Yesterday, the FDA issued its final order reclassifying tanning beds from low-risk (class I) to moderate-risk (class II) devices. The order primarily impacts bed manufacturers, in that: (1) it requires that manufacturers include language on tanning beds that explicitly warns against use by persons under the age of 18 years; and (2) certain marketing materials promoting tanning beds must carry additional warning language and contraindications, including “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
While we are disappointed that the FDA did not actively include our industry in this process before issuing the order, it does not come as a complete surprise as it basically implements what the FDA proposed in May 2013. If your employees or customers ask, let them know we remain committed to responsible access to UV exposure for the millions of Americans who choose to tan.
There is nothing you need to do at the present time in your salons. The bed manufacturers have roughly 15 months before the warning labels are required. We’ll keep you updated on any more developments.
Please direct any questions to firstname.lastname@example.org.
American Suntanning Association