164 
HR 1108 RFS 
Food, Drug, and Cosmetic Act (21 U.S.C. 
333(f)(8)) as amended by subsection (c), as in-
cluding at least 5 violations of particular re-
quirements over a 36-month period at a par-
ticular retail outlet that constitute a repeated 
violation and providing for civil penalties in ac-
cordance with paragraph (2); 
(B) providing for timely and effective no-
tice by certified or registered mail or personal 
delivery to the retailer of each alleged violation 
at a particular retail outlet prior to conducting 
a followup compliance check, such notice to be 
sent to the location specified on the retailer’s 
registration or to the retailer’s registered agent 
if the retailer has provider such agent informa-
tion to the Food and Drug Administration prior 
to the violation; 
(C) providing for a hearing pursuant to the 
procedures established through regulations of 
the Food and Drug Administration for assess-
ing civil money penalties, including at a retail-
er’s request a hearing by telephone or at the 
nearest regional or field office of the Food and 
Drug Administration, and providing for an ex-
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00164
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
165 
HR 1108 RFS 
pedited procedure for the administrative appeal 
of an alleged violation; 
(D) providing that a person may not be 
charged with a violation at a particular retail 
outlet unless the Secretary has provided notice 
to the retailer of all previous violations at that 
outlet; 
(E) establishing that civil money penalties 
for multiple violations shall increase from one 
violation to the next violation pursuant to para-
graph (2) within the time periods provided for 
in such paragraph; 
(F) providing that good faith reliance on 
the presentation of a false government-issued 
photographic identification that contains a date 
of birth does not constitute a violation of any 
minimum age requirement for the sale of to-
bacco products if the retailer has taken effective 
steps to prevent such violations, including— 
(i) adopting and enforcing a written 
policy against sales to minors; 
(ii) informing its employees of all ap-
plicable laws; 
(iii) establishing disciplinary sanctions 
for employee noncompliance; and 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00165
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
166 
HR 1108 RFS 
(iv) requiring its employees to verify 
age by way of photographic identification 
or electronic scanning device; and 
(G) providing for the Secretary, in deter-
mining whether to impose a no-tobacco-sale 
order and in determining whether to com-
promise, modify, or terminate such an order, to 
consider whether the retailer has taken effective 
steps to prevent violations of the minimum age 
requirements for the sale of tobacco products, 
including the steps listed in subparagraph (F). 
(2) PENALTIES FOR VIOLATIONS.— 
(A) IN GENERAL.—The amount of the civil 
penalty to be applied for violations of restric-
tions promulgated under section 906(d), as de-
scribed in paragraph (1), shall be as follows: 
(i) With respect to a retailer with an 
approved training program, the amount of 
the civil penalty shall not exceed— 
(I) in the case of the first viola-
tion, $0.00 together with the issuance 
of a warning letter to the retailer; 
(II) in the case of a second viola-
tion within a 12-month period, $250; 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00166
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
167 
HR 1108 RFS 
(III) in the case of a third viola-
tion within a 24-month period, $500; 
(IV) in the case of a fourth viola-
tion 
within 
a 
24-month 
period, 
$2,000; 
(V) in the case of a fifth violation 
within a 36-month period, $5,000; 
and 
(VI) in the case of a sixth or sub-
sequent violation within a 48-month 
period, $10,000 as determined by the 
Secretary on a case-by-case basis. 
(ii) With respect to a retailer that 
does not have an approved training pro-
gram, the amount of the civil penalty shall 
not exceed— 
(I) in the case of the first viola-
tion, $250; 
(II) in the case of a second viola-
tion within a 12-month period, $500; 
(III) in the case of a third viola-
tion 
within 
a 
24-month 
period, 
$1,000; 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00167
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
168 
HR 1108 RFS 
(IV) in the case of a fourth viola-
tion 
within 
a 
24-month 
period, 
$2,000; 
(V) in the case of a fifth violation 
within a 36-month period, $5,000; 
and 
(VI) in the case of a sixth or sub-
sequent violation within a 48-month 
period, $10,000 as determined by the 
Secretary on a case-by-case basis. 
(B) TRAINING PROGRAM.—For purposes of 
subparagraph (A), the term ‘‘approved training 
program’’ means a training program that com-
plies with standards developed by the Food and 
Drug Administration for such programs. 
(C) CONSIDERATION
OF
STATE
PEN-
ALTIES.—The Secretary shall coordinate with 
the States in enforcing the provisions of this 
Act and, for purposes of mitigating a civil pen-
alty to be applied for a violation by a retailer 
of any restriction promulgated under section 
906(d), shall consider the amount of any pen-
alties paid by the retailer to a State for the 
same violation. 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00168
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
169 
HR 1108 RFS 
(3) GENERAL EFFECTIVE DATE.—The amend-
ments made by paragraphs (2), (3), and (4) of sub-
section (c) shall take effect upon the issuance of 
guidance described in paragraph (1) of this sub-
section. 
(4) SPECIAL
EFFECTIVE
DATE.—The amend-
ment made by subsection (c)(1) shall take effect on 
the date of enactment of this Act. 
(5) PACKAGE
LABEL
REQUIREMENTS.—The 
package label requirements of paragraphs (2), (3), 
and (4) of section 903(a) of the Federal Food, 
Drug, and Cosmetic Act (as amended by this Act) 
shall take effect on the date that is 12 months after 
the date of enactment of this Act. The effective date 
shall be with respect to the date of manufacture, 
provided that, in any case, beginning 30 days after 
such effective date, a manufacturer shall not intro-
duce into the domestic commerce of the United 
States any product, irrespective of the date of manu-
facture, that is not in conformance with section 
903(a)(2), (3), and (4) and section 920(a) of the 
Federal Food, Drug, and Cosmetic Act. 
(6) ADVERTISING REQUIREMENTS.—The adver-
tising requirements of section 903(a)(8) of the Fed-
eral Food, Drug, and Cosmetic Act (as amended by 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00169
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
170 
HR 1108 RFS 
this Act) shall take effect on the date that is 12 
months after the date of enactment of this Act. 
SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PUR-
CHASE TOBACCO PRODUCTS. 
The Secretary of Health and Human Services shall— 
(1) convene an expert panel to conduct a study 
on the public health implications of raising the min-
imum age to purchase tobacco products; and 
(2) not later than 5 years after the date of the 
enactment of this Act, submit a report to the Con-
gress on the results of such study. 
SEC. 105. TOBACCO INDUSTRY CONCENTRATION. 
(a) STUDY.—The Federal Trade Commission shall 
conduct a study on the causes and effects of concentration 
in the tobacco industry. 
(b) PUBLIC REPORT.—The Federal Trade Commis-
sion shall transmit to Congress a report not later than 
5 years after the date of enactment of this Act, and a 
subsequent report on the date that is 10 years after the 
date of enactment of this Act. Such reports shall include— 
(1) an analysis of trends in the market share of 
any dominant tobacco product manufacturer in any 
class of tobacco products; or 
(2) an analysis of trends in competition or the 
emergence of a monopoly; and 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00170
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
171 
HR 1108 RFS 
(3) recommendations to Congress on any cor-
rective actions that should be taken to address to-
bacco industry concentration. 
SEC. 106. ENFORCEMENT ACTION PLAN FOR ADVERTISING 
AND PROMOTION RESTRICTIONS. 
(a) ACTION PLAN.— 
(1) DEVELOPMENT.—Not later than 6 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services (in this sec-
tion referred to as the ‘‘Secretary’’) shall develop 
and publish an action plan to enforce restrictions 
adopted pursuant to section 906 of the Federal 
Food, Drug, and Cosmetic Act, as added by section 
101(b) of this Act, or pursuant to section 102(a) of 
this Act, on promotion and advertising of menthol 
and other cigarettes to youth. 
(2) CONSULTATION.—The action plan required 
by paragraph (1) shall be developed in consultation 
with public health organizations and other stake-
holders with demonstrated expertise and experience 
in serving minority communities. 
(3) PRIORITY.—The action plan required by 
paragraph (1) shall include provisions designed to 
ensure enforcement of the restrictions described in 
paragraph (1) in minority communities. 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00171
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
172 
HR 1108 RFS 
(b) STATE AND LOCAL ACTIVITIES.— 
(1) INFORMATION ON AUTHORITY.—Not later 
than 3 months after the date of the enactment of 
this Act, the Secretary shall inform State, local, and 
tribal governments of the authority provided to such 
entities under section 5(c) of the Federal Cigarette 
Labeling and Advertising Act, as added by section 
203 of this Act, or preserved by such entities under 
section 916 of the Federal Food, Drug, and Cos-
metic Act, as added by section 101(b) of this Act. 
(2) COMMUNITY ASSISTANCE.—At the request 
of communities seeking assistance to prevent under-
age tobacco use, the Secretary shall provide such as-
sistance, including assistance with strategies to ad-
dress the prevention of underage tobacco use in com-
munities with a disproportionate use of menthol 
cigarettes by minors. 
TITLE 
II—TOBACCO 
PRODUCT 
WARNINGS; 
CONSTITUENT 
AND 
SMOKE 
CONSTITUENT 
DISCLOSURE 
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 
(a) AMENDMENT.—Section 4 of the Federal Ciga-
rette Labeling and Advertising Act (15 U.S.C. 1333) is 
amended to read as follows: 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00172
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
173 
HR 1108 RFS 
‘‘SEC. 4. LABELING. 
‘‘(a) LABEL REQUIREMENTS.— 
‘‘(1) IN GENERAL.—It shall be unlawful for any 
person to manufacture, package, sell, offer to sell, 
distribute, or import for sale or distribution within 
the United States any cigarettes the package of 
which fails to bear, in accordance with the require-
ments of this section, 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 great-
ly reduces serious risks to your health. 
‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—Each 
label statement required by paragraph (1) shall be 
located in the upper portion of the front and rear 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00173
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
174 
HR 1108 RFS 
panels of the package, directly on the package un-
derneath the cellophane or other clear wrapping. 
Each label statement shall comprise at least the top 
30 percent of the front and rear panels of the pack-
age. The word ‘WARNING’ shall appear in capital 
letters and all text shall be in conspicuous and leg-
ible 17-point type, unless the text of the label state-
ment would occupy more than 70 percent of such 
area, in which case the text may be in a smaller con-
spicuous and legible 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 
white on a black background, in a manner that con-
trasts, by typography, layout, or color, with all other 
printed material on the package, in an alternating 
fashion under the plan submitted under subsection 
(c). 
‘‘(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. 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00174
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
175 
HR 1108 RFS 
‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 
of cigarettes shall not be in violation of this sub-
section for packaging that— 
‘‘(A) contains a warning label; 
‘‘(B) is supplied to the retailer by a 
license- or permit-holding tobacco product man-
ufacturer, importer, or distributor; and 
‘‘(C) is not altered by the retailer in a way 
that is material to the requirements of this sub-
section. 
‘‘(b) ADVERTISING REQUIREMENTS.— 
‘‘(1) IN GENERAL.—It shall be unlawful for any 
tobacco product manufacturer, importer, distributor, 
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). 
‘‘(2) TYPOGRAPHY, ETC.—Each label statement 
required by subsection (a) in cigarette advertising 
shall comply with the standards set forth in this 
paragraph. For press and poster advertisements, 
each such statement and (where applicable) any re-
quired statement relating to tar, nicotine, or other 
constituent (including a smoke constituent) yield 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00175
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
176 
HR 1108 RFS 
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 ad-
vertisement within the trim area. The Secretary may 
revise the required type sizes in such area in such 
manner as the Secretary determines appropriate. 
The word ‘WARNING’ shall appear in capital let-
ters, and each label statement shall appear in con-
spicuous and legible type. The text of the label state-
ment shall be black if the background is white and 
white if the background is black, under the plan sub-
mitted under subsection (c). The label statements 
shall be enclosed by a rectangular border that 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 state-
ments. The text of such label statements shall be in 
a typeface pro rata to the following requirements: 
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 advertisement; 
27-point type for a half-page tabloid newspaper ad-
vertisement; 31.5-point type for a double page 
spread magazine or whole-page magazine advertise-
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00176
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
177 
HR 1108 RFS 
ment; 22.5-point type for a 28 centimeter by 3 col-
umn advertisement; and 15-point type for a 20 cen-
timeter by 2 column advertisement. The label state-
ments shall be in English, except that— 
‘‘(A) in the case of an advertisement that 
appears in a newspaper, magazine, periodical, 
or other publication that is not in English, the 
statements shall appear in the predominant lan-
guage of the publication; and 
‘‘(B) in the case of any other advertise-
ment that is not in English, the statements 
shall appear in the same language as that prin-
cipally used in the advertisement. 
‘‘(3) 
MATCHBOOKS.—Notwithstanding 
para-
graph (2), for matchbooks (defined as containing not 
more than 20 matches) customarily given away with 
the purchase of tobacco products, each label state-
ment required by subsection (a) may be printed on 
the inside cover of the matchbook. 
‘‘(4) 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; the text, format, and type sizes of any re-
quired tar, nicotine yield, or other constituent (in-
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00177
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
178 
HR 1108 RFS 
cluding smoke constituent) disclosures; or the text, 
format, and type sizes for any other disclosures re-
quired under the Federal Food, Drug, and Cosmetic 
Act. The text of any such label statements or disclo-
sures shall be required to appear only within the 20 
percent area of cigarette advertisements provided by 
paragraph (2). The Secretary shall promulgate regu-
lations which provide for adjustments 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. 
‘‘(c) MARKETING REQUIREMENTS.— 
‘‘(1) RANDOM DISPLAY.—The label statements 
specified in subsection (a)(1) shall be randomly dis-
played in each 12-month period, in as equal a num-
ber of times as is possible on each brand of the 
product and be randomly distributed in all areas of 
the United States in which the product is marketed 
in accordance with a plan submitted by the tobacco 
product manufacturer, importer, distributor, or re-
tailer and approved by the Secretary. 
‘‘(2) ROTATION.—The label statements speci-
fied in subsection (a)(1) shall be rotated quarterly in 
alternating sequence in advertisements for each 
brand of cigarettes in accordance with a plan sub-
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00178
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
179 
HR 1108 RFS 
mitted by the tobacco product manufacturer, im-
porter, distributor, or retailer to, and approved by, 
the Secretary. 
‘‘(3) REVIEW.—The Secretary shall review each 
plan submitted under paragraph (2) and approve it 
if the plan— 
‘‘(A) will provide for the equal distribution 
and display on packaging and the rotation re-
quired in advertising under this subsection; and 
‘‘(B) assures that all of the labels required 
under this section will be displayed by the to-
bacco product manufacturer, importer, dis-
tributor, or retailer at the same time. 
‘‘(4) APPLICABILITY TO RETAILERS.—This sub-
section and subsection (b) apply to a retailer only if 
that retailer is responsible for or directs the label 
statements required under this section except that 
this paragraph shall not relieve a retailer of liability 
if the retailer displays, in a location open to the pub-
lic, an advertisement that does not contain a warn-
ing label or has been altered by the retailer in a way 
that is material to the requirements of this sub-
section and subsection (b).’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect 12 months after the date 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00179
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
180 
HR 1108 RFS 
of enactment of this Act. Such effective date shall be with 
respect to the date of manufacture, provided that, in any 
case, beginning 30 days after such effective date, a manu-
facturer shall not introduce into the domestic commerce 
of the United States any product, irrespective of the date 
of manufacture, that is not in conformance with section 
4 of the Federal Cigarette Labeling and Advertising Act 
(15 U.S.C. 1333), as amended by subsection (a). 
SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING 
LABEL STATEMENTS. 
(a) PREEMPTION.—Section 5(a) of the Federal Ciga-
rette Labeling and Advertising Act (15 U.S.C. 1334(a)) 
is amended by striking ‘‘No’’ and inserting ‘‘Except to the 
extent the Secretary requires additional or different state-
ments on any cigarette package by a regulation, by an 
order, by a standard, by an authorization to market a 
product, or by a condition of marketing a product, pursu-
ant to the Family Smoking Prevention and Tobacco Con-
trol Act (and the amendments made by that Act), or as 
required under section 903(a)(2) or section 920(a) of the 
Federal Food, Drug, and Cosmetic Act, no’’. 
(b) CHANGE IN REQUIRED STATEMENTS.—Section 4 
of the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1333), as amended by section 201, is further 
amended by adding at the end the following: 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00180
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS