In the U.S., approximately 34 million individuals choose to patronize a tanning salon each year because salons: are an ideal, year-round source of controlled ultraviolet radiation exposure, and provide an environment that significantly reduces the risk of overexposure (defined as a UVR dose sufficient to cause sunburn) and underexposure (defined as a UVR dose that is too low to stimulate the optimal level of vitamin D)
Since 1986, indoor-tanning industry manufacturers have followed the FDA’s Sunlamp Standard to ensure their Class I products are in compliance. The FDA exposure-schedule calculation system is one of the most protective of any regulatory system in the world, thanks to FDA scientist David Lytle—he made the decision to incorporate two safety factors in the FDA system to differentiate it from the IEC/CIE system used in Europe. The two safety factors are:
- Defining the 1.0 weighting factor range from 250 nm to 302 nm as opposed to the CIE range of 250 nm to 298 nm (see Graph 1).
- Defining 1 MED as 156 J/m^2 as opposed to the CIE definition of 200 J/m^2 (see Graph 2).
Together, these two safety factors reduce the maximum allowable session time by a significant amount and, therefore, are more protective.
Now, let’s compare the maximum-allowable session time with the commonly used 160-watt lamp for the FDA, Health Canada and CIE systems when a maximum allowable dose (MAD) of 4.0 MED is delivered. (The Health Canada system uses a hybrid of the FDA and CIE systems, defining the weighting factor in the same range as CIE and defining 1.0 MED as 156.25 J/m^2.) With the FDA system, the maximum-allowable session time is 13 minutes; with the Health Canada system, it is 17 minutes; and, with the CIE system, it is 21.4 minutes.
We do agree that the CIE calculation is biologically correct if your objective is to accurately predict the time it will take to sunburn, i.e., the time it takes to deliver a dose of 1.0 MED. However, the primary purpose of an exposure schedule used by tanning salons is to minimize the possibility of sunburn. So, let’s look at the 1.0 MED times for each system: the FDA time is 3.2 minutes, the Health Canada time 4.3 minutes and the CIE time is 5.3 minutes.
Clearly, the Lytle safety factors significantly reduce the maximum-allowable session time in comparison to the other systems and the FDA system safety margin for 1.0 MED is more protective when compared to the other systems.
The bottom line is that, for the past 23 years, the provisions of the FDA Sunlamp Standard have proven to be effective. And, given the outstanding safety record of the tanning industry, we reasonably wonder why the FDA recently announced the intent to change from its existing (and proven) system to the unproven European Union (EU) 0.3 W/m^2 maximum-irradiance system—especially considering that the EU system is not scientifically valid and will negatively affect the U.S. tanning industry (much like it has done to the European tanning industry). We believe that a far better approach would be to make a few necessary modifications to the existing FDA system, including:
1. Modifying the initial session time (IST) to incorporate differences in skin type/subtype. When announcing the ANPRM, Director of the Center of Devices and Radiation Health Howard Cyr, Ph. D., stated that the FDA would “expand the exposure schedule to different skin types” in order to recognize that darker skin types/subtypes have a higher tolerance to UVR (TUVR).