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Dietary Supplement and Nonprescription Drug Consumer Protection Act

Public Law 109-462 · S. 3546 · 109th Congress · began in the Senate

Signed by George W. Bush (R) on Dec 22, 2006 · Health

Sponsor: Sen. Orrin Hatch (R-UT)

Cosponsors (5): Sen. Richard Durbin,

Passage votesYeaNay

  • HouseRecorded vote: 203 yea, 98 nay203–98
  • SenateUnanimous consent
Data notes

The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.

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Summary

The Congressional Research Service’s plain-language summary of what the law does.

Dietary Supplement and Nonprescription Drug Consumer Protection Act - (Sec. 2) 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 of a serious adverse event associated with use of such drug or supplement 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. Allows a retailer whose name appears on the label as a distributor to authorize the manufacturer or packer to submit the required reports so long as the retailer directs all reported adverse events to such manufacturer or packer.

Requires the Secretary to develop systems to ensure that duplicate reports of a serious adverse event are consolidated.

Allows the Secretary to establish an exemption from such reporting that would have no adverse effect on public health.

Considers a serious adverse event report to be: (1) a safety report that may be accompanied by a statement, which shall be included in any public disclosure of the report, 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 and a medical or similar file the disclosure of which violates the Freedom of Information Act unless all personally identifiable information is redacted.

Provides that the submission of any adverse event report shall not be construed as an admission that the drug or supplement involved caused or contributed to the adverse event.

Prohibits any state or local government from establishing or continuing any requirements related to a mandatory system for adverse event reports for nonprescription drugs or dietary supplements that are not identical to the requirements of 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 a domestic address or phone number for the reporting of a serious adverse event.

(Sec. 4) Prohibits the falsification of a serious adverse event report.

(Sec. 5) Prohibits the importation of a drug or supplement subject to this Act if the Secretary has credible information indicating that the responsible person has not complied with the requirements of this Act or has not allowed access to its records.

Who voted for it

Every House member of the 109th Congress on the ideology compass. Highlighted: the 203 who voted yea on final passage. Faded: everyone else, including those who voted nay, did not vote, or had not yet taken office.

203 yea98 nay132 present or did not vote

Dimension 2
Economic left–right
More liberalMore conservative

Democrats who voted yea(134)

  • Rep. Jim McDermottD-WA-7
  • Rep. Dennis KucinichD-OH-10
  • Rep. Barbara LeeD-CA-9
  • Rep. Jan SchakowskyD-IL-9
  • Rep. Lynn WoolseyD-CA-6
  • Rep. Donald PayneD-NJ-10
  • Rep. Maurice HincheyD-NY-22
  • Rep. John LewisD-GA-5
  • Rep. John OlverD-MA-1
  • Rep. Tammy BaldwinD-WI-2
  • Rep. Michael CapuanoD-MA-8
  • Rep. James OberstarD-MN-8
  • Rep. Jerrold NadlerD-NY-8
  • Rep. José SerranoD-NY-16
  • Rep. Mel WattD-NC-12
  • Rep. Jim McGovernD-MA-3
  • Rep. Mike HondaD-CA-15
  • Rep. Jesse JacksonD-IL-2
  • Rep. Barney FrankD-MA-4
  • Rep. Stephanie JonesD-OH-11
  • Rep. Bobby ScottD-VA-3
  • Rep. Eddie JohnsonD-TX-30
  • Rep. John TierneyD-MA-6
  • Rep. Sheila Jackson LeeD-TX-18
  • Rep. Tom UdallD-NM-3
  • Rep. Charlie RangelD-NY-15
  • Rep. Julia CarsonD-IN-7
  • Rep. Linda SánchezD-CA-39
  • Rep. Ed TownsD-NY-10
  • Rep. Gwen MooreD-WI-4
  • Rep. Martin SaboD-MN-5
  • Rep. Rush HoltD-NJ-12
  • Rep. Dave ObeyD-WI-7
  • Rep. Xavier BecerraD-CA-31
  • Rep. Bobby RushD-IL-1
  • Rep. Gary AckermanD-NY-5
  • Rep. Bennie ThompsonD-MS-2
  • Rep. Lois CappsD-CA-23
  • Rep. Frank PalloneD-NJ-6
  • Rep. Nancy PelosiD-CA-8
  • Rep. Neil AbercrombieD-HI-1
  • Rep. Grace NapolitanoD-CA-38
  • Rep. Lloyd DoggettD-TX-25
  • Rep. Robert BradyD-PA-1
  • Rep. David WuD-OR-1
  • Rep. Betty McCollumD-MN-4
  • Rep. Al GreenD-TX-9
  • Rep. Rosa DeLauroD-CT-3
  • Rep. Emanuel CleaverD-MO-5
  • Rep. Michael McNultyD-NY-21
  • Rep. Nita LoweyD-NY-18
  • Rep. Anthony WeinerD-NY-9
  • Rep. Carolyn MaloneyD-NY-14
  • Rep. Bart StupakD-MI-1
  • Rep. Elijah CummingsD-MD-7
  • Rep. Debbie Wasserman SchultzD-FL-20
  • Rep. Dale KildeeD-MI-5
  • Rep. Lucille Roybal-AllardD-CA-34
  • Rep. Patrick KennedyD-RI-1
  • Rep. Gregory MeeksD-NY-6
  • Rep. Joe CrowleyD-NY-7
  • Rep. Jim ClyburnD-SC-6
  • Rep. Brian BairdD-WA-3
  • Rep. Peter ViscloskyD-IN-1
  • Rep. Stephen LynchD-MA-9
  • Rep. Sander LevinD-MI-12
  • Rep. Howard BermanD-CA-28
  • Rep. Steven RothmanD-NJ-9
  • Rep. Tom AllenD-ME-1
  • Rep. Anna EshooD-CA-14
  • Rep. Nick RahallD-WV-3
  • Rep. Chris Van HollenD-MD-8
  • Rep. Mark UdallD-CO-2
  • Rep. Brad ShermanD-CA-27
  • Rep. Michael MichaudD-ME-2
  • Rep. Albio SiresD-NJ-13
  • Rep. Jay InsleeD-WA-1
  • Rep. Rahm EmanuelD-IL-5
  • Rep. G.K. ButterfieldD-NC-1
  • Rep. David PriceD-NC-4
  • Rep. Ellen TauscherD-CA-10
  • Rep. Kendrick MeekD-FL-17
  • Rep. Joe BacaD-CA-43
  • Rep. Timothy BishopD-NY-1
  • Rep. Rick LarsenD-WA-2
  • Rep. Jim LangevinD-RI-2
  • Rep. Eliot EngelD-NY-17
  • Rep. Susan DavisD-CA-53
  • Rep. Brad MillerD-NC-13
  • Rep. Steny HoyerD-MD-5
  • Rep. Rob AndrewsD-NJ-1
  • Rep. Benjamin CardinD-MD-3
  • Rep. Adam SchiffD-CA-29
  • Rep. Steve IsraelD-NY-2
  • Rep. Gene GreenD-TX-29
  • Rep. Allyson SchwartzD-PA-13
  • Rep. Russ CarnahanD-MO-3
  • Rep. Albert WynnD-MD-4
  • Rep. Carolyn McCarthyD-NY-4
  • Rep. Shelley BerkleyD-NV-1
  • Rep. Charlie GonzalezD-TX-20
  • Rep. Bob EtheridgeD-NC-2
  • Rep. Silvestre ReyesD-TX-16
  • Rep. Daniel LipinskiD-IL-3
  • Rep. Paul KanjorskiD-PA-11
  • Rep. Ron KindD-WI-3
  • Rep. Jim CooperD-TN-5
  • Rep. Jim DavisD-FL-11
  • Rep. Adam SmithD-WA-9
  • Rep. Mike RossD-AR-4
  • Rep. John SprattD-SC-5
  • Rep. David ScottD-GA-13
  • Rep. A. Dutch RuppersbergerD-MD-2
  • Rep. Leonard BoswellD-IA-3
  • Rep. John SalazarD-CO-3
  • Rep. John TannerD-TN-8
  • Rep. Vic SnyderD-AR-2
  • Rep. Dennis MooreD-KS-3
  • Rep. Earl PomeroyD-ND
  • Rep. Ben ChandlerD-KY-6
  • Rep. Stephanie Herseth SandlinD-SD
  • Rep. Ike SkeltonD-MO-4
  • Rep. Sanford BishopD-GA-2
  • Rep. Gene TaylorD-MS-4
  • Rep. Chet EdwardsD-TX-17
  • Rep. Mike McIntyreD-NC-7
  • Rep. Allen BoydD-FL-2
  • Rep. Melissa BeanD-IL-8
  • Rep. Henry CuellarD-TX-28
  • Rep. Charles MelanconD-LA-3
  • Rep. Lincoln DavisD-TN-4
  • Rep. John BarrowD-GA-12
  • Rep. Jim MathesonD-UT-2
  • Rep. Dan BorenD-OK-2

Republicans who voted yea(69)

  • Rep. Christopher ShaysR-CT-4
  • Rep. Rob SimmonsR-CT-2
  • Rep. Chris SmithR-NJ-4
  • Rep. Sherry BoehlertR-NY-24
  • Rep. Frank LoBiondoR-NJ-2
  • Rep. John McHughR-NY-23
  • Rep. Nancy JohnsonR-CT-5
  • Rep. David ReichertR-WA-8
  • Rep. Wayne GilchrestR-MD-1
  • Rep. Sue KellyR-NY-19
  • Rep. Michael CastleR-DE
  • Rep. Shelley CapitoR-WV-2
  • Rep. Fred UptonR-MI-6
  • Rep. Jon PorterR-NV-3
  • Rep. Pete KingR-NY-3
  • Rep. Mark KirkR-IL-10
  • Rep. Ray LaHoodR-IL-18
  • Rep. Jim WalshR-NY-25
  • Rep. Tim MurphyR-PA-18
  • Rep. Mike FergusonR-NJ-7
  • Rep. Frank WolfR-VA-10
  • Rep. Ralph RegulaR-OH-16
  • Rep. Tom OsborneR-NE-3
  • Rep. Jim RamstadR-MN-3
  • Rep. Kenny HulshofR-MO-9
  • Rep. Jerry WellerR-IL-11
  • Rep. Jeff FortenberryR-NE-1
  • Rep. Greg WaldenR-OR-2
  • Rep. Tom LathamR-IA-4
  • Rep. Dave CampR-MI-4
  • Rep. Richard PomboR-CA-11
  • Rep. Mary Bono MackR-CA-45
  • Rep. Vernon EhlersR-MI-3
  • Rep. John ShimkusR-IL-19
  • Rep. Dave HobsonR-OH-7
  • Rep. Anne NorthupR-KY-3
  • Rep. Candice MillerR-MI-10
  • Rep. Bill ThomasR-CA-22
  • Rep. Judy BiggertR-IL-13
  • Rep. Hal RogersR-KY-5
  • Rep. Ken CalvertR-CA-44
  • Rep. Ander CrenshawR-FL-4
  • Rep. Buck McKeonR-CA-25
  • Rep. Jean SchmidtR-OH-2
  • Rep. Robert AderholtR-AL-4
  • Rep. Kay GrangerR-TX-12
  • Rep. David DreierR-CA-26
  • Rep. Doc HastingsR-WA-4
  • Rep. John DoolittleR-CA-4
  • Rep. Vito FossellaR-NY-13
  • Rep. Mark GreenR-WI-8
  • Rep. Mike RogersR-MI-8
  • Rep. Michael BurgessR-TX-26
  • Rep. Mario Diaz-BalartR-FL-25
  • Rep. Dave WeldonR-FL-15
  • Rep. Duncan HunterR-CA-52
  • Rep. Lee TerryR-NE-2
  • Rep. Terry EverettR-AL-2
  • Rep. Katherine HarrisR-FL-13
  • Rep. Ric KellerR-FL-8
  • Rep. Steve BuyerR-IN-4
  • Rep. Denny HastertR-IL-14
  • Rep. Daniel LungrenR-CA-3
  • Rep. Brian BilbrayR-CA-50
  • Rep. Joe BartonR-TX-6
  • Rep. Connie MackR-FL-14
  • Rep. Chris CannonR-UT-3
  • Rep. Steve ChabotR-OH-1
  • Rep. Dana RohrabacherR-CA-46
Data notes

The House’s recorded vote on the final version of the law (roll call 1210 in Voteview), matched to the vote the record cites and checked against its totals. Positions are each member’s DW-NOMINATE score for that Congress, as on the Ideology page; left to right is more liberal to more conservative. Paired and announced yea votes count as yea. Lists follow the compass, most liberal first. A name links to a profile only for members of the current Congress. A law passed by voice vote or unanimous consent has no member list, and neither does a vote Voteview has not yet recorded.

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Committees

The committees the bill was sent to, and what each did with it.

Data notes

A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.

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Related bills

1 bill the Library of Congress relates to this one.

  • H.R. 6168Related bill

    Dietary Supplement and Nonprescription Drug Consumer Protection Act

Data notes

Related bills are identified by the Congressional Research Service, the House and the Senate: companion and identical bills, bills with similar text, bills that were folded into this law, and rules that brought it to the floor. A bill that is itself a public law in this site’s data links here; the others link to Congress.gov.

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Timeline

From introduction to signing, newest first: the committees, the floor and the president. 20 actions.

  1. Dec 22, 2006Became lawBecame law · Became Public Law No: 109-462.
  2. Became lawBecame law · Signed by President.
  3. Dec 20, 2006FloorFloor · Presented to President.
  4. Dec 9, 2006FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
  5. FloorFloor · 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).House roll call 543
  6. FloorFloor · Considered as unfinished business.
  7. FloorFloor · 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.
  8. FloorFloor · DEBATE - The House proceeded with forty minutes of debate on S. 3546.
  9. FloorFloor · Considered under suspension of the rules.
  10. FloorFloor · Mr. Barton (TX) moved to suspend the rules and pass the bill.
  11. Dec 7, 2006FloorFloor · Held at the desk.
  12. FloorFloor · Received in the House.
  13. FloorFloor · Message on Senate action sent to the House.
  14. Dec 6, 2006FloorFloor · Passed Senate with an amendment by Unanimous Consent.
  15. Sep 5, 2006CalendarCalendar · Placed on Senate Legislative Calendar under General Orders. Calendar No. 586.
  16. CommitteeCommittee · 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.
  17. Jun 28, 2006CommitteeCommittee · Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
  18. Jun 21, 2006CommitteeCommittee · Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  19. CommitteeCommittee · Sponsor introductory remarks on measure. (CR S6285-6287)
  20. IntroducedIntroduced · Introduced in Senate
Data notes

Every action the Library of Congress lists for the bill, from introduction to signing, plus the dated committee hearings. The source lists many steps twice (the chamber’s own entry and the Library of Congress copy, or a presidential and a became-law entry with the same words); those are shown once. Amendments are listed in their own section.

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Amendments

No amendments to this bill are on record.

Data notes

Amendments offered to this bill in either chamber, as the Library of Congress records them: each with a status read from its last recorded step: agreed to, rejected, withdrawn, ruled out of order, fell with another amendment, or offered with no vote recorded (most Senate amendments are only ever offered). The wording of each amendment is the source’s. Amendments to amendments and amendments to other bills are not listed.

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Official record

The bill’s full text is on Congress.gov. Data through Oct 7, 2026.