```

[109th Congress Public Law 462]
[From the U.S. Government Printing Office]

[DOCID: f:publ462.109]

[[Page 120 STAT. 3469]]

Public Law 109-462
109th Congress

                                 An Act

 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
      serious adverse event reporting for dietary supplements and 
    nonprescription drugs, and for other purposes. <<NOTE: Dec. 22, 
                          2006 -  [S. 3546]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Dietary 
Supplement and Nonprescription Drug Consumer Protection Act.>> 

SECTION 1. <<NOTE: 21 USC 301 note.>> SHORT TITLE.

    This Act may be cited as the ``Dietary Supplement and 
Nonprescription Drug Consumer Protection Act''.

SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NONPRESCRIPTION DRUGS.

    (a) In General.--Chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 371 et seq.) is amended by adding at the end the 
following:

              ``Subchapter H--Serious Adverse Event Reports

``SEC. 760. <<NOTE: 21 USC 379aa.>> SERIOUS ADVERSE EVENT REPORTING FOR 
            NONPRESCRIPTION DRUGS.

    ``(a) Definitions.--In this section:
            ``(1) Adverse event.--The term `adverse event' means any 
        health-related event associated with the use of a 
        nonprescription drug that is adverse, including--
                    ``(A) an event occurring from an overdose of the 
                drug, whether accidental or intentional;
                    ``(B) an event occurring from abuse of the drug;
                    ``(C) an event occurring from withdrawal from the 
                drug; and
                    ``(D) any failure of expected pharmacological action 
                of the drug.
            ``(2) Nonprescription drug.--The term `nonprescription drug' 
        means a drug that is--
                    ``(A) not subject to section 503(b); and
                    ``(B) not subject to approval in an application 
                submitted under section 505.
            ``(3) Serious adverse event.--The term `serious adverse 
        event' is an adverse event that--
                    ``(A) results in--
                          ``(i) death;
                          ``(ii) a life-threatening experience;
                          ``(iii) inpatient hospitalization;
                          ``(iv) a persistent or significant disability 
                      or incapacity; or

[[Page 120 STAT. 3470]]

                          ``(v) a congenital anomaly or birth defect; or
                    ``(B) requires, based on reasonable medical 
                judgment, a medical or surgical intervention to prevent 
                an outcome described under subparagraph (A).
            ``(4) Serious adverse event report.--The term `serious 
        adverse event report' means a report that is required to be 
        submitted to the Secretary under subsection (b).

    ``(b) Reporting Requirement.--
            ``(1) In general.--The manufacturer, packer, or distributor 
        whose name (pursuant to section 502(b)(1)) appears on the label 
        of a nonprescription drug marketed in the United States 
        (referred to in this section as the `responsible person') shall 
        submit to the Secretary any report received of a serious adverse 
        event associated with such drug when used in the United States, 
        accompanied by a copy of the label on or within the retail 
        package of such drug.
            ``(2) Retailer.--A retailer whose name appears on the label 
        described in paragraph (1) as a distributor may, by agreement, 
        authorize the manufacturer or packer of the nonprescription drug 
        to submit the required reports for such drugs to the Secretary 
        so long as the retailer directs to the manufacturer or packer 
        all adverse events associated with such drug that are reported 
        to the retailer through the address or telephone number 
        described in section 502(x).

    ``(c) Submission of Reports.--
            ``(1) Timing of reports.--The responsible person shall 
        submit to the Secretary a serious adverse event report no later 
        than 15 business days after the report is received through the 
        address or phone number described in section 502(x).
            ``(2) New medical information.--The responsible person shall 
        submit to the Secretary any new medical information, related to 
        a submitted serious adverse event report that is received by the 
        responsible person within 1 year of the initial report, no later 
        than 15 business days after the new information is received by 
        the responsible person.
            ``(3) Consolidation of reports.--The Secretary shall develop 
        systems to ensure that duplicate reports of, and new medical 
        information related to, a serious adverse event shall be 
        consolidated into a single report.
            ``(4) Exemption.--The Secretary, after providing notice and 
        an opportunity for comment from interested parties, may 
        establish an exemption to the requirements under paragraphs (1) 
        and (2) if the Secretary determines that such exemption would 
        have no adverse effect on public health.

    ``(d) Contents of Reports.--Each serious adverse event report under 
this section shall be submitted to the Secretary using the MedWatch 
form, which may be modified by the Secretary for nonprescription drugs, 
and may be accompanied by additional information.
    ``(e) Maintenance and Inspection of Records.--
            ``(1) Maintenance.--The responsible person shall maintain 
        records related to each report of an adverse event received by 
        the responsible person for a period of 6 years.
            ``(2) Records inspection.--
                    ``(A) In general.--The responsible person shall 
                permit an authorized person to have access to records 
                required

[[Page 120 STAT. 3471]]

                to be maintained under this section, during an 
                inspection pursuant to section 704.
                    ``(B) Authorized person.--For purposes of this 
                paragraph, the term `authorized person' means an officer 
                or employee of the Department of Health and Human 
                Services who has--
                          ``(i) appropriate credentials, as determined 
                      by the Secretary; and
                          ``(ii) been duly designated by the Secretary 
                      to have access to the records required under this 
                      section.

    ``(f) Protected Information.--A serious adverse event report 
submitted to the Secretary under this section, including any new medical 
information submitted under subsection (c)(2), or an adverse event 
report voluntarily submitted to the Secretary shall be considered to 
be--
            ``(1) a safety report under section 756 and may be 
        accompanied by a statement, which shall be a part of any report 
        that is released for public disclosure, that denies that the 
        report or the records constitute an admission that the product 
        involved caused or contributed to the adverse event; and
            ``(2) a record about an individual under section 552a of 
        title 5, United States Code (commonly referred to as the 
        `Privacy Act of 1974') and a medical or similar file the 
        disclosure of which would constitute a violation of section 552 
        of such title 5 (commonly referred to as the `Freedom of 
        Information Act'), and shall not be publicly disclosed unless 
        all personally identifiable information is redacted.

    ``(g) Rule of Construction.--The submission of any adverse event 
report in compliance with this section shall not be construed as an 
admission that the nonprescription drug involved caused or contributed 
to the adverse event.
    ``(h) Preemption.--
            ``(1) In general.--No State or local government shall 
        establish or continue in effect any law, regulation, order, or 
        other requirement, related to a mandatory system for adverse 
        event reports for nonprescription drugs, that is different from, 
        in addition to, or otherwise not identical to, this section.
            ``(2) Effect of section.--
                    ``(A) In general.--Nothing in this section shall 
                affect the authority of the Secretary to provide adverse 
                event reports and information to any health, food, or 
                drug officer or employee of any State, territory, or 
                political subdivision of a State or territory, under a 
                memorandum of understanding between the Secretary and 
                such State, territory, or political subdivision.
                    ``(B) Personally-identifiable information.--
                Notwithstanding any other provision of law, personally-
                identifiable information in adverse event reports 
                provided by the Secretary to any health, food, or drug 
                officer or employee of any State, territory, or 
                political subdivision of a State or territory, shall 
                not--
                          ``(i) be made publicly available pursuant to 
                      any State or other law requiring disclosure of 
                      information or records; or
                          ``(ii) otherwise be disclosed or distributed 
                      to any party without the written consent of the 
                      Secretary

[[Page 120 STAT. 3472]]

                      and the person submitting such information to the 
                      Secretary.
                    ``(C) Use of safety reports.--Nothing in this 
                section shall permit a State, territory, or political 
                subdivision of a State or territory, to use any safety 
                report received from the Secretary in a manner 
                inconsistent with subsection (g) or section 756.

    ``(i) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary.''.
    (b) Modifications.--The <<NOTE: 21 USC 379aa note.>> Secretary of 
Health and Human Services may modify requirements under the amendments 
made by this section in accordance with section 553 of title 5, United 
States Code, to maintain consistency with international harmonization 
efforts over time.

    (c) Prohibited Act.--Section 301(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(e)) is amended by--
            (1) striking ``, or 704(a);'' and inserting ``, 704(a), or 
        760;''; and
            (2) striking ``, or 564'' and inserting ``, 564, or 760''.

    (d) 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:
    ``(x) If it is a nonprescription drug (as defined in section 760) 
that is marketed in the United States, unless the label of such drug 
includes a domestic address or domestic phone number through which the 
responsible person (as described in section 760) may receive a report of 
a serious adverse event (as defined in section 760) with such drug.''.
    (e) Effective Dates.--
            (1) In general.--Except <<NOTE: 21 USC 352 note.>> as 
        provided in paragraph (2), the amendments made by this section 
        shall take effect 1 year after the date of enactment of this 
        Act.
            (2) Misbranding.--Section 502(x) of the Federal Food, Drug, 
        and Cosmetic Act (as added by this section) shall apply to any 
        nonprescription drug (as defined in such section 502(x)) labeled 
        on or after the date that is 1 year after the date of enactment 
        of this Act.
            (3) Guidance.--Not <<NOTE: 21 USC 379aa note.>> later than 
        270 days after the date of enactment of this Act, the Secretary 
        of Health and Human Services shall issue guidance on the minimum 
        data elements that should be included in a serious adverse event 
        report described under the amendments made by this Act.

SEC. 3. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY SUPPLEMENTS.

    (a) In General.--Chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 371 et seq.) is amended by adding at the end the 
following:

``SEC. 761. <<NOTE: 21 USC 379aa-1.>> SERIOUS ADVERSE EVENT REPORTING 
            FOR DIETARY SUPPLEMENTS.

    ``(a) Definitions.--In this section:
            ``(1) Adverse event.--The term `adverse event' means any 
        health-related event associated with the use of a dietary 
        supplement that is adverse.
            ``(2) Serious adverse event.--The term `serious adverse 
        event' is an adverse event that--

[[Page 120 STAT. 3473]]

                    ``(A) results in--
                          ``(i) death;
                          ``(ii) a life-threatening experience;
                          ``(iii) inpatient hospitalization;
                          ``(iv) a persistent or significant disability 
                      or incapacity; or
                          ``(v) a congenital anomaly or birth defect; or
                    ``(B) requires, based on reasonable medical 
                judgment, a medical or surgical intervention to prevent 
                an outcome described under subparagraph (A).
            ``(3) Serious adverse event report.--The term `serious 
        adverse event report' means a report that is required to be 
        submitted to the Secretary under subsection (b).

    ``(b) Reporting Requirement.--
            ``(1) In general.--The manufacturer, packer, or distributor 
        of a dietary supplement whose name (pursuant to section 
        403(e)(1)) appears on the label of a dietary supplement marketed 
        in the United States (referred to in this section as the 
        `responsible person') shall submit to the Secretary any report 
        received of a serious adverse event associated with such dietary 
        supplement when used in the United States, accompanied by a copy 
        of the label on or within the retail packaging of such dietary 
        supplement.
            ``(2) Retailer.--A retailer whose name appears on the label 
        described in paragraph (1) as a distributor may, by agreement, 
        authorize the manufacturer or packer of the dietary supplement 
        to submit the required reports for such dietary supplements to 
        the Secretary so long as the retailer directs to the 
        manufacturer or packer all adverse events associated with such 
        dietary supplement that are reported to the retailer through the 
        address or telephone number described in section 403(y).

    ``(c) Submission of Reports.--
            ``(1) Timing of reports.--The responsible person shall 
        submit to the Secretary a serious adverse event report no later 
        than 15 business days after the report is received through the 
        address or phone number described in section 403(y).
            ``(2) New medical information.--The responsible person shall 
        submit to the Secretary any new medical information, related to 
        a submitted serious adverse event report that is received by the 
        responsible person within 1 year of the initial report, no later 
        than 15 business days after the new information is received by 
        the responsible person.
            ``(3) Consolidation of reports.--The Secretary shall develop 
        systems to ensure that duplicate reports of, and new medical 
        information related to, a serious adverse event shall be 
        consolidated into a single report.
            ``(4) Exemption.--The Secretary, after providing notice and 
        an opportunity for comment from interested parties, may 
        establish an exemption to the requirements under paragraphs (1) 
        and (2) if the Secretary determines that such exemption would 
        have no adverse effect on public health.

    ``(d) Contents of Reports.--Each serious adverse event report under 
this section shall be submitted to the Secretary using the MedWatch 
form, which may be modified by the Secretary for dietary supplements, 
and may be accompanied by additional information.
    ``(e) Maintenance and Inspection of Records.--

[[Page 120 STAT. 3474]]

            ``(1) Maintenance.--The responsible person shall maintain 
        records related to each report of an adverse event received by 
        the responsible person for a period of 6 years.
            ``(2) Records inspection.--
                    ``(A) In general.--The responsible person shall 
                permit an authorized person to have access to records 
                required to be maintained under this section during an 
                inspection pursuant to section 704.
                    ``(B) Authorized person.--For purposes of this 
                paragraph, the term `authorized person' means an officer 
                or employee of the Department of Health and Human 
                Services, who has--
                          ``(i) appropriate credentials, as determined 
                      by the Secretary; and
                          ``(ii) been duly designated by the Secretary 
                      to have access to the records required under this 
                      section.

    ``(f) Protected Information.--A serious adverse event report 
submitted to the Secretary under this section, including any new medical 
information submitted under subsection (c)(2), or an adverse event 
report voluntarily submitted to the Secretary shall be considered to 
be--
            ``(1) a safety report under section 756 and may be 
        accompanied by a statement, which shall be a part of any report 
        that is released for public disclosure, that denies that the 
        report or the records constitute an admission that the product 
        involved caused or contributed to the adverse event; and
            ``(2) a record about an individual under section 552a of 
        title 5, United States Code (commonly referred to as the 
        `Privacy Act of 1974') and a medical or similar file the 
        disclosure of which would constitute a violation of section 552 
        of such title 5 (commonly referred to as the `Freedom of 
        Information Act'), and shall not be publicly disclosed unless 
        all personally identifiable information is redacted.

    ``(g) Rule of Construction.--The submission of any adverse event 
report in compliance with this section shall not be construed as an 
admission that the dietary supplement involved caused or contributed to 
the adverse event.
    ``(h) Preemption.--
            ``(1) In general.--No State or local government shall 
        establish or continue in effect any law, regulation, order, or 
        other requirement, related to a mandatory system for adverse 
        event reports for dietary supplements, that is different from, 
        in addition to, or otherwise not identical to, this section.
            ``(2) Effect of section.--
                    ``(A) In general.--Nothing in this section shall 
                affect the authority of the Secretary to provide adverse 
                event reports and information to any health, food, or 
                drug officer or employee of any State, territory, or 
                political subdivision of a State or territory, under a 
                memorandum of understanding between the Secretary and 
                such State, territory, or political subdivision.
                    ``(B) Personally-identifiable information.--
                Notwithstanding any other provision of law, personally-
                identifiable information in adverse event reports 
                provided by the Secretary to any health, food, or drug 
                officer or employee of any State, territory, or 
                political subdivision of a State or territory, shall 
                not--

[[Page 120 STAT. 3475]]

                          ``(i) be made publicly available pursuant to 
                      any State or other law requiring disclosure of 
                      information or records; or
                          ``(ii) otherwise be disclosed or distributed 
                      to any party without the written consent of the 
                      Secretary and the person submitting such 
                      information to the Secretary.
                    ``(C) Use of safety reports.--Nothing in this 
                section shall permit a State, territory, or political 
                subdivision of a State or territory, to use any safety 
                report received from the Secretary in a manner 
                inconsistent with subsection (g) or section 756.

    ``(i) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary.''.
    (b) Prohibited Act.--Section 301(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(e)) is amended by--
            (1) striking ``, or 760;'' and inserting ``, 760, or 761;''; 
        and
            (2) striking ``, or 760'' and inserting ``, 760, or 761''.

    (c) Misbranding.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
    ``(y) If it is a dietary supplement that is marketed in the United 
States, unless the label of such dietary supplement includes a domestic 
address or domestic phone number through which the responsible person 
(as described in section 761) may receive a report of a serious adverse 
event with such dietary supplement.''.
    (d) Effective Date.--
            (1) In general.--Except <<NOTE: 21 USC 343 note.>> as 
        provided in paragraph (2), the amendments made by this section 
        shall take effect 1 year after the date of enactment of this 
        Act.
            (2) Misbranding.--Section 403(y) of the Federal Food, Drug, 
        and Cosmetic Act (as added by this section) shall apply to any 
        dietary supplement labeled on or after the date that is 1 year 
        after the date of enactment of this Act.
            (3) Guidance.--Not <<NOTE: 21 USC 379aa note.>> later than 
        270 days after the date of enactment of this Act, the Secretary 
        of Health and Human Services shall issue guidance on the minimum 
        data elements that should be included in a serious adverse event 
        report as described under the amendments made by this Act.

SEC. 4. PROHIBITION OF FALSIFICATION OF REPORTS.

    (a) In General.--Section 301 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 331) is amended by adding at the end the following:
    ``(ii) The falsification of a report of a serious adverse event 
submitted to a responsible person (as defined under section 760 or 761) 
or the falsification of a serious adverse event report (as defined under 
section 760 or 761) submitted to the Secretary.''.
    (b) Effective Date.--The <<NOTE: 21 USC 331 note.>> amendment made 
by this section shall take effect 1 year after the date of enactment of 
this Act.

SEC. 5. IMPORTATION OF CERTAIN NONPRESCRIPTION DRUGS AND DIETARY 
            SUPPLEMENTS.

    (a) In General.--Section 801 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 381) is amended--
            (1) in subsection (a), by inserting after the third sentence 
        the following: ``If such article is subject to a requirement 
        under

[[Page 120 STAT. 3476]]

        section 760 or 761 and if the Secretary has credible evidence or 
        information indicating that the responsible person (as defined 
        in such section 760 or 761) has not complied with a requirement 
        of such section 760 or 761 with respect to any such article, or 
        has not allowed access to records described in such section 760 
        or 761, then such article shall be refused admission, except as 
        provided in subsection (b) of this section.''; and
            (2) in the second sentence of subsection (b)--
                    (A) by inserting ``(1)'' before ``an article 
                included'';
                    (B) by inserting before ``final determination'' the 
                following: ``or (2) with respect to an article included 
                within the provision of the fourth sentence of 
                subsection (a), the responsible person (as defined in 
                section 760 or 761) can take action that would assure 
                that the responsible person is in compliance with 
                section 760 or 761, as the case may be,''; and
                    (C) by inserting ``, or, with respect to clause (2), 
                the responsible person,'' before ``to perform''.

    (b) Effective Date.--The <<NOTE: 21 USC 381 note.>> amendments made 
by this section shall take effect 1 year after the date of enactment of 
this Act.

    Approved December 22, 2006.

LEGISLATIVE HISTORY--S. 3546:
---------------------------------------------------------------------------

SENATE REPORTS: No. 109-324 (Comm. on Health, Education, Labor, and 
Pensions).
CONGRESSIONAL RECORD, Vol. 152 (2006):
            Dec. 6, considered and passed Senate.
            Dec. 8, considered and passed House.

                                  <all>
```