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FDA Regulation of Indoor Tanning Devices and Opportunities for Skin Cancer Prevention

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JAMA

 

Almost 1 year ago, because of evidence of the risks of skin cancer and other health problems associated with indoor tanning, the US Food and Drug Administration (FDA) began regulating indoor tanning equipment as class II medical devices with black box warnings indicating they should not be used by minors younger than 18 years.1 Intended as a way to reduce skin cancer, FDA’s approach may be insufficient and puts the agency in the unusual situation of balancing the safety and health benefits of a technology with very limited therapeutic benefit with commercial interests. It is time for a broader public health approach to indoor tanning’s risks.

SKIN CANCER’S PREVENTABLE BURDEN

Skin cancer is the most common malignancy in the United States with nearly 4 million cases diagnosed each year, and the incidence is increasing.2 It is estimated that nearly $8 billion annually is accounted for by treatment, lost productivity, and other associated costs.2 Most skin cancer cases, including as many as 90% of melanomas, are preventable by reducing UV radiation exposure, especially in adolescence and young adulthood when much of the cancer-causing damage occurs.2

Although UV radiation exposure through sunlight is a leading contributor to skin cancer, one estimate suggests that more than 10% of annual skin cancer cases in the United States are related to indoor tanning, which significantly increases melanoma and nonmelanoma skin cancer risk.3 Even if this estimate is high and indoor tanning accounts for only 1%, 3%, or 5% of all skin cancers, then 40 000, 120 000, and 200 000 annual skin cancer cases, respectively, may be related to indoor tanning. In the US population, indoor tanning is most common among adolescents and young adults, particularly young women.2 Melanoma, the most deadly form of skin cancer, is among the most commonly diagnosed cancers among young women aged 15 to 39 years, with an estimated incidence of 9.7 per 100 000 women in this age group.2 The increased incidence of melanoma among young women is partially associated with the high prevalence of indoor tanning in this population.2

Darren Mays, PhD, MPH1; John Kraemer, JD, MPH2,3

For those in public health and cancer prevention, this is a familiar story, with parallels to efforts to reduce tobacco use that have only been successful in recent decades. Indoor tanning is most prevalent among youths and young adults and appears to be driven in part by perceptions that tanned skin is healthier and more attractive. Increasing evidence also suggests that indoor tanning may be an addictive behavior with a plausible underlying biological mechanism relating to the release of endogenous opioids on exposure to UV light.4 Indoor tanning industry marketing, promotions, and discounts also contribute to this behavior, often by targeting young people. The skin cancer risks associated with indoor tanning primarily manifest later in life, and the perceived benefits of tanned skin are thought by young people to outweigh future risks.2

 

WEAK REGULATION

FDA regulation of tobacco products through the Family Smoking Prevention and Tobacco Control Act is poised to reduce tobacco-related death and disease as the agency exercises its regulatory authority. Like tobacco products, a national regulatory framework designed to prevent and reduce indoor tanning could reduce public health burden and financial costs of skin cancer.

Indoor tanning devices are classified by the International Agency for Research on Cancer as carcinogenic to humans because of evidence of increased melanoma and nonmelanoma skin cancer risks associated with their use.2 Until recently, FDA regulated indoor tanning devices as class I medical devices presenting minimal risks and largely exempt from any premarket controls. Due in part to increased evidence of the risks of skin cancer associated with indoor tanning, as well as public health advocacy for stricter regulations, in June 2014 FDA published a new rule changing indoor tanning devices to class II devices with additional premarket controls and revised labeling requirements.1 Indoor tanning device manufacturers are now required to submit a premarket notification before devices are made available for consumer use—although FDA only reviews a new product for its equivalence to those already on the market. Tanning devices must conspicuously display a text-only, black box warning label stating that they should not be used by individuals younger than 18 years. Consumer-facing materials (eg, user manuals, brochures) are also required to display several warning and contraindication statements, some of which focus on high-risk groups (eg, those with a personal or family history of skin cancer).

Regulating indoor tanning devices as medical devices, a broad class of products that are ultimately intended to offer therapeutic benefits to consumers, may have made sense when FDA began regulating tanning devices in the 1970s. At that time, tanning lamps were mostly used by dermatologists, but today commercial tanning devices are widely available to consumers through retail outlets (eg, salons, health clubs, gyms) and for use in their own homes. Although the new rule changing indoor tanning devices from class I to class II medical devices can be viewed as progress, from a public health perspective the indoor tanning device regulations are not commensurate to those of other regulated products that are known carcinogens with very little or no therapeutic benefit. Simultaneously, there is emerging evidence that state-level policies restricting a minor’s access to indoor tanning devices are effectively reducing the prevalence of this cancer risk behavior among youth. One recent study of state-based data indicated that female adolescents are 30% less likely to indoor tan in states with any type of policy in place to restrict youth’s access (eg, parental permission, minimum age requirements) compared with states with no policies in place.5However, FDA did not leverage its authority last year to put a broader regulatory framework in place, which could have included a national minimum age requirement and stronger indoor tanning device warning labels.

A REGULATORY OPPORTUNITY

How can the public health community continue to make progress that will ultimately produce strong national policies surrounding indoor tanning? Critical factors seem to be aligning for such policy change to take place, but additional momentum is needed to promote change at a national scale. The US national political environment makes more expansive regulation by either FDA or Congress seem unlikely in the near future.

States may ultimately provide the additional impetus needed. More than 40 states and several county and local governments have implemented policies such as age restrictions or parental permission requirements targeting indoor tanning among minors, but specific policies vary.5 State and local actions—beyond improving health in their own right—could be harnessed to open a political window for federal regulation. Federal law preempts state regulation of most medical devices, but this does not apply to devices like tanning lamps that are approved as “substantially equivalent” to devices already on the market.6 This means that state legislatures could create conflicting safety standards, such as requiring different design features, which could lead to 2 outcomes. First, it would, over time, improve the public health. Second, it would likely increase uncertainty and costs for manufacturers, who would have to comply with differing standards in different states. This could encourage the tanning industry to favor federal regulation, trading regulatory requirements for certainty—an approach that has been previously used to create national toy safety standards and an underlying basis for uniform national auto safety standards. A risk of this approach is that future federal regulation, which would preempt state regulation, might weaken state policies. Public health advocates should closely monitor any federal action, and federal regulators should only create policy that creates net public health gains.

 

ADAPTING TOBACCO CONTROL APPROACHES

Beyond state and local governments, other organizations can play an important role in building momentum toward a national indoor tanning prevention policy. The recent US Surgeon General’s Call to Action to Prevent Skin Cancer2 should increase the importance and visibility of skin cancer prevention, including the public health problem of indoor tanning. Many public health and health care professional organizations have issued statements advocating for a total ban on indoor tanning for those younger than 18 years, similar to tobacco products. Given recent evidence that many young adults may have access to indoor tanning directly on or near college campuses, universities can play an important role by implementing “tan-free” policies similar to tobacco-free policies.

Public health and health care professionals can play a vital role by advocating for change in indoor tanning policies at the state and local level. State- and local-level change and continued pressure from health professional and advocacy groups may produce comprehensive national policies to prevent and reduce skin cancer caused by indoor tanning comparable with those for other cancer risk behaviors.

read more at JAMA

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