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.
[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2147 Introduced in House (IH)]
103d CONGRESS
1st Session
H. R. 2147
To amend the Federal Food, Drug, and Cosmetic Act to regulate the
manufacture, labeling, sale, distribution, and advertising and
promotion of tobacco and other products containing nicotine, tar,
additives and other potentially harmful constituents, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 18, 1993
Mr. Synar (for himself, Mr. Durbin, Mr. Andrews of Texas, Mr. Wyden,
Mrs. Collins of Illinois, Ms. Schenk, Mr. Blackwell, Mr. Wheat, Mr.
Huffington, and Mr. Evans) introduced the following bill; which was
referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to regulate the
manufacture, labeling, sale, distribution, and advertising and
promotion of tobacco and other products containing nicotine, tar,
additives and other potentially harmful constituents, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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.
<all>
HR 2147 IH----2
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health and the Environment.
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