On Monday, the FDA issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
According to the American Academy of Dermatology, there is a 75 percent increase in the risk of melanoma, the deadliest type of skin cancer, in those who have been exposed to ultraviolet radiation from indoor tanning, and the risk increases with each use. The proposed order does not prohibit the use of sunlamp products by those under the age of 18, but it provides a warning on the consequences.
The order would reclassify sunlamp products from a low risk device (class I) to a moderate risk device (class II). Examples of class I devices include surgical gloves and elastic bandages. Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said that such products are not required to be reviewed before going on the market.
Dr. Shuren said that contrary to claims by some manufacturers and salon owners, users frequently get sunburned while using the devices — a strong indication that indoor tanning contributes to skin cancer risk, according to MedPage Today.
The proposal would reclassify tanning beds as Class II devices — similar to CT scanners, which also expose users to radiation. “Using indoor tanning beds can damage your skin and increase your risk of developing skin cancer,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information.”
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. 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.
The Indoor Tanning Association, a Washington, D.C., trade group that represents tanning-bed makers and salon owners, said in a statement that it already adheres to the “highest professional standards” and is concerned the proposed changes would “burden our members with additional unnecessary governmental costs in an already difficult economic climate,” according to the Wall Street Journal.
The FDA will take comments on the proposed order for 90 days.