WASHINGTON, DC – At the urging of U.S. Senator Jack Reed (D-RI) -- the author of the Tanning Accountability and Notification (TAN) Act -- the U.S. Food and Drug Administration (FDA) today announced plans to reclassify sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products and tanning beds as Class II medical devices. 

Reclassifying these ultraviolet tanning devices as moderate risk devices (Class II) will require them to bear warning labels about the risk of cancer, alerting people to the dangers associated with their use.   The manufacturers of these sunlamp products will now include a visible black-box warning on the device that explicitly states that the sunlamp product should not be used on persons under the age of 18 years.  In addition, certain marketing materials for sunlamp products and UV lamps must include specific warning statements.

“This is a public health issue and a consumer protection issue.  I am glad the FDA is finally stepping up to help educate consumers about cancer risks and better protect young people.  Studies show that prolonged exposure to ultraviolet light can increase the risk of skin cancer.  Making warning labels more visible, and the dangers of indoor tanning more clear, will give consumers, especially young people, the information they need to better protect themselves,” said Reed, who also successfully pushed the FDA to implement sunscreen labeling standards.  “Today’s action is an important step to stem the troubling growth in the occurrence of skin cancer and melanoma in the United States, but there is still more to do.”

Reed’s Tanning Accountability and Notification (TAN) Act was signed into law in 2007, directing the FDA to review the warning labels on indoor tanning beds and approve a safe and effective national standard to educate consumers about the risks of prolonged exposure to ultraviolet light.  Reed’s law required the FDA to issue a report to Congress on whether the labeling requirements for indoor tanning devices provide sufficient information to consumers regarding the risks using these devices pose for the development of irreversible damage to the eyes and skin, including skin cancer.  Not surprisingly, the FDA found in its report to Congress that updating current labeling requirements for tanning beds would better protect consumers from irreversible skin damage.  The FDA’s report stated: “Based on its analysis of the results of the consumer study required by [law], FDA has determined that there are warnings that are capable of adequately communicating the risks of indoor tanning, and that a modified warning statement label may more effectively convey these risks than the current labeling requirements.  FDA has also determined that changes to the positioning requirements for the warning statement label may communicate such risks more effectively.”

However, before today, the FDA has not updated its warnings on tanning beds since 1979.

According to a January 2014 report published in JAMA Dermatology, over 419,000 cases of skin cancer in the U.S. can be attributed to indoor tanning.  This new finding supplements existing research that indicates melanoma risk increases by 75 percent for individuals exposed to tanning lamps, and the disturbing trends that show a rising incidence of melanoma among Americans while rates for other cancers have decreased.  These overwhelming figures underscore the pressing need for these FDA guidelines for sunlamp products to help prevent new cases of skin cancer and melanoma.

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