H. R. 1256—51 
‘‘(2) consider approving the extended use of nicotine replace-
ment products (such as nicotine patches, nicotine gum, and 
nicotine lozenges) for the treatment of tobacco dependence; 
and 
‘‘(3) review and consider the evidence for additional indica-
tions for nicotine replacement products, such as for craving 
relief or relapse prevention. 
‘‘(b) REPORT ON INNOVATIVE PRODUCTS.— 
‘‘(1) IN GENERAL.—Not later than 3 years after the date 
of enactment of the Family Smoking Prevention and Tobacco 
Control Act, the Secretary, after consultation with recognized 
scientific, medical, and public health experts (including both 
Federal agencies and nongovernmental entities, the Institute 
of Medicine of the National Academy of Sciences, and the 
Society for Research on Nicotine and Tobacco), shall submit 
to the Congress a report that examines how best to regulate, 
promote, and encourage the development of innovative products 
and treatments (including nicotine-based and non-nicotine- 
based products and treatments) to better achieve, in a manner 
that best protects and promotes the public health— 
‘‘(A) total abstinence from tobacco use; 
‘‘(B) reductions in consumption of tobacco; and 
‘‘(C) reductions in the harm associated with continued 
tobacco use. 
‘‘(2) RECOMMENDATIONS.—The report under paragraph (1) 
shall include the recommendations of the Secretary on how 
the Food and Drug Administration should coordinate and facili-
tate the exchange of information on such innovative products 
and treatments among relevant offices and centers within the 
Administration and within the National Institutes of Health, 
the Centers for Disease Control and Prevention, and other 
relevant agencies. 
‘‘SEC. 919. USER FEES. 
‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Beginning on the 
date of enactment of the Family Smoking Prevention and Tobacco 
Control Act, the Secretary shall in accordance with this section 
assess user fees on, and collect such fees from, each manufacturer 
and importer of tobacco products subject to this chapter. The fees 
shall be assessed and collected with respect to each quarter of 
each fiscal year, and the total amount assessed and collected for 
a fiscal year shall be the amount specified in subsection (b)(1) 
for such year, subject to subsection (c). 
‘‘(b) ASSESSMENT OF USER FEE.— 
‘‘(1) AMOUNT OF ASSESSMENT.—The total amount of user 
fees authorized to be assessed and collected under subsection 
(a) for a fiscal year is the following, as applicable to the fiscal 
year involved: 
‘‘(A) For fiscal year 2009, $85,000,000 (subject to sub-
section (e)). 
‘‘(B) For fiscal year 2010, $235,000,000. 
‘‘(C) For fiscal year 2011, $450,000,000. 
‘‘(D) For fiscal year 2012, $477,000,000. 
‘‘(E) For fiscal year 2013, $505,000,000. 
‘‘(F) For fiscal year 2014, $534,000,000. 
‘‘(G) For fiscal year 2015, $566,000,000. 
‘‘(H) For fiscal year 2016, $599,000,000.
H. R. 1256—52 
‘‘(I) For fiscal year 2017, $635,000,000. 
‘‘(J) For fiscal year 2018, $672,000,000. 
‘‘(K) For fiscal year 2019 and each subsequent fiscal 
year, $712,000,000. 
‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS OF TOBACCO 
PRODUCTS.— 
‘‘(A) IN GENERAL.—The total user fees assessed and 
collected under subsection (a) each fiscal year with respect 
to each class of tobacco products shall be an amount that 
is equal to the applicable percentage of each class for 
the fiscal year multiplied by the amount specified in para-
graph (1) for the fiscal year. 
‘‘(B) APPLICABLE PERCENTAGE.— 
‘‘(i) IN GENERAL.—For purposes of subparagraph 
(A), the applicable percentage for a fiscal year for each 
of the following classes of tobacco products shall be 
determined in accordance with clause (ii): 
‘‘(I) Cigarettes. 
‘‘(II) Cigars, including small cigars and cigars 
other than small cigars. 
‘‘(III) Snuff. 
‘‘(IV) Chewing tobacco. 
‘‘(V) Pipe tobacco. 
‘‘(VI) Roll-your-own tobacco. 
‘‘(ii) ALLOCATIONS.—The applicable percentage of 
each class of tobacco product described in clause (i) 
for a fiscal year shall be the percentage determined 
under section 625(c) of Public Law 108–357 for each 
such class of product for such fiscal year. 
‘‘(iii) REQUIREMENT
OF
REGULATIONS.—Notwith-
standing clause (ii), no user fees shall be assessed 
on a class of tobacco products unless such class of 
tobacco products is listed in section 901(b) or is deemed 
by the Secretary in a regulation under section 901(b) 
to be subject to this chapter. 
‘‘(iv) REALLOCATIONS.—In the case of a class of 
tobacco products that is not listed in section 901(b) 
or deemed by the Secretary in a regulation under sec-
tion 901(b) to be subject to this chapter, the amount 
of user fees that would otherwise be assessed to such 
class of tobacco products shall be reallocated to the 
classes of tobacco products that are subject to this 
chapter in the same manner and based on the same 
relative percentages otherwise determined under 
clause (ii). 
‘‘(3) DETERMINATION OF USER FEE BY COMPANY.— 
‘‘(A) IN GENERAL.—The total user fee to be paid by 
each manufacturer or importer of a particular class of 
tobacco products shall be determined for each quarter by 
multiplying— 
‘‘(i) such manufacturer’s or importer’s percentage 
share as determined under paragraph (4); by 
‘‘(ii) the portion of the user fee amount for the 
current quarter to be assessed on all manufacturers 
and importers of such class of tobacco products as 
determined under paragraph (2).
H. R. 1256—53 
‘‘(B) NO FEE IN EXCESS OF PERCENTAGE SHARE.—No 
manufacturer or importer of tobacco products shall be 
required to pay a user fee in excess of the percentage 
share of such manufacturer or importer. 
‘‘(4) ALLOCATION OF ASSESSMENT WITHIN EACH CLASS OF 
TOBACCO PRODUCT.—The percentage share of each manufac-
turer or importer of a particular class of tobacco products 
of the total user fee to be paid by all manufacturers or importers 
of that class of tobacco products shall be the percentage deter-
mined for purposes of allocations under subsections (e) through 
(h) of section 625 of Public Law 108–357. 
‘‘(5) ALLOCATION FOR CIGARS.—Notwithstanding paragraph 
(4), if a user fee assessment is imposed on cigars, the percentage 
share of each manufacturer or importer of cigars shall be based 
on the excise taxes paid by such manufacturer or importer 
during the prior fiscal year. 
‘‘(6) TIMING OF ASSESSMENT.—The Secretary shall notify 
each manufacturer and importer of tobacco products subject 
to this section of the amount of the quarterly assessment 
imposed on such manufacturer or importer under this sub-
section for each quarter of each fiscal year. Such notifications 
shall occur not later than 30 days prior to the end of the 
quarter for which such assessment is made, and payments 
of all assessments shall be made by the last day of the quarter 
involved. 
‘‘(7) MEMORANDUM OF UNDERSTANDING.— 
‘‘(A) IN
GENERAL.—The Secretary shall request the 
appropriate Federal agency to enter into a memorandum 
of understanding that provides for the regular and timely 
transfer from the head of such agency to the Secretary 
of the information described in paragraphs (2)(B)(ii) and 
(4) and all necessary information regarding all tobacco 
product manufacturers and importers required to pay user 
fees. The Secretary shall maintain all disclosure restric-
tions established by the head of such agency regarding 
the information provided under the memorandum of under-
standing. 
‘‘(B) ASSURANCES.—Beginning not later than fiscal year 
2015, and for each subsequent fiscal year, the Secretary 
shall ensure that the Food and Drug Administration is 
able to determine the applicable percentages described in 
paragraph (2) and the percentage shares described in para-
graph (4). The Secretary may carry out this subparagraph 
by entering into a contract with the head of the Federal 
agency referred to in subparagraph (A) to continue to pro-
vide the necessary information. 
‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN
GENERAL.—Fees authorized under subsection (a) 
shall be collected and available for obligation only to the extent 
and in the amount provided in advance in appropriations Acts, 
subject to paragraph (2)(D). Such fees are authorized to remain 
available until expended. Such sums as may be necessary may 
be transferred from the Food and Drug Administration salaries 
and expenses appropriation account without fiscal year limita-
tion to such appropriation account for salaries and expenses 
with such fiscal year limitation. 
‘‘(2) AVAILABILITY.—
H. R. 1256—54 
‘‘(A) IN GENERAL.—Fees appropriated under paragraph 
(3) are available only for the purpose of paying the costs 
of the activities of the Food and Drug Administration 
related to the regulation of tobacco products under this 
chapter and the Family Smoking Prevention and Tobacco 
Control Act (referred to in this subsection as ‘tobacco regu-
lation activities’), except that such fees may be used for 
the reimbursement specified in subparagraph (C). 
‘‘(B) PROHIBITION AGAINST USE OF OTHER FUNDS.— 
‘‘(i) IN
GENERAL.—Except as provided in clause 
(ii), fees collected under subsection (a) are the only 
funds authorized to be made available for tobacco regu-
lation activities. 
‘‘(ii) STARTUP
COSTS.—Clause (i) does not apply 
until October 1, 2009. Until such date, any amounts 
available to the Food and Drug Administration 
(excluding user fees) shall be available and allocated 
as needed to pay the costs of tobacco regulation activi-
ties. 
‘‘(C) REIMBURSEMENT OF START-UP AMOUNTS.— 
‘‘(i) IN GENERAL.—Any amounts allocated for the 
start-up period pursuant to subparagraph (B)(ii) shall 
be reimbursed through any appropriated fees collected 
under subsection (a), in such manner as the Secretary 
determines appropriate to ensure that such allocation 
results in no net change in the total amount of funds 
otherwise available, for the period from October 1, 
2008, through September 30, 2010, for Food and Drug 
Administration programs and activities (other than 
tobacco regulation activities) for such period. 
‘‘(ii) TREATMENT
OF
REIMBURSED
AMOUNTS.— 
Amounts reimbursed under clause (i) shall be available 
for the programs and activities for which funds allo-
cated for the start-up period were available, prior to 
such allocation, until September 30, 2010, notwith-
standing any otherwise applicable limits on amounts 
for such programs or activities for a fiscal year. 
‘‘(D) FEE COLLECTED DURING START-UP PERIOD.—Not-
withstanding the first sentence of paragraph (1), fees under 
subsection (a) may be collected through September 30, 2009 
under subparagraph (B)(ii) and shall be available for obliga-
tion and remain available until expended. Such offsetting 
collections shall be credited to the salaries and expenses 
account of the Food and Drug Administration. 
‘‘(E) OBLIGATION OF START-UP COSTS IN ANTICIPATION 
OF
AVAILABLE
FEE
COLLECTIONS.—Notwithstanding any 
other provision of law, following the enactment of an appro-
priation for fees under this section for fiscal year 2010, 
or any portion thereof, obligations for costs of tobacco regu-
lation activities during the start-up period may be incurred 
in anticipation of the receipt of offsetting fee collections 
through procedures specified in section 1534 of title 31, 
United States Code. 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For fiscal year 
2009 and each subsequent fiscal year, there is authorized to 
be appropriated for fees under this section an amount equal 
to the amount specified in subsection (b)(1) for the fiscal year.
H. R. 1256—55 
‘‘(d) COLLECTION
OF UNPAID FEES.—In any case where the 
Secretary does not receive payment of a fee assessed under sub-
section (a) within 30 days after it is due, such fee shall be treated 
as a claim of the United States Government subject to subchapter 
II of chapter 37 of title 31, United States Code. 
‘‘(e) APPLICABILITY TO FISCAL YEAR 2009.—If the date of enact-
ment of the Family Smoking Prevention and Tobacco Control Act 
occurs during fiscal year 2009, the following applies, subject to 
subsection (c): 
‘‘(1) The Secretary shall determine the fees that would 
apply for a single quarter of such fiscal year according to 
the application of subsection (b) to the amount specified in 
paragraph (1)(A) of such subsection (referred to in this sub-
section as the ‘quarterly fee amounts’). 
‘‘(2) For the quarter in which such date of enactment occurs, 
the amount of fees assessed shall be a pro rata amount, deter-
mined according to the number of days remaining in the quarter 
(including such date of enactment) and according to the daily 
equivalent of the quarterly fee amounts. Fees assessed under 
the preceding sentence shall not be collected until the next 
quarter. 
‘‘(3) For the quarter following the quarter to which para-
graph (2) applies, the full quarterly fee amounts shall be 
assessed and collected, in addition to collection of the pro rata 
fees assessed under paragraph (2).’’. 
(c) CONFORMING AMENDMENT.—Section 9(1) of the Comprehen-
sive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 
4408(i)) is amended to read as follows: 
‘‘(1) The term ‘smokeless tobacco’ has the meaning given 
such term by section 900(18) of the Federal Food, Drug, and 
Cosmetic Act.’’. 
SEC. 102. FINAL RULE. 
(a) CIGARETTES AND SMOKELESS TOBACCO.— 
(1) IN GENERAL.—On the first day of publication of the 
Federal Register that is 180 days or more after the date of 
enactment of this Act, the Secretary of Health and Human 
Services shall publish in the Federal Register a final rule 
regarding cigarettes and smokeless tobacco, which— 
(A) is deemed to be issued under chapter 9 of the 
Federal Food, Drug, and Cosmetic Act, as added by section 
101 of this division; and 
(B) shall be deemed to be in compliance with all 
applicable provisions of chapter 5 of title 5, United States 
Code, and all other provisions of law relating to rulemaking 
procedures. 
(2) CONTENTS OF RULE.—Except as provided in this sub-
section, the final rule published under paragraph (1), shall 
be identical in its provisions to part 897 of the regulations 
promulgated by the Secretary of Health and Human Services 
in the August 28, 1996, issue of the Federal Register (61 
Fed. Reg. 44615–44618). Such rule shall— 
(A) provide for the designation of jurisdictional 
authority that is in accordance with this subsection in 
accordance with this division and the amendments made 
by this division; 
(B) strike Subpart C—Labels and section 897.32(c);
H. R. 1256—56 
(C) strike paragraphs (a), (b), and (i) of section 897.3 
and insert definitions of the terms ‘‘cigarette’’, ‘‘cigarette 
tobacco’’, and ‘‘smokeless tobacco’’ as defined in section 
900 of the Federal Food, Drug, and Cosmetic Act; 
(D) insert ‘‘or roll-your-own paper’’ in section 897.34(a) 
after ‘‘other than cigarettes or smokeless tobacco’’; 
(E) include such modifications to section 897.30(b), if 
any, that the Secretary determines are appropriate in light 
of governing First Amendment case law, including the deci-
sion of the Supreme Court of the United States in Lorillard 
Tobacco Co. v. Reilly (533 U.S. 525 (2001)); 
(F) become effective on the date that is 1 year after 
the date of enactment of this Act; and 
(G) amend paragraph (d) of section 897.16 to read 
as follows: 
‘‘(d)(1) Except as provided in subparagraph (2), no manufac-
turer, distributor, or retailer may distribute or cause to be distrib-
uted any free samples of cigarettes, smokeless tobacco, or other 
tobacco products (as such term is defined in section 201 of the 
Federal Food, Drug, and Cosmetic Act). 
‘‘(2)(A) Subparagraph (1) does not prohibit a manufacturer, 
distributor, or retailer from distributing or causing to be distributed 
free samples of smokeless tobacco in a qualified adult-only facility. 
‘‘(B) This subparagraph does not affect the authority of a State 
or local government to prohibit or otherwise restrict the distribution 
of free samples of smokeless tobacco. 
‘‘(C) For purposes of this paragraph, the term ‘qualified adult- 
only facility’ means a facility or restricted area that— 
‘‘(i) requires each person present to provide to a law enforce-
ment officer (whether on or off duty) or to a security guard 
licensed by a governmental entity government-issued identifica-
tion showing a photograph and at least the minimum age 
established by applicable law for the purchase of smokeless 
tobacco; 
‘‘(ii) does not sell, serve, or distribute alcohol; 
‘‘(iii) is not located adjacent to or immediately across from 
(in any direction) a space that is used primarily for youth- 
oriented marketing, promotional, or other activities; 
‘‘(iv) is a temporary structure constructed, designated, and 
operated as a distinct enclosed area for the purpose of distrib-
uting free samples of smokeless tobacco in accordance with 
this subparagraph; 
‘‘(v) is enclosed by a barrier that— 
‘‘(I) is constructed of, or covered with, an opaque mate-
rial (except for entrances and exits); 
‘‘(II) extends from no more than 12 inches above the 
ground or floor (which area at the bottom of the barrier 
must be covered with material that restricts visibility but 
may allow airflow) to at least 8 feet above the ground 
or floor (or to the ceiling); and 
‘‘(III) prevents persons outside the qualified adult-only 
facility from seeing into the qualified adult-only facility, 
unless they make unreasonable efforts to do so; and 
‘‘(vi) does not display on its exterior— 
‘‘(I) any tobacco product advertising;
H. R. 1256—57 
‘‘(II) a brand name other than in conjunction with 
words for an area or enclosure to identify an adult-only 
facility; or 
‘‘(III) any combination of words that would imply to 
a reasonable observer that the manufacturer, distributor, 
or retailer has a sponsorship that would violate section 
897.34(c). 
‘‘(D) Distribution of samples of smokeless tobacco under this 
subparagraph permitted to be taken out of the qualified adult- 
only facility shall be limited to 1 package per adult consumer 
containing no more than 0.53 ounces (15 grams) of smokeless 
tobacco. If such package of smokeless tobacco contains individual 
portions of smokeless tobacco, the individual portions of smokeless 
tobacco shall not exceed 8 individual portions and the collective 
weight of such individual portions shall not exceed 0.53 ounces 
(15 grams). Any manufacturer, distributor, or retailer who distrib-
utes or causes to be distributed free samples also shall take reason-
able steps to ensure that the above amounts are limited to one 
such package per adult consumer per day. 
‘‘(3) Notwithstanding subparagraph (2), no manufacturer, dis-
tributor, or retailer may distribute or cause to be distributed any 
free samples of smokeless tobacco— 
‘‘(A) to a sports team or entertainment group; or 
‘‘(B) at any football, basketball, baseball, soccer, or hockey 
event or any other sporting or entertainment event determined 
by the Secretary to be covered by this subparagraph. 
‘‘(4) The Secretary shall implement a program to ensure compli-
ance with this paragraph and submit a report to the Congress 
on such compliance not later than 18 months after the date of 
enactment of the Family Smoking Prevention and Tobacco Control 
Act. 
‘‘(5) Nothing in this paragraph shall be construed to authorize 
any person to distribute or cause to be distributed any sample 
of a tobacco product to any individual who has not attained the 
minimum age established by applicable law for the purchase of 
such product.’’. 
(3) AMENDMENTS TO RULE.—Prior to making amendments 
to the rule published under paragraph (1), the Secretary shall 
promulgate a proposed rule in accordance with chapter 5 of 
title 5, United States Code. 
(4) RULE OF CONSTRUCTION.—Except as provided in para-
graph (3), nothing in this section shall be construed to limit 
the authority of the Secretary to amend, in accordance with 
chapter 5 of title 5, United States Code, the regulation promul-
gated pursuant to this section, including the provisions of such 
regulation relating to distribution of free samples. 
(5) ENFORCEMENT OF RETAIL SALE PROVISIONS.—The Sec-
retary of Health and Human Services shall ensure that the 
provisions of this division, the amendments made by this divi-
sion, and the implementing regulations (including such provi-
sions, amendments, and regulations relating to the retail sale 
of tobacco products) are enforced with respect to the United 
States and Indian tribes. 
(6) QUALIFIED
ADULT-ONLY
FACILITY.—A qualified adult- 
only facility (as such term is defined in section 897.16(d) of 
the final rule published under paragraph (1)) that is also a 
retailer and that commits a violation as a retailer shall not
H. R. 1256—58 
be subject to the limitations in section 103(q) and shall be 
subject to penalties applicable to a qualified adult-only facility. 
(7) CONGRESSIONAL
REVIEW
PROVISIONS.—Section 801 of 
title 5, United States Code, shall not apply to the final rule 
published under paragraph (1). 
(b) LIMITATION ON ADVISORY OPINIONS.—As of the date of enact-
ment of this Act, the following documents issued by the Food 
and Drug Administration shall not constitute advisory opinions 
under section 10.85(d)(1) of title 21, Code of Federal Regulations, 
except as they apply to tobacco products, and shall not be cited 
by the Secretary of Health and Human Services or the Food and 
Drug Administration as binding precedent: 
(1) The preamble to the proposed rule in the document 
titled ‘‘Regulations Restricting the Sale and Distribution of 
Cigarettes and Smokeless Tobacco Products to Protect Children 
and Adolescents’’ (60 Fed. Reg. 41314–41372 (August 11, 1995)). 
(2) The document titled ‘‘Nicotine in Cigarettes and Smoke-
less Tobacco Products is a Drug and These Products Are Nico-
tine Delivery Devices Under the Federal Food, Drug, and Cos-
metic Act’’ (60 Fed. Reg. 41453–41787 (August 11, 1995)). 
(3) The preamble to the final rule in the document titled 
‘‘Regulations Restricting the Sale and Distribution of Cigarettes 
and Smokeless Tobacco to Protect Children and Adolescents’’ 
(61 Fed. Reg. 44396–44615 (August 28, 1996)). 
(4) The document titled ‘‘Nicotine in Cigarettes and Smoke-
less Tobacco is a Drug and These Products are Nicotine Delivery 
Devices Under the Federal Food, Drug, and Cosmetic Act; Juris-
dictional Determination’’ (61 Fed. Reg. 44619–45318 (August 
28, 1996)). 
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL 
PROVISIONS. 
(a) AMENDMENT
OF FEDERAL FOOD, DRUG, AND COSMETIC 
ACT.—Except as otherwise expressly provided, whenever in this 
section an amendment is expressed in terms of an amendment 
to, or repeal of, a section or other provision, the reference is to 
a section or other provision of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.). 
(b) SECTION 301.—Section 301 (21 U.S.C. 331) is amended— 
(1) in subsection (a), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(2) in subsection (b), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(3) in subsection (c), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(4) in subsection (e)— 
(A) by striking the period after ‘‘572(i)’’; and 
(B) by striking ‘‘or 761 or the refusal to permit access 
to’’ and inserting ‘‘761, 909, or 920 or the refusal to permit 
access to’’; 
(5) in subsection (g), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(6) in subsection (h), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(7) in subsection (j)— 
(A) by striking the period after ‘‘573’’; and
H. R. 1256—59 
(B) by striking ‘‘708, or 721’’ and inserting ‘‘708, 721, 
904, 905, 906, 907, 908, 909, or 920(b)’’; 
(8) in subsection (k), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(9) by striking subsection (p) and inserting the following: 
‘‘(p) The failure to register in accordance with section 510 
or 905, the failure to provide any information required by section 
510(j), 510(k), 905(i), or 905(j), or the failure to provide a notice 
required by section 510(j)(2) or 905(i)(3).’’; 
(10) by striking subsection (q)(1) and inserting the fol-
lowing: 
‘‘(q)(1) The failure or refusal— 
‘‘(A) to comply with any requirement prescribed under sec-
tion 518, 520(g), 903(b), 907, 908, or 915; 
‘‘(B) to furnish any notification or other material or informa-
tion required by or under section 519, 520(g), 904, 909, or 
920; or 
‘‘(C) to comply with a requirement under section 522 or 
913.’’; 
(11) in subsection (q)(2), by striking ‘‘device,’’ and inserting 
‘‘device or tobacco product,’’; 
(12) in subsection (r), by inserting ‘‘or tobacco product’’ 
after the term ‘‘device’’ each time that such term appears; 
and 
(13) by adding at the end the following: 
‘‘(oo) The sale of tobacco products in violation of a no-tobacco- 
sale order issued under section 303(f). 
‘‘(pp) The introduction or delivery for introduction into inter-
state commerce of a tobacco product in violation of section 911. 
‘‘(qq)(1) Forging, counterfeiting, simulating, or falsely rep-
resenting, or without proper authority using any mark, stamp 
(including tax stamp), tag, label, or other identification device upon 
any tobacco product or container or labeling thereof so as to render 
such tobacco product a counterfeit tobacco product. 
‘‘(2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, stone, or 
other item that is designed to print, imprint, or reproduce the 
trademark, trade name, or other identifying mark, imprint, or device 
of another or any likeness of any of the foregoing upon any tobacco 
product or container or labeling thereof so as to render such tobacco 
product a counterfeit tobacco product. 
‘‘(3) The doing of any act that causes a tobacco product to 
be a counterfeit tobacco product, or the sale or dispensing, or 
the holding for sale or dispensing, of a counterfeit tobacco product. 
‘‘(rr) The charitable distribution of tobacco products. 
‘‘(ss) The failure of a manufacturer or distributor to notify 
the Attorney General and the Secretary of the Treasury of their 
knowledge of tobacco products used in illicit trade. 
‘‘(tt) Making any express or implied statement or representation 
directed to consumers with respect to a tobacco product, in a label 
or labeling or through the media or advertising, that either conveys, 
or misleads or would mislead consumers into believing, that— 
‘‘(1) the product is approved by the Food and Drug Adminis-
tration; 
‘‘(2) the Food and Drug Administration deems the product 
to be safe for use by consumers;