Fairness in Tobacco and Nicotine Regulation Act of 1993

Summary: Fairness in Tobacco and Nicotine Regulation Act of 1993 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Secretary of Health and Human Services to promulgate regulations governing the manufacture, distribution, sale, labeling, and advertising and promotion (manufacture) of tobacco products which are consistent with regulations governing other products which are ingested, but bars the Secretary from outlawing the sale and distribution of a tobacco product solely because tobacco causes disease. 
Sets minimum requirements pursuant to such regulations, including a prohibition on the sale or distribution of tobacco products to minors. 
Establishes in the Food and Drug Administration (FDA) the Tobacco and Nicotine Products Advisory Committee which shall review:  (1) the available scientific evidence on the effects of tobacco products on human health, including the effects of environmental tobacco smoke on nonsmokers; (2) the manufacturing process of tobacco products; (3) the role of nicotine as part of the smoking habit; (4) the marketing and promotional techniques used by tobacco manufacturers; and (5) current Federal, State, and local laws governing the manufacture of tobacco products. 
Requires each tobacco product manufacturer to:  (1) register with the Secretary; and (2) pay an annual fee determined by the Secretary based upon the total market share for each brand of tobacco product.  Credits fees collected for a fiscal year to the appropriation account for salaries and expenses of the FDA. 
Amends:  (1) the Federal Cigarette Labeling and Advertising Act (FCLAA) and the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA) to modify warning labels to emphasize the addictive nature of smoking; and (2) the FFDCA to include tobacco products within recordkeeping requirements applicable to the interstate shipment and factory inspection of food, drugs, devices, and cosmetics. 
Authorizes the Secretary to: (1) modify the warning labels required by the FCLAA and CSTHEA if the modification in the content of the label does not weaken the health message and is in the best interests of the public health; and (2) increase the size and placement of such required labels.

SECTION 1. SHORT TITLE; REFERENCE.

    (a) Short Title.--This Act may be cited as the ``Fairness in 
Tobacco and Nicotine Regulation Act of 1993''.
    (b) Reference.--Whenever in this Act (other than sections 5(b)(1) 
and 5(b)(2)) an amendment or repeal is expressed in terms of an 
amendment to, or repeal of, a section or other provision, the reference 
shall be considered to be made to a section or other provision of the 
Federal Food, Drug, and Cosmetic Act.

SEC. 2. FINDINGS.

    The Congress finds that--
            (1) Cigarette smoking and tobacco use account for 
        approximately 450,000 deaths each year in the United States.
            (2) Cigarette smoking accounts for approximately $65 
        billion in lost productivity and health care costs.
            (3) Environmental tobacco smoke is a cause of disease in 
        nonsmokers.
            (4) In spite of well established dangers of cigarette 
        smoking and tobacco use, no Federal regulatory agency has the 
        authority to regulate the manufacture, sale, distribution, 
        labeling, and advertising of such products.
            (5) Tobacco is as addictive as cocaine and heroin.
            (6) The tobacco industry spends approximately $4 billion 
        each year to promote its products.
            (7) The tobacco industry's voluntary advertising code which 
        was enacted to prohibit the use of images of sexual attraction, 
        sophistication, and athletic abilities and the making of 
        implied health claims has for the last 30 years not been 
        followed or enforced.
            (8) Each day 3,000 children try cigarettes for the first 
        time and many become life-long addicted smokers.
            (9) There is no Federal minimum age of sale of cigarettes 
        and tobacco products.
            (10) The labeling of tobacco products is inadequate as to 
        provide smokers and nonsmokers alike with full and complete 
        information about tobacco products.
            (11) The tobacco industry adds chemical additives to their 
        products that are neither disclosed to the public or tested for 
        health and safety in a comparable manner to food.
            (12) There is no listing of chemical constituents found in 
        mainstream and sidestream smoke (including benzene, arsenic, 
        cyanide, etc.).
            (13) The Food and Drug Administration is the most qualified 
        Federal agency to comprehensively regulate tobacco products.
            (14) It is inconsistent for the Food and Drug 
        Administration to regulate the manufacture, sale, distribution, 
        labeling, advertising, and promotion of other nicotine 
        containing products used as substitutes for cigarette smoking 
        and tobacco use and not be able to regulate tobacco products in 
        a comparable manner.

SEC. 3. DEFINITIONS.

    Section 201 (21 U.S.C. 321) is amended by adding at the end thereof 
the following new paragraphs:
    ``(gg) The term `tobacco product' means cigarettes, cigars, little 
cigars, pipe tobacco, smokeless tobacco, snuff, and chewing tobacco.
    ``(hh) The term `tobacco additive' means any substance the intended 
use of which results or may reasonably be expected to result, directly 
or indirectly, in its becoming a component or otherwise affecting the 
characteristics of any tobacco product.
    ``(ii) The term `constituent' means any element of cigarette 
mainstream or sidestream smoke which is present in quantities which 
represent a potential health hazard or where the health effect is 
unknown.
    ``(jj) The term `tar' means mainstream total articulate matter 
minus nicotine and water.

SEC. 4. ENFORCEMENT.

    Section 301 (21 U.S.C. 331) is amended by adding at the end thereof 
the following new subsection:
    ``(u) The manufacture, labeling, sale, distribution, advertising, 
and promotion of tobacco products in violation of regulations of the 
Secretary pursuant to section 701.''

SEC. 5. REGULATION OF TOBACCO PRODUCTS.

    (a) Regulation.--The Federal Food, Drug, and Cosmetic Act is 
amended by redesignating chapters VII, VIII, and IX as chapters VIII, 
IX, and X, respectively, and by adding after chapter VI the following:

                    ``CHAPTER VII--TOBACCO PRODUCTS

                             ``regulations

    ``Sec. 701. (a) Promulgation.--The Secretary shall promulgate 
regulations governing the manufacture, distribution, sale, labeling, 
and advertising and promotion of tobacco products which are consistent 
with the manner in which other products which are ingested into the 
body are regulated, except that the Secretary may not promulgate a 
regulation which prohibits the sale and distribution of a tobacco 
product solely on the basis of the fact that tobacco causes disease. 
Such regulations shall be promulgated not later than 12 months after 
the date the Secretary receives the recommendations of the Tobacco and 
Nicotine Products Advisory Committee under section 702(e).
    ``(b) Minimum Requirements.--
            ``(1) Sale or distribution.--Regulations under subsection 
        (a) shall with respect to the sale or distribution of tobacco 
        products make unlawful--
                    ``(A) the sale of a tobacco product intended for 
                use by man to any person under the age of 18 years or 
                under such other age greater than 18 years as the State 
                in which the sale occurs may establish by law,
                    ``(B) the distribution of a tobacco product as a 
                free sample or the distribution of a tobacco product as 
                a result of coupons or other materials which allow for 
                the obtaining of free or discounted tobacco products, 
                or
                    ``(C) the sale or distribution of a tobacco product 
                if the label fails to carry the following statement: 
                ``Federal Law Prohibits Sale To Minors''.
        The Secretary shall enforce this paragraph in a manner that can 
        reasonably be expected to ensure that tobacco products are not 
        made available to individuals under the age of 18 years.
            ``(2) Labeling.--
                    ``(A) In general.--Regulations under subsection (a) 
                with respect to the labeling of tobacco products shall 
                require that a tobacco product shall be deemed 
                misbranded if--
                            ``(i) it is not in compliance with the 
                        labeling requirements of the Federal Cigarette 
                        Labeling and Advertising Act and the 
                        Comprehensive Smokeless Tobacco Health 
                        Education Act of 1986,
                            ``(ii) it does not include a warning and 
                        information about the dangers associated with 
                        environmental tobacco smoke,
                            ``(iii) it does not provide a list of 
                        chemical additives and constituents found in 
                        tobacco products and tobacco smoke, or
                            ``(iv) it contains any implied or direct 
                        health claim, including the use of such terms 
                        as light, lower tar, medium, lowest, or 
                        nicotine free, unless such terms have been 
                        approved by the Secretary on the basis of sound 
                        scientific data and the Secretary determines 
                        that such terms will have a significant impact 
                        on the health consequences associated with 
                        cigarette smoking and other tobacco use.
                    ``(B) Specific information.--The Secretary may 
                include in regulations under subsection (a) relating to 
                labeling of tobacco products labeling requirements 
                requiring manufacturers of tobacco products to provide 
                to consumers by way of labeling of packages, package 
                inserts, or other means--
                            ``(i) information about the adverse effects 
                        of tobacco products,
                            ``(ii) adequate warnings and directions for 
                        use,
                            ``(iii) contraindications,
                            ``(iv) adequate warnings against use in 
                        pathological conditions, and
                            ``(v) any other information deemed 
                        necessary by the Secretary.''.
            ``(3) Advertising and Promotion.--
                    ``(A) Consistency.--Regulations under subsection 
                (a) with respect to the advertising and promotion of 
                tobacco products shall be consistent with regulations 
                governing the advertising and promotion of prescription 
                drugs, especially such drugs which contain nicotine.
                    ``(B) Sponsorship.--In such regulations, the 
                Secretary shall make it unlawful for any sporting 
                event, cultural event, or any other event or function 
                open to the public to be sponsored by a tobacco 
                manufacturer who at such event or function displays the 
                name or logo of any brand of cigarettes or tobacco 
                product of such manufacturer.
                    ``(C) Construction.--Such regulations and the 
                authority provided the Secretary does not repeal or 
                modify the authority of the Federal Trade Commission in 
                carrying out its responsibilities.
            ``(4) Manufacturing.--Regulations under subsection (a) 
        governing the manufacture of tobacco products shall--
                    ``(A) require that all additives used in the 
                manufacture of tobacco products are safe,
                    ``(B) classify as a drug any nicotine containing 
                product which does not meet the definition of a tobacco 
                product, and
                    ``(C) have the authority to subpoena any document 
                which relates to the manner in which tobacco products 
                are manufactured.

                          ``advisory committee

    ``Sec. 702. (a) Establishment.--To assist in the development of 
regulations required by section 701, there is established in the Food 
and Drug Administration a Tobacco and Nicotine Products Advisory 
Committee (hereinafter in this section referred to as the ``advisory 
committee'').
    ``(b) Membership.--
            ``(1) Secretarial appointments.--The Secretary shall 
        appoint to the advisory committee 10 individuals who are 
        qualified by training and experience to evaluate and make 
        recommendations for the issuance of regulations governing the 
        manufacture, distribution, sale, labeling, and advertising and 
        promotion of tobacco products which, to the greatest extent 
        practical, promote and protect the public's health without 
        banning the product. The 10 members shall consist of--
                    ``(A) one expert in the field of nicotine 
                addiction,
                    ``(B) one expert in the field of pharmacology,
                    ``(C) one expert in the field of food and drug law,
                    ``(D) one expert in the field of marketing and 
                promotion of products,
                    ``(E) one expert in the field of public education,
                    ``(F) one expert in the field of toxicology,
                    ``(G) two representing the interests of family 
                medicine, internal medicine, or pediatrics, and
                    ``(H) two consumer representatives from the public 
                health community.
            ``(2) Ex officio.--The Directors of the National Cancer 
        Institute, the National Heart, Lung, and Blood Institute, the 
        National Institute of Drug Abuse, the Centers for Disease 
        Control and Prevention, and the Surgeon General of the United 
        States shall serve as ex officio members of the advisory 
        committee.
            ``(3) Chairman.--The chairman of the advisory committee 
        shall be appointed by the Secretary with the advice and consent 
        of the Commissioner of Food and Drugs.
            ``(4) Appointment date.--The Secretary shall make 
        appointments to the advisory committee within 60 days of the 
        date of the enactment of this section.
    ``(c) Function.--The advisory committee shall give specific 
consideration to--
            ``(1) reviewing the available scientific evidence on the 
        effects of tobacco products on human health, including the 
        effects of environmental tobacco smoke on nonsmokers,
            ``(2) reviewing the manufacturing process of tobacco 
        products, including the use of additives, sprayed on chemicals, 
        product development, and product manipulation,
            ``(3) reviewing the role of nicotine as part of the smoking 
        habit, including its addictive properties and health effects,
            ``(4) reviewing the marketing and promotional techniques 
        used by tobacco manufacturers in selling their products, and
            ``(5) reviewing current Federal, State, and local laws 
        governing the manufacture, distribution, sale, labeling, and 
        advertising and promotion of tobacco products.
    ``(d) Authority.--The advisory committee may for the purpose of 
carrying out its functions hold such hearings, sit and act at such 
times and places, take such testimony, and receive such evidence as the 
advisory committee deems appropriate.
    ``(e) Recommendations.--The advisory committee shall make 
recommendations respecting the issuance of regulations under section 
701 within 12 months of the appointment of the 10 members of the 
advisory committee.

                             ``registration

    ``Sec. 703. Each tobacco product manufacturer shall register with 
the Secretary. Any such manufacturer who is in business on the date of 
the enactment of this Act shall register with the Secretary not later 
than 120 days after the date of the enactment of this section.

                   ``tobacco product manufacturer fee

    ``Sec. 704.(a) Fee purpose.--For the purpose of paying the costs of 
implementing this chapter, each tobacco product manufacturer shall pay 
an annual fee established pursuant to paragraph (2). Such fee shall be 
payable on or before January 31 of each year.
    ``(b) Establishment by the Secretary.--Subject to the amount 
established in appropriation Acts, the annual tobacco product 
manufacturer fee shall be determined by the Secretary based upon the 
total market share for each brand of tobacco product.
    ``(c) Crediting and Availability of Fees.--
            ``(1) In general.--Fees collected for a fiscal year 
        pursuant to subsection (a) shall be credited to the 
        appropriation account for salaries and expenses of the Food and 
        Drug Administration and shall be available in accordance with 
        appropriation Acts until expended without fiscal year 
        limitation.
            ``(2) Collections and appropriation acts.--The fees 
        authorized by subsection (a)--
                    ``(A) shall be collected in each fiscal year in an 
                amount equal to the amount specified in appropriation 
                Acts for such fiscal year, and
                    ``(B) shall only be collected and available to 
                defray the costs of implementing this chapter.''.
    (b) Conforming Amendments.--
            (1) Tobacco labeling and advertising.--The Federal 
        Cigarette Labeling and Advertising Act (15 U.S.C. 1331 et seq.) 
        is amended--
                    (A) in section 4 (15 U.S.C. 1333) by striking out 
                ``SURGEON GENERAL'S WARNING: Cigarette Smoke Contains 
                Carbon Monoxide'' each place it appears and inserting 
                in lieu thereof ``SURGEON GENERAL'S WARNING: Smoking is 
                Addictive. Once You Start You May Not Be Able to 
                Stop'', and
                    (B) by repealing sections 5(b) and 7 (15 U.S.C. 
                1334(b), 1335a).
            (2) Smokeless tobacco.--The Comprehensive Smokeless Tobacco 
        Health Education Act of 1986 is amended--
                    (A) in section 3(a)(1) (15 U.S.C. 4402(a)(1)), by 
                striking out the close quotation marks and the period 
                following at the end and inserting the following:
                    ``WARNING: THIS PRODUCT IS ADDICTIVE. ONCE YOU 
                START YOU MAY NOT BE ABLE TO QUIT'.'',
                    (B) in section 3(b)(1) (15 U.S.C. 4402(b)(1), by 
                inserting in the matter in subparagraph (B) the 
                following:
























            (3) Records of interstate shipment.--Section 703 (21 U.S.C. 
        373) is amended--
                    (A) by striking out ``or cosmetics'' and inserting 
                in lieu thereof ``cosmetics, or tobacco products'', and
                    (B) by striking out ``or cosmetic'' and inserting 
                in lieu thereof ``cosmetic, or tobacco product''.
            (4) Factory inspection.--Section 704 (21 U.S.C. 374) is 
        amended--
                    (A) in subsection (a)(1), by striking out ``or 
                cosmetics'' and inserting in lieu thereof ``cosmetics, 
                or tobacco products'',
                    (B) in subsection (a)(1), by striking out ``or 
                restricted devices'' each place it appears and 
                inserting in lieu thereof ``, restricted devices, or 
                tobacco products'', and
                    (C) in subsection (b), by striking out ``or 
                cosmetic'' and inserting in lieu thereof ``cosmetic, or 
                tobacco product''.
            (5) Redesignations.--Sections 701 through 711 are 
        redesignated as sections 801 through 811, respectively, section 
        721 is redesignated as section 821, sections 731 through 736 
        are redesignated as sections 831 through 836, respectively, 
        sections 801 through 803 are redesignated as sections 901 
        through 903, respectively, sections 901 through 903 are 
        redesignated as sections 1001 through 1003, respectively, and 
        the references to the redesignated sections are changed to 
        refer to the sections as redesignated.
    (c) Secretarial Authority.--The Secretary of Health and Human 
Services may, by regulation--
            (1) modify the warning labels required by the Federal 
        Cigarette Labeling and Advertising Act and the Comprehensive 
        Smokeless Tobacco Health Education Act of 1986 if the 
        modification in the content of the label does not weaken the 
        health message contained in the label and is in the best 
        interests of the public health, and
            (2) increase the size and placement of such required 
        labels.

                                 

HR 2147 IH----2