(HealthDay News) – The U.S. Food and Drug Administration has proposed an order to reclassify sunlamp products from a low-risk to a moderate-risk device, which would require comprehensive risk labeling on such products.
The FDA has issued a proposed order that would reclassify sunlamp products from a class I low-risk device to a class II moderate-risk device. This would necessitate the use of labeling to include a recommendation to warn young people not to use these devices.
Sunlamp devices are currently exempt from any pre-market FDA review. However, if the order is finalized, manufacturers would have to submit pre-market notification to the FDA and would have to demonstrate that their products meet certain performance testing requirements, address specific design characteristics, and provide comprehensive labeling that presents consumers with clear information about the associated risks. The proposed order would include a contraindication against use by under-18-year-olds and a warning that frequent users should undergo regular screening for skin cancer. Comments can be submitted to the FDA for 90 days.
“Using indoor tanning beds can damage your skin and increase your risk of developing skin cancer,” Margaret A. Hamburg, MD, Commissioner of the FDA, 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.”