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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

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Status

Became Public Law No: 109-462.

Sponsors

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Subjects

Discovery layer

Source updated

6 December 2025

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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.

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Documents

13 official files

Public Law (text)

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