1.This Act may be cited as the
Tanning Bed Cancer Control Act of
2011
.
2.Congress finds as follows:
(1)Two million Americans—approximately 70
percent of whom are girls and women—visit a tanning salon each day.
(2)In July 2009, the
World Health Organization International Agency for Research on Cancer Monograph
Working Group raised the classification of the use of UV-emitting tanning
devices to Group 1, carcinogenic to humans
.
(3)The new carcinogen
classification places tanning beds alongside tobacco smoke, asbestos, and
uranium as known cancer-causing agents.
(4)The World Health
Organization reports that the risk of cutaneous melanoma is increased by 75
percent when use of tanning devices starts before 30 years of age.
(5)According to the
American Academy of Dermatology, there were over 120,000 new melanomas
diagnosed in the United States during 2009 and approximately 8,650 people were
estimated to die from melanoma during 2009.
(6)In a December 2008
Report to Congress, FDA determined, through its own analysis, that the current
warning labels for indoor tanning devices do not effectively communicate the
risks associated with indoor tanning and is therefore reviewing modifications
to the labeling requirements in an effort to better inform consumers about the
risks associated with sunlamp products.
(7)According to section 514 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360d), the Secretary of Health and
Human Services determines that a performance standard is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
(8)If tanning devices
do not provide reasonable assurances of safe and effective performance, the
Secretary shall seek to reclassify these devices as is most appropriate based
on the scientific evidence and to put in place safeguards for consumer access
to these devices.
3.
(a)Not later than 1 year after the date of
enactment of this Act, the Commissioner of Food and Drugs (hereinafter in this
Act referred to as the Commissioner) shall complete a study to
examine the classification of ultraviolet tanning lamps as class I
devices.
(b)Not later than 1 year after the completion
of the study under subsection (a), the Commissioner shall, based on the results
of such study—
(1)issue a rule
providing for the reclassification under section 513(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 260c(e)) of an ultraviolet tanning lamp as a
class II or class III device; or
(2)submit to the
Congress a report that provides a justification for not issuing such a
rule.
4.
(a)Not later than 1 year after the date of
enactment of this Act, the Commissioner shall complete a study on performance
standards established under section 514 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360d) for ultraviolet tanning lamps to examine the adequacy of
such performance standards.
(b)Revision of
performance standardsExcept as provided in subsection (c), the
Commissioner, based on the results of the study under subsection (a), shall,
not later than 1 year after the completion of such study—
(1)issue a rule
providing for more stringent performance standards for ultraviolet tanning
lamps, including with respect to the strength of ultraviolet rays emitted by
such devices and the amount of time a user should remain exposed to such
devices; or
(2)submit to the
Congress a report that provides a justification for not issuing such a
rule.
(c)The Commissioner
shall carry out the recommendations made in the report submitted under section
230 of the Food and Drug Administration Amendments Act of 2007 (Public Law
110–85) regarding the labeling of ultraviolet tanning lamps.
5.No
limitation on recall authorityNothing in this Act shall be construed to
limit the authority of the Commissioner under section 518(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)) with regard to an ultraviolet
tanning lamp.
6.In this Act:
(1)The term
ultraviolet tanning lamp—
(A)refers to an
ultraviolet ray-emitting device for purposes of tanning, including indoor
tanning devices and sunlamps for tanning; and
(B)notwithstanding subparagraph (A), does not
include an ultraviolet ray-emitting device for purposes of use as part of a
treatment regimen prescribed by a licensed health care professional.
(2)The terms
class I, class II, and class III have
the meanings given such terms in section 513(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(h)).
(3)The terms
device, interstate commerce, label, and
labeling have the meanings given such terms under section 201 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).