March 30, 2010 — A ban on tanning-bed use by people with the palest skin isamong several new restrictions recommended by an FDA advisory panel.
Earlier reports from the panel’s March 25 meeting focused on its advice torestrict tanning bed use to adults age 18 and older. But that wasn’t theonly restriction the panel advised the FDA to adopt.
Perhaps the most interesting change would be the panel’s recommendation toprohibit the use of tanning beds by people with Fitzpatrick skin type 1. Peoplewith this very pale skin type (such as red-haired people with freckles) getsunburns instead of tans when exposed to sunlight or tanning lamps.
The biggest recommended change is the panel’s unanimous proposal to changetanning beds’ Class I device designation, the least restrictive classificationintended for devices that pose minimal risk to users or operators. Elasticbandages and hand-held surgical devices are examples of Class I devices.
Half the panel supported making tanning beds Class II devices, which requirespecial assurances — such as labeling requirements or mandatory performancestandards — that they will not cause harm. Class II devices include X-raymachines and powered wheelchairs.
The other half of the panel wants tanning beds listed as Class III devices,which not only require special controls such as operator training requirementsbut require premarket approval by the FDA. Class III devices include implantedpacemakers and silicon breast-augmentation gels.
The panel also recommended other special controls:
- Strengthening current requirements for protective eyewear
- Equipping tanning beds with mechanisms that prevent their activation untila customer acknowledges reading and accepting a series of warnings about indoortanning risks
- A registry program for all tanning bed users, possibly supported by a userfee
- Strengthening requirements for tanning bed operator education, training,testing, and recertification
- Collection of data on the irradiance put out by tanning beds, possibly tobe included in the user registry
- Restricting tanning bed use by pregnant women and by people who takecertain drugs or use certain cosmetics that interact with UV light
- Even stronger restrictions on tanning beds sold for in-home use
The panel said there was no need to separately regulate tanning beds thatare UV-A only, UV-B only, or a mixture of both.
Response to Panel’s Proposed Tanning Bed Restrictions
Medical groups praised the panel’s recommendations.
“The skin cancer and dermatologic communities came together and presentedcompelling personal stories and rigorous scientific evidence demonstrating thedangers of indoor tanning,” Allan Halpern, MD, vice president of the SkinCancer Foundation, says in a news release. “The advisory panel made excellentrecommendations and now it’s up to the FDA to take action.”
The panel’s recommendations are another blow to the tanning industry, whichjust last week was hit by a 10% tax as part of the health care reform law.
The Indoor Tanning Association, which represents the 18,000 tanning salonsin the U.S., says it “respectfully disagrees” with the panelrecommendations.
In a statement provided to WebMD, the group says it feels that current FDAregulations are sufficient to protect “the millions of Americans who use ourservices each year.”
“Industry standard practices already are far more stringent than the currentFDA regulations require,” the statement says. “In fact, the U.S. tanningindustry abides by the strongest set of industry regulations found anywhere inthe world.”
The Indoor Tanning Association says tanning salons already:
- Provide customers with information on tanning bed risks via a signedconsent form
- Require teen users to have a parent’s signed approval
- Train staff members to recommend tanning schedules tailored to eachcustomer’s skin type to avoid sunburn or overexposure