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United States · Law · S

S. 3546 (109th)

Dietary Supplement and Nonprescription Drug Consumer Protection Act

enactedUnited States· United States Congress· EN

Introduced

21 June 2006

Last action

22 December 2006 · President

Status

Became Public Law No: 109-462.

Sponsors

Sen. Hatch, Orrin G. [R-UT], Sen. Durbin, Richard J. [D-IL], Sen. Harkin, Tom [D-IA], Sen. Enzi, Michael B. [R-WY], Sen. Kennedy, Edward M. [D-MA], Sen. Cornyn, John [R-TX]

Subjects

Healthcare

Source updated

6 December 2025

Healthcare

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Summary

Dietary Supplement and Nonprescription Drug Consumer Protection Act - Amends the Federal Food, Drug, and Cosmetic Act to require a manufacturer, packer, or distributor whose name appears on the label of a nonprescription drug or dietary supplement marketed in the United States to: (1) submit to the Secretary of Health and Human Services within 15 business days any report received of a serious adverse event associated with such drug or supplement when used in the United States; (2) submit within 15 business days any related medical information that is received within one year of the initial report; (3) maintain records related to each report for six years; and (4) permit inspection of such records. Requires the Secretary to develop systems to ensure that duplicate reports of a serious adverse event are consolidated into a single report. Allows the Secretary to establish an exemption from such reporting that would have no adverse effect on public health. Prohibits any state or local government from establishing or continuing any requirement related to a mandatory system for adverse event reports for nonprescription drugs or dietary supplements that is not identical to this Act. Prohibits the responsible person from: (1) refusing to permit access to any required record; or (2) failing to establish or maintain any record, or make any report, required under this Act. Deems a nonprescription drug or dietary supplement that is marketed in the United States to be misbranded, unless its label includes an address or phone number for the reporting of a serious adverse event.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 21 June 2006

    Introduced

    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Source: IntroReferral

  2. 21 June 2006

    Introduced

    Sponsor introductory remarks on measure. (CR S6285-6287)

    Source: IntroReferral

  3. 21 June 2006

    Introduced

    Introduced in Senate

    Source: IntroReferral

  4. 28 June 2006

    Reported

    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

    Source: Committee

  5. 5 September 2006

    Calendars

    Placed on Senate Legislative Calendar under General Orders. Calendar No. 586.

    Source: Calendars

  6. 5 September 2006

    Reported

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. With written report No. 109-324.

    Source: Committee

  7. 5 September 2006

    Reported

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. With written report No. 109-324.

    Source: Committee

  8. 6 December 2006

    Passed

    Passed Senate with an amendment by Unanimous Consent. (consideration: CR S11376-11381; text as passed Senate: CR S11377-11378)

    Source: Floor

  9. 6 December 2006

    Passed

    Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(consideration: CR S11376-11381; text as passed Senate: CR S11377-11378)

    Source: Floor

  10. 7 December 2006

    Floor

    Held at the desk.

    Source: Floor

  11. 7 December 2006

    Floor

    Received in the House.

    Source: Floor

  12. 7 December 2006

    Floor

    Message on Senate action sent to the House.

    Source: Floor

  13. 9 December 2006

    Passed

    Motion to reconsider laid on the table Agreed to without objection.

    Source: Floor

  14. 9 December 2006

    Vote

    On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 203 - 98 (Roll no. 543). (text: CR 12/8/2006 H9243-9245)

    Source: Floor

  15. 9 December 2006

    Vote

    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 203 - 98 (Roll no. 543).(text: CR 12/8/2006 H9243-9245)

    Source: Floor

  16. 9 December 2006

    Floor

    Considered under suspension of the rules. (consideration: CR 12/8/2006 H9243-9246)

    Source: Floor

  17. 9 December 2006

    Vote

    At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.

    Source: Floor

  18. 9 December 2006

    Floor

    DEBATE - The House proceeded with forty minutes of debate on S. 3546.

    Source: Floor

  19. 9 December 2006

    Floor

    Mr. Barton (TX) moved to suspend the rules and pass the bill.

    Source: Floor

  20. 20 December 2006

    Floor

    Presented to President.

    Source: Floor

  21. 20 December 2006

    President

    Presented to President.

    Source: President

  22. 22 December 2006

    Became law

    Became Public Law No: 109-462.

    Source: President

  23. 22 December 2006

    Became law

    Signed by President.

    Source: BecameLaw

  24. 22 December 2006

    President

    Signed by President.

    Source: President

Votes

No vote records are attached yet.

Versions

Documents

13 official files

Public Law (text)

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  • Public Law (text)

    Public Law · EN · 22 December 2006

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  • Public Law (PDF)

    Public Law · EN · 22 December 2006

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  • Public Law

    summary · EN · 22 December 2006

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  • Enrolled Bill (text)

    Enrolled Bill · EN · 14 December 2006

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  • Enrolled Bill (PDF)

    Enrolled Bill · EN · 14 December 2006

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  • Engrossed in Senate (text)

    Engrossed in Senate · EN · 6 December 2006

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  • Engrossed in Senate (PDF)

    Engrossed in Senate · EN · 6 December 2006

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  • Reported to Senate (text)

    Reported to Senate · EN · 5 September 2006

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  • Reported to Senate (PDF)

    Reported to Senate · EN · 5 September 2006

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  • Reported to Senate with amendment(s)

    summary · EN · 5 September 2006

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  • Introduced in Senate (text)

    Introduced in Senate · EN · 21 June 2006

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  • Introduced in Senate (PDF)

    Introduced in Senate · EN · 21 June 2006

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  • Introduced in Senate

    summary · EN · 21 June 2006

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