1.This Act may be cited as the
Consumers Have Options for Molar Protection Act of
2009
or the CHOMP Act of
2009
.
2.Provision of fact
sheet to patients prior to dental restoration work
(a)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:
311.Provision of
fact sheet to patients prior to dental restoration work
(a)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)
(1)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)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)The
Secretary shall make the fact sheet developed under paragraph (1) available to
all licensed dentists in the United States.
(c)
(1)Whoever violates subsection (a) shall be fined not more
than $5,000.
(2)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)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)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.
3.Labeling of
dental restorative materials
(a)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)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)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.