3.0.0 6168 2023-01-12T17:52:16Z 2023-01-12T17:52:16Z House H HR 2006-09-25 109 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2006-10-02T17:55:00Z Referred to 2006-09-25T16:16:00Z Dietary Supplement and Nonprescription Drug Consumer Protection Act 109 3546 S 2006-12-22 Became Public Law No: 109-462. Related bill CRS 2006-10-02 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2006-09-25 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2006-09-25 Sponsor introductory remarks on measure. (CR E1826) IntroReferral B00100 9 Library of Congress 2006-09-25 Introduced in House IntroReferral Intro-H 9 Library of Congress 2006-09-25 Introduced in House IntroReferral 1000 9 Library of Congress C000116 Rep. Cannon, Chris [R-UT-3] CHRIS CANNON R UT 3 N P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2006-11-14 False Health Agriculture and Food Birth defects Business records Civil Rights and Liberties, Minority Issues Commerce Crime and Law Enforcement Death Dietary supplements Drug abuse Drug adulteration Drug industry Evidence (Law) Federal preemption Food safety Foreign Trade and International Finance Fraud Freedom of information Government Operations and Politics Government paperwork Import restrictions Labeling Law Local laws Nonprescription drugs Right of privacy State laws Health 00 2006-09-25 Introduced in House 2006-10-31T15:05:58Z 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 a domestic address or phone number for the reporting of a serious adverse event.

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

]]> Dietary Supplement and Nonprescription Drug Consumer Protection Act Display Title Dietary Supplement and Nonprescription Drug Consumer Protection Act Official Title as Introduced 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. Introduced in House IH Short Titles as Introduced Dietary Supplement and Nonprescription Drug Consumer Protection Act Introduced in House 2006-09-25T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109hr6168ih/xml/BILLS-109hr6168ih.xml 2006-10-02 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.