I 

111TH CONGRESS 

2D SESSION H. R. 4615 

To amend the Federal Food, Drug, and Cosmetic Act to require dentists 

to provide patients with a fact sheet before performing any dental restoration work, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 4, 2010 

Ms. WATSON (for herself, Mr. STARK, Mr. CUMMINGS, Ms. KILPATRICK of 

Michigan, Ms. WOOLSEY, Mrs. NAPOLITANO, Ms. JACKSON LEE of 

Texas, Mr. KENNEDY, Ms. BORDALLO, Ms. CHU, Mr. HONDA, Mr. 

FALEOMAVAEGA, and Mr. PAYNE) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

require dentists to provide patients with a fact sheet 

before performing any dental restoration work, 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 ‘‘Consumers Have Op5 tions for Molar Protection Act of 2009’’ or the ‘‘CHOMP 

6 Act of 2009’’. 


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1 SEC. 2. PROVISION OF FACT SHEET TO PATIENTS PRIOR TO 

2 DENTAL RESTORATION WORK. 

3 (a) IN GENERAL.—Chapter III of the Federal, Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amend5 ed by adding at the end the following: 

6 ‘‘SEC. 311. PROVISION OF FACT SHEET TO PATIENTS PRIOR 

7 TO DENTAL RESTORATION WORK. 

8 ‘‘(a) REQUIREMENT.—A dentist shall— 

9 ‘‘(1) before performing any dental restoration 

10 work— 

11 ‘‘(A) provide the patient with the fact 

12 sheet developed by the Secretary under sub13 section (b); and 

14 ‘‘(B) obtain the patient’s signature ac15 knowledging receipt of the fact sheet; and 

16 ‘‘(2) place a copy of the signed acknowledgment 

17 in the patient’s record. 

18 ‘‘(b) FACT SHEET.— 

19 ‘‘(1) DEVELOPMENT.—The Secretary shall de20 velop not later than 1 year after the date of the en21 actment of this section, and periodically review and 

22 update as scientifically warranted, a fact sheet de23 scribing and comparing the risks and efficacy of the 

24 various types of dental restorative materials that 

25 may be used to repair a patient’s oral condition or 

26 defect. 


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1 ‘‘(2) CONTENTS.—The fact sheet developed 

2 under paragraph (1) shall include each of the fol3 lowing: 

4 ‘‘(A) A description of the groups of mate5 rials that are available to the dental profession 

6 for restoration of an oral condition or defect. 

7 ‘‘(B) A comparison of the relative benefits 

8 and detriments of each group of materials. 

9 ‘‘(C) A comparison of the cost consider10 ations associated with each group of materials. 

11 ‘‘(D) A reference to encourage discussion 

12 between the patient and dentist regarding den13 tal restorative materials and to inform the pa14 tient of his or her options. 

15 ‘‘(3) AVAILABILITY.—The Secretary shall make 

16 the fact sheet developed under paragraph (1) avail17 able to all licensed dentists in the United States. 

18 ‘‘(c) PENALTY.— 

19 ‘‘(1) IN GENERAL.—Whoever violates subsection 

20 (a) shall be fined not more than $5,000. 

21 ‘‘(2) CALCULATION.—In calculating the max22 imum authorized amount of a fine under paragraph 

23 (1), the number of violations shall be calculated by 

24 multiplying $5,000 by the number of dental restoraVerDate Nov 24 2008 05:25 Feb 05, 2010 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4615.IH H4615

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1 tive materials placed into a patient’s mouth in viola2 tion of subsection (a). 

3 ‘‘(d) DEFINITIONS.—In this section: 

4 ‘‘(1) The term ‘dental restoration work’— 

5 ‘‘(A) means the placement of a dental re6 storative material into a patient’s mouth; and 

7 ‘‘(B) excludes any surgical, endodontic, 

8 periodontic, or orthodontic dental procedure in 

9 which a dental restorative material is not used. 

10 ‘‘(2) The term ‘dental restorative material’ 

11 means any structure or device placed into a patient’s 

12 mouth with the intent that it remain there for an in13 definite period beyond the completion of the dental 

14 procedure. 

15 ‘‘(3) The term ‘patient’ means the patient or 

16 the patient’s parent, legal guardian, or other author17 ized representative.’’. 

18 (b) APPLICABILITY.—The requirement of section 

19 311(a) of the Federal Food, Drug, and Cosmetic Act, as 

20 added by subsection (a), applies with respect to any dental 

21 restoration work (as defined in such section) on or after 

22 the date that is 2 years after the date of the enactment 

23 of this Act. 


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1 SEC. 3. LABELING OF DENTAL RESTORATIVE MATERIALS. 

2 (a) MISBRANDING.—Section 502 of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend4 ed by adding at the end the following: 

5 ‘‘(aa) If it is a dental restorative material (as defined 

6 in section 311(d)), and its labeling fails to include text 

7 (developed by the Secretary) describing the health risks 

8 associated with the material.’’. 

9 (b) DEVELOPMENT OF TEXT.—The Secretary of 

10 Health and Human Services, acting through the Commis11 sioner of Food and Drugs, shall develop text to be included 

12 in the labeling of dental restorative material, as required 

13 by section 502(aa) of the Federal Food, Drug, and Cos14 metic Act, as added by subsection (a). 

15 (c) APPLICABILITY.—The requirement of section 

16 502(aa) of the Federal Food, Drug, and Cosmetic Act, 

17 as added by subsection (a), applies with respect to any 

18 dental restorative material that is introduced or delivered 

19 for introduction into interstate commerce on or after the 

20 date that is 1 year after the date of the enactment of this 

21 Act. 

Æ 


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