conducted focus group meetings with a total of 48 participants. Each meeting was attended by both "experienced indoor tanners" and those who had never used the devices. The participants were split into three groups: teenagers aged 14-17 years who were in high school; adults with a college degree; and adults without a college degree.

The groups were asked to review the current warning and a new, shortened version, and were asked questions about each. The participants also were asked to look at a photo of a tanning bed and to state where they would be most likely to notice a warning.

According to the FDXs report, most of the focus group participants said that the new, alternative warning was easier to understand and that they would be more likely to pay attention to it.

The newer warning had a dearer format with bullet points stating, among other things, that ultraviolet radiation causes skin cancer, injury to the eyes and skin, and skin aging. The warning also said to avoid overexposure, wear protective eye wear, read instructions carefully, and to consult a physician before tanning.

The participants suggested placing the warning next to the control panel or on the head side of the canopy of the tanning bed and said that it should be away from other labels so "as not to detract from the label's importance."

The FDA would need to propose a rule to require new labels. According to the report, it "is considering amending the warning label requirements for sunlamp products to include specific formatting requirements to more clearly and effectively convey the risks that these devices pose for the development of irreversible damage to the eyes and skin, including skin cancer." The agency has also begun consumer education efforts, primarily through a section of its Web site.

However, the American Academy of Dermatology does not believe that a warning label on tanning beds is enough. "The Academy strongly believes that a warning label on the tanning equipment simply is not enough to influence an individual's decision to forego tanning. We hope that the TAN Act is a first step that will lead to more impactful legislation and regulation at the state and federal levels, which will restrict access to indoor tanning facilities for at least minors, and ultimately significantly reduce the incidence of skin cancer," Dr. C. William Hanke, AAD president, expressed in the statement.

The report to Congress can be found at www.fda.gov / cdrh / mdufma / reporttanning.html.

ALICIA AULT

Associate Editor, Practice Trends