FDA pilot study flawed

[Bill]

Photodermatology, Photoimmunology & Photomedicine

Volume 23 Issue 1 Page 57-58, February 2007
To cite this article: Robert M. Sayre, John C. Dowdy (2007) Indoor tanning exposure schedule: FDA pilot study flawed
Photodermatology, Photoimmunology & Photomedicine 23 (1) , 57–58 doi:10.1111/j.1600-0781.2007.00271.x

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Letter to the editor

Indoor tanning exposure schedule: FDA pilot study flawed

• Robert M. Sayre1,21Department of Medicine, Division of Dermatology, University of Tennessee Center for the Health Sciences, Memphis, TN 38104, USA and 2Rapid Precision Testing Laboratories, Cordova, TN 38018, USA,
• John C. Dowdy22Rapid Precision Testing Laboratories, Cordova, TN 38018, USA

• 1Department of Medicine, Division of Dermatology, University of Tennessee Center for the Health Sciences, Memphis, TN 38104, USA and 2Rapid Precision Testing Laboratories, Cordova, TN 38018, USA

Corresponding author:
8225 Rockcreek Parkway
Cordova, TN 38016
USATo the Editor,
The recent submission of Miller et al. (1) (Reduction of the UV burden to indoor tanners through new exposure schedules: a pilot study. Photodermatol Photoimmunol Photomed, 2006, 22, 59–66), while interesting, lacks appropriate exposure dose and schedule controls. The authors examine three exposure schedules but do not examine the exposure schedule delineated by existing FDA guidelines (2) as presented in their formal charge (3) published in a 1999 Advanced Notice of Proposed Rule Making. In fact, the authors do not describe the 120 V residential-type canopy unit used in their work relative to FDA-mandated maximum timer (2), relating it to the existing commercial tanning units.
The current US indoor tanning exposure schedule (2) is designed to acclimatize an individual, minimizing the risk of sunburn occurring by allowing exposures every other day or three times weekly, with the initial exposure being 3/4 of an MED of the most sensitive individual. Each week, the dose of the week's exposure is increased until in the fourth week the dose reaches the maximum four MED exposure allowed called the Te or Tmax. This allows gradual acclimatization through a weekly increase in UV dose. Thereafter, the current agency guidance (2) instructs tanners to be exposed to the timer maximum either once or twice weekly. In the US, exposure schedules have been in use since 1986, while Europe and the remainder of the world have only recently developed standards (4) defining timer maxima or exposure schedule dosimetry.
Miller and colleagues suggest that Caswell's (5) 2000 study followed the current FDA recommended exposure schedule. However, this study only followed the current guidelines until the Tmax was reached in 4 weeks, after which tanners received a 25% increased dose three times weekly for an additional month. Miller and colleagues unfortunately appear to reference the results of this study in lieu of actually running a control group following the current exposure guidelines. Exceeding the Tmax by </IMG>25% is something that tanning equipment manufactures and salons would not attempt, as doing so might jeopardize or void their insurance and invite regulatory action.
A major point of concern is that Miller and colleagues did not determine the degree of erythemic UV acclimatization maintained by once or twice a month exposures compared with acclimatization maintained by following the once or twice-weekly exposures under current FDA guidance. Miller and colleagues seem to assume that if a site looks tanned, then acclimatized erythemic tolerance is still extant, and further suggest that Caswell (5) supports this interpretation. Caswell did not test this maintenance of acclimatization and, while similarly cited for a poster presented at the Photomedicine Society meeting in 2001 (6), we have not compared the persistence of a tan with retention of acclimatization to UV injury either.
Their proposal of exposures once or twice monthly to maintain tanning may likely to be too infrequent to retain sufficient acclimatization to withstand their significantly greater proposed exposure doses. Despite claims of dose equivalence, the proposed 600 EEU (6 SED) maximum exposure is </IMG>30–60% larger, depending on specific lamp spectrum, than the </IMG>4.5 SED UV dose now allowed (7), as we have previously cautioned the authors. Less frequent exposure, combined with increased exposure doses, promotes episodic exposure of non-acclimatized skin. This will clearly place tanners at increased risk of inadvertent overexposure and may increase the incidence of injuries incurred during indoor tanning.
The tanning that the authors describe is from test exposures to the lower back of the several individuals; yet, conclusions are suggested to apply to the entire bodies of all individuals. This is problematic in that erythemic sensitivity is different for different body areas (8) and presumably so is tanning, as tanning equipment designed to specifically expose different parts of the body, such as faces or legs, has been in use for many years. Miller and colleagues conclude that their pilot exposure schedules reduce UV accumulation without ‘compromising the cosmetic effect’ based solely on instrumental or third-person visual scoring. In contrast, individuals seeking to develop a tan for cosmetic effect will do so in a self-evaluating manner until satisfied with the desired effect. Failure to consider how tanners might rate their own responses cannot be disregarded; otherwise, they may simply disregard the guidance. Furthermore, restriction of indoor tanning below a level perceived as reasonable by tanners, while of questionable enforceability, may also encourage the higher risk alternative behavior of outdoor sunbathing (9).
Our concerns highlight studies that need to be carried out to define the relationship of a fading tan with residual acclimatization to burning. We suggest that several additional relatively simple lines of investigation be undertaken before revision of current guidelines. Studies need to becarried out, involving a wider variety of commercial tanning units using full-body exposure of larger groups of people, to directly compare existing exposure schedule guidance with proposed changes in the exposure schedule. These studies should be carried out at multiple sites across the country to account for geographic variation of solar UV. Most importantly, while technicians can collect instrumental data of tanning response, if new schedules are to produce cosmetically acceptable results, then tanners themselves must be satisfied.
Miller and colleagues have not directly examined the recommendations in the current FDA guidance document (2) for indoor tanning. This is perplexing because until 2004, the USA and Canada were the only nations to require a specific timer maximum and recommended exposure schedule based on spectral risk analysis (7). The recent government study appears to support the agency's political agenda of harmonization with recently enacted European tanning regulations (4) that have yet to achieve parity (7) with current US practice. Such degradation of existing national standards is contrary to the basic tenants of international standards harmonization.
The successful results of current FDA sunlamp exposure guidance, established in 1986, are frankly impressive. With over a million tanners each day, it is difficult to locate reports of injuries despite allegation that exposure guidance is not widely followed (10). This obviously brings into question the necessity to revise guidance that historically appears to have proven more than adequate.

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[HunyBee]

Uhhh, I am seriously too ADHD to read all that at once...

[Ezliving_Jim]

I saw this. The authors of the study countered Sayre's criticism point-by-point. So did others.

I filed this under Science Friction.