The U.S. Food and Drug Administration on Monday announced a proposal to change pre-market manufacturing standards for sunbeds, including a suggestion that sunbed labels add a statement urging young people not to use sunbeds.
FDA’s proposal comes three years after a non-binding FDA advisory panel urged the agency to seek changes, including reclassifying sunlamp products as Class II medical device instead of a Class I device. The reclassification would require manufacturers to change the way they introduce new sunlamp products — a change that, by itself, does not change the end-consumer experience with sunbeds.
“If the order is finalized, manufacturers would have to submit a pre-market notification (510(k)) to the FDA for these devices, which are currently exempt from any pre-market review,” the FDA said in a statement. “Manufacturers would have to show that their products have met certain performance testing requirements, address certain product design characteristics and provide comprehensive labeling that presents consumers with clear information on the risks of use. The order proposes to include a contraindication against use on people under 18 years old, and the labeling would have to include a warning that frequent users of sunlamp products should be regularly screened for skin cancer.”
Sunbeds already include clear warning labels — labels the sunbed market worked with FDA to create. In a 2002 meeting with FDA, the sunbed community and FDA constructively agreed on changes to that warning label spurred by a 1999 request that sunbed rules be reviewed.
FDA has not involved the American Suntanning Association in development of the current proposal.
“The professional sunbed community has not had any input in this preliminary proposal thus far. We remain dedicated to sunburn prevention and look forward to working with the FDA to improve consumer protection and to assure that all information regarding indoor tanning is in accordance with the science,” the ASA said in a statement released to the media 30 minutes after Monday’s press conference.
The ASA will work with other industry groups to participate in the process with the FDA constructively.
The FDA will take comments on the proposed order for 90 days.
To read the FDA’s press release click here.
To read the FDA’s proposal, click here.
To read current FDA regulations, click here.