HR 1108 RFS 
turer, packer, or distributor with respect to that to-
bacco product— 
‘‘(A) a true statement of the tobacco prod-
uct’s established name as described in para-
graph (4), printed prominently; and 
‘‘(B) a brief statement of— 
‘‘(i) the uses of the tobacco product 
and relevant warnings, precautions, side 
effects, and contraindications; 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 appropriate to 
protect the public health, a full description 
of the components of such tobacco product 
or the formula 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 to-
bacco product standard established under section 
907, unless it bears such labeling as may be pre-
scribed in such tobacco product standard; or 
‘‘(10) if there was a failure or refusal— 
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HR 1108 RFS 
‘‘(A) to comply with any requirement pre-
scribed under section 904 or 908; or 
‘‘(B) to furnish any material or informa-
tion 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. No 
regulation issued under this subsection may require prior 
approval by the Secretary of the content of any advertise-
ment, except for modified risk tobacco products as pro-
vided in section 911. No advertisement of a tobacco prod-
uct published after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act shall, with 
respect to the language of label statements as prescribed 
under section 4 of the Federal Cigarette Labeling and Ad-
vertising Act and section 3 of the Comprehensive Smoke-
less Tobacco Health Education Act of 1986 or the regula-
tions issued under such sections, be subject to the provi-
sions of sections 12 through 15 of the Federal Trade Com-
mission Act. 
‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE 
SECRETARY. 
‘‘(a) REQUIREMENT.—Each tobacco product manu-
facturer or importer, or agents thereof, shall submit to 
the Secretary the following information: 
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‘‘(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, in-
cluding tobacco, substances, compounds, and addi-
tives that are, as of such date, added by the manu-
facturer 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 regula-
tions promulgated by the Secretary in accordance 
with section 4(e) of the Federal Cigarette Labeling 
and Advertising Act. 
‘‘(3) Beginning 3 years after the date of enact-
ment of this Act, a listing of all constituents, includ-
ing 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 be-
ginning 3 years after the date of enactment of this 
chapter, the manufacturer, importer, or agent shall 
comply with regulations promulgated under section 
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915 in reporting information under this paragraph, 
where applicable. 
‘‘(4) Beginning 6 months after the date of en-
actment of the Family Smoking Prevention and To-
bacco Control Act, all documents developed after the 
date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act that relate to health, 
toxicological, behavioral, or physiologic effects of 
current or future tobacco products, their constitu-
ents (including smoke constituents), ingredients, 
components, and additives. 
‘‘(b) DATA SUBMISSION.—At the request of the Sec-
retary, each tobacco product manufacturer or importer of 
tobacco products, or agents thereof, shall submit the fol-
lowing: 
‘‘(1) Any or all documents (including under-
lying scientific information) relating to research ac-
tivities, and research findings, conducted, supported, 
or possessed by the manufacturer (or agents thereof) 
on the health, toxicological, behavioral, or physio-
logic effects of tobacco products and their constitu-
ents (including smoke constituents), ingredients, 
components, and additives. 
‘‘(2) Any or all documents (including under-
lying scientific information) relating to research ac-
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