118
order on that person prohibiting the sale of tobacco
products in that outlet. A no-tobacco-sale order may
be imposed with a civil penalty under paragraph
(1).’’;
(5) in subparagraph (A) of paragraph (4), as so
redesignated—
(A) by striking ‘‘assessed’’ the first time it
appears and inserting ‘‘assessed, or a no-to-
bacco-sale order may be imposed,’’; and
(B) by striking ‘‘penalty’’ and inserting
‘‘penalty, or upon whom a no-tobacco-order is
to be imposed,’’;
(6) in subparagraph (B) of paragraph (4), as so
redesignated—
(A) by inserting after ‘‘penalty,’’ the fol-
lowing: ‘‘or the period to be covered by a no-to-
bacco-sale order,’’; and
(B) by adding at the end the following: ‘‘A
no-tobacco-sale order permanently prohibiting
an individual retail outlet from selling tobacco
products shall include provisions that allow the
outlet, after a specified period of time, to re-
quest that the Secretary compromise, modify,
or terminate the order.’’;
119
(7) by adding at the end of paragraph (4), as
so redesignated, the following:
‘‘(D) The Secretary may compromise, mod-
ify, or terminate, with or without conditions,
any no-tobacco-sale order.’’;
(8) in paragraph (5), as so redesignated—
(A) by striking ‘‘(3)(A)’’ and inserting
‘‘(4)(A)’’;
(B) by inserting ‘‘or the imposition of a
no-tobacco-sale order’’ after ‘‘penalty’’ the first
2 places it appears;
(C) by striking ‘‘issued.’’ and inserting
‘‘issued, or on which the no-tobacco-sale order
was imposed, as the case may be.’’; and
(9) in paragraph (6), as so redesignated, by
striking ‘‘paragraph (4)’’ each place it appears and
inserting ‘‘paragraph (5)’’.
(d) SECTION 304.—Section 304 (21 U.S.C. 334) is
amended—
(1) in subsection (a)(2), by striking ‘‘and’’ be-
fore ‘‘(D)’’;
(2) in subsection (a)(2), by striking ‘‘device.’’
and inserting a comma and the following:
‘‘(E) Any adulterated or misbranded to-
bacco product.’’;
120
(3) in subsection (d)(1), by inserting ‘‘tobacco
product,’’ after ‘‘device,’’;
(4) in subsection (g)(1), by inserting ‘‘or to-
bacco product’’ after ‘‘device’’ each place it appears;
and
(5) in subsection (g)(2)(A), by inserting ‘‘or to-
bacco product’’ after ‘‘device’’ each place it appears.
(e) SECTION
702.—Section 702(a) (21 U.S.C.
372(a)) is amended—
(1) by inserting ‘‘(1)’’ after ‘‘(a)’’; and
(2) by adding at the end thereof the following:
‘‘(2) For a tobacco product, to the extent feasible,
the Secretary shall contract with the States in accordance
with paragraph (1) to carry out inspections of retailers
in connection with the enforcement of this Act.’’.
(f) SECTION 703.—Section 703 (21 U.S.C. 373) is
amended—
(1) by inserting ‘‘tobacco product,’’ after ‘‘de-
vice,’’ each place it appears; and
(2) by inserting ‘‘tobacco products,’’ after ‘‘de-
vices,’’ each place it appears.
(g) SECTION 704.—Section 704 (21 U.S.C. 374) is
amended—
121
(1) in subsection (a)(1)(A), by inserting ‘‘to-
bacco products,’’ after ‘‘devices,’’ each place it ap-
pears;
(2) in subsection (a)(1)(B), by inserting ‘‘or to-
bacco products’’ after ‘‘restricted devices’’ each place
it appears; and
(3) in subsection (b), by inserting ‘‘tobacco
product,’’ after ‘‘device,’’.
(h) SECTION
705.—Section 705(b) (21 U.S.C.
375(b)) is amended by inserting ‘‘tobacco products,’’ after
‘‘devices,’’.
(i) SECTION 709.—Section 709 (21 U.S. C. 379) is
amended by inserting ‘‘or tobacco product’’ after ‘‘device’’.
(j) SECTION 801.—Section 801 (21 U.S.C. 381) is
amended—
(1) in subsection (a), by inserting ‘‘tobacco
products,’’ after ‘‘devices,’’ the first time it appears;
(2) in subsection (a), by inserting ‘‘or sub-
section (j) of section 905’’ after ‘‘section 510’’;
(3) in subsection (a), by striking ‘‘drugs or de-
vices’’ each time it appears and inserting ‘‘drugs, de-
vices, or tobacco products’’; and
(4) in subsection (e)(1), by inserting ’tobacco
product’ after ’device’.
122
(k) SECTION 1003.—Section 1003(d)(2)(C) (as re-
designated by section 101(a)) is amended—
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and
(2) inserting a comma and ‘‘and tobacco prod-
ucts’’ after ‘‘devices’’.
(l) 
EFFECTIVE
DATE
FOR
NO-TOBACCO-SALE
ORDER AMENDMENTS.—The amendments made by sub-
section (c), other than the amendment made by paragraph
(2) thereof, shall take effect only upon the promulgation
of final regulations by the Secretary—
(1) defining the term ‘‘repeated violation’’, as
used in section 303(f) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 333(f)) as amended by
subsection (c), by identifying the number of viola-
tions of particular requirements over a specified pe-
riod of time that constitute a repeated violation;
(2) providing for notice to the retailer of each
violation at a particular retail outlet;
(3) providing that a person may not be charged
with repeated violations at a particular retail outlet
unless the Secretary has provided notice of previous
violations at that outlet;
(4) establishing a period of time during which,
if there are no violations by a particular retail out-
let, that outlet will not be considered to have been
123
the site of repeated violations when the next viola-
tion occurs; and
(5) providing that good faith reliance on false
identification does not constitute a violation of any
minimum age requirement for the sale of tobacco
products.
SEC. 506. CIGARETTE LABEL AND ADVERTISING WARNINGS.
Section 4 of the Federal Cigarette Labeling and Ad-
vertising Act (15 U.S.C. 1333) is amended to read as fol-
lows:
‘‘SEC. 4. LABELING.
‘‘(a) LABEL REQUIREMENTS.—
‘‘(1) IN GENERAL.—It shall be unlawful for any
person to manufacture, package, or import for sale
or distribution within the United States any ciga-
rettes the package of which fails to bear, in accord-
ance with the requirements of this section, one of
the following labels:
‘‘WARNING: Cigarettes are addictive’’
‘‘WARNING: Tobacco smoke can harm your chil-
dren’’
‘‘WARNING: Cigarettes cause fatal lung disease’’
‘‘WARNING: Cigarettes cause cancer’’
‘‘WARNING: Cigarettes cause strokes and heart
disease’’
124
‘‘WARNING: Smoking during pregnancy can harm
your baby’’
‘‘WARNING: Smoking can kill you’’
‘‘WARNING: Tobacco smoke causes fatal lung dis-
ease in non-smokers’’
‘‘WARNING: Quitting smoking now greatly reduces
serious risks to your health’’
‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—
‘‘(A) IN GENERAL.—Each label statement
required by paragraph (1) shall be located in
the upper portion of the front and rear panels
of the package, directly on the package under-
neath the cellophane or other clear wrapping.
Except as provided in subparagraph (B), each
label statement shall comprise at least the top
25 percent of the front and rear panels of the
package. The word ‘‘WARNING’’ shall appear
in capital letters and all text shall be in con-
spicuous and legible 17-point type, unless the
text of the label statement would occupy more
than 70 percent of such area, in which case the
text may be in a smaller conspicuous and leg-
ible type size, provided that at least 60 percent
of such area is occupied by required text. The
text shall be black on a white background, or
125
white on a black background, in a manner that
contrasts, by typography, layout, or color, with
all other printed material on the package, in an
alternating fashion under the plan submitted
under subsection (b)(4).
‘‘(B) FLIP-TOP BOXES.—For any cigarette
brand package manufactured or distributed be-
fore January 1, 2000, which employs a flip-top
style (if such packaging was used for that
brand in commerce prior to June 21, 1997), the
label statement required by paragraph (1) shall
be located on the flip-top area of the package,
even if such area is less than 25 percent of the
area of the front panel. Except as provided in
this paragraph, the provisions of this subsection
shall apply to such packages.
‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU-
TION.—The provisions of this subsection do not
apply to a tobacco product manufacturer or dis-
tributor of cigarettes which does not manufacture,
package, or import cigarettes for sale or distribution
within the United States.
‘‘(b) ADVERTISING REQUIREMENTS.—
‘‘(1) IN GENERAL.—It shall be unlawful for any
tobacco product manufacturer, importer, distributor,
126
or retailer of cigarettes to advertise or cause to be
advertised within the United States any cigarette
unless its advertising bears, in accordance with the
requirements of this section, one of the labels speci-
fied in subsection (a) of this section.
‘‘(2) TYPOGRAPHY, ETC.—Each label statement
required by subsection (a) of this section in cigarette
advertising shall comply with the standards set forth
in this paragraph. For press and poster advertise-
ments, each such statement and (where applicable)
any required statement relating to tar, nicotine, or
other constituent yield shall comprise at least 20
percent of the area of the advertisement and shall
appear in a conspicuous and prominent format and
location at the top of each advertisement within the
trim area. The Secretary may revise the required
type sizes in such area in such manner as the Sec-
retary determines appropriate. The word ‘‘WARN-
ING’’ shall appear in capital letters, and each label
statement shall appear in conspicuous and legible
type. The text of the label statement shall be black
if the background is white and white if the back-
ground is black, under the plan submitted under
paragraph (4) of this subsection. The label state-
ments shall be enclosed by a rectangular border that
127
is the same color as the letters of the statements
and that is the width of the first downstroke of the
capital ‘‘W’’ of the word ‘‘WARNING’’ in the label
statements. The text of such label statements shall
be in a typeface pro rata to the following require-
ments: 45-point type for a whole-page broadsheet
newspaper advertisement; 39-point type for a half-
page broadsheet newspaper advertisement; 39-point
type for a whole-page tabloid newspaper advertise-
ment; 27-point type for a half-page tabloid news-
paper advertisement; 31.5-point type for a double
page spread magazine or whole-page magazine ad-
vertisement; 22.5-point type for a 28 centimeter by
3 column advertisement; and 15-point type for a 20
centimeter by 2 column advertisement. The label
statements shall be in English, except that in the
case of—
‘‘(A) an advertisement that appears in a
newspaper, magazine, periodical, or other publi-
cation that is not in English, the statements
shall appear in the predominant language of the
publication; and
‘‘(B) in the case of any other advertise-
ment that is not in English, the statements
128
shall appear in the same language as that prin-
cipally used in the advertisement.
‘‘(3) ADJUSTMENT BY SECRETARY.—The Sec-
retary may, through a rulemaking under section 553
of title 5, United States Code, adjust the format and
type sizes for the label statements required by this
section or the text, format, and type sizes of any re-
quired tar, nicotine yield, or other constituent disclo-
sures, or to establish the text, format, and type sizes
for any other disclosures required under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.). The text of any such label statements or dis-
closures shall be required to appear only within the
20 percent area of cigarette advertisements provided
by paragraph (2) of this subsection. The Secretary
shall promulgate regulations which provide for ad-
justments in the format and type sizes of any text
required to appear in such area to ensure that the
total text required to appear by law will fit within
such area.
‘‘(4) MARKETING REQUIREMENTS.—
‘‘(A) The label statements specified in sub-
section (a)(1) shall be randomly displayed in
each 12-month period, in as equal a number of
times as is possible on each brand of the prod-
129
uct and be randomly distributed in all areas of
the United States in which the product is mar-
keted in accordance with a plan submitted by
the tobacco product manufacturer, importer,
distributor, or retailer and approved by the Sec-
retary.
‘‘(B) The label statements specified in sub-
section (a)(1) shall be rotated quarterly in al-
ternating sequence in advertisements for each
brand of cigarettes in accordance with a plan
submitted by the tobacco product manufacturer,
importer, distributor, or retailer to, and ap-
proved by, the Secretary.
‘‘(C) The Secretary shall review each plan
submitted under subparagraph (B) and approve
it if the plan—
‘‘(i) will provide for the equal distribu-
tion and display on packaging and the ro-
tation required in advertising under this
subsection; and
‘‘(ii) assures that all of the labels re-
quired under this section will be displayed
by the tobacco product manufacturer, im-
porter, distributor, or retailer at the same
time.’’.
130
SEC. 507. AUTHORITY TO REVISE CIGARETTE WARNING
LABEL STATEMENTS.
Section 4 of the Federal Cigarette Labeling and Ad-
vertising Act (15 U.S.C. 1333), as amended by section
506, is further amended by adding at the end the fol-
lowing:
‘‘(c) CHANGE IN REQUIRED STATEMENTS.—The Sec-
retary may, by a rulemaking conducted under section 553
of title 5, United States Code, adjust the format, type size,
and text of any of the warning label statements required
by subsection (a) of this section subject to the limitation
on proportional size of the warning contained in sub-
sections (a)(2) and (b)(2), or establish the format, type
size, and text of any other disclosures required under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.), if the Secretary finds that such a change would
promote greater public understanding of the risks associ-
ated with the use of smokeless tobacco products.’’.
SEC. 508. SMOKELESS TOBACCO LABELS AND ADVERTISING
WARNINGS.
Section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4402) is amend-
ed to read as follows:
‘‘SEC. 3. SMOKELESS TOBACCO WARNING.
‘‘(a) GENERAL RULE.—
131
‘‘(1) It shall be unlawful for any person to man-
ufacture, package, or import for sale or distribution
within the United States any smokeless tobacco
product unless the product package bears, in accord-
ance with the requirements of this Act, one of the
following labels:
‘‘WARNING: This product can cause mouth cancer’’
‘‘WARNING: This product can cause gum disease
and tooth loss’’
‘‘WARNING: This product is not a safe alternative
to cigarettes’’
‘‘WARNING: Smokeless tobacco is addictive’’
‘‘(2) Each label statement required by para-
graph (1) shall be—
‘‘(A) located on the 2 principal display
panels of the package, and each label statement
shall comprise at least 25 percent of each such
display panel; and
‘‘(B) in 17-point conspicuous and legible
type and in black text on a white background,
or white text on a black background, in a man-
ner that contrasts by typography, layout, or
color, with all other printed material on the
package, in an alternating fashion under the
plan submitted under subsection (b)(3), except
132
that if the text of a label statement would oc-
cupy more than 70 percent of the area specified
by subparagraph (A), such text may appear in
a smaller type size, so long as at least 60 per-
cent of such warning area is occupied by the
label statement.
‘‘(3) The label statements required by para-
graph (1) shall be introduced by each tobacco prod-
uct manufacturer, packager, importer, distributor, or
retailer of smokeless tobacco products concurrently
into the distribution chain of such products.
‘‘(4) The provisions of this subsection do not
apply to a tobacco product manufacturer or dis-
tributor of any smokeless tobacco product that does
not manufacture, package, or import smokeless to-
bacco products for sale or distribution within the
United States.
‘‘(b) REQUIRED LABELS.—
‘‘(1) It shall be unlawful for any tobacco prod-
uct manufacturer, packager, importer, distributor, or
retailer of smokeless tobacco products to advertise or
cause to be advertised within the United States any
smokeless tobacco product unless its advertising
bears, in accordance with the requirements of this
section, one of the labels specified in subsection (a).
133
‘‘(2) Each label statement required by sub-
section (a) in smokeless tobacco advertising shall
comply with the standards set forth in this para-
graph. For press and poster advertisements, each
such statement and (where applicable) any required
statement relating to tar, nicotine, or other con-
stituent yield shall—
‘‘(A) comprise at least 20 percent of the
area of the advertisement, and the warning area
shall be delineated by a dividing line of con-
trasting color from the advertisement; and
‘‘(B) the word ‘‘WARNING’’ shall appear
in capital letters and each label statement shall
appear in conspicuous and legible type. The text
of the label statement shall be black on a white
background, or white on a black background, in
an alternating fashion under the plan submitted
under paragraph (3).
‘‘(3)(A) The label statements specified in sub-
section (a)(1) shall be randomly displayed in each
12-month period, in as equal a number of times as
is possible on each brand of the product and be ran-
domly distributed in all areas of the United States
in which the product is marketed in accordance with
a plan submitted by the tobacco product manufac-
135
SEC. 509. AUTHORITY TO REVISE SMOKELESS TOBACCO
PRODUCT WARNING LABEL STATEMENTS.
Section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4402), as
amended by section 508, is further amended by adding
at the end the following:
‘‘(d) AUTHORITY
TO
REVISE
WARNING
LABEL
STATEMENTS.—The Secretary may, by a rulemaking con-
ducted under section 553 of title 5, United States Code,
adjust the format, type size, and text of any of the warn-
ing label statements required by subsection (a) of this sec-
tion, subject to the limitations on proportional size of the
warning contained in paragraphs (2) and (3) of subsection
(a), or establish the format, type size, and text of any
other disclosures required under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary
finds that such a change would promote greater public un-
derstanding of the risks associated with the use of smoke-
less tobacco products.’’.
SEC. 510. TAR, NICOTINE, AND OTHER SMOKE CON-
STITUENT DISCLOSURE TO THE PUBLIC.
Section 4(a) of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1333(a)), as amended by sec-
tion 506, is further amended by adding at the end the
following:
136
‘‘(4)(A) The Secretary shall, by a rulemaking
conducted under section 553 of title 5, United
States Code, determine (in the Secretary’s sole dis-
cretion) whether cigarette and other tobacco product
manufacturers shall be required to include in the
area of each cigarette advertisement specified by
subsection (b) of this section, or on the package
label, or both, the tar and nicotine yields of the ad-
vertised or packaged brand. Any such disclosure
shall be in accordance with the methodology estab-
lished under such regulations, shall conform to the
type size requirements of subsection (b) of this sec-
tion, and shall appear within the area specified in
subsection (b) of this section.
‘‘(B) Any differences between the requirements
established by the Secretary under subparagraph (A)
and tar and nicotine yield reporting requirements es-
tablished by the Federal Trade Commission shall be
resolved by a memorandum of understanding be-
tween the Secretary and the Federal Trade Commis-
sion.
‘‘(C) In addition to the disclosures required by
subparagraph (A) of this paragraph, the Secretary
may, under a rulemaking conducted under section
553 of title 5, United States Code, prescribe disclo-
137
sure requirements regarding the level of any ciga-
rette or other tobacco product smoke constituent.
Any such disclosure may be required if the Secretary
determines that disclosure would be of benefit to the
public health, or otherwise would increase consumer
awareness of the health consequences of the use of
tobacco products, except that no such prescribed dis-
closure shall be required on the face of any cigarette
package or advertisement. Nothing in this section
shall prohibit the Secretary from requiring such pre-
scribed disclosure through a cigarette or other to-
bacco product package or advertisement insert, or by
any other means under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).’’.
SEC. 511. REGULATION REQUIREMENT.
(a) TESTING, REPORTING, AND DISCLOSURE.—Not
later than 24 months after the date of enactment of this
Act, the Secretary, through the Commissioner of Food and
Drugs, shall promulgate regulations under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
that meet the requirements of subsection (b) of this sec-
tion.
(b) CONTENTS OF RULES.—The rules promulgated
under subsection (a) shall require the testing, reporting,
and disclosure of tobacco product smoke constituents and
138
ingredients that the Secretary determines should be dis-
closed to the public in order to protect the public health.
Such constituents shall include tar, nicotine, carbon mon-
oxide, and such other smoke constituents or ingredients
as the Secretary may determine to be appropriate. The
rule may require that tobacco product manufacturers,
packagers, or importers make such disclosures relating to
tar and nicotine through labels or advertising, and make
such disclosures regarding other smoke constituents or in-
gredients as the Secretary determines are necessary to
protect the public health.
(c) AUTHORITY.—The Food and Drug Administra-
tion shall have authority to conduct or to require the test-
ing, reporting, or disclosure of tobacco product smoke con-
stituents.
SEC. 512. FTC JURISDICTION NOT AFFECTED.
(a) IN GENERAL.—Except where expressly provided
in this Act, nothing in this Act shall be construed as lim-
iting or diminishing the authority of the Federal Trade
Commission to enforce the laws under its jurisdiction with
respect to the advertising, sale, or distribution of tobacco
products.
(b) ENFORCEMENT BY FTC.—Any advertising that
violates this Act is an unfair or deceptive act or practice
under section 5(a) of the Federal Trade Commission Act
139
(15 U.S.C. 45(a)) and shall be considered a violation of
a rule promulgated under section 18 of that Act (15
U.S.C. 57a).
Æ