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Recommended Exposure
Schedules for Sunlamps and Tanning Beds: Past, Present and Future.
Cyr, W. Howard1.
U.S. Food and Drug Administration, Center for Devices and Radiological
Health1
Abstract-
The U.S. Food and Drug Administration (FDA) requires manufacturers of
sunlamps and tanning beds to provide "a
recommended exposure schedule including the duration and spacing of
sequential exposures and maximum exposure time(s) in minutes"
[21 CFR 1040.20(d)(1)(iv)]. A recommended exposure schedule was described
in a 1986 FDA Policy Letter and was developed in order to "allow
a person to gradually build-up skin pigmentation and to maintain a tan
while controlling the risk of acute injury and delayed adverse effects".
FDA has recently announced its intention to amend the existing regulations
on sunlamps and tanning beds to account for scientific advances since
1986, and to attempt to achieve international harmonization of its standards.
Several changes have been discussed including the addition of a possible
annual UV dose limit based on the risk of skin cancer (UV doses weighted
with a cancer action spectrum), in a manner similar to that of the International
Electrotechnical Commission (IEC). In addition, the value for minimal
erythema dose (MED) may be changed from the 1986 value of 156 J/m2 to
a value that is more consistent with research data (200 J/m2). Also,
the time between consecutive tanning sessions has been debated. Recent
studies indicate that the FDA recommended exposure schedule does not
lead to skin burns, but does require several tanning sessions before
pigmentation develops. In addition, a more recent study indicates that
an UV-induced tan may last for several weeks, if not months. Ongoing
research on methods to measure skin pigmentation could lead to better
prediction of UV sensitivity and improved exposure schedules for different
skin types. FDA continues to work with the indoor tanning industry,
the medical community, academia and others in considering possible changes
to its existing regulations.
Keywords: ultraviolet,
sunlamp, regulation, dose
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