A regulatory void in urgent need of filling is establishment of a national regulatory framework for prevention and limitation of indoor tanning to help alleviate the cancer burden on the healthcare system and save billions in the cost of treating preventable skin cancer. So say two Georgetown University public health experts in a Viewpoint article published online in JAMA (Journal of the American Medical Association).
In their article, Darren Mays, PhD, MPH of the Department of Oncology at Georgetown University Medical Center and the Lombardi Comprehensive Cancer Center, in Washington, DC, and John Kraemer, JD, MPH of the Department of Health Systems Administration at Georgetown University School of Nursing and Health Studies and the Neill Institute for National and Global Health Law at Georgetown University propose that a regulatory opportunity exists similar to how toy safety standards were achieved that could help establish strong, national policies regarding indoor tanning.
In the JAMA article entitled “FDA Regulation of Indoor Tanning Devices and Opportunities for Skin Cancer Prevention“ (JAMA. Published online May 27, 2015. doi:10.1001/jama.2015.5975), the coauthors note that last year, responding to evidence of increased skin cancer risk and other health problems associated with indoor tanning, the US Food and Drug Administration (FDA) reclassified indoor tanning equipment as class II medical devices with mandatory black box warnings indicating they should not be used by minors younger than 18 years. While intended as a measure to reduce skin cancer, Mays and Kraemer observe that the FDA’s approach may not be enough and that adjudicating this issue puts the agency in the unusual situation of balancing the safety and health benefits of a technology with very limited therapeutic benefit against its associated commercial interests. They contend that this extraordinary sett of circumstances calls for a broader and more coherent public health approach to indoor tanning risks.
Mays and Kraemer cite data from a recent U.S. Surgeon General’s report saying skin cancer is now the most common malignancy in the United States, with nearly four million new cases diagnosed annually and incidence increasing, noting an estimated nearly $8 billion in cumulative cost annually of treatment, lost productivity, and other associated preventable expenditures. Most skin cancer, including as many as 90 percent of melanoma cases, is preventable by reducing UV radiation exposure, especially during adolescence and young adulthood when the largest proportion of cancer-causing dermal damage typically occurs.
The coauthors note that while UV radiation exposure via sunlight is a leading skin cancer contributor, one cited estimate suggests that more than 10 percent of annual skin cancer cases in the United States are related to indoor tanning, which significantly increases risk of both melanoma and non-melanoma skin cancer.
However, the authors note that even if that estimate is high and indoor tanning accounts for only 1%, 3%, or 5% of all skin cancers, these percentages translate to 40,000, 120,000, and 200,000 annual skin cancer cases respectively that may be related to indoor tanning, which in the US is most common among adolescents and young adults. Indoor tanning is especially popular with young women aged 15 to 39 years, a cohort for whom Melanoma, the most deadly form of skin cancer, is among the most commonly diagnosed cancers, with an estimated incidence of 9.7 per 100,000 women in this age group, and believed to be partially associated with high prevalence of indoor tanning by persons in that demographic.
The coauthors say that for those on the front lines of public health and cancer prevention, this story has a familiar ring, paralleling efforts to reduce tobacco use that finally gained traction in recent decades. They observe that the erroneous perception among youth and young adults that tanned skin is healthier and more attractive appears to be a driver of indoor tanning growth, with evidence is increasing that also suggests indoor tanning may be an addictive behavior with a plausible underlying biological mechanism relating to the release of endogenous opioids up on exposure to UV light.
Dr. Mays, who has received a young investigator award from the Harry J. Lloyd Charitable Trust, which provides grants to research that advances strategies to prevent and treat melanoma, notes in a Georgetown University Medical Center news article that tanning addiction and its corollary behavior, Tanorexia, now have their own Wikipedia entry, and that Tanorexia is linked to low weight and body image distortion, which Mays believes could be a component of tanning addiction, noting that some genes involved in addiction are related to dopamine, serotonin and opioid neurotransmitters, which suggests that certain genetic attributes may relate to how people react to these neurotransmitters, helping to drive habitual addictive behavior.
However, indoor tanning industry marketing, promotions, and discounts that often target young people also contribute to this behavior, which often but not always will have few or no immediate negative consequences, with the skin cancer risks associated with indoor tanning primarily manifesting later in life and the perceived benefits of tanned skin imagined by young people to outweigh future risk of illness or the seemingly remote prospect of early death.
Mays and Kraemer advocate a national regulatory framework, similar to the one governing sales of tobacco products, designed to prevent and reduce indoor tanning could ease the public health burden and financial costs of skin cancer. They observe that indoor tanning devices are classified as carcinogenic to humans by the International Agency for Research on Cancer due to evidence of increased melanoma and non-melanoma skin cancer risks associated with their use, but until recently, the FDA regulated indoor tanning devices as class I medical devices presenting minimal risks, leaving them largely exempt from pre-market controls. However, due in part to increased evidence of skin cancer risks associated with indoor tanning, as well as public health advocacy for stricter indoor tanning regulations, in June 2014 the FDA reclassified indoor tanning devices as class II devices with additional pre-market controls and revised labeling requirements, Indoor tanning device manufacturers will now be obliged to submit a pre-market notification before these devices are made available for consumer use, although FDA only reviews a new product for its equivalence to similar devices already on the market.
Mays and Kraemer comment that while regulating indoor tanning devices as medical devices, implying therapeutic benefits to consumers, may have made sense when the FDA began regulating these devices back in the 1970s, at which time, tanning lamps were mostly used by dermatologists. However, they observe that today, commercial tanning devices are widely available to consumers through an array of retail outlets (e.g.: salons, health clubs, gyms) as well as for use in consumers’ own homes. So they maintain that while the new rule changing indoor tanning devices from class I to class II medical devices can be viewed as small progress, from a public health perspective indoor tanning device regulations are still nowhere near being commensurate to those of other regulated products whose use is known to be carcinogenic and that have very little or no therapeutic benefit. They note that while federal efforts have been thus far largely ineffectual, evidence is emerging that state-level policies restricting an indoor tanning device access to minors are effectively reducing prevalence of this cancer risk behavior among youth.
They cite one recent study of state-based data indicating that in states with any type of youth access restriction policy in place (e.g.: parental permission, minimum age requirements), female adolescents are 30 percent less likely to indoor tan compared with teenaged girls in states that have no such policies in place. They criticize the FDA for not leveraging its authority more effectively last year by imposing a broader regulatory framework that could have, for example, included a national minimum age requirement and stronger indoor tanning device warning labels.
Mays and Kraemer conclude that while certain critical factors now seem to be moving into alignment for such policy changes to take place, it will take additional impetus and momentum to promote change at a national scale, and the current US national political environment makes more expansive regulation by either FDA or Congress seem unlikely in the near future. Consequently, it will be up to the States to take up the regulatory slack until that federal environment changes. They note that 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, and suggest that State and local actions could be leveraged to open a political window for federal regulation.
For example, federal law preempts state regulation of most medical devices, but not for devices like tanning lamps that are approved as substantially equivalent to devices already on the market. Consequently, State legislatures could, and are indeed likely to create conflicting safety standards, such as requiring different design features that would over time, improve public health, but also increase uncertainty and costs for manufacturers, who would be obliged to comply with differing standards in different states — a point that could influence the tanning industry to accept federal regulation, swapping a concatenation of uncoordinated State requirements for the certainty of unified national regulatory standards — an approach previously used to create national toy safety standards and an underlying basis for uniform national auto safety standards.
Beyond government regulation, Mays and Kraemer cite the recent US Surgeon General’s Call to Action to Prevent Skin Cancer as hopefully serving to increase the importance and visibility of skin cancer prevention, including the public health problem of indoor tanning, noting that public health and health care professional organizations have issued statements advocating a total ban on indoor tanning for those younger than 18 years, similar to tobacco products. They also advocate that institutes like colleges and universities implement tan-free policies similar to current tobacco-free policies, and say 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, and that professional and advocacy groups develop comprehensive national policies to prevent and reduce skin cancer caused by indoor tanning comparable with those for other cancer risk behaviors.
Sources:
Georgetown University
JAMA
Image Credits:
Georgetown University
ICF International
