by Brian Wolfman
Yesterday, the Food and Drug Administration issued this proposed order regarding tanning beds. The FDA is proposing to reclassify these ultra violet devices to require more warnings — including that minors not use them at all — because they are a cancer hazard. The proposal would also require the products to meet certain perfomance standards. Basically, the problem is that hanging out in tanning
beds causes melanoma, an often fatal form of skin cancer. Tanning devices can also cause skin burns.
One ramification of the FDA's order (if finalized) is that manufacturers would be required to submit their tanning devices for pre-market review. The FDA would then review the product to determine whether it meets the warning requirements and various performance specifications outlined in the proposed order. (Under current law, tanning devices are exempt from any pre-market scrutiny.)
Here is an excerpt from the FDA's press release:
[T]he U.S. Food and Drug Administration 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). “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 FDA will take comments on the proposed order for 90 days.
Brady Dennis has written this Washington Post story on the FDA proposal.
