Regulatory Focus™ > News Articles > Tanning Beds to be Subject to more Stringent Regulatory Requirements in Light of Cancer Risks

Tanning Beds to be Subject to more Stringent Regulatory Requirements in Light of Cancer Risks

Posted 07 May 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) on Monday announced its intent to reclassify and rename ultraviolet tanning bed products, explaining that the products are associated with a 75% increase in the risk of melanoma and thus should not be used by children.

Background

At present, the tanning beds-which FDA wants to reclassify as "sunlamp products"-are Class I medical devices that are exempt from premarket review procedures.

The devices have been marketed since before the 1976 Medical Device Amendments, which effectively regulated medical devices for the first time by instituting basic requirements for safety and effectiveness.  In 1977, an FDA panel advised that the products, then known as UV lamps, be classified as Class II medical devices and subjected to FDA's "special controls" regimen.

While those recommendations were accepted, a change by FDA in 1982 would prove important: Only UV lamps meant for dermatological disorders would be subject to the Class II controls, while UV lamps meant for tanning would still be classified as Class I medical devices. That rule was finalized in 1988, and was reaffirmed in 1990.

In 1994, restrictions were further relaxed for the device when FDA exempted UV lamps from premarket notification submission, though the agency notes that some of these companies had already received clearance from FDA for earlier premarket notification submissions, better known as 510(k) submissions.

New Assessment of Cancer Risks

But as FDA's proposed rule in the Federal Register on 6 May 2013 makes clear, those devices are far more dangerous than most consumers know.

"According to the American Academy of Dermatology, there is a 75% 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," FDA explained in a statement on its website.

Those risks are leading the agency to re-evaluate the way in which it regulated the devices, essentially clawing back the last three decades of its regulatory framework in favor of one that regulates the devices more stringently. Under the new classification, the devices would be moderate risk, Class II medical devices and subject to a 510(k) application that would need to be cleared by FDA.

A Risk to the Young

According to FDA, the biggest problem may not be the devices themselves-dangerous though they may be-but rather the audience with which the device is most popular: Young people, and particularly those under the age of 18.

The new order would require stringent labeling meant to warn those under the age of 18 of the consequences of using sunlamp products-a sort of Surgeon General's warning, but for ultraviolet light instead of cigarettes.

"FDA's proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information," FDA Commissioner Margaret Hamburg explained in a statement. While the proposed order would not prohibit the use of the products by those under 18-a position which would be difficult for FDA to enforce even if it did-it does require a statement to be displayed on the device indicating that people who frequent tanning beds should be regularly screened for melanoma and other forms of skin cancer.

The proposed rule is available for comment for 90 days after 9 May 2013, when it is scheduled for official publication in the Federal Register.


FDA Federal Register Notice

FDA Statement


Tags: 510(k)

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