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 res-
toration 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. 
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 ‘‘Consumers Have Op-
tions for Molar Protection Act of 2009’’ or the ‘‘CHOMP 
Act of 2009’’. 
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SEC. 2. PROVISION OF FACT SHEET TO PATIENTS PRIOR TO 
DENTAL RESTORATION WORK. 
(a) IN GENERAL.—Chapter III of the Federal, Food, 
Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 311. PROVISION OF FACT SHEET TO PATIENTS PRIOR 
TO DENTAL RESTORATION WORK. 
‘‘(a) REQUIREMENT.—A dentist shall— 
‘‘(1) before performing any dental restoration 
work— 
‘‘(A) provide the patient with the fact 
sheet developed by the Secretary under sub-
section (b); and 
‘‘(B) obtain the patient’s signature ac-
knowledging receipt of the fact sheet; and 
‘‘(2) place a copy of the signed acknowledgment 
in the patient’s record. 
‘‘(b) FACT SHEET.— 
‘‘(1) DEVELOPMENT.—The Secretary shall de-
velop not later than 1 year after the date of the en-
actment of this section, and periodically review and 
update as scientifically warranted, a fact sheet de-
scribing and comparing the risks and efficacy of the 
various types of dental restorative materials that 
may be used to repair a patient’s oral condition or 
defect. 
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‘‘(2) CONTENTS.—The fact sheet developed 
under paragraph (1) shall include each of the fol-
lowing: 
‘‘(A) A description of the groups of mate-
rials that are available to the dental profession 
for restoration of an oral condition or defect. 
‘‘(B) A comparison of the relative benefits 
and detriments of each group of materials. 
‘‘(C) A comparison of the cost consider-
ations associated with each group of materials. 
‘‘(D) A reference to encourage discussion 
between the patient and dentist regarding den-
tal restorative materials and to inform the pa-
tient of his or her options. 
‘‘(3) AVAILABILITY.—The Secretary shall make 
the fact sheet developed under paragraph (1) avail-
able to all licensed dentists in the United States. 
‘‘(c) PENALTY.— 
‘‘(1) IN GENERAL.—Whoever violates subsection 
(a) shall be fined not more than $5,000. 
‘‘(2) CALCULATION.—In calculating the max-
imum authorized amount of a fine under paragraph 
(1), the number of violations shall be calculated by 
multiplying $5,000 by the number of dental restora-
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tive materials placed into a patient’s mouth in viola-
tion of subsection (a). 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) The term ‘dental restoration work’— 
‘‘(A) means the placement of a dental re-
storative material into a patient’s mouth; and 
‘‘(B) excludes any surgical, endodontic, 
periodontic, or orthodontic dental procedure in 
which a dental restorative material is not used. 
‘‘(2) The term ‘dental restorative material’ 
means any structure or device placed into a patient’s 
mouth with the intent that it remain there for an in-
definite period beyond the completion of the dental 
procedure. 
‘‘(3) The term ‘patient’ means the patient or 
the patient’s parent, legal guardian, or other author-
ized representative.’’. 
(b) APPLICABILITY.—The requirement of section 
311(a) of the Federal Food, Drug, and Cosmetic Act, as 
added by subsection (a), applies with respect to any dental 
restoration work (as defined in such section) on or after 
the date that is 2 years after the date of the enactment 
of this Act. 
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SEC. 3. LABELING OF DENTAL RESTORATIVE MATERIALS. 
(a) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by adding at the end the following: 
‘‘(aa) If it is a dental restorative material (as defined 
in section 311(d)), and its labeling fails to include text 
(developed by the Secretary) describing the health risks 
associated with the material.’’. 
(b) DEVELOPMENT
OF TEXT.—The Secretary of 
Health and Human Services, acting through the Commis-
sioner of Food and Drugs, shall develop text to be included 
in the labeling of dental restorative material, as required 
by section 502(aa) of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a). 
(c) APPLICABILITY.—The requirement of section 
502(aa) of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (a), applies with respect to any 
dental restorative material that is introduced or delivered 
for introduction into interstate commerce on or after the 
date that is 1 year after the date of the enactment of this 
Act. 
Æ 
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