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.
MAY 4 — The American Suntanning Association (ASA) congratulates West Virginia lawmakers this week for enacting parental-consent legislation that ASA supported and that professional sunbed centers have used as a standard for years.
West Virginia Gov. Earl Ray Tomblin signed the law May 1, which will take effect in July. It formalizes the protocol professional salons have already had in place: Requiring parents to sign consent for teenagers to use sunbeds in a salon. This standard recognizes that many medical professionals believe sunburn prevention — not total sun avoidance — is what needs to be emphasized in public policy on this topic.
ASA this spring encouraged the West Virginia House of Representatives to enact the standard as a practical alternative to legislation in the West Virginia Senate that would have banned all teenagers from using sunbeds in a salon. Total bans would lead families who wish to tan to unregulated home sunbeds and more-frequent outdoor tanning — both of which are more likely to lead to sunburn and overexposure.
“Nationwide, ASA is working with state legislatures to support informed parental consent as the standard for sunbed usage by teenage clients,” ASA President Bart Bonn said. “We have always supported constructive legislation on this topic.”
The American Suntanning Association (ASA) is the largest network of professional businesses dedicated to providing responsible indoor tanning services while increasing public awareness about the facts associated with moderate UV and spray-on tanning. For more information about ASA visit www.AmericanSuntanning.org.
A recent episode of MTV’s “True Life” followed two young adults that were self-proclaimed “tanning addicts.” The episode was filled with misconceptions about tanning, including outdoor, indoor and spray tanning. As the leader in responsible tanning, the American Suntanning Association wants to clear up some of that misinformation.
Nobody should tan indoors or outdoors multiple times a day. Moderate indoor suntanning is all about looking good while reducing the risk of sunburn. Trained indoor suntanning operators, with the help of session management software, won’t allow customers to tan more than once in a 24-hour period. Operators also control all exposure times to minimize a client’s risk of overexposure and sunburn.
The “75% increased risk of melanoma” statistic is misleading. This statistic came from a World Health Organization study that combined the data from medical phototherapy equipment, unsupervised home units and commercial sunbeds. Results of the study showed medical equipment to increase risk 96%, unsupervised home units 40%, and commercial sunbeds only 6%, which is statistically insignificant. The statistics were combined for the 75% and incorrectly attributed to sunbeds.
Spray tanning is not just like applying makeup to your skin. The primary ingredient used in most spray-on tanning equipment today is called dihydroxyacetone (DHA). DHA, a colorless sugar, interacts with the outermost layer of the skin to darken skin color in a period of several hours. It takes about 12-24 hours for the DHA in your skin to reach its full tanning potential and a spray-on tan can last as long as 7-10 days. Some spray solution does include an instant bronzer to give instant results while the DHA darkens. Spray tanning does not offer any sunburn prevention.
The American Suntanning Association is a values-based coalition of suntan centers committed to teaching the vision of responsible and balanced sun care. For more information, visit TanResponsibly.com.
The Biebs was spotted at a tanning salon in Paris! Not sure if he was there for a spray tan or a UV tan, but he’s looking great either way!
Meredith Hoffman at DNAInfo.com reports on alternative reasons people regularly visit tanning salons.