[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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