H. R. 1256—9 
‘‘(4) A tobacco product shall not be marketed in combination 
with any other article or product regulated under this Act (including 
a drug, biologic, food, cosmetic, medical device, or a dietary supple-
ment).’’. 
(b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—The Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended— 
(1) by redesignating chapter IX as chapter X; 
(2) by redesignating sections 901 through 910 as sections 
1001 through 1010; and 
(3) by inserting after chapter VIII the following: 
‘‘CHAPTER IX—TOBACCO PRODUCTS 
‘‘SEC. 900. DEFINITIONS. 
‘‘In this chapter: 
‘‘(1) ADDITIVE.—The term ‘additive’ means any substance 
the intended use of which results or may reasonably be expected 
to result, directly or indirectly, in its becoming a component 
or otherwise affecting the characteristic of any tobacco product 
(including any substances intended for use as a flavoring or 
coloring or in producing, manufacturing, packing, processing, 
preparing, treating, packaging, transporting, or holding), except 
that such term does not include tobacco or a pesticide chemical 
residue in or on raw tobacco or a pesticide chemical. 
‘‘(2) BRAND.—The term ‘brand’ means a variety of tobacco 
product distinguished by the tobacco used, tar content, nicotine 
content, flavoring used, size, filtration, packaging, logo, reg-
istered trademark, brand name, identifiable pattern of colors, 
or any combination of such attributes. 
‘‘(3) CIGARETTE.—The term ‘cigarette’— 
‘‘(A) means a product that— 
‘‘(i) is a tobacco product; and 
‘‘(ii) meets the definition of the term ‘cigarette’ 
in section 3(1) of the Federal Cigarette Labeling and 
Advertising Act; and 
‘‘(B) includes tobacco, in any form, that is functional 
in the product, which, because of its appearance, the type 
of tobacco used in the filler, or its packaging and labeling, 
is likely to be offered to, or purchased by, consumers as 
a cigarette or as roll-your-own tobacco. 
‘‘(4) CIGARETTE
TOBACCO.—The term ‘cigarette tobacco’ 
means any product that consists of loose tobacco that is 
intended for use by consumers in a cigarette. Unless otherwise 
stated, the requirements applicable to cigarettes under this 
chapter shall also apply to cigarette tobacco. 
‘‘(5) COMMERCE.—The term ‘commerce’ has the meaning 
given that term by section 3(2) of the Federal Cigarette Labeling 
and Advertising Act. 
‘‘(6) COUNTERFEIT TOBACCO PRODUCT.—The term ‘counter-
feit tobacco product’ means a tobacco product (or the container 
or labeling of such a product) that, without authorization, bears 
the trademark, trade name, or other identifying mark, imprint, 
or device, or any likeness thereof, of a tobacco product listed 
in a registration under section 905(i)(1). 
‘‘(7) DISTRIBUTOR.—The term ‘distributor’ as regards a 
tobacco product means any person who furthers the distribution 
of a tobacco product, whether domestic or imported, at any
H. R. 1256—10 
point from the original place of manufacture to the person 
who sells or distributes the product to individuals for personal 
consumption. Common carriers are not considered distributors 
for purposes of this chapter. 
‘‘(8) ILLICIT TRADE.—The term ‘illicit trade’ means any prac-
tice or conduct prohibited by law which relates to production, 
shipment, receipt, possession, distribution, sale, or purchase 
of tobacco products including any practice or conduct intended 
to facilitate such activity. 
‘‘(9) INDIAN COUNTRY.—The term ‘Indian country’ has the 
meaning given such term in section 1151 of title 18, United 
States Code. 
‘‘(10) INDIAN
TRIBE.—The term ‘Indian tribe’ has the 
meaning given such term in section 4(e) of the Indian Self- 
Determination and Education Assistance Act. 
‘‘(11) LITTLE CIGAR.—The term ‘little cigar’ means a product 
that— 
‘‘(A) is a tobacco product; and 
‘‘(B) meets the definition of the term ‘little cigar’ in 
section 3(7) of the Federal Cigarette Labeling and Adver-
tising Act. 
‘‘(12) NICOTINE.—The term ‘nicotine’ means the chemical 
substance 
named 
3-(1-Methyl-2-pyrrolidinyl) 
pyridine 
or 
C[10]H[14]N[2], including any salt or complex of nicotine. 
‘‘(13) PACKAGE.—The term ‘package’ means a pack, box, 
carton, or container of any kind or, if no other container, 
any wrapping (including cellophane), in which a tobacco product 
is offered for sale, sold, or otherwise distributed to consumers. 
‘‘(14) RETAILER.—The term ‘retailer’ means any person, 
government, or entity who sells tobacco products to individuals 
for personal consumption, or who operates a facility where 
self-service displays of tobacco products are permitted. 
‘‘(15) ROLL-YOUR-OWN TOBACCO.—The term ‘roll-your-own 
tobacco’ means any tobacco product which, because of its 
appearance, type, packaging, or labeling, is suitable for use 
and likely to be offered to, or purchased by, consumers as 
tobacco for making cigarettes. 
‘‘(16) SMALL TOBACCO PRODUCT MANUFACTURER.—The term 
‘small tobacco product manufacturer’ means a tobacco product 
manufacturer that employs fewer than 350 employees. For pur-
poses of determining the number of employees of a manufac-
turer under the preceding sentence, the employees of a manu-
facturer are deemed to include the employees of each entity 
that controls, is controlled by, or is under common control 
with such manufacturer. 
‘‘(17) SMOKE CONSTITUENT.—The term ‘smoke constituent’ 
means any chemical or chemical compound in mainstream or 
sidestream tobacco smoke that either transfers from any compo-
nent of the cigarette to the smoke or that is formed by the 
combustion or heating of tobacco, additives, or other component 
of the tobacco product. 
‘‘(18) SMOKELESS TOBACCO.—The term ‘smokeless tobacco’ 
means any tobacco product that consists of cut, ground, pow-
dered, or leaf tobacco and that is intended to be placed in 
the oral or nasal cavity. 
‘‘(19) STATE; TERRITORY.—The terms ‘State’ and ‘Territory’ 
shall have the meanings given to such terms in section 201.
H. R. 1256—11 
‘‘(20) 
TOBACCO
PRODUCT
MANUFACTURER.—The 
term 
‘tobacco product manufacturer’ means any person, including 
any repacker or relabeler, who— 
‘‘(A) manufactures, fabricates, assembles, processes, or 
labels a tobacco product; or 
‘‘(B) imports a finished tobacco product for sale or 
distribution in the United States. 
‘‘(21) TOBACCO WAREHOUSE.— 
‘‘(A) Subject to subparagraphs (B) and (C), the term 
‘tobacco warehouse’ includes any person— 
‘‘(i) who— 
‘‘(I) removes foreign material from tobacco leaf 
through nothing other than a mechanical process; 
‘‘(II) humidifies tobacco leaf with nothing other 
than potable water in the form of steam or mist; 
or 
‘‘(III) de-stems, dries, and packs tobacco leaf 
for storage and shipment; 
‘‘(ii) who performs no other actions with respect 
to tobacco leaf; and 
‘‘(iii) who provides to any manufacturer to whom 
the person sells tobacco all information related to the 
person’s actions described in clause (i) that is necessary 
for compliance with this Act. 
‘‘(B) The term ‘tobacco warehouse’ excludes any person 
who— 
‘‘(i) reconstitutes tobacco leaf; 
‘‘(ii) is a manufacturer, distributor, or retailer of 
a tobacco product; or 
‘‘(iii) applies any chemical, additive, or substance 
to the tobacco leaf other than potable water in the 
form of steam or mist. 
‘‘(C) The definition of the term ‘tobacco warehouse’ 
in subparagraph (A) shall not apply to the extent to which 
the Secretary determines, through rulemaking, that regula-
tion under this chapter of the actions described in such 
subparagraph is appropriate for the protection of the public 
health. 
‘‘(22) UNITED STATES.—The term ‘United States’ means the 
50 States of the United States of America and the District 
of Columbia, the Commonwealth of Puerto Rico, Guam, the 
Virgin Islands, American Samoa, Wake Island, Midway Islands, 
Kingman Reef, Johnston Atoll, the Northern Mariana Islands, 
and any other trust territory or possession of the United States. 
‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—Tobacco products, including modified risk 
tobacco products for which an order has been issued in accordance 
with section 911, shall be regulated by the Secretary under this 
chapter and shall not be subject to the provisions of chapter V. 
‘‘(b) APPLICABILITY.—This chapter shall apply to all cigarettes, 
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and 
to any other tobacco products that the Secretary by regulation 
deems to be subject to this chapter. 
‘‘(c) SCOPE.— 
‘‘(1) IN GENERAL.—Nothing in this chapter, or any policy 
issued or regulation promulgated thereunder, or in sections
H. R. 1256—12 
101(a), 102, or 103 of title I, title II, or title III of the Family 
Smoking Prevention and Tobacco Control Act, shall be con-
strued to affect, expand, or limit the Secretary’s authority over 
(including the authority to determine whether products may 
be regulated), or the regulation of, products under this Act 
that are not tobacco products under chapter V or any other 
chapter. 
‘‘(2) LIMITATION OF AUTHORITY.— 
‘‘(A) IN GENERAL.—The provisions of this chapter shall 
not apply to tobacco leaf that is not in the possession 
of a manufacturer of tobacco products, or to the producers 
of tobacco leaf, including tobacco growers, tobacco ware-
houses, and tobacco grower cooperatives, nor shall any 
employee of the Food and Drug Administration have any 
authority to enter onto a farm owned by a producer of 
tobacco leaf without the written consent of such producer. 
‘‘(B) EXCEPTION.—Notwithstanding subparagraph (A), 
if a producer of tobacco leaf is also a tobacco product 
manufacturer or controlled by a tobacco product manufac-
turer, the producer shall be subject to this chapter in 
the producer’s capacity as a manufacturer. The exception 
in this subparagraph shall not apply to a producer of 
tobacco leaf who grows tobacco under a contract with a 
tobacco product manufacturer and who is not otherwise 
engaged in the manufacturing process. 
‘‘(C) RULE OF CONSTRUCTION.—Nothing in this chapter 
shall be construed to grant the Secretary authority to 
promulgate regulations on any matter that involves the 
production of tobacco leaf or a producer thereof, other than 
activities by a manufacturer affecting production. 
‘‘(d) RULEMAKING PROCEDURES.—Each rulemaking under this 
chapter shall be in accordance with chapter 5 of title 5, United 
States Code. This subsection shall not be construed to affect the 
rulemaking provisions of section 102(a) of the Family Smoking 
Prevention and Tobacco Control Act. 
‘‘(e) CENTER FOR TOBACCO PRODUCTS.—Not later than 90 days 
after the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, the Secretary shall establish within the 
Food and Drug Administration the Center for Tobacco Products, 
which shall report to the Commissioner of Food and Drugs in 
the same manner as the other agency centers within the Food 
and Drug Administration. The Center shall be responsible for the 
implementation of this chapter and related matters assigned by 
the Commissioner. 
‘‘(f) OFFICE TO ASSIST SMALL TOBACCO PRODUCT MANUFACTUR-
ERS.—The Secretary shall establish within the Food and Drug 
Administration an identifiable office to provide technical and other 
nonfinancial assistance to small tobacco product manufacturers to 
assist them in complying with the requirements of this Act. 
‘‘(g) CONSULTATION PRIOR TO RULEMAKING.—Prior to promul-
gating rules under this chapter, the Secretary shall endeavor to 
consult with other Federal agencies as appropriate. 
‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 
‘‘A tobacco product shall be deemed to be adulterated if— 
‘‘(1) it consists in whole or in part of any filthy, putrid, 
or decomposed substance, or is otherwise contaminated by any