Healthy Kids Act

TABLE OF CONTENTS:

Title I: Healthy Kids Trust Fund

Subtitle A: General Provisions

Subtitle B: Payments

Title II: FDA Jurisdiction Over Tobacco Products

Title III: Youth Smoking Reduction Targets and Incentives to

Reduce Youth Smoking Rates

Title IV: Tobacco Transition Assistance Fund

Title V: Standards to Reduce Involuntary Exposure to Tobacco

Smoke

Title VI: Public Health and Other Programs

Subtitle A: Research Programs

Subtitle B: Education and Prevention Programs

Subtitle C: Miscellaneous Programs

Title VII: Liability Protection; Consent Decrees; National

Protocol

Subtitle A: Liability Protection and Attorney Fees

Subtitle B: Consent Decrees

Subtitle C: National Tobacco Control Protocol

Title VIII: Miscellaneous Provisions

Title IX: Provisions Relating to Native Americans

Healthy Kids Act - Title I: Healthy Kids Trust Fund - Subtitle A: General Provisions - (Sec. 101) Establishes the Health Enhancement and Lowered Tobacco Hazards for Young Kids Trust Fund (HEALTHY Kids Trust Fund)(Fund). Appropriates to the Fund the initial payment under section 102 of this Act and 75 percent of annual assessments under section 102, fines or penalties under section 103, and amounts repaid or recovered under title III. Authorizes appropriations to the Fund as repayable advances. Makes specified percentages of Fund amounts available without further appropriation for carrying out provisions of this Act, for the Hospital Insurance Trust Fund, and for reducing the Federal debt subject to limit. Excludes amounts for the Hospital Insurance Trust Fund and the debt from consideration for the Emergency Deficit Control Act of 1985, the Congressional Budget Act of 1974, and House Concurrent Resolution 67 of the 104th Congress.

(Sec. 102) Requires each tobacco product manufacturer (including repackers, labelers, and relabelers) to pay annually to the Fund amounts based on that manufacturer's stock market capitalization as compared to the average stock market capitalization of all manufacturers. Mandates annual assessments on each manufacturer based on the number of specified products removed during the year. Provides for floor stock treatment.

Makes the initial capitalization-based payment and any penalties under title III not tax deductible. Amends the Federal bankruptcy code regarding the priority of unsecured Federal claims for payments, assessments, or penalties to be paid into the Fund. Prohibits manufacturers from using any liability insurance to make payments into the Fund. Mandates regulations regarding placing a Healthy Kids Stamp on each tobacco product package for which an assessment has been paid.

Exempts a manufacturer who has consent decrees with more than 25 States before 1998 from the initial payment and certain portions of annual payments.

(Sec. 103) Establishes a tobacco manufacturer licensing program. Requires a manufacturer or importer to be licensed to manufacture, distribute, or import tobacco products and to be eligible for protections under subtitle A of title VII. Mandates, for assessment nonpayment, manufacturer and importer license ineligibility and license revocation or suspension.

(Sec. 104) Imposes a minimum monetary penalty for noncompliance with section 102.

Subtitle B: Payments - Chapter 1: To States - Requires that funds under section 101 be made available to reimburse each eligible State for: (1) State expenditures under title XIX (Medicaid) of the Social Security Act for the treatment of individuals with tobacco-related conditions; (2) other State expenses incurred in providing treatment for tobacco-related conditions; and (3) providing funds to local governments. Requires States, in order to receive the funds, to: (1) agree to resolve any State civil action against a tobacco manufacturer, distributor, or retailer; (2) submit a plan regarding payments to local governments; and (3) have procedures to provide an equitable portion of the funds to local government entities for the local entities' tobacco-related health costs.

Chapter 2: Federal Health Programs - Establishes the National Institutes of Health Trust Fund for Health Research (Research Fund), transferring to it amounts made available under section 101. Sets forth the portions of Research Fund amounts to be used for specified purposes.

Chapter 3: Investments for Children - Requires use of amounts under section 101: (1) working through the Child Care and Development Block Grant Act of 1990, to improve child care, early childhood development, school-aged care, parent education and supportive services, health services, and services for children with disabilities; and (2) for grants to State and local educational agencies to train, recruit, and hire elementary school teachers, thus reducing average class size for certain grades.

(Sec. 133) Amends Medicaid provisions regarding presumptive eligibility for children to include in the definition of "qualified entity" elementary or secondary schools, child care resource and referral agencies, and agencies authorized to determine child eligibility for health assistance under title XXI (Children's Health Insurance) of the Social Security Act.

Modifies requirements regarding certain Medicaid expenditures that are counted against individual State allotments.

Allows an alien who lawfully entered the United States after August 22, 1996, to be eligible for child health assistance under title XXI and Medicaid, notwithstanding the five-year means-tested public benefit waiting period or any other provision of law.

Declares that a State does not have the authority to determine the Medicaid eligibility of a qualified alien.

Makes the above amendments of this section effective as if they had been included in the Balanced Budget Act of 1997.

Mandates a performance bonus payment to each State relating to increases in the number of Medicaid-enrolled children.

(Sec. 134) Mandates a demonstration project providing for payment under title XVIII (Medicare) of the Social Security Act of routine patient care costs that are provided to an individual with cancer and enrolled in Medicare as part of the individual's participation in a clinical trial and that are not otherwise eligible for Medicare payment. Requires use of amounts available under section 101 to carry out this section.

Title II: FDA Jurisdiction Over Tobacco Products - Deems specified regulations to have been promulgated under the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by this title.

(Sec. 203) Amends the FDCA to include nicotine in tobacco products in the definition of "drug" and tobacco product delivery components in the definition of "device." Authorizes regulation of any tobacco product as a drug, device, or both. Deems tobacco misbranded if it: (1) states or implies that it presents a reduced health risk unless the product will achieve the best public health result; or (2) violates the FDCA or its regulations. Makes noncompliance with specified provisions added to the FDCA by this Act a prohibited act under the FDCA. Makes provisions preempting State and local requirements inapplicable to tobacco product devices.

(Sec. 204) Exempts tobacco products from device Class II special controls if the Secretary of Health and Human Services finds that special controls will achieve the best public health result. Declares that, for the purposes of listed provisions, the safety and effectiveness of a tobacco product device need not be found if the action to be taken under any such provision would achieve the best public health result. Authorizes a tobacco product recall if the best public health result would be achieved.

(Sec. 205) Establishes the Scientific Advisory Committee to assist the Secretary, examine the effects of tobacco product nicotine yield level alteration, examine whether there is a nicotine threshold below which dependence is not produced, and review other safety, dependence, or health issues regarding tobacco products.

Authorizes the Secretary to adopt a tobacco product performance standard regardless of whether the product has been classified under device classification provisions. Allows the standard to include: (1) reduction or elimination of nicotine; or (2) reduction or elimination of other constituents. Authorizes the Secretary to require that a manufacturer test, report, and disclose tobacco and tobacco smoke constituents, including in labeling and advertising.

Requires manufacturers to annually submit: (1) an ingredient list for each brand it manufactures; and (2) a safety assessment for each new ingredient it desires to make a part of the product, with current ingredients receiving a safety assessment within five years after enactment of this Act. Requires that the safety assessment demonstrate that the ingredient will not present any risk to consumers or the public in the intended quantities. Mandates regulations to prohibit any ingredient if: (1) no safety assessment has been submitted as required; or (2) the Secretary finds that safety has not been demonstrated.

Requires tobacco product packages to disclose: (1) all ingredients; and (2) the percentages of domestic and foreign tobacco. Authorizes the Secretary to require disclosure of an ingredient that relates to a trade secret if the Secretary determines that the disclosure will promote the public health.

Mandates specified warnings on cigarette and smokeless tobacco packages and advertising. Preempts related State or local requirements. Declares that nothing in this paragraph relieves any person from liability to any other person at common law or under State statutory law. Makes it unlawful to advertise tobacco products on electronic communications subject to Federal Communications Commission jurisdiction.

Directs the Secretary to restrict the access of minors to tobacco products. Requires States, in order to receive amounts under section 111 of this Act, to have a program meeting or exceeding the requirements of the model State program under which a retailer would be required to obtain a State or local license to distribute tobacco products. Includes in minimum model program requirements: (1) licensing fees to defray program administration; (2) prohibiting retail distribution without a license; (3) prohibiting distribution to minors; (4) monetary penalties for violations; and (5) suspension and revocation for repeated distribution to minors or violation of State or local law. Provides for specified penalties for distribution to minors, including penalties imposed on employees of retailers, minors (including loss of driving privileges), and retailers. Authorizes enforcement grants to States. Authorizes the Secretary to enforce the prohibition of distribution to minors. Declares that the provisions of this paragraph do not preempt State or local laws providing greater restrictions than these provisions. Mandates a Federal tobacco licensing program regarding military installations, U.S. embassies, Federally-owned facilities, duty-free shops, and any other Federal entity or Federal property. Treats an Indian tribe or tribal organization as a State for applying and enforcing the provisions of this paragraph regarding Indian reservations.

Requires each manufacturer to submit to the Secretary each document in the manufacturer's possession: (1) relating to tobacco-caused health effects in humans or animals (including addiction), control of nicotine, tobacco sale or marketing, or research involving safer tobacco products; or (2) produced, or ordered to be produced, in any health-related civil or criminal proceeding, including attorney-client and other documents produced, or ordered to be produced, for in camera inspection. Directs the Secretary to make the documents available to the public. Exempts from public disclosure trade secrets and attorney-client privilege materials unless the Secretary determines disclosure is necessary to promote the public health.

Authorizes any individual to begin a civil action: (1) against any person allegedly in violation of these provisions; or (2) against the Secretary or the Commissioner of Food and Drugs for alleged failure to perform as required.

Prohibits regulations having the effect of placing burdens on tobacco producers in excess of the burdens generally placed on other agricultural commodity producers.

Repeals the Federal Cigarette Labeling and Advertising Act and the Comprehensive Smokeless Tobacco Health Education Act of 1986.

Title III: Youth Smoking Reduction Targets and Incentives to Reduce Youth Smoking Rates - Mandates an annual survey of the percentage of individuals under 18 using tobacco products.

(Sec. 303) Requires annual determinations of whether the required percentage reduction in underage tobacco use has been achieved. Specifies the required reductions in cigarette and smokeless tobacco products. Requires each manufacturer to reduce the percentage of children who use the manufacturer's brand accordingly.

(Sec. 304) Mandates industry-wide and individual manufacturer monetary penalties if targets are not met for a year. Multiplies the penalties for consecutive failure years. Requires regulations to prohibit the sale of single packs of a manufacturer's tobacco products in cases of repeated noncompliance with required reductions and to require generic packaging in severe repeated noncompliance.

Authorizes regulations requiring reductions in the use of other tobacco products by individuals under 18, including manufacturer monetary penalties for reduction failures.

Title IV: Tobacco Transition Assistance Trust Fund - Establishes the Tobacco Transition Trust Fund and transfers to it amounts available under section 101. Authorizes appropriations to the Fund as repayable advances as necessary for Fund expenditures. Makes the Fund available for transition assistance to tobacco producers and tobacco-growing communities to adjust to reduced demand for tobacco, including economic development assistance, producer and factory worker retraining, or producer scholarships. Makes those amounts available only if a law is enacted by January 1, 2000, specifically prescribing Fund authorized uses. Declares that this title constitutes budget authority in advance of appropriations Acts. Terminates the authority of this title unless such a prescribing law is enacted.

Title V: 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 certain types of facilities)) to implement a smoke-free environment policy. Allows designated smoking areas meeting specified requirements. Sets forth special rules for: (1) schools and other facilities serving children; and (2) public transportation. Requires States, in order to receive funds under this Act, to demonstrate enforcement.

Title VI: Public Health and Other Programs - Subtitle A: Research Programs - Mandates programs (through grants, contracts, or otherwise) to: (1) promote expanded research concerning specified aspects of tobacco and health; and (2) for the conduct of research on the cultural, social, behavioral, neurological, and psychological reasons that individuals refrain from using, begin, continue, or quit using tobacco products.

(Sec. 603) Mandates surveillance and evaluation to monitor patterns of tobacco use and determine the effectiveness of various anti-tobacco programs funded under this Act.

Requires that funding be made available for the activities under this subtitle.

Subtitle B: Education and Prevention Programs - Mandates a program of grants to States for: (1) school-, college-, or university-based education programs concerning tobacco product use dangers; and (2) community-based prevention programs. Requires that funding be made available.

Subtitle C: Miscellaneous Programs - Requires a program to reduce tobacco use through national and local media-based (such as counter-advertising campaigns) and nonmedia-based education, prevention, and cessation campaigns. Requires that funding be made available.

(Sec. 622) Establishes the National Tobacco Cessation Program. Authorizes grants, contracts, and cooperative agreements. Requires making funding available.

(Sec. 623) Establishes a program to provide assistance and compensation to individuals (and entities providing services to individuals) suffering from tobacco-related conditions, targeting uninsured or underinsured individuals who can demonstrate financial hardship. Requires making funding available.

(Sec. 624) Authorizes multilateral assistance to foreign countries to assist in reducing and preventing the use of tobacco in foreign countries, focusing on preventing use by minors. Requires making funding available.

Establishes in the District of Columbia a private, nonprofit corporation to be known as the American Center on Global Health and Tobacco (ACT). Requires that an International Advisory Council advise ACT. Mandates the annual transfer of a specified amount to carry out this paragraph. Makes ACT and its grantees subject to the oversight and supervision of the Congress.

(Sec. 625) Mandates the National Event Sponsorship Program, authorizing grants for the sponsorship of athletic or other social or cultural events that, before enactment of this Act, was provided by a tobacco manufacturer or distributor. Requires making funding available. Terminates the Program ten years after enactment of this Act.

(Sec. 626) Requires a program of grants to States to augment existing programs to reduce alcohol and illicit drug use by individuals under 18. Requires making funding available.

Title VII: Liability Protection; Consent Decrees; National Protocol - Subtitle A: Liability Protection and Attorney Fees - Requires that, in order to receive funds under section 111, a State resolve any existing, and agree not to start any new, civil action seeking recovery for expenditures attributable to tobacco-related conditions commenced by the State against a manufacturer, distributor, or retailer and pending at enactment of this Act. Bars the Federal Government from starting any such action. Prohibits construing these provisions to limit an individual's right to start a civil action for past, present, or future conduct by tobacco product manufacturers, distributors, or retailers.

(Sec. 702) Establishes an Arbitration Panel to award attorney's fees and expenses relating to litigation affected by, or legal services resulting in, this Act. Prohibits any Panel award from affecting any fee payments required under any provision of this Act.

Subtitle B: Consent Decrees - Requires that, in order to receive funds under section 111 a State, and in order to receive liability protections under subtitle A tobacco manufacturer, enter into consent decrees under this subtitle. Allows a State to qualify with good faith but unsuccessful efforts. Requires that the decrees resolve State actions for claims associated with manufacturer conduct before this Act. Sets forth required terms, conditions, and limitations. Makes the decrees enforceable by the signatories and the Attorney General. Requires, prior to decree entry by a court, that the decrees be: (1) approved by the Secretary and the Attorney General; (2) fair and reasonable; and (3) in the public interest.

Subtitle C: National Tobacco Control Protocol - Chapter 1: Establishment - Requires that a tobacco manufacturer, in order to receive liability protections under subtitle A, enter into a National Tobacco Control Protocol with the U.S. Attorney General and the attorney general of each State that does not opt out. Requires that the Protocol be a binding contract embodying the terms of this subtitle and designed to be enforceable in Federal or State courts.

Chapter 2: Terms and Conditions - Declares that this chapter is a part of the Protocol.

(Sec. 726) Prohibits tobacco advertising: (1) outdoors; (2) except as allowed in this Act, in any arena or stadium where athletic or other social or cultural activities occur; (3) using a human image or cartoon character; (4) on the Internet, unless inaccessible in or from the United States; and (5) subject to exception, at the point of sale.

(Sec. 727) Prohibits a manufacturer from using a trade or brand name of a non-tobacco product for a cigarette or smokeless tobacco product, unless in use before 1998.

Sets forth situations in which tobacco brand names or other identification indicia may, with prior notice to the Secretary, be used in advertising and labeling. Prohibits payment for the placement of tobacco products in television programs, motion pictures, or videos or on video game machines. Prohibits direct or indirect payment or consideration for promoting tobacco product image or use through print, film, or broadcast media that appeals to individuals under 18 or through a live performance artist that appeals to such individuals.

(Sec. 728) Allows, subject to exceptions, tobacco product labeling and advertising to use only black text on a white background. Limits audio (alone or with video) to words only, prohibiting music and sound effects.

(Sec. 729) Prohibits: (1) the use of a tobacco product brand name, logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of product identification on any service or nontobacco item; (2) offering tobacco purchasers any non-tobacco item in consideration of purchase; and (3) manufacturers, distributors, and retailers from sponsoring athletic or other social or cultural event in which any indicia of product identification is used (but allows sponsorship under the corporate name, if in use before 1995 and if the corporate name does not include any indicia of product identification).

Chapter 3: Enforcement - Allows the Attorney General to bring an action for enforcement, or restrain a breach, of the Protocol. Allows restraining orders, orders of specific performance, civil monetary penalties, and (for officers of manufacturers who knowingly violate the Protocol) criminal penalties, including incarceration. Authorizes grants and contracts for State enforcement. Authorizes use of amounts from the HEALTHY Kids Trust Fund and Department of Justice funds for Attorney General enforcement.

(Sec. 732) Authorizes the attorney general of a State to bring an action for enforcement, or to restrain a breach, of the Protocol if the alleged violation occurred in that State. Provides for concurrent Federal and State court jurisdiction in such actions. Allows the remedies specified in section 731.

(Sec. 733) Authorizes a manufacturer to file an action seeking a declaration of its Protocol rights and obligations.

Authorizes any person to bring an action to enforce the Protocol, with any damages remitted to the Treasury.

Entitles any manufacturer to intervene as a matter of right in any Federal or State Attorney General enforcement action.

Title VIII: Miscellaneous Provisions - Prohibits the use of funds made available by appropriations or otherwise for specified actions, including: (1) promoting the export, reexport, sale, manufacture, advertising, or use of tobacco products to or in a foreign country; or (2) subject to exception, seeking the removal or reduction of any foreign restriction on the importation, export, sale, manufacture, advertising, use, imposition of tariffs, or taxation of tobacco products.

(Sec. 802) Prohibits reprisals against a whistleblower employee of any tobacco product manufacturer, distributor, or retailer for disclosing to specified Federal agencies or State or local authorities information regarding a violation of law related to this Act or related State or local laws. Allows the whistleblower to receive a portion of a payment to the Government resulting from the whistleblower's disclosure.

(Sec. 803) Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to make it unlawful for any domestic concern, directly or through a foreign subsidiary or affiliate, to use the mails or interstate commerce to contribute to: (1) the foreign sale or distribution of tobacco products to children or the foreign advertising of tobacco products in a way that appeals to children; and (2) the tobacco product export from any country without a package warning label in the primary language or languages of the country of sale or distribution that complies with domestic labeling requirements. Adds the unlawful acts of this section to the FDCA list of prohibited acts and entitles a person who provides information leading to a related criminal conviction to a portion of the criminal fine collected.

(Sec. 804) Allows State or local measures to further this Act's purposes not less stringent than the requirements of this Act.

Title IX: Miscellaneous Provisions - Declares that the provisions of this Act shall apply to the manufacture, distribution, and sale of tobacco products in any area in tribal or tribal organization jurisdiction, with exceptions for religious practices. Mandates regulations applying the Federal Food, Drug, and Cosmetic Act requirements regarding tobacco products to such areas. Provides for the treatment of tribes and tribal organizations under various provisions of this Act. Prohibits manufacturers from engaging in any activity in such areas that is prohibited under the Protocol. Requires that amounts made available under certain portions of section 101 be provided to the Indian Health Service for anti-tobacco-related consumption and cessation activities.

Allows tribes and tribal organizations to: (1) take measures to further this Act's purposes in addition to the requirements of this Act; and (2) have rules or practices providing greater protection from the health hazards of environmental tobacco smoke. Prohibits a State from imposing requirements regarding the application of this Act to Indian tribes and tribal organizations.