Regulatory Focus™ > News Articles > Final Rule Seeks More Stringent Regulation of Tanning Lamps

Final Rule Seeks More Stringent Regulation of Tanning Lamps

Posted 29 May 2014 | By Alexander Gaffney, RAC

Final Rule Seeks More Stringent Regulation of Tanning Lamps

The US Food and Drug Administration (FDA) has issued a final rule which will regulate ultraviolet lamps used for tanning more stringently, reflecting the lamps' association with skyrocketing rates of skin cancer.

Background

At present, sunlamp products—commonly used in tanning beds—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 devices 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 has argued, 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 wrote in 2013. The products pose "serious health risks," the agency reiterated in a March 2014 posting aimed at consumers.

So in May 2013, FDA proposed requiring all sunlamp products to fall under a Class II (moderate-risk) classification, thereby requiring them to adhere to general and special controls and to obtain market clearance through a 510(k) (also known as a premarket notification) application.

The rule proposed in 2013 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. The warning would be contained in a prominent black box on the product.

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.

Changes to the Final Rule

In response to the rule, FDA received a massive number of comments—more than 2,500, the agency said.

In response, FDA has made one significant change to the proposed rule. For example, while it originally planned to regulate "ultraviolet lamps" as "sunlamps," it said that commenters had convinced it that this definition was overly broad and not "sufficiently clear." Under the new rule, it indicates that the rule applies to "both sunlamp products and UV lamps intended for use in sunlamp products." Some labeling requirements will differ depending on if a product is a sunlamp product or a UV lamp, FDA explained.

Marketers of sunlamp and UV lamp products currently on the market will have 450 days (15 months) to submit a 510(k) to FDA after the rule is finalized (90 days). FDA said it intends to receive about 25 applications for these devices. The regulator said it intends to approve the products within approximately 90 days of "active FDA review," though in practice these reviews can often take much longer.

Products that do not have a submitted or cleared 510(k) at that time will be forced to cease marketing, FDA explained.

Crucially, FDA clarifies that all sunlamp products—regardless of whether they have already been sold or not—will have to adhere to the special labeling controls included in the guidance within 450 days. This requirement will either have to be borne by the sunlamp manufacturer or, if they are no longer in business, by the sunlamp product owners. Whether or not this will happen—of if the agency even has the authority to order this—is another question entirely.

Regardless of authority, the label will read:

"Attention: This sunlamp product should not be used on persons under the age of 18 years."

In addition, all advertising materials will be required to contain that same warning, along with contraindications against use in persons with skin lesions, open wounds, a history of skin cancer or active skin cancer. In addition, the promotional warnings should include one to be "regularly evaluated for skin cancer."

The regulation goes into effect in about 90 days.

Federal Register Notice

FDA Announcement


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