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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Tanning Bed Cancer 

5 Control Act of 2010’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds as follows: 


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1 (1) One million Americans—70 percent of 

2 whom are girls and women—visit a tanning salon 

3 each day. 

4 (2) In July 2009, the World Health Organiza5 tion International Agency for Research on Cancer 

6 Monograph Working Group raised the classification 

7 of the use of UV-emitting tanning devices to Group 

8 1, ‘‘carcinogenic to humans.’’ 

9 (3) The new carcinogen classification places 

10 tanning beds alongside tobacco smoke, asbestos, and 

11 uranium as known cancer-causing agents. 

12 (4) The World Health Organization reports 

13 that the risk of cutaneous melanoma is increased by 

14 75 percent when use of tanning devices starts before 

15 30 years of age. 

16 (5) According to the American Academy of Der17 matology, there were over 120,000 new melanomas 

18 diagnosed in the United States during 2009 and ap19 proximately 8,650 people were estimated to die from 

20 melanoma during 2009. 

21 (6) In a December 2008 Report to Congress, 

22 FDA determined, through its own analysis, that the 

23 current warning labels for indoor tanning devices do 

24 not effectively communicate the risks associated with 

25 indoor tanning and is therefore reviewing modificaVerDate Nov 24 2008 23:10 Jan 27, 2010 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4520.IH H4520

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1 tions to the labeling requirements in an effort to bet2 ter inform consumers about the risks associated with 

3 sunlamp products. 

4 (7) According to section 514 of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 360d), 

6 the Secretary of Health and Human Services deter7 mines performance standards are established by pro8 viding that a drug or device allows for the reason9 able assurance of safe and effective performance. 

10 (8) If tanning devices do not provide reasonable 

11 assurances of safe and effective performance, the 

12 Secretary shall seek to reclassify these devices as is 

13 most appropriate based on the scientific evidence 

14 and to put in place safeguards for consumer access 

15 to these devices. 

16 SEC. 3. RECLASSIFICATION. 

17 (a) STUDY.—Not later than 1 year after the date of 

18 enactment of this Act, the Commissioner of Food and 

19 Drugs (hereinafter in this Act referred to as the ‘‘Commis20 sioner’’) shall complete a study to examine the classifica21 tion of ultraviolet tanning lamps as class I devices. 

22 (b) RECLASSIFICATION.—Not later than 1 year after 

23 the completion of the study under subsection (a), the Com24 missioner shall, based on the results of such study— 


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1 (1) issue a rule providing for the reclassification 

2 under section 513(e) of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 260c(e)) of an ultraviolet 

4 tanning lamp as a class II or class III device; or 

5 (2) submit to the Congress a report that pro6 vides a justification for not issuing such a rule. 

7 SEC. 4. PERFORMANCE STANDARDS. 

8 (a) STUDY.—Not later than 1 year after the date of 

9 enactment of this Act, the Commissioner shall complete 

10 a study on performance standards established under sec11 tion 514 of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 360d) for ultraviolet tanning lamps to examine 

13 the adequacy of such performance standards. 

14 (b) REVISION OF PERFORMANCE STANDARDS.—Ex15 cept as provided in subsection (c), the Commissioner, 

16 based on the results of the study under subsection (a), 

17 shall, not later than 1 year after the completion of such 

18 study— 

19 (1) issue a rule providing for more stringent 

20 performance standards for ultraviolet tanning lamps, 

21 including with respect to the strength of ultraviolet 

22 rays emitted by such devices and the amount of time 

23 a user should remain exposed to such devices; or 

24 (2) submit to the Congress a report that pro25 vides a justification for not issuing such a rule. 


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1 (c) LABELING REQUIREMENTS.—The Commissioner 

2 shall carry out the recommendations made in the report 

3 submitted under section 230 of the Food and Drug Ad4 ministration Amendments Act of 2007 (Public Law 110– 

5 85) regarding the labeling of ultraviolet tanning lamps. 

6 SEC. 5. NO LIMITATION ON RECALL AUTHORITY. 

7 Nothing in this Act shall be construed to limit the 

8 authority of the Commissioner under section 518(e) of the 

9 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

10 360h(e)) with regard to an ultraviolet tanning lamp. 

11 SEC. 6. DEFINITIONS. 

12 In this Act: 

13 (1) The term ‘‘ultraviolet tanning lamp’’— 

14 (A) refers to an ultraviolet ray-emitting de15 vice for purposes of tanning, including indoor 

16 tanning devices and sunlamps for tanning; and 

17 (B) notwithstanding subparagraph (A), 

18 does not include an ultraviolet ray-emitting de19 vice for purposes of use as part of a treatment 

20 regimen prescribed by a licensed health care 

21 professional. 

22 (2) The terms ‘‘class I’’, ‘‘class II’’, and ‘‘class 

23 III’’ have the meanings given such terms in section 

24 513(h) of the Federal Food, Drug, and Cosmetic 

25 Act (21 U.S.C. 360c(h)). 


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1 (3) The terms ‘‘device’’, ‘‘interstate commerce’’, 

2 ‘‘label’’, and ‘‘labeling’’ have the meanings given 

3 such terms under section 201 of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 321). 

Æ 


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