H. R. 1256—13 
added poisonous or added deleterious substance that may 
render the product injurious 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 con-
tents injurious to health; 
‘‘(4) the manufacturer or importer of the tobacco 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 estab-
lished under section 907 unless such tobacco product is in 
all respects in conformity with such standard; 
‘‘(6)(A) it is required by section 910(a) to have premarket 
review and does not have an order in effect 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 storage are not in conformity 
with applicable requirements under section 906(e)(1) or an 
applicable condition 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 distributor; 
‘‘(B) an accurate statement of the quantity of the con-
tents in terms of weight, measure, or numerical count; 
‘‘(C) an accurate statement of the percentage 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 variations 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 information required 
by or under authority of this chapter to appear on the label 
or labeling is not prominently placed thereon with such 
conspicuousness (as compared 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 nonproprietary name, its estab-
lished name prominently printed in type as required by the 
Secretary by regulation;
H. R. 1256—14 
‘‘(5) if the Secretary has issued regulations requiring that 
its labeling bear adequate directions for 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 regulations; 
‘‘(6) if it was manufactured, prepared, propagated, com-
pounded, 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 required by section 905(i), if a notice or 
other information 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 identification of tobacco 
products prescribed under section 905(e) as the Secretary by 
regulation requires; 
‘‘(7) if, in the case of any tobacco product distributed or 
offered for sale in any State— 
‘‘(A) its advertising is false or misleading in any par-
ticular; 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 manufacturer, packer, 
or distributor thereof includes in all advertisements and other 
descriptive printed matter issued or caused to be issued by 
the manufacturer, packer, or distributor with respect to that 
tobacco product— 
‘‘(A) a true statement of the tobacco product’s estab-
lished name as described in paragraph (4), printed promi-
nently; and 
‘‘(B) a brief statement of— 
‘‘(i) the uses of the tobacco product and relevant 
warnings, precautions, side effects, and contraindica-
tions; and 
‘‘(ii) in the case of specific tobacco products made 
subject to a finding by the Secretary after notice and 
opportunity for comment that such action is appro-
priate to protect the public health, a full description 
of the components of such tobacco product or the for-
mula showing quantitatively each ingredient of such 
tobacco product to the extent required in regulations 
which shall be issued by the Secretary after an oppor-
tunity for a hearing; 
‘‘(9) if it is a tobacco product subject to a tobacco product 
standard established under section 907, unless it bears such 
labeling as may be prescribed in such tobacco product standard; 
or 
‘‘(10) if there was a failure or refusal— 
‘‘(A) to comply with any requirement prescribed under 
section 904 or 908; or 
‘‘(B) to furnish any material or information required 
under section 909. 
‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.—The Secretary 
may, by regulation, require prior approval of statements made 
on the label of a tobacco product to ensure that such statements 
do not violate the misbranding provisions of subsection (a) and 
that such statements comply with other provisions of the Family
H. R. 1256—15 
Smoking Prevention and Tobacco Control Act (including the amend-
ments made by such Act). No regulation issued under this sub-
section may require prior approval by the Secretary of the content 
of any advertisement, except for modified risk tobacco products 
as provided in section 911. No advertisement of a tobacco product 
published after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act shall, with respect to the lan-
guage of label statements as prescribed under section 4 of the 
Federal Cigarette Labeling and Advertising Act and section 3 of 
the Comprehensive Smokeless Tobacco Health Education Act of 
1986 or the regulations issued under such sections, be subject 
to the provisions of sections 12 through 15 of the Federal Trade 
Commission Act. 
‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SEC-
RETARY. 
‘‘(a) REQUIREMENT.—Each tobacco product manufacturer or 
importer, or agents thereof, shall submit to the Secretary the fol-
lowing information: 
‘‘(1) Not later than 6 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act, 
a listing of all ingredients, including tobacco, substances, com-
pounds, and additives that are, as of such date, added by 
the manufacturer to the tobacco, paper, filter, or other part 
of each tobacco product by brand and by quantity in each 
brand and subbrand. 
‘‘(2) A description of the content, delivery, and form of 
nicotine in each tobacco product measured in milligrams of 
nicotine in accordance with regulations promulgated by the 
Secretary in accordance with section 4(e) of the Federal Ciga-
rette Labeling and Advertising Act. 
‘‘(3) Beginning 3 years after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act, a listing 
of all constituents, including smoke constituents as applicable, 
identified by the Secretary as harmful or potentially harmful 
to health in each tobacco product, and as applicable in the 
smoke of each tobacco product, by brand and by quantity in 
each brand and subbrand. Effective beginning 3 years after 
such date of enactment, the manufacturer, importer, or agent 
shall comply with regulations promulgated under section 915 
in 
reporting 
information 
under 
this 
paragraph, 
where 
applicable. 
‘‘(4) Beginning 6 months after the date of enactment of 
the Family Smoking Prevention and Tobacco Control Act, all 
documents developed after such date of enactment that relate 
to health, toxicological, behavioral, or physiologic effects of cur-
rent or future tobacco products, their constituents (including 
smoke constituents), ingredients, components, and additives. 
‘‘(b) DATA SUBMISSION.—At the request of the Secretary, each 
tobacco product manufacturer or importer of tobacco products, or 
agents thereof, shall submit the following: 
‘‘(1) Any or all documents (including underlying scientific 
information) relating to research activities, and research 
findings, conducted, supported, or possessed by the manufac-
turer (or agents thereof) on the health, toxicological, behavioral, 
or physiologic effects of tobacco products and their constituents
H. R. 1256—16 
(including smoke constituents), ingredients, components, and 
additives. 
‘‘(2) Any or all documents (including underlying scientific 
information) relating to research activities, and research 
findings, conducted, supported, or possessed by the manufac-
turer (or agents thereof) that relate to the issue of whether 
a reduction in risk to health from tobacco products can occur 
upon the employment of technology available or known to the 
manufacturer. 
‘‘(3) Any or all documents (including underlying scientific 
or financial information) relating to marketing research 
involving the use of tobacco products or marketing practices 
and the effectiveness of such practices used by tobacco manufac-
turers and distributors. 
An importer of a tobacco product not manufactured in the United 
States shall supply the information required of a tobacco product 
manufacturer under this subsection. 
‘‘(c) TIME FOR SUBMISSION.— 
‘‘(1) IN GENERAL.—At least 90 days prior to the delivery 
for introduction into interstate commerce of a tobacco product 
not on the market on the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act, the manufacturer 
of such product shall provide the information required under 
subsection (a). 
‘‘(2) DISCLOSURE OF ADDITIVE.—If at any time a tobacco 
product manufacturer adds to its tobacco products a new 
tobacco additive or increases the quantity of an existing tobacco 
additive, the manufacturer shall, except as provided in para-
graph (3), at least 90 days prior to such action so advise 
the Secretary in writing. 
‘‘(3) DISCLOSURE
OF
OTHER
ACTIONS.—If at any time a 
tobacco product manufacturer eliminates or decreases an 
existing additive, or adds or increases an additive that has 
by regulation been designated by the Secretary as an additive 
that is not a human or animal carcinogen, or otherwise harmful 
to health under intended conditions of use, the manufacturer 
shall within 60 days of such action so advise the Secretary 
in writing. 
‘‘(d) DATA LIST.— 
‘‘(1) IN GENERAL.—Not later than 3 years after the date 
of enactment of the Family Smoking Prevention and Tobacco 
Control Act, and annually thereafter, the Secretary shall pub-
lish in a format that is understandable and not misleading 
to a lay person, and place on public display (in a manner 
determined by the Secretary) the list established under sub-
section (e). 
‘‘(2) CONSUMER
RESEARCH.—The Secretary shall conduct 
periodic consumer research to ensure that the list published 
under paragraph (1) is not misleading to lay persons. Not 
later than 5 years after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act, the Secretary 
shall submit to the appropriate committees of Congress a report 
on the results of such research, together with recommendations 
on whether such publication should be continued or modified. 
‘‘(e) DATA COLLECTION.—Not later than 24 months after the 
date of enactment of the Family Smoking Prevention and Tobacco 
Control Act, the Secretary shall establish, and periodically revise