To understand what will likely happen if the FDA follows through with its stated intention to reduce the maximum allowable dose (MAD) and adopt the 0.3 W/m^2 European Union (EU) maximum-irradiance standard, let’s look at the following:
Is reducing the MAD necessary? The answer to this can be found in a letter to the editor in Photodermatology, Photoimmunology & Photomedicine, titled “Indoor Tanning Exposure Schedule: FDA Pilot Study Flawed,” by Robert Sayre and John Dowdy. The authors said “the successful results of current FDA sunlamp exposure guidance, established in 1986, are impressive” and that “with more than 1 million tanners each day, it is difficult to locate reports of injuries despite allegations that exposure guidance is not widely followed—which obviously brings into question the necessity to revise guidance that historically appears to have proven to be more than adequate.”
FDA officials Sharon Miller, Barbara Zmudzka and Janusz Beer responded to Sayre’s and Dowdy’s comments in their own letter to the editor, titled “Criticism of FDA Pilot Study Unfounded (Response to R. M. Sayre and J.C. Dowdy).” They said, “Sayre and Dowdy base this assertion on the statistics of acute injuries. Indeed, in its early stages, the tanning industry was plagued with severe burns, photokeratitis and even fatal outcomes when clients combined the use of tanning devices with photosensitizing drugs. After the FDA Performance Standard for Sunlamp Products went into effect, the number of acute deleterious outcomes went down.”
Let’s take a look at the misleading statements made in that response. First, to say that the tanning industry was plagued with severe burns, photokeratitis and fatal outcomes does not account for the fact that such injuries were caused by Americans using table-top devices that emitted high levels of UVB (and in some cases UVC)—not from the use of commercial tanning devices. Furthermore, those injuries occurred long before the start of the indoor-tanning industry in the United States.
Second, the statement regarding the number of acute deleterious outcomes after the sunlamp standard went into effect actually proves (however unintentionally) that Sayre and Dowdy were correct and that reducing the MAD is not necessary. In addition, two modifications made by the FDA's David Lytle to the (proposed) IEC/CIE plan in 1986 significantly increased the safety margin of tanning devices in the U.S., and served to reduce the maximum exposure time of U.S. tanning devices by 50 percent as compared to countries using the IEC/CIE erythemal action spectrum. As mentioned in last month’s article, it is deeply disturbing that the FDA representatives to IEC/CIE have not insisted that countries interested in increasing the safety of their tanning public adopt this more protective exposure schedule.
Authors Note: Previously, we requested information about complaints made to the FDA regarding tanning devices. We received data spanning 15 years—and there were only 54 complaints made for commercial tanning salons, none of which were fatalities. Based upon this data, and the number of tanning sessions during this time period, we estimated that there was one complaint made for every 100 million tanning sessions. We challenge the FDA to provide data showing another industry under their jurisdiction that has a better safety record.
Will reducing the MAD and adopting the 0.3 W/m^2 maximum-irradiance standard have an impact? First of all, reducing the MAD will negatively impact tanning clients because it will take an exposure time of 19.4 minutes in a 160-watt tanning device to equal the tanning power delivered today in 9.3 minutes. Moreover, based upon the results in Europe, reducing the MAD and adopting the 0.3 W/m^2 maximum-irradiance standard will cause hundreds of small salons to close their doors within the first year of adoption.
Does the 0.3 W/m^2 maximum-irradiance standard have scientific validity? The adoption of the 0.3 W/m^2 maximum-irradiance standard by the EU was a political decision made by a small group of anti-tanning regulators. It was not based upon scientific criteria; rather it was a biased and discriminatory attempt to damage the European tanning industry. For instance, in the draft stage of the regulations, the maximum-irradiance level was set at 0.6 W/m^2, which correctly reflected the fact that a 0.3 W/m^2 irradiance level in sunlight (striking only one side of the body) is equivalent to a 0.6 W/m^2 irradiance level in a 360-degree tanning device. However, the anti-tanning regulators pulled a fast one and adopted the 0.3 W/m^2 maximum-irradiance level notwithstanding the fact that doing so was not scientifically justified.
Has the FDA considered the “unintended consequences” that will likely result from reducing the MAD and adopting the 0.3 W/m^2 maximum-irradiance standard? Based upon its track record (from its recommendation of adopting the scientifically unsupportable and unworkable X/Y ratio concept to its failure to recognize that its own exposure schedule is the most protective of any system in the world), it is doubtful that the FDA has thought about what will happen if the MAD is reduced and the 0.3 W/m^2 maximum-irradiance standard is adopted.
So the critical question is—what we can do to protect the future of the indoor tanning industry? Check back next month for our May 2009 article, which will cover what we believe will be beneficial to the FDA, the tanning public and the indoor-tanning industry. Stay tuned.
Patricia E. Reykdal and Donald L. Smith operate the Non-Ionizing Radiation Research Institute in Tucson, Ariz. They have written many articles promoting the benefits of controlled ultraviolet radiation exposure (CURE). You can e-mail comments or questions to dermwatcher@msn.com.
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