May 7, 2013
FDA Proposing Stricter Warning Labels For Indoor Tanning Beds
redOrbit Staff & Wire Reports - Your Universe Online
The US Food and Drug Administration (FDA) is pushing for stricter warning labels on tanning beds — labels which would recommend that such devices not be used by anyone under the age of 18.According to Liz Szabo of USA Today, sunlamp products that emit ultraviolet radiation are currently regulated as class 1 devices, putting them in the same “low-risk” category as adhesive bandages and tongue depressors.
Class 1 devices do not need to be reviewed by the FDA before they go to market, Jeff Shuren, director of the agency´s Center for Devices and Radiological Health, told Szabo. However, under the agency´s proposed regulatory changes, tanning lamps would be reclassified as “moderate-risk” class 2 devices, placing them in the same category as CT scanners.
“Using indoor tanning beds can damage your skin and increase your risk of developing skin cancer,” FDA Commissioner Dr. Margaret A. Hamburg said in a statement. “The FDA´s proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information.”
If the reclassification is approved, manufacturers would need to notify the FDA before putting their devices on sale, proving that they meet specific performance testing requirements. They would also have to address some characteristics of the product design and include comprehensive labeling addressing the risks of using the tanning beds. Those labels would have to include a warning that the devices should only be used by adults, and that frequent sunlamp users should undergo regular skin cancer screenings, the agency said.
Shuren told Szabo that the changes were first recommended by an FDA advisory panel three years ago, and that reviewing tanning machines before they went on sale would help ensure that they were operating safely. He added that the agency is concerned about software issues that could cause timer malfunctions, which in turn could expose users to too much radiation, as well as electrical failures that have resulted in customers getting burned.
“The FDA's proposed regulations stop short of recommendations made by the International Agency for Research on Cancer, part of the World Health Organization, which in 2009 concluded that commercial tanning devices were more dangerous than previously thought and recommended people under 18 be banned from using them,” Toni Clarke of Reuters explained.
“The FDA's regulations also stop short of new rules being developed by some US states,” she said, noting that more than three-fifths of all states regulate the use of tanning facilities to some degree. “Delaware, New Hampshire and North Dakota, for example, ban the use of indoor tanning by anyone under age 14 unless medically necessary and they require parental consent for those between the ages of 14 and 18.”
Georgia, Illinois and Maine are among the states banning the use of beds for children under the age of 14, and in January, California became the first state to prohibit use of tanning beds by those under 18 years of age. Eighteen other states require operators of those facilities to limit exposure time to manufacturers´ recommendations while also providing eye protection to users, according to Reuters.
“An estimated 5.6 percent of U.S. adults reported indoor tanning at least once in 2010, with the highest rates among white, female 18 to 25-year-olds, according to the CDC, which notes that frequent exposure to UV rays for people under the age of 35 increases the risk of developing melanoma by 75 percent,” Clarke added.