WASHINGTON, DC – Today, over four years after the World Health Organization (WHO) labeled UV-emitting tanning bed devices a carcinogen, a group of nine U.S. Senators led by Jack Reed (D-RI), are urging the Food and Drug Administration (FDA) to promptly finalize rules reclassifying tanning lamps and beds as Class II medical devices. 

On May 6, 2013 the FDA released a proposed order that would reclassify ultraviolet tanning devices as moderate risk devices (Class II), which would require them to bear warning labels about the risk of cancer, alerting people to the dangers associated with their use.  The proposed order also sought comment on the use of these devices by minors.

The Senators wrote FDA Commissioner Hamburg: “We write to urge the Food and Drug Administration (FDA) to finalize its proposed order to reclassify sunlamp products to Class II medical devices promptly, update the warning labels on sunlamps, and restrict minors under the age of 18 from the use and purchase of sunlamps.  We commend the FDA for taking an important first step in protecting individuals from the dangers of sunlamp products with its proposed order. Indeed, indoor tanning is a growing health issue.  One million Americans, approximately 70 percent of whom are girls and women, visit a tanning salon each day.” 

Joining Reed in sending the letter were U.S. Senators Tom Harkin (D-IA), Patrick Leahy (D-VT), Robert Menendez (D-NJ), Sheldon Whitehouse (D-RI), Richard Blumenthal (D-CT), Diane Feinstein (D-CA), Elizabeth Warren (D-MA), and Jay Rockefeller (D-WV).

Currently, sunlamp products are classified as Class I medical devices, an indication that there is a reasonable assurance of its safety, much like that of other Class I medical devices such as elastic bandages and examination gloves.  However, according to an American Cancer Society study, people who utilize tanning beds are up to 75 percent more likely to develop skin cancer than those who do not.

Senator Reed is the author of the Tanning Accountability and Notification (TAN) Act, which 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, the FDA has not updated its warnings on tanning beds since 1979.

“This is a public health issue and a consumer protection issue.  The FDA should step up and help educate consumers.  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.

Reed noted that indoor tanning may particularly pose a potential health risk to young people.  Earlier this year, a study by dermatologists at the Washington University School of Medicine in St. Louis found that 65 percent of 250 tanning businesses surveyed would accept children ages 10 to 12, often without parental permission.  For the first time ever, the proposed FDA order considers applying a special control on the use of  tanning beds by persons under the age of 18.

“We also strongly urge the FDA to implement a special control on sunlamp products with respect to the use and purchase of the devices by minors under the age of 18. The WHO also reported that the risk of melanoma increases by 75 percent when use of sunlamps start before 35 years of age. As you know, age restrictions exist for the use and purchase of other known carcinogens, like cigarettes. To be sure, prohibiting minors under the age of 18 from using or purchasing sunlamp products would be consistent with existing rules and regulations,” the Senators concluded.

Full text of the letter follows (PDF attached):

Dear Commissioner Hamburg,

We write to urge the Food and Drug Administration (FDA) to finalize its proposed order to reclassify sunlamp products to Class II medical devices promptly, update the warning labels on sunlamps, and restrict minors under the age of 18 from the use and purchase of sunlamps.

We commend the FDA for taking an important first step in protecting individuals from the dangers of sunlamp products with its proposed order. Indeed, indoor tanning is a growing health issue. One million Americans, approximately 70 percent of whom are girls and women, visit a tanning salon each day. 

Currently, sunlamp products are classified as Class I medical devices, an indication that there is a reasonable assurance of its safety, much like that of other Class I medical devices like elastic bandages and examination gloves. However, there is documented risk of exposure to ultraviolet light stemming from sunlamp products. Moreover, in a review of 19 international studies, the World Health Organization (WHO) found that the use of sunlamp products increases the risk of skin cancer. Reclassifying sunlamp products to Class II medical devices would ensure a comprehensive pre-market review and that certain performance standards are met, consistent with riskier devices.

The proposed order would also update the warning labels on sunlamp products, which will help ensure consumers are aware that there is a risk of using these devices. Warning labels on sunlamp products have not been updated since 1979.

The Senators also called for the FDA to strengthen the warning labels directly on tanning devices so they are clearly visible consumers can easily understand them.  “The current out-of-date labels are printed in small typeface and often placed out of direct sight of the consumer.  This has been area of longstanding concern.  As such, we urge the FDA to require that the text and placement of sunlamp warning labels be revised, consistent with the “Alternative Warning Statement” outlined in the 2011 Report to Congress pursuant to Section 230 of the Food and Drug Administration Amendments Act of 2007,” the Senators wrote.

We also strongly urge the FDA to implement a special control on sunlamp products with respect to the use and purchase of the devices by minors under the age of 18. The WHO also reported that the risk of melanoma increases by 75 percent when use of sunlamps start before 35 years of age.  As you know, age restrictions exist for the use and purchase of other known carcinogens, like cigarettes. To be sure, prohibiting minors under the age of 18 from using or purchasing sunlamp products would be consistent with existing rules and regulations. 

Thank you for taking action to address the dangers posed by sunlamp products, and we look forward to working with you as you finalize this proposed order.

Sincerely,

Reed

Harkin

Leahy

Menendez

Whitehouse

Blumenthal

Feinstein

Warren

Rockefeller