Indoor Tanning Lamps Get New FDA Hazard Classification
Federal health officials have proposed recategorizing all tanning beds as a moderately dangerous medical device due to the risk of cancer, requiring new label warnings that would indicate youths should not to use them.
The FDA announced a proposed rule on May 6, which would put tanning beds and similar products into a category known as sunlamps and reclassify the devices from a class I (low risk) medical device category to a class II (moderate risk) device.
The classification will not ban tanning bed use by those under the age of 18, but warns against children using a sunlamp.
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“Using indoor tanning beds can damage your skin and increase your risk of developing skin cancer,” said FDA Commissioner Dr. Margaret Hamburg. “The FDA’s proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information.”
The reclassification still needs to be finalized, but once that happens all sunlamp manufacturers will have to go through the FDA’s 510(k) approval process. The process, which is controversial because of its lack of testing requirements, typically only requires that a product show that it is substantially equivalent to an existing device that has been approved by the FDA.
The FDA indicates that putting tanning beds through the 510(k) process for approval will force manufacturers to make sure that their products have met some performance testing requirements and design characteristics. It will also require that they all carry label warnings, which would include a contraindication for people under 18 years old and would also warn that frequent use could increase the risk of skin cancer.
Tanning Bed Cancer Risks
The FDA reports that the American Academy of Dermatology estimates that there is a 75% increased risk of melanoma, an often deadly form of skin cancer, for people who use tanning beds. That risk increases every time they tan.
Concerns over indoor tanning came to the forefront following a report by the World Health Organization in July 2009, which determined that ultraviolet radiation from tanning beds was a definite carcinogen.
Approximately 70,000 Americans are diagnosed with melanoma each year, causing nearly 9,000 deaths annually. Another 170,000 cases of non-melanoma skin cancer are found each year, linked directly to indoor tanning bed use.
The tanning bed industry has fought against pending restrictions even as study after study linked indoor tanning, particularly among young, white females, to increased skin cancer risk. New Jersey, California and Vermont now all ban the use of tanning beds by minors, and 30 states have some form of restriction on their use.
The proposed reclassification has been added to the Federal Register, the public and interested parties have 90 days to comment before a final determination is made.
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