FDA’s Proposed Dose Reduction MustBe Protested

FDA’s Proposed Dose Reduction Must Be Protested

by Patricia E. Reykdal and Donald L. Smith

The FDA document titled “Office of Science and Engineering Laboratories Annual Report - Fiscal Year 2004” contains a disturbing statement: “The FDA recommended tanning schedule can be modified so that cumulative UV doses would be three to four times lower than those currently used. This would not compromise the desired cosmetic effect.” The adoption of this provision would be an unmitigated disaster for the indoor tanning industry and a major victory for the anti-tanning coalition. Therefore, we must unite to protest these proposed changes.

If adopted, the FDA reduction in the UV dose would take two forms: 1) reducing the ISD (initial session dose) from 0.75 MED (117 J/m^2) to 0.5 MED (78 J/m^2); and 2) reducing the MAD (maximum allowable dose) from 4.0 MED (624 J/m^2) by two-thirds (208 J/m^2 = 1.3 MED) or three-fourths (156 J/m^2 = 1.0 MED). This means that, after the effective date, sunbed manufacturers would be forced to utilize sunlamps that deliver a MAD of only 1.3 MED or 1.0 MED in the MTI (maximum timer interval), and clients would be limited to an ISD of 0.5 MED during their first three sessions.

(Note: Lurking just beneath the surface, we believe, is the real agenda of the anti-tanning coalition—which is to impose an annual dose limit of 15 kJ/m^2 for clients of indoor tanning salons. An annual limit of 15 kJ/m^2 is an annual dose of 96.2 MED, which equals 24 sessions of 4.0 MED per year.)

We got sick and tired of reading statements such as “a sunbed is six to 30 times stronger than the sun” and/or “a session in a tanning bed is equal to a day at the beach” without any data being provided regarding the spectral characteristics of either sunlight or the sunlamp/sunbed being compared. For this reason, we instigated the Reference Sun® project in order to make possible a reference-standard baseline for comparing sunlight to sunlamps/sunbeds.

We spent more than three years compiling a series of Reference Sun data files (i.e., Reference Sun 10, 12, 15, 20 and 30) and we are pleased to report we now have reference standards that we can use for comparing sunlight to sunbeds with 10-, 12-, 15-, 20- and 30-minute Te (4.0 MED) times. In summary, the appropriate Reference Sun provides a reference standard that can be used to make apples-to-apples comparisons between sunlight and sunlamps/sunbeds and scientifically compare different sunlamps and sunbeds.

Therefore, from this point forward, only comparisons between sunlight and a sunlamp/sunbed that utilizes the appropriate Reference Sun data will be considered by the indoor tanning industry to be scientifically valid.

If the only consideration was to reduce the number of skin-damaging photons, the FDA modification would make sense, as the graph titled “Skin Damaging Power Comparison-1” shows. However, reducing the MAD by two-thirds (to 1.3 MED) or three-fourths (to 1.0 MED) would destroy the ability of new sunbeds 1) to deliver enough tanning photons sufficient to satisfy our clients, and 2) to deliver a dose of vitamin D-effective photons sufficient to stimulate the production of an optimal level of pre-vitamin D. In summary, the adoption of the FDA proposal to lower the MAD would seriously damage the indoor tanning industry.

New-era sunlamps help reduce the potential to damage skin without throwing out the baby with the bath water because they 1) “left-shift” just enough photons to make possible the desired Te (4.0 MED) times and to stimulate the production of pre-vitamin D and melanin; 2) eliminate as many photons in the critical 320 nm-340 nm (UVA2) range as possible; and 3) “right-shift” more photons into the important tanning-power range.

The result is that new-era sunlamps have 1) far less power to cause damage to skin, and 2) much more power to tan skin than do either the Reference Sun and/or traditional sunlamps.

As the graph titled “Skin Damaging Power Comparison-2” shows, a sunbed equipped with an average of the 160-watt new-era sunlamps we tested reduced skin-damaging potential as much as the proposed FDA modifications, and a sunbed equipped with the best new-era sunlamp reduced skin-damaging potential by an additional 36 percent. And they do so without sacrificing tanning power or the power to stimulate production of pre-vitamin D and melanin.

The graph titled “Tanning Photon Comparison” shows the FDA proposed modifications would significantly reduce tanning power while new-era sunlamps—especially the best of those we tested—dramatically increase tanning power. Thus, the FDA proposed reductions in the MAD, in an attempt to reduce the potential to damage skin, would make it impossible to deliver a dose of tanning photons sufficient to satisfy clients of indoor tanning salons.

The FDA-proposed reductions to the MAD also would reduce the vitamin D-effective photons below the level required to stimulate optimal production of pre-vitamin D within a 12-minute session time. (See the graph titled “Vitamin D-effective Photon Comparison.”) Although the new-era sunlamps are not quite as efficient as traditional sunlamps, they will stimulate adequate production of vitamin D within a 12-minute session.

The indoor tanning industry—and especially sunlamp companies such as Cosmedico, Heraeus, Interlectric, LightSources, Philips, Voltarc and Wolff System—can take great pride in the fact that sunlamps have been developed that reduce the risk of skin damage without sacrificing tanning power and/or power to stimulate production of pre-vitamin D and melanin.

Since the regulatory community doesn’t seem to be aware of the technological revolution ushered in by the availability of new-era sunlamps, we recently wrote a letter to the FDA recommending that a meeting be convened this fall to discuss the benefits of new-era sunlamps to the segment of the American public that chooses, of its own free will, to patronize an indoor tanning salon. It is becoming increasingly obvious that the indoor tanning industry is light-years ahead of the regulators and, hopefully, this meeting will help remedy that unacceptable situation.

Because the proposed modifications that the FDA set forth in the “Office of Science and Engineering Laboratories Annual Report - Fiscal Year 2004” has the potential to seriously damage the indoor tanning industry, tanning professionals need to take a few minutes to make their views known. We need at least 1,000 indoor tanning salons to weigh in on an important survey.

Log on to www.lookingfit.com and click the link titled “Let FDA know what you think.” Answer the questions listed there about the information provided in this article, fill out demographic information, and submit the data. We’ll compile the results and send them to the appropriate FDA officials.

Patricia E. Reykdal, who owns and operates four tanning salons in Tucson, Ariz., and her husband, Donald L. Smith, who is director of research of the Non-Ionizing Radiation Research Institute, have written more than 100 articles promoting sensible, moderate and responsible exposure to ultraviolet radiation.

For More Information

If you want to learn more about the Reference Sun® concept, how sunlight really compares to sunlamps and how new-era sunlamps compare to traditional and HID/high-pressure sunlamps, you won’t want to miss our session at the ITA Tanning World Expo in Nashville, Tenn.: