I 
111TH CONGRESS 
2D SESSION 
H. R. 4520 
To help prevent the occurrence of cancer resulting from the use of ultraviolet 
tanning lamps by imposing more stringent controls on the use of such 
devices, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 26, 2010 
Mrs. MALONEY (for herself, Mr. DENT, Mr. GRIJALVA, and Mr. BRADY of 
Pennsylvania) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To help prevent the occurrence of cancer resulting from 
the use of ultraviolet tanning lamps by imposing more 
stringent controls on the use of such devices, and for 
other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Tanning Bed Cancer 
Control Act of 2010’’. 
SEC. 2. FINDINGS. 
Congress finds as follows: 
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(1) One million Americans—70 percent of 
whom are girls and women—visit a tanning salon 
each day. 
(2) In July 2009, the World Health Organiza-
tion 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 Der-
matology, there were over 120,000 new melanomas 
diagnosed in the United States during 2009 and ap-
proximately 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 modifica-
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tions to the labeling requirements in an effort to bet-
ter 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 deter-
mines performance standards are established by pro-
viding that a drug or device allows for the reason-
able assurance of safe and effective performance. 
(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. 
SEC. 3. RECLASSIFICATION. 
(a) STUDY.—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 ‘‘Commis-
sioner’’) shall complete a study to examine the classifica-
tion of ultraviolet tanning lamps as class I devices. 
(b) RECLASSIFICATION.—Not later than 1 year after 
the completion of the study under subsection (a), the Com-
missioner shall, based on the results of such study— 
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(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 pro-
vides a justification for not issuing such a rule. 
SEC. 4. PERFORMANCE STANDARDS. 
(a) STUDY.—Not later than 1 year after the date of 
enactment of this Act, the Commissioner shall complete 
a study on performance standards established under sec-
tion 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 STANDARDS.—Ex-
cept 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 pro-
vides a justification for not issuing such a rule. 
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(c) LABELING REQUIREMENTS.—The Commissioner 
shall carry out the recommendations made in the report 
submitted under section 230 of the Food and Drug Ad-
ministration Amendments Act of 2007 (Public Law 110– 
85) regarding the labeling of ultraviolet tanning lamps. 
SEC. 5. NO LIMITATION ON RECALL AUTHORITY. 
Nothing 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. 
SEC. 6. DEFINITIONS. 
In this Act: 
(1) The term ‘‘ultraviolet tanning lamp’’— 
(A) refers to an ultraviolet ray-emitting de-
vice for purposes of tanning, including indoor 
tanning devices and sunlamps for tanning; and 
(B) notwithstanding subparagraph (A), 
does not include an ultraviolet ray-emitting de-
vice 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)). 
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(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). 
Æ 
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