‘‘(3) BASIS OF ASSESSMENT.—The safety as-
sessment of an ingredient, constituents, substance,
or compound described in paragraphs (1) and (2)
shall—
‘‘(A) be based on the best scientific evi-
dence available at the time of the submission of
the assessment; and
‘‘(B) result in a finding that there is a rea-
sonable certainty in the minds of competent sci-
entists that the ingredient, constituents, sub-
stance, or compound is not harmful in the
quantities used under the intended conditions of
use.
‘‘(c) PROHIBITION.—
‘‘(1) REGULATIONS.—Not later than 12 months
after the date of enactment of this chapter, the Sec-
retary shall promulgate regulations to prohibit the
use of any ingredient, constituent, substance, or
compound in the tobacco product of a manufac-
turer—
‘‘(A) if no safety assessment has been sub-
mitted by the manufacturer for the ingredient,
constituent, substance, or compound as other-
wise required under this section;
100
‘‘(B) if the Secretary disapproves of the
safety of the ingredient, constituent, substance,
or compound that was the subject of the assess-
ment under paragraph (2); or
‘‘(C) if such ingredient, constituent, sub-
stance, or compound is a new ingredient that
has not been approved for use by the Secretary.
‘‘(2) REVIEW OF ASSESSMENTS.—
‘‘(A) GENERAL REVIEW.—Not later than
180 days after the receipt of a safety assess-
ment under subsection (b), the Secretary shall
review the findings contained in such assess-
ment and approve or disapprove of the safety of
the ingredient, constituents, substance, or
compound that was the subject of the assess-
ment. The Secretary may, for good cause, ex-
tend the period for such approval. The Sec-
retary shall provide notice to the manufacturer
of an action under this subparagraph.
‘‘(B) INACTION
BY
SECRETARY.—If the
Secretary fails to act with respect to an assess-
ment of an existing ingredient, constituent, sub-
stance, or additive during the period referred to
in subparagraph (A), the manufacturer of the
tobacco product involved may continue to use
101
the ingredient, constituents, substance, or
compound involved until such time as the Sec-
retary makes a determination with respect to
the assessment.
‘‘(d) DISCLOSURE OF INGREDIENTS TO THE PUB-
LIC.—
‘‘(1) INITIAL
DISCLOSURE.—The regulations
promulgated in accordance with section 904(a) shall,
at a minimum, require that a tobacco product be
deemed to be misbranded if the labeling of the pack-
age of such product does not disclose all ingredients,
constituents, substances, or compounds contained in
the product in accordance with regulations promul-
gated by the Secretary.
‘‘(2) DISCLOSURE OF PERCENTAGE OF DOMES-
TIC AND FOREIGN TOBACCO.—The regulations re-
ferred to in paragraph (1) shall, at a minimum, re-
quire that a tobacco product be deemed to be mis-
branded if the labeling of the package of such prod-
uct does not disclose, with respect to the tobacco
contained in the product—
‘‘(A) the percentage that is domestic to-
bacco; and
‘‘(B) the percentage that is foreign to-
bacco.
102
‘‘(e) CONFIDENTIALITY.—
‘‘(1) PETITION BY MANUFACTURER.—Upon the
submission of a list under subsection (a), a manufac-
turer may petition the Secretary to exempt certain
ingredients, constituents, substances, or compounds
on such list from public disclosure under subsection
(e) on the basis that such information should be con-
sidered confidential as a trade secret. Such petition
may be accompanied by such data as the manufac-
turer elects to submit.
‘‘(2) DETERMINATION.—Not later than 60 days
after receiving a petition under paragraph (1), the
Secretary, in consultation with the Attorney General,
shall make a determination with respect to whether
the information described in the petition should be
exempt from disclosure under paragraph (1) as a
trade secret. The Secretary shall provide the manu-
facturer involved with notice of such determination.
but the decision of the Secretary shall be final.
‘‘(3) PROCEDURES FOR CONFIDENTIAL INFOR-
MATION.—The Secretary shall develop procedures to
maintain the confidentiality of information that is
treated as a trade secret under a determination
under paragraph (2). Such procedures shall in-
clude—
103
‘‘(A) a requirement that such information
be maintained in a secure facility; and
‘‘(B) a requirement that only the Sec-
retary, or the authorized agents of the Sec-
retary, will have access to the information and
shall be instructed to maintain the confidential-
ity of such information.
‘‘(4) HEALTH
DISCLOSURE.—Notwithstanding
a determination under paragraph (2), the Secretary
may require that any ingredient, constituents, sub-
stance, or compound contained in a tobacco product
that is determined to be exempt from disclosure as
a trade secret be disclosed if the Secretary deter-
mines that such ingredient, constituents, substance,
or compound is not safe as provided for in sub-
section (d).
‘‘(5) OTHER
DISCLOSURE.—Any information
that the Secretary determines is not subject to dis-
closure to the public under this subsection, shall be
exempt from disclosure pursuant to subsection (a) of
section 552 of title 5, United States Code, by reason
of subsection (b)(4) of such section, and shall be
considered confidential and shall not be disclosed,
except that such information may be disclosed to
other officers or employees as provided for in para-
104
graph (3)(B) or when relevant in any proceeding
under this Act.
‘‘SEC. 910. TOBACCO PRODUCT WARNINGS, LABELING AND
PACKAGING.
‘‘(a) CIGARETTE WARNINGS.—
‘‘(1) IN GENERAL.—
‘‘(A) PACKAGING.—It shall be unlawful for
any person to manufacture, package, or import
for sale or distribution within the United States
any cigarettes the package of which fails to
bear, in accordance with the requirements of
this subsection, one of the following labels:
‘‘WARNING: Cigarettes Are Addictive.
‘‘WARNING: Tobacco Smoke Can Harm
Your Children.
‘‘WARNING: Cigarettes Cause Fatal Lung
Disease.
‘‘WARNING: Cigarettes Cause Cancer.
‘‘WARNING: Cigarettes Cause Strokes
And Heart Disease.
‘‘WARNING: Smoking During Pregnancy
Can Harm Your Baby.
‘‘WARNING: Smoking Can Kill You.
‘‘WARNING: 
Tobacco 
Smoke 
Causes
Fatal Lung Disease In Nonsmokers.
105
‘‘WARNING: 
Quitting 
Smoking 
Now
Greatly Reduces Serious Risks To Your
Health.
‘‘(B) ADVERTISING.—It shall be unlawful
for any manufacturer or importer of cigarettes
to advertise or cause to be advertised within the
United States any cigarette unless the advertis-
ing bears, in accordance with the requirements
of this subsection, one of the following labels:
‘‘WARNING: Cigarettes Are Addictive.
‘‘WARNING: Tobacco Smoke Can Harm
Your Children.
‘‘WARNING: Cigarettes Cause Fatal Lung
Disease.
‘‘WARNING: Cigarettes Cause Cancer.
‘‘WARNING: Cigarettes Cause Strokes
And Heart Disease.
‘‘WARNING: Smoking During Pregnancy
Can Harm Your Baby.
‘‘WARNING: Smoking Can Kill You.
‘‘WARNING: 
Tobacco 
Smoke 
Causes
Fatal Lung Disease In Nonsmokers.
‘‘WARNING: 
Quitting 
Smoking 
Now
Greatly Reduces Serious Risks To Your
Health.
106
‘‘(2) REQUIREMENTS FOR LABELING.—
‘‘(A) LOCATION.—Each label statement re-
quired by subparagraph (A) of paragraph (1)
shall be located on the upper portion of the
front panel of the cigarette package (or carton)
and occupy not less than 25 percent of such
front panel.
‘‘(B) TYPE AND COLOR.—With respect to
each label statement required by subparagraph
(A) of paragraph (1), the phrase ‘WARNING’
shall appear in capital letters and the label
statement shall be printed in 17 point type with
adjustments as determined appropriate by the
Secretary to reflect the length of the required
statement. All the letters in the label shall ap-
pear in conspicuous and legible type, in contrast
by typography, layout, or color with all other
printed material on the package, and be printed
in an alternating black-on-white and white-on-
black format as determined appropriate by the
Secretary.
‘‘(C) EXCEPTION.—The provisions of sub-
paragraph (A) shall not apply in the case of a
flip-top cigarette package (offered for sale on
June 1, 1997) where the front portion of the
107
flip-top does not comprise at least 25 percent of
the front panel. In the case of such a package,
the label statement required by subparagraph
(A) of paragraph (1) shall occupy the entire
front portion of the flip top.
‘‘(3) REQUIREMENTS FOR ADVERTISING.—
‘‘(A) LOCATION.—Each label statement re-
quired by subparagraph (B) of paragraph (1)
shall occupy not less than 20 percent of the
area of the advertisement involved.
‘‘(B) TYPE AND COLOR.—
‘‘(i) TYPE.—With respect to each
label statement required by subparagraph
(B) of paragraph (1), the phrase ‘WARN-
ING’ shall appear in capital letters and the
label statement shall be printed in the fol-
lowing types:
‘‘(I) With respect to whole page
advertisements on broadsheet news-
paper—45 point type.
‘‘(II) With respect to half page
advertisements on broadsheet news-
paper—39 point type.
108
‘‘(III) With respect to whole page
advertisements 
on 
tabloid 
news-
paper—39 point type.
‘‘(IV) With respect to half page
advertisements 
on 
tabloid 
news-
paper—27 point type.
‘‘(V) With respect to DPS maga-
zine advertisements—31.5 point type.
‘‘(VI) With respect to whole page
magazine advertisements—31.5 point
type.
‘‘(VII) With respect to 28cm x 3
column advertisements—22.5 point
type.
‘‘(VIII) With respect to 20cm x 2
column 
advertisements—15 
point
type.
The Secretary may revise the required type
sizes as the Secretary determines appro-
priate within the 20 percent requirement.
‘‘(ii) COLOR.—All the letters in the
label under this subparagraph shall appear
in conspicuous and legible type, in contrast
by typography, layout, or color with all
other printed material on the package, and
109
be printed in an alternating black-on-white
and white-on-black format as determined
appropriate by the Secretary.
‘‘(4) ROTATION OF LABEL STATEMENTS.—
‘‘(A) IN GENERAL.—Except as provided in
subparagraph (B), the label statements speci-
fied in subparagraphs (A) and (B) of paragraph
(1) shall be rotated by each manufacturer or
importer of cigarettes quarterly in alternating
sequence on packages of each brand of ciga-
rettes manufactured by the manufacturer or
importer and in the advertisements for each
such brand of cigarettes in accordance with a
plan submitted by the manufacturer or im-
porter and approved by the Secretary. The Sec-
retary shall approve a plan submitted by a
manufacturer or importer of cigarettes which
will provide the rotation required by this para-
graph and which assures that all of the labels
required by subparagraphs (A) and (B) will be
displayed by the manufacturer or importer at
the same time.
‘‘(B) APPLICATION OF OTHER ROTATION
REQUIREMENTS.—
110
‘‘(i) IN
GENERAL.—A manufacturer
or importer of cigarettes may apply to the
Secretary to have the label rotation de-
scribed in clause (iii) apply with respect to
a brand style of cigarettes manufactured
or imported by such manufacturer or im-
porter if—
‘‘(I) the number of cigarettes of
such brand style sold in the fiscal year
of the manufacturer or importer pre-
ceding the submission of the applica-
tion is less than 1⁄4 of 1 percent of all
the cigarettes sold in the United
States in such year; and
‘‘(II) more than 1⁄2 of the ciga-
rettes manufactured or imported by
such manufacturer or importer for
sale 
in 
the 
United 
States 
are
packaged into brand styles which meet
the requirements of subclause (I).
If an application is approved by the Sec-
retary, the label rotation described in
clause (iii) shall apply with respect to the
applicant during the 1-year period begin-
111
ning on the date of the application ap-
proval.
‘‘(ii) 
PLAN.—An 
applicant 
under
clause (i) shall include in its application a
plan under which the label statements
specified in subparagraph (A) of paragraph
(1) will be rotated by the applicant manu-
facturer or importer in accordance with the
label rotation described in clause (iii).
‘‘(iii) OTHER
ROTATION
REQUIRE-
MENTS.—Under the label rotation which
the manufacturer or importer with an ap-
proved application may put into effect,
each of the labels specified in subpara-
graph (A) of paragraph (1) shall appear on
the packages of each brand style of ciga-
rettes with respect to which the application
was approved an equal number of times
within the 12-month period beginning on
the date of the approval by the Secretary
of the application.
‘‘(5) APPLICATION
OF
REQUIREMENT.—Para-
graph (1) does not apply to a distributor, a retailer
of cigarettes who does not manufacture, package, or
112
import cigarettes for sale or distribution within the
United States.
‘‘(6) TELEVISION AND RADIO ADVERTISING.—It
shall be unlawful to advertise cigarettes and little ci-
gars on any medium of electronic communications
subject to the jurisdiction of the Federal Commu-
nications Commission.
‘‘(b) SMOKELESS TOBACCO PRODUCTS.—
‘‘(1) IN GENERAL.—
‘‘(A) PACKAGING.—It shall be unlawful for
any person to manufacture, package, or import
for sale or distribution within the United States
any smokeless tobacco product the package of
which fails to bear, in accordance with the re-
quirements of this subsection, one of the follow-
ing labels:
WARNING: This Product Can Cause
Mouth Cancer.
WARNING: This Product Can Kill You.
WARNING: This Product Can Cause Gum
Disease And Tooth Loss.
WARNING: This Product Is Not A Safe
Alternative To Cigarettes.
WARNING: This Product Contains Can-
cer-Causing Chemicals.
113
WARNING: Smokeless Tobacco Is Addict-
ive.
‘‘(B) ADVERTISING.—It shall be unlawful
for any manufacturer or importer of smokeless
tobacco products to advertise or cause to be ad-
vertised within the United States any smokeless
tobacco product unless the advertising bears, in
accordance with the requirements of this sub-
section, one of the following labels:
WARNING: This Product Can Cause
Mouth Cancer.
WARNING: This product Can Kill You.
WARNING: This Product Can Cause Gum
Disease And Tooth Loss.
WARNING: This Product Is Not A Safe
Alternative To Cigarettes.
WARNING: This Product Contains Can-
cer-Causing Chemicals.
WARNING: Smokeless Tobacco Is Addict-
ive.
‘‘(2) REQUIREMENTS FOR LABELING.—
‘‘(A) LOCATION.—Each label statement re-
quired by subparagraph (A) of paragraph (1)
shall be located on the principal display panel
114
of the product and occupy not less than 25 per-
cent of such panel.
‘‘(B) TYPE AND COLOR.—With respect to
each label statement required by subparagraph
(A) of paragraph (1), the phrase ‘WARNING’
shall appear in capital letters and the label
statement shall be printed in 17 point type with
adjustments as determined appropriate by the
Secretary to reflect the length of the required
statement. All the letters in the label shall ap-
pear in conspicuous and legible type in contrast
by typography, layout, or color with all other
printed material on the package and be printed
in an alternating black on white and white on
black format as determined appropriate by the
Secretary.
‘‘(3) ADVERTISING AND ROTATION.—The provi-
sions of paragraph (3) and (4)(A) of subsection (a)
shall apply to advertisements for smokeless tobacco
products and the rotation of the label statements re-
quired under paragraph (1)(A) on such products.
‘‘(4) APPLICATION
OF
REQUIREMENT.—Para-
graph (1) does not apply to a distributor or a re-
tailer of smokeless tobacco products who does not