156 
being misled about the harmfulness of the product because 
of such regulation, inspection, or compliance.’’. 
(c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) 
is amended— 
(1) in paragraph (1)(A), by inserting ‘‘or to-
bacco products’’ after the term ‘‘devices’’ each place 
such term appears; 
(2) in paragraph (5)— 
(A) 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,’’; 
(B) 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 fol-
lowing: ‘‘A no-tobacco-sale order perma-
nently prohibiting an individual retail out-
let from selling tobacco products shall in-
157 
clude provisions that allow the outlet, after 
a specified period of time, to request that 
the Secretary compromise, modify, or ter-
minate the order.’’; and 
(C) by adding at the end the following: 
‘‘(D) The Secretary may compromise, modify, or ter-
minate, with or without conditions, any no-tobacco-sale 
order.’’; 
(3) 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 
(4) by adding at the end the following: 
‘‘(8) If the Secretary finds that a person has com-
mitted 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 per-
son prohibiting the sale of tobacco products in that outlet. 
A no-tobacco-sale order may be imposed with a civil pen-
alty 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
158 
regulations of the Food and Drug Administration for as-
sessing civil money penalties, including at a retailer’s re-
quest 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.’’. 
(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 to-
bacco product’’ after the term ‘‘device’’ each place 
such term appears; and 
(4) in subsection (g)(2)(A), by inserting ‘‘or to-
bacco product’’ after ‘‘device’’. 
(e) SECTION 505.—Section 505(n)(2) (21 U.S.C. 
355(n)(2)) is amended by striking ‘‘section 904’’ and in-
serting ‘‘section 1004’’.
159 
(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 Secretary shall contract with the States in accordance 
with this paragraph 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.
160 
(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, to-
bacco products, or cosmetics’’; 
(B) by striking ‘‘or restricted devices’’ each 
place it appears and inserting ‘‘restricted de-
vices, or tobacco products’’; 
(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 inspec-
tion 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,’’.
166 
(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; 
(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.
167 
(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; 
(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-
168 
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. 
(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
169 
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 
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 en-
actment of this Act, submit a report to the Congress 
on the results of such study. 
SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING 
AND PROMOTION RESTRICTIONS. 
(a) ACTION PLAN.—
170 
(1) DEVELOPMENT.—Not later than 6 months 
after the date of 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. 
(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 trib-
al governments of the authority provided to such en-
tities under section 5(c) of the Federal Cigarette La-