A bill to amend the Public Health Act and the Federal Food, Drug and Cosmetic Act to prevent the use of tobacco products by minors, to reduce the level of tobacco addiction, to compensate Federal and State Governments for a portion of the health costs of tobacco-related illnesses, to enhance the national investment in biomedical and basic scientific research, and to expand programs to address the needs of children, and for other puropses.
TABLE OF CONTENTS:
Title I: Amendments to the Public Health Service Act
Relating to Tobacco
Title II: FDA Jurisdiction Over Tobacco Products
Title III: Standards to Reduce Involuntary Exposure to
Tobacco Smoke
Title IV: Tobacco Market Transition Assistance
Subtitle A: Tobacco Quota Buyout Contracts and Producer
Transition Payments
Subtitle B: No Net Cost Tobacco Program
Subtitle C: Tobacco Community Empowerment Block Grants
Title V: Miscellaneous Provisions
Healthy and Smoke Free Children Act - Title I: Amendments to the Public Health Service Act Relating to Tobacco - Amends the Public Health Service Act to mandate payments to States for the States' expenses for treating tobacco-related illnesses or conditions and for services for children.
Makes certain amounts available for specified activities under this Act and its amendments, including: (1) the costs associated with Food and Drug Administration tobacco-related activities; (2) national biomedical and basic scientific research activities and child development and research activities; and (3) assistance and compensation to individuals with tobacco-related illnesses and conditions.
Establishes the National Biomedical and Basic Scientific Research Board to make grants and contracts for the expansion of basic and biomedical research and to provide graduate training in that research.
Mandates grants or contracts for the conduct and support of research, training, and demonstration projects regarding child health and development.
Mandates, to discourage individuals from using tobacco products and to assist quitting: (1) research on methods, drugs, and devices; (2) programs to reduce tobacco use through education, prevention, and cessation campaigns; and (3) programs through the Centers for Disease Control and Prevention.
Mandates block grants to States for tobacco use reduction and education activities. Requires a Federal model smoking cessation program and Federal regulations regarding approval of cessation programs and devices. Includes in the allowed uses of block grants activities for the transitional sponsorship of certain activities.
Mandates an annual survey on children's tobacco use.
Requires each tobacco manufacturer to reduce the number of children using its products by specified percentages in specified years. Imposes a per-unit fee for failing to meet targets. Mandates regulations: (1) prohibiting the sale of tobacco product single packs in cases of repeated noncompliance; and (2) requiring generic packaging in cases of severe repeated noncompliance. Requires fee amounts to be made available: (1) to the National Biomedical and Basic Scientific Research Board for research, training, and demonstration project grants; (2) for healthy child development grants; and (3) for reduction and addiction prevention research grants and grants under the national tobacco usage reduction and education program.
Prohibits reprisals against whistleblower employees of tobacco manufacturers, distributors, and retailers.
Establishes the National Tobacco Document Depository, requiring that it be open to the public and maintained as a resource for individuals interested in the manufacturers' corporate records and research. Requires manufacturers, the Tobacco Institute, and the Council for Tobacco Research, U.S.A., to provide specified Depository contents. Directs the Judicial Conference of the United States to establish a Tobacco Documents Dispute Resolution Panel to resolve all claims of attorney-client, work product, or trade secrets privilege.
Establishes the Tobacco Oversight and Compliance Board to monitor tobacco industry compliance with this Act. Mandates manufacturer submission and Board disclosure of documents: (1) relating to tobacco health effects (including addiction), manipulation or control of nicotine, or the sale or marketing of tobacco products to children; or (2) produced or ordered to be produced by the manufacturer in State of Minnesota v. Philip Morris, Inc.
Title II: FDA Jurisdiction Over Tobacco Products - Declares that the Secretary of Health and Human Services, through the Food and Drug Administration, shall have the authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate the manufacture, labeling, sale, distribution, and advertising of tobacco products.
(Sec. 203) Amends the FDCA to include nicotine in tobacco products in the definitions of "drug" and "device." Deems tobacco misbranded if it violates the FDCA or its regulations. Requires that tobacco products be classified as Class II devices. Prohibits the Secretary from prohibiting tobacco products under specified provisions. Sets forth tobacco product performance standard requirements. Declares that a tobacco product is a restricted device.
(Sec. 204) Establishes the Scientific Advisory Committee to assist the Secretary regarding a performance standard. Allows a standard involving the reduction or elimination of nicotine, other constituents, or harmful components. Mandates regulations: (1) for the testing, reporting, and disclosure of smoke constituents; and (2) limiting cigarette tar.
Deems tobacco products misbranded if there are claims (not scientifically proven) of reduced health risk. Requires manufacturers to: (1) notify the Commissioner of Food and Drugs of any technology that would reduce risk; and (2) permit licensing of the technology to other manufacturers. Allows the Commissioner, on determining the technology feasible, to require manufacturers to either manufacture the less hazardous products or license the technology's use by other manufacturers. Requires the Commissioner, if no manufacturer agrees to manufacture less hazardous products, to provide for the manufacture of the products through the Public Health Service.
Allows good manufacturing practice regulations, but prohibits placing burdens on tobacco producers in excess of the burdens placed on other agricultural commodity producers.
Mandates annual disclosure to the Secretary of tobacco product ingredients (including added substances and nicotine). Requires ingredient safety assessments and prohibits inclusion of current ingredients with disapproved assessments and new ingredients without approved assessments. Provides for public disclosure.
Mandates specified warnings on packaging and in advertising of cigarettes and smokeless tobacco products. Declares that this paragraph does not relieve any person from liability at common law or under State statutory law. Exempts exports from warning requirements.
Requires specified use statements on cigarettes and smokeless tobacco describing the product as a nicotine delivery device for persons 18 or older.
Allows State and local governments to impose additional controls to limit tobacco use by minors.
Title III: Standards to Reduce Involuntary Exposure to Tobacco Smoke - Amends the Occupational Safety and Health Act of 1970 to require the responsible entity for each non-residential public building (regularly entered by at least ten individuals at least one day per week (except portions of a building used as a bar, tobacco merchant, designated smoking hotel room, or prison)) to implement a smoke-free environment policy. Allows designated smoking areas meeting specified requirements.
Title IV: Tobacco Market Transition Assistance - Subtitle A: Tobacco Quota Buyout Contracts and Producer Transition Payments - Directs the Secretary of Agriculture to offer to enter into: (1) a buyout contract with the owner of a tobacco basic marketing quota; (2) a producer transition payment contract with producers of quota tobacco that were quota lessees or quota tenants; and (3) a producer nonquota transition payment contract with producers of nonquota tobacco. Requires the contracting quota owners to permanently relinquish the quota and producers (quota and non-quota) to permanently refrain from growing tobacco for which a quota program is in effect.
Subtitle B: No Net Cost Tobacco Program - Amends the Agricultural Act of 1949 to extend the termination date of a requirement that producers, purchasers, and importers of tobacco for which price support is available pay a nonrefundable marketing assessment to the Commodity Credit Corporation. Requires that payment amounts be sufficient to cover the costs of the administration of certain tobacco quota and price support programs.
Subtitle C: Tobacco Community Empowerment Block Grants - Mandates grants to tobacco States to enable the States to: (1) empower tobacco producers and tobacco manufacturing workers by providing economic alternatives to tobacco; and (2) carry out non-tobacco economic development initiatives in tobacco communities.
Title V: Miscellaneous Provisions - Declares that it is the sense of the Senate that: (1) the Congress should increase excise taxes on tobacco products; (2) the tax should be indexed; and (3) the tax should not be deductible.
Sponsor introductory remarks on measure. (CR E698)
Introduced in Senate
Sponsor introductory remarks on measure. (CR S12163-12164)
Read twice and referred to the Committee on Labor and Human Resources.
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