H. R. 1256—60 
‘‘(3) the product is endorsed by the Food and Drug Adminis-
tration for use by consumers; or 
‘‘(4) the product is safe or less harmful by virtue of— 
‘‘(A) its regulation or inspection by the Food and Drug 
Administration; or 
‘‘(B) its compliance with regulatory requirements set 
by the Food and Drug Administration; 
including any such statement or representation rendering the 
product misbranded under section 903.’’. 
(c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) is amended— 
(1) in paragraph (5)— 
(A) by striking ‘‘paragraph (1), (2), (3), or (4)’’ each 
place such appears and inserting ‘‘paragraph (1), (2), (3), 
(4), or (9)’’; 
(B) in subparagraph (A)— 
(i) by striking ‘‘assessed’’ the first time it appears 
and inserting ‘‘assessed, or a no-tobacco-sale order may 
be imposed,’’; and 
(ii) by striking ‘‘penalty’’ the second time it appears 
and inserting ‘‘penalty, or upon whom a no-tobacco- 
sale order is to be imposed,’’; 
(C) in subparagraph (B)— 
(i) by inserting after ‘‘penalty,’’ the following: ‘‘or 
the period to be covered by a no-tobacco-sale order,’’; 
and 
(ii) by adding at the end the following: ‘‘A no- 
tobacco-sale order permanently prohibiting an indi-
vidual retail outlet from selling tobacco products shall 
include provisions that allow the outlet, after a speci-
fied period of time, to request that the Secretary com-
promise, modify, or terminate the order.’’; and 
(D) by adding at the end the following: 
‘‘(D) The Secretary may compromise, modify, or terminate, with 
or without conditions, any no-tobacco-sale order.’’; 
(2) in paragraph (6)— 
(A) by inserting ‘‘or the imposition of a no-tobacco- 
sale order’’ after the term ‘‘penalty’’ each place such term 
appears; and 
(B) by striking ‘‘issued.’’ and inserting ‘‘issued, or on 
which the no-tobacco-sale order was imposed, as the case 
may be.’’; and 
(3) by adding at the end the following: 
‘‘(8) If the Secretary finds that a person has committed repeated 
violations of restrictions promulgated under section 906(d) at a 
particular retail outlet then the Secretary may impose a no-tobacco- 
sale 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). Prior to the entry of a no- 
sale order under this paragraph, a person shall be entitled to 
a hearing pursuant to the procedures established through regula-
tions of the Food and Drug Administration for assessing civil money 
penalties, including at a retailer’s request a hearing by telephone, 
or at the nearest regional or field office of the Food and Drug 
Administration, or at a Federal, State, or county facility within 
100 miles from the location of the retail outlet, if such a facility 
is available.
H. R. 1256—61 
‘‘(9) CIVIL MONETARY PENALTIES FOR VIOLATION OF TOBACCO 
PRODUCT REQUIREMENTS.— 
‘‘(A) IN GENERAL.—Subject to subparagraph (B), any person 
who violates a requirement of this Act which relates to tobacco 
products shall be liable to the United States for a civil penalty 
in an amount not to exceed $15,000 for each such violation, 
and not to exceed $1,000,000 for all such violations adjudicated 
in a single proceeding. 
‘‘(B) ENHANCED PENALTIES.— 
‘‘(i) Any person who intentionally violates a require-
ment of section 902(5), 902(6), 904, 908(c), or 911(a), shall 
be subject to a civil monetary penalty of— 
‘‘(I) not to exceed $250,000 per violation, and not 
to exceed $1,000,000 for all such violations adjudicated 
in a single proceeding; or 
‘‘(II) in the case of a violation that continues after 
the Secretary provides written notice to such person, 
$250,000 for the first 30-day period (or any portion 
thereof) that the person continues to be in violation, 
and such amount shall double for every 30-day period 
thereafter that the violation continues, not to exceed 
$1,000,000 for any 30-day period, and not to exceed 
$10,000,000 for all such violations adjudicated in a 
single proceeding. 
‘‘(ii) Any person who violates a requirement of section 
911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil mone-
tary penalty of— 
‘‘(I) not to exceed $250,000 per violation, and not 
to exceed $1,000,000 for all such violations adjudicated 
in a single proceeding; or 
‘‘(II) in the case of a violation that continues after 
the Secretary provides written notice to such person, 
$250,000 for the first 30-day period (or any portion 
thereof) that the person continues to be in violation, 
and such amount shall double for every 30-day period 
thereafter that the violation continues, not to exceed 
$1,000,000 for any 30-day period, and not to exceed 
$10,000,000 for all such violations adjudicated in a 
single proceeding. 
‘‘(iii) In determining the amount of a civil penalty 
under clause (i)(II) or (ii)(II), the Secretary shall take into 
consideration whether the person is making efforts toward 
correcting the violation of the requirements of the section 
for which such person is subject to such civil penalty.’’. 
(d) SECTION 304.—Section 304 (21 U.S.C. 334) is amended— 
(1) in subsection (a)(2)— 
(A) by striking ‘‘and’’ before ‘‘(D)’’; and 
(B) by striking ‘‘device.’’ and inserting the following: 
‘‘device, and (E) Any adulterated or misbranded tobacco 
product.’’; 
(2) in subsection (d)(1), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(3) in subsection (g)(1), by inserting ‘‘or tobacco product’’ 
after the term ‘‘device’’ each place such term appears; and 
(4) in subsection (g)(2)(A), by inserting ‘‘or tobacco product’’ 
after ‘‘device’’.
H. R. 1256—62 
(e) SECTION 505.—Section 505(n)(2) (21 U.S.C. 355(n)(2)) is 
amended by striking ‘‘section 904’’ and inserting ‘‘section 1004’’. 
(f) SECTION 523.—Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) 
is amended by striking ‘‘section 903(g)’’ and inserting ‘‘section 
1003(g)’’. 
(g) SECTION
702.—Section 702(a)(1) (U.S.C. 372(a)(1)) is 
amended— 
(1) by striking ‘‘(a)(1)’’ and inserting ‘‘(a)(1)(A)’’; and 
(2) by adding at the end the following: 
‘‘(B)(i) For a tobacco product, to the extent feasible, the Sec-
retary shall contract with the States in accordance with this para-
graph to carry out inspections of retailers within that State in 
connection with the enforcement of this Act. 
‘‘(ii) The Secretary shall not enter into any contract under 
clause (i) with the government of any of the several States to 
exercise enforcement authority under this Act on Indian country 
without the express written consent of the Indian tribe involved.’’. 
(h) SECTION 703.—Section 703 (21 U.S.C. 373) is amended— 
(1) by inserting ‘‘tobacco product,’’ after the term ‘‘device,’’ 
each place such term appears; and 
(2) by inserting ‘‘tobacco products,’’ after the term ‘‘devices,’’ 
each place such term appears. 
(i) SECTION 704.—Section 704 (21 U.S.C. 374) is amended— 
(1) in subsection (a)(1)— 
(A) by striking ‘‘devices, or cosmetics’’ each place it 
appears and inserting ‘‘devices, tobacco products, or cos-
metics’’; 
(B) by striking ‘‘or restricted devices’’ each place it 
appears and inserting ‘‘restricted devices, or tobacco prod-
ucts’’; and 
(C) by striking ‘‘and devices and subject to’’ and all 
that follows through ‘‘other drugs or devices’’ and inserting 
‘‘devices, and tobacco products and subject to reporting 
and inspection under regulations lawfully issued pursuant 
to section 505 (i) or (k), section 519, section 520(g), or 
chapter IX and data relating to other drugs, devices, or 
tobacco products’’; 
(2) in subsection (b), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; and 
(3) in subsection (g)(13), by striking ‘‘section 903(g)’’ and 
inserting ‘‘section 1003(g)’’. 
(j) SECTION 705.—Section 705(b) (21 U.S.C. 375(b)) is amended 
by inserting ‘‘tobacco products,’’ after ‘‘devices,’’. 
(k) SECTION 709.—Section 709 (21 U.S.C. 379a) is amended 
by inserting ‘‘tobacco product,’’ after ‘‘device,’’. 
(l) SECTION 801.—Section 801 (21 U.S.C. 381) is amended— 
(1) in subsection (a)— 
(A) by inserting ‘‘tobacco products,’’ after the term 
‘‘devices,’’; 
(B) by inserting ‘‘or section 905(h)’’ after ‘‘section 510’’; 
and 
(C) by striking the term ‘‘drugs or devices’’ each time 
such term appears and inserting ‘‘drugs, devices, or tobacco 
products’’; 
(2) in subsection (e)(1)— 
(A) by inserting ‘‘tobacco product’’ after ‘‘drug, device,’’; 
and
H. R. 1256—63 
(B) by inserting ‘‘, and a tobacco product intended 
for export shall not be deemed to be in violation of section 
906(e), 907, 911, or 920(a),’’ before ‘‘if it—’’; and 
(3) by adding at the end the following: 
‘‘(p)(1) Not later than 36 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act, and 
annually thereafter, the Secretary shall submit to the Committee 
on Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Representa-
tives, a report regarding— 
‘‘(A) the nature, extent, and destination of United States 
tobacco product exports that do not conform to tobacco product 
standards established pursuant to this Act; 
‘‘(B) the public health implications of such exports, 
including any evidence of a negative public health impact; 
and 
‘‘(C) recommendations or assessments of policy alternatives 
available to Congress and the executive branch to reduce any 
negative public health impact caused by such exports. 
‘‘(2) The Secretary is authorized to establish appropriate 
information disclosure requirements to carry out this subsection.’’. 
(m) SECTION 1003.—Section 1003(d)(2)(C) (as redesignated by 
section 101(b)) is amended— 
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 
(2) inserting ‘‘, and tobacco products’’ after ‘‘devices’’. 
(n) SECTION 1009.—Section 1009(b) (as redesignated by section 
101(b)) is amended by striking ‘‘section 908’’ and inserting ‘‘section 
1008’’. 
(o) SECTION 409 OF THE FEDERAL MEAT INSPECTION ACT.— 
Section 409(a) of the Federal Meat Inspection Act (21 U.S.C. 679(a)) 
is amended by striking ‘‘section 902(b)’’ and inserting ‘‘section 
1002(b)’’. 
(p) RULE
OF
CONSTRUCTION.—Nothing in this section is 
intended or shall be construed to expand, contract, or otherwise 
modify or amend the existing limitations on State government 
authority over tribal restricted fee or trust lands. 
(q) GUIDANCE AND EFFECTIVE DATES.— 
(1) IN
GENERAL.—The Secretary of Health and Human 
Services shall issue guidance— 
(A) defining the term ‘‘repeated violation’’, as used 
in section 303(f)(8) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), 
as including at least 5 violations of particular requirements 
over a 36-month period at a particular retail outlet that 
constitute a repeated violation and providing for civil pen-
alties in accordance with paragraph (2); 
(B) providing for timely and effective notice 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 registra-
tion or to the retailer’s registered agent if the retailer 
has provider such agent information 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 
assessing 
civil 
money 
penalties,
H. R. 1256—64 
including at a retailer’s request a hearing by telephone 
or at the nearest regional or field office of the Food and 
Drug Administration, and providing for an expedited proce-
dure 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 paragraph (2) within the time periods 
provided for in such paragraph; 
(F) providing that good faith reliance on the presen-
tation of a false government-issued photographic identifica-
tion that contains a date of birth does not constitute a 
violation of any minimum age requirement for the sale 
of tobacco 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 applicable laws; 
(iii) 
establishing 
disciplinary 
sanctions 
for 
employee noncompliance; and 
(iv) requiring its employees to verify age by way 
of photographic identification or electronic scanning 
device; and 
(G) providing for the Secretary, in determining whether 
to impose a no-tobacco-sale order and in determining 
whether to compromise, 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 restrictions promulgated under 
section 906(d), as described 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 violation, $0.00 
together with the issuance of a warning letter 
to the retailer; 
(II) in the case of a second violation within 
a 12-month period, $250; 
(III) in the case of a third violation within 
a 24-month period, $500; 
(IV) in the case of a fourth violation 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 subsequent viola-
tion within a 48-month period, $10,000 as deter-
mined by the Secretary on a case-by-case basis.
H. R. 1256—65 
(ii) With respect to a retailer that does not have 
an approved training program, the amount of the civil 
penalty shall not exceed— 
(I) in the case of the first violation, $250; 
(II) in the case of a second violation within 
a 12-month period, $500; 
(III) in the case of a third violation within 
a 24-month period, $1,000; 
(IV) in the case of a fourth violation 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 subsequent viola-
tion within a 48-month period, $10,000 as deter-
mined 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 complies with standards developed by the 
Food and Drug Administration for such programs. 
(C) CONSIDERATION
OF
STATE
PENALTIES.—The Sec-
retary shall coordinate with the States in enforcing the 
provisions of this Act and, for purposes of mitigating a 
civil penalty to be applied for a violation by a retailer 
of any restriction promulgated under section 906(d), shall 
consider the amount of any penalties paid by the retailer 
to a State for the same violation. 
(3) GENERAL EFFECTIVE DATE.—The amendments made by 
paragraphs (2), (3), and (4) of subsection (c) shall take effect 
upon the issuance of guidance described in paragraph (1) of 
this subsection. 
(4) SPECIAL EFFECTIVE DATE.—The amendment 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 (3) and (4) of section 903(a) of 
the Federal Food, Drug, and Cosmetic Act (as amended by 
this division) shall take effect on the date that is 12 months 
after the date of enactment of this Act. The package label 
requirements of paragraph (2) of such section 903(a) for ciga-
rettes shall take effect on the date that is 15 months after 
the issuance of the regulations required by section 4(d) of 
the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 
1333), as amended by section 201 of this division. The package 
label requirements of paragraph (2) of such section 903(a) for 
tobacco products other than cigarettes 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 introduce 
into the domestic commerce of the United States any product, 
irrespective of the date of manufacture, that is not in conform-
ance with section 903(a) (2), (3), and (4) and section 920(a) 
of the Federal Food, Drug, and Cosmetic Act. 
(6) ADVERTISING REQUIREMENTS.—The advertising require-
ments of section 903(a)(8) of the Federal Food, Drug, and Cos-
metic Act (as amended by this division) shall take effect on
H. R. 1256—66 
the date that is 12 months after the date of enactment of 
this Act. 
SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PURCHASE 
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 minimum age to pur-
chase tobacco products; and 
(2) not later than 5 years after the date of enactment 
of this Act, submit a report to the Congress on the results 
of such study. 
SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING AND PRO-
MOTION RESTRICTIONS. 
(a) ACTION PLAN.— 
(1) DEVELOPMENT.—Not later than 6 months after the date 
of enactment of this Act, the Secretary of Health and Human 
Services (in this section 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 division, 
or pursuant to section 102(a) of this division, 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 stakeholders with demonstrated exper-
tise 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. 
(b) STATE AND LOCAL ACTIVITIES.— 
(1) INFORMATION ON AUTHORITY.—Not later than 3 months 
after the date of 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 division, or preserved by such entities under section 
916 of the Federal Food, Drug, and Cosmetic Act, as added 
by section 101(b) of this division. 
(2) COMMUNITY
ASSISTANCE.—At the request of commu-
nities seeking assistance to prevent underage tobacco use, the 
Secretary shall provide such assistance, including assistance 
with strategies to address the prevention of underage tobacco 
use in communities with a disproportionate use of menthol 
cigarettes by minors. 
SEC. 106. STUDIES OF PROGRESS AND EFFECTIVENESS. 
(a) FDA REPORT.—Not later than 3 years after the date of 
enactment of this Act, and not less than every 2 years thereafter, 
the Secretary of Health and Human Services shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives, a report concerning— 
(1) the progress of the Food and Drug Administration in 
implementing this division, including major accomplishments, 
objective measurements of progress, and the identification of 
any areas that have not been fully implemented;
H. R. 1256—67 
(2) impediments identified by the Food and Drug Adminis-
tration to progress in implementing this division and to meeting 
statutory timeframes; 
(3) data on the number of new product applications received 
under section 910 of the Federal Food, Drug, and Cosmetic 
Act and modified risk product applications received under sec-
tion 911 of such Act, and the number of applications acted 
on under each category; and 
(4) data on the number of full time equivalents engaged 
in implementing this division. 
(b) GAO REPORT.—Not later than 5 years after the date of 
enactment of this Act, the Comptroller General of the United States 
shall conduct a study of, and submit to the Committees described 
in subsection (a) a report concerning— 
(1) the adequacy of the authority and resources provided 
to the Secretary of Health and Human Services for this division 
to carry out its goals and purposes; and 
(2) any recommendations for strengthening that authority 
to more effectively protect the public health with respect to 
the manufacture, marketing, and distribution of tobacco prod-
ucts. 
(c) PUBLIC AVAILABILITY.—The Secretary of Health and Human 
Services and the Comptroller General of the United States, respec-
tively, shall make the reports required under subsection (a) and 
(b) available to the public, including by posting such reports on 
the respective Internet websites of the Food and Drug Administra-
tion and the Government Accountability Office. 
TITLE II—TOBACCO PRODUCT WARN-
INGS; 
CONSTITUENT 
AND 
SMOKE 
CONSTITUENT DISCLOSURE 
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 
(a) AMENDMENT.—Section 4 of the Federal Cigarette Labeling 
and Advertising Act (15 U.S.C. 1333) is amended to read as follows: 
‘‘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 
requirements 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 dis-
ease. 
‘‘WARNING: Smoking during pregnancy can harm your 
baby. 
‘‘WARNING: Smoking can kill you. 
‘‘WARNING: Tobacco smoke causes fatal lung disease 
in nonsmokers.
H. R. 1256—68 
‘‘WARNING: Quitting smoking now greatly 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 panels of the package, directly on the 
package underneath the cellophane or other clear wrapping. 
Each label statement shall comprise the top 50 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 
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 contrasts, 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 DISTRIBUTION.—The provi-
sions of this subsection do not apply to a tobacco product 
manufacturer or distributor of cigarettes which does not manu-
facture, package, or import cigarettes for sale or distribution 
within the United States. 
‘‘(4) APPLICABILITY TO RETAILERS.—A retailer of cigarettes 
shall not be in violation of this subsection for packaging that— 
‘‘(A) contains a warning label; 
‘‘(B) is supplied to the retailer by a license- or permit- 
holding tobacco product manufacturer, importer, or dis-
tributor; and 
‘‘(C) is not altered by the retailer in a way that is 
material to the requirements of this subsection. 
‘‘(b) ADVERTISING REQUIREMENTS.— 
‘‘(1) IN
GENERAL.—It shall be unlawful for any tobacco 
product manufacturer, importer, distributor, or retailer of ciga-
rettes 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 specified 
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 required statement relating to tar, nicotine, or other con-
stituent (including a smoke 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 Secretary determines appropriate. 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 if the background 
is white and white if the background is black, under the plan 
submitted 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’