The FDA’s TAN Act Response: Predicted Sunlamp Standard Changes

In our last article, we said the FDA’s response to the TAN Act contains an ominous warning that must not be ignored. Specifically, the FDA stated that the maximum allowable dose of 4 MED—which has been effectively used since 1986—is actually excessive and can be reduced to 1.3 or 1 MED without affecting tanners’ results. In addition, the FDA stated its intent to use research from international experts on the International Electrotechnical Commission (IEC) when considering any proposed changes to the sunlamp performance standard—which means that the FDA most likely intends to adopt the 0.3 W/m^2 European Union maximum-irradiance standard.

The purpose of this follow-up article is to:

• Provide history regarding the FDA’s recommendation to adopt the unproven X/Y ratio system.
• Illustrate our prediction that the FDA will attempt to merge the existing sunlamp standard (currently used for calculating exposure times) with the maximum-irradiance standard and why we believe that approach lacks scientific validity.
• Explain the negative impact the maximum-irradiance standard has had in Europe and why that effect has been worse than expected.
• Explore the failure of FDA representatives to promote the fact that the FDA’s current system is the most protective of the tanning public.

The FDA recommendation to adopt the X/Y ratio system. At the October 2003 Technical Electronic Products Radiation Safety Standards Committee (TEPRSSC) meeting, the FDA recommended scrapping its current system for controlling exposure times and adopting the X/Y ratio system. The committee approved adopting the system even though the FDA had no data regarding how this would affect the indoor-tanning industry and could not explain which levels above or below the X/Y parameters would indicate an increased risk of skin damage. Those outstanding questions, coupled with the fact that the TEPRSSC was disbanded shortly after the 2003 meeting, explain why the FDA has not actually pursued the adoption of the X/Y ratio system despite the committee’s approval.

Authors’ Note: Governmental agencies are required to provide information about what they intend to propose at least 30 days in advance of a meeting. We tried—without success—to procure advance notice of what the FDA intended to present to TEPRSSC at that October 2003 meeting; however, the TEPRSSC members somehow received information regarding the proposal six weeks before the meeting. The lesson learned from this experience is that we must take steps to ensure we aren’t blindsided again as the FDA moves forward with the changes we expect them to make.

Merging existing protocol with the 0.3 W/m^2 maximum-irradiance standard. We predict that the FDA will leave the existing calculation matrix in place, but switch from its current erythemal action spectrum (EAS) to the less-protective IEC erythemal action spectrum. We also predict that the FDA will add a provision limiting tanning devices to a maximum-irradiance of 0.3 W/m^2.

In order to show what this change will mean in the real world, let’s compare exposure times of a traditional 160-watt lamp (with a maximum irradiance of 0.624 W/m^2) with lamps that have maximum irradiances of 0.6 W/m^2 and 0.3 W/m^2. When the maximum erythemal dose (MED) is 4, exposure times rise from 13 minutes for the current 0.624 W/m^2 lamp to 13.5 minutes for the 0.6 W/m^2 lamp and 27 minutes for the 0.3 W/m^2 lamp. When the MED is limited to 1.3, the exposure times are 6.9 minutes, 7.2 minutes and 14.4 minutes, respectively. When the MED is limited to 1, the exposure times are 5.3 minutes, 5.6 minutes and 11.1 minutes.

Let’s also compare the same irradiance sources for Tt (tanning power) time and vitamin D-effective time (the time it takes to stimulate the equivalent of taking a 10,000 IU supplement). It would take 19.4 minutes for the 0.3 W/m^2 lamp to deliver the same amount of tanning power that is delivered in 9.3 minutes by the existing 0.624 W/m^2 lamp or 9.7 minutes by the 0.6 W/m^2 lamp. In addition, it would take 26.2 minutes for the 0.3 W/m^2 lamp to stimulate production of vitamin D equivalent to 10,000 IUs compared to 6.1 minutes with the existing 0.624 W/m^2 lamp or 6.6 minutes with the 0.6 W/m^2 lamp.

In summary, the 160-watt lamp used today—with a 13-minute exposure time to reach 4 MED—is legal for use in a 12-minute MET device. Also, it has enough tanning power to satisfy even the most demanding client and emits enough vitamin D-effective photons to stimulate an adequate amount of vitamin D (25-OH-D) in the given amount of time. Reducing the maximum irradiance to 0.6 W/m^2 would be acceptable, but as you can see from the tables above, lowering it to 0.3 W/m^2 causes both the tanning power and the power to stimulate vitamin D production to be lowered to an unacceptable level. The bottom line is that a tanning device employing lamps limited to a maximum irradiance of 0.3 W/m^2 will not be acceptable to the clients of U.S. indoor-tanning salons.