[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4615 Introduced in House (IH)]
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Consumers Have Options for Molar
Protection Act of 2009'' or the ``CHOMP Act of 2009''.
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 amended 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 subsection (b); and
``(B) obtain the patient's signature acknowledging
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 develop not later
than 1 year after the date of the enactment of this section,
and periodically review and update as scientifically warranted,
a fact sheet describing 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.
``(2) Contents.--The fact sheet developed under paragraph
(1) shall include each of the following:
``(A) A description of the groups of materials 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 considerations
associated with each group of materials.
``(D) A reference to encourage discussion between
the patient and dentist regarding dental restorative
materials and to inform the patient of his or her
options.
``(3) Availability.--The Secretary shall make the fact
sheet developed under paragraph (1) available 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 maximum authorized
amount of a fine under paragraph (1), the number of violations
shall be calculated by multiplying $5,000 by the number of
dental restorative materials placed into a patient's mouth in
violation of subsection (a).
``(d) Definitions.--In this section:
``(1) The term `dental restoration work'--
``(A) means the placement of a dental restorative
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 indefinite period beyond the
completion of the dental procedure.
``(3) The term `patient' means the patient or the patient's
parent, legal guardian, or other authorized 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.
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 amended 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 Commissioner 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
Cosmetic 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.
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