HR 1108 RFS 
‘‘(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 there-
under, or in sections 101(a), 102, or 103 of title I, 
title II, or title III of the Family Smoking Preven-
tion and Tobacco Control Act, shall be construed 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 prod-
ucts 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 to-
bacco 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 Ad-
ministration have any authority to enter onto a 
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farm owned by a producer of tobacco leaf with-
out the written consent of such producer. 
‘‘(B) EXCEPTION.—Notwithstanding sub-
paragraph (A), if a producer of tobacco leaf is 
also a tobacco product manufacturer or con-
trolled by a tobacco product manufacturer, the 
producer shall be subject to this chapter in the 
producer’s capacity as a manufacturer. The ex-
ception in this subparagraph shall not apply to 
a producer of tobacco leaf who grows tobacco 
under a contract with a tobacco product manu-
facturer 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 produc-
tion. 
‘‘(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 
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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 this chapter, 
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 re-
sponsible for the implementation of this chapter and re-
lated matters assigned by the Commissioner. 
‘‘(f) OFFICE TO ASSIST SMALL TOBACCO PRODUCT 
MANUFACTURERS.—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 promulgating 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— 
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‘‘(1) it consists in whole or in part of any filthy, 
putrid, or decomposed substance, or is otherwise 
contaminated by any added poisonous or added dele-
terious substance that may render the product inju-
rious to health; 
‘‘(2) it has been prepared, packed, or held 
under insanitary conditions whereby it may have 
been contaminated with filth, or whereby it may 
have been rendered injurious to health; 
‘‘(3) its package is composed, in whole or in 
part, of any poisonous or deleterious substance 
which may render the contents injurious to health; 
‘‘(4) the manufacturer or importer of the to-
bacco product fails to pay a user fee assessed to 
such manufacturer or importer pursuant to section 
919 by the date specified in section 919 or by the 
30th day after final agency action on a resolution of 
any dispute as to the amount of such fee; 
‘‘(5) it is, or purports to be or is represented 
as, a tobacco product which is subject to a tobacco 
product standard established under section 907 un-
less such tobacco product is in all respects in con-
formity with such standard; 
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‘‘(6)(A) it is required by section 910(a) to have 
premarket review and does not have an order in ef-
fect under section 910(c)(1)(A)(i); or 
‘‘(B) it is in violation of an order under section 
910(c)(1)(A); 
‘‘(7) the methods used in, or the facilities or 
controls used for, its manufacture, packing, or stor-
age are not in conformity with applicable require-
ments under section 906(e)(1) or an applicable con-
dition prescribed by an order under section 
906(e)(2); or 
‘‘(8) it is in violation of section 911. 
‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—A tobacco product shall be 
deemed to be misbranded— 
‘‘(1) if its labeling is false or misleading in any 
particular; 
‘‘(2) if in package form unless it bears a label 
containing— 
‘‘(A) the name and place of business of the 
tobacco product manufacturer, packer, or dis-
tributor; 
‘‘(B) an accurate statement of the quantity 
of the contents in terms of weight, measure, or 
numerical count; 
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‘‘(C) an accurate statement of the percent-
age of the tobacco used in the product that is 
domestically grown tobacco and the percentage 
that is foreign grown tobacco; and 
‘‘(D) the statement required under section 
920(a), 
except that under subparagraph (B) reasonable vari-
ations shall be permitted, and exemptions as to 
small packages shall be established, by regulations 
prescribed by the Secretary; 
‘‘(3) if any word, statement, or other informa-
tion required by or under authority of this chapter 
to appear on the label or labeling is not prominently 
placed thereon with such conspicuousness (as com-
pared with other words, statements, or designs in 
the labeling) and in such terms as to render it likely 
to be read and understood by the ordinary individual 
under customary conditions of purchase and use; 
‘‘(4) if it has an established name, unless its 
label bears, to the exclusion of any other nonpropri-
etary name, its established name prominently print-
ed in type as required by the Secretary by regula-
tion; 
‘‘(5) if the Secretary has issued regulations re-
quiring that its labeling bear adequate directions for 
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use, or adequate warnings against use by children, 
that are necessary for the protection of users unless 
its labeling conforms in all respects to such regula-
tions; 
‘‘(6) if it was manufactured, prepared, propa-
gated, compounded, or processed in an establishment 
not duly registered under section 905(b), 905(c), 
905(d), or 905(h), if it was not included in a list re-
quired by section 905(i), if a notice or other infor-
mation respecting it was not provided as required by 
such section or section 905(j), or if it does not bear 
such symbols from the uniform system for identifica-
tion of tobacco products prescribed under section 
905(e) as the Secretary by regulation requires; 
‘‘(7) if, in the case of any tobacco product dis-
tributed or offered for sale in any State— 
‘‘(A) its advertising is false or misleading 
in any particular; or 
‘‘(B) it is sold or distributed in violation of 
regulations prescribed under section 906(d); 
‘‘(8) unless, in the case of any tobacco product 
distributed or offered for sale in any State, the man-
ufacturer, packer, or distributor thereof includes in 
all advertisements and other descriptive printed mat-
ter issued or caused to be issued by the manufac-
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