HR 1108 RFS 
tivities, and research findings, conducted, supported, 
or possessed by the manufacturer (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 under-
lying scientific or financial information) relating to 
marketing research involving the use of tobacco 
products or marketing practices and the effective-
ness of such practices used by tobacco manufactur-
ers 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 com-
merce of a tobacco product not on the market on the 
date of enactment of the Family Smoking Preven-
tion 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 to-
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bacco products a new tobacco additive or increases 
the quantity of an existing tobacco additive, the 
manufacturer shall, except as provided in paragraph 
(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 in-
creases an additive that has by regulation been des-
ignated 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 man-
ufacturer shall within 60 days of such action so ad-
vise 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 publish in a format 
that is understandable and not misleading to a lay 
person, and place on public display (in a manner de-
termined by the Secretary) the list established under 
subsection (e). 
‘‘(2) CONSUMER
RESEARCH.—The Secretary 
shall conduct periodic consumer research to ensure 
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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 Con-
gress a report on the results of such research, to-
gether with recommendations on whether such publi-
cation should be continued or modified. 
‘‘(e) DATA COLLECTION.—Not later than 24 months 
after the date of enactment of the Family Smoking Pre-
vention and Tobacco Control Act, the Secretary shall es-
tablish, and periodically revise as appropriate, a list of 
harmful and potentially harmful constituents, including 
smoke constituents, to health in each tobacco product by 
brand and by quantity in each brand and subbrand. The 
Secretary shall publish a public notice requesting the sub-
mission by interested persons of scientific and other infor-
mation concerning the harmful and potentially harmful 
constituents in tobacco products and tobacco smoke. 
‘‘SEC. 905. ANNUAL REGISTRATION. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) 
MANUFACTURE, 
PREPARATION, 
COMPOUNDING, OR PROCESSING.—The term ‘manu-
facture, preparation, compounding, or processing’ 
shall include repackaging or otherwise changing the 
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container, wrapper, or labeling of any tobacco prod-
uct package in furtherance of the distribution of the 
tobacco product from the original place of manufac-
ture to the person who makes final delivery or sale 
to the ultimate consumer or user. 
‘‘(2) NAME.—The term ‘name’ shall include in 
the case of a partnership the name of each partner 
and, in the case of a corporation, the name of each 
corporate officer and director, and the State of in-
corporation. 
‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.— 
On or before December 31 of each year, every person who 
owns or operates any establishment in any State engaged 
in the manufacture, preparation, compounding, or proc-
essing of a tobacco product or tobacco products shall reg-
ister with the Secretary the name, places of business, and 
all such establishments of that person. If the enactment 
of this Act occurs in the second half of the calendar year, 
the Secretary shall designate a date no later than 6 
months into the subsequent calendar year by which reg-
istration pursuant to this subsection shall occur. 
‘‘(c) REGISTRATION BY NEW OWNERS AND OPERA-
TORS.—Every person upon first engaging in the manufac-
ture, preparation, compounding, or processing of a tobacco 
product or tobacco products in any establishment owned 
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or operated in any State by that person shall immediately 
register with the Secretary that person’s name, place of 
business, and such establishment. 
‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.— 
Every person required to register under subsection (b) or 
(c) shall immediately register with the Secretary any addi-
tional establishment which that person owns or operates 
in any State and in which that person begins the manufac-
ture, preparation, compounding, or processing of a tobacco 
product or tobacco products. 
‘‘(e) UNIFORM
PRODUCT
IDENTIFICATION
SYS-
TEM.—The Secretary may by regulation prescribe a uni-
form system for the identification of tobacco products and 
may require that persons who are required to list such 
tobacco products under subsection (i) shall list such to-
bacco products in accordance with such system. 
‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA-
TION.—The Secretary shall make available for inspection, 
to any person so requesting, any registration filed under 
this section. 
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB-
LISHMENTS.—Every establishment registered with the 
Secretary under this section shall be subject to inspection 
under section 704 or subsection (h), and every such estab-
lishment engaged in the manufacture, compounding, or 
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processing of a tobacco product or tobacco products shall 
be so inspected by 1 or more officers or employees duly 
designated by the Secretary at least once in the 2-year 
period beginning with the date of registration of such es-
tablishment under this section and at least once in every 
successive 2-year period thereafter. 
‘‘(h) REGISTRATION
BY
FOREIGN
ESTABLISH-
MENTS.—Any establishment within any foreign country 
engaged in the manufacture, preparation, compounding, 
or processing of a tobacco product or tobacco products, 
shall register under this section under regulations promul-
gated by the Secretary. Such regulations shall require 
such establishment to provide the information required by 
subsection (i) and shall include provisions for registration 
of any such establishment upon condition that adequate 
and effective means are available, by arrangement with the 
government of such foreign country or otherwise, to enable 
the Secretary to determine from time to time whether to-
bacco products manufactured, prepared, compounded, or 
processed in such establishment, if imported or offered for 
import into the United States, shall be refused admission 
on any of the grounds set forth in section 801(a). 
‘‘(i) REGISTRATION INFORMATION.— 
‘‘(1) PRODUCT LIST.—Every person who reg-
isters with the Secretary under subsection (b), (c), 
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(d), or (h) shall, at the time of registration under 
any such subsection, file with the Secretary a list of 
all tobacco products which are being manufactured, 
prepared, compounded, or processed by that person 
for commercial distribution and which have not been 
included in any list of tobacco products filed by that 
person with the Secretary under this paragraph or 
paragraph (2) before such time of registration. Such 
list shall be prepared in such form and manner as 
the Secretary may prescribe and shall be accom-
panied by— 
‘‘(A) in the case of a tobacco product con-
tained in the applicable list with respect to 
which a tobacco product standard has been es-
tablished under section 907 or which is subject 
to section 910, a reference to the authority for 
the marketing of such tobacco product and a 
copy of all labeling for such tobacco product; 
‘‘(B) in the case of any other tobacco prod-
uct contained in an applicable list, a copy of all 
consumer information and other labeling for 
such tobacco product, a representative sampling 
of advertisements for such tobacco product, 
and, upon request made by the Secretary for 
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good cause, a copy of all advertisements for a 
particular tobacco product; and 
‘‘(C) if the registrant filing a list has de-
termined that a tobacco product contained in 
such list is not subject to a tobacco product 
standard established under section 907, a brief 
statement of the basis upon which the reg-
istrant made such determination if the Sec-
retary requests such a statement with respect 
to that particular tobacco product. 
‘‘(2) 
CONSULTATION
WITH
RESPECT
TO 
FORMS.—The Secretary shall consult with the Sec-
retary of the Treasury in developing the forms to be 
used for registration under this section to minimize 
the burden on those persons required to register 
with both the Secretary and the Tax and Trade Bu-
reau of the Department of the Treasury. 
‘‘(3) BIANNUAL REPORT OF ANY CHANGE IN 
PRODUCT LIST.—Each person who registers with the 
Secretary under this section shall report to the Sec-
retary once during the month of June of each year 
and once during the month of December of each 
year the following: 
‘‘(A) A list of each tobacco product intro-
duced by the registrant for commercial distribu-
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tion which has not been included in any list 
previously filed by that person with the Sec-
retary under this subparagraph or paragraph 
(1). A list under this subparagraph shall list a 
tobacco product by its established name and 
shall be accompanied by the other information 
required by paragraph (1). 
‘‘(B) If since the date the registrant last 
made a report under this paragraph that person 
has discontinued the manufacture, preparation, 
compounding, or processing for commercial dis-
tribution of a tobacco product included in a list 
filed under subparagraph (A) or paragraph (1), 
notice of such discontinuance, the date of such 
discontinuance, and the identity of its estab-
lished name. 
‘‘(C) If since the date the registrant re-
ported under subparagraph (B) a notice of dis-
continuance that person has resumed the manu-
facture, preparation, compounding, or proc-
essing for commercial distribution of the to-
bacco product with respect to which such notice 
of discontinuance was reported, notice of such 
resumption, the date of such resumption, the 
identity of such tobacco product by established 
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name, and other information required by para-
graph (1), unless the registrant has previously 
reported such resumption to the Secretary 
under this subparagraph. 
‘‘(D) Any material change in any informa-
tion previously submitted under this paragraph 
or paragraph (1). 
‘‘(j) REPORT PRECEDING INTRODUCTION OF CER-
TAIN
SUBSTANTIALLY
EQUIVALENT
PRODUCTS
INTO 
INTERSTATE COMMERCE.— 
‘‘(1) IN
GENERAL.—Each person who is re-
quired to register under this section and who pro-
poses to begin the introduction or delivery for intro-
duction into interstate commerce for commercial dis-
tribution of a tobacco product intended for human 
use that was not commercially marketed (other than 
for test marketing) in the United States as of Feb-
ruary 15, 2007, shall, at least 90 days prior to mak-
ing such introduction or delivery, report to the Sec-
retary (in such form and manner as the Secretary 
shall prescribe)— 
‘‘(A) the basis for such person’s determina-
tion that— 
‘‘(i) the tobacco product is substan-
tially equivalent, within the meaning of 
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section 910, to a tobacco product commer-
cially marketed (other than for test mar-
keting) in the United States as of Feb-
ruary 15, 2007, or to a tobacco product 
that the Secretary has previously deter-
mined, pursuant to subsection (a)(3) of 
section 910, is substantially equivalent and 
that is in compliance with the require-
ments of this Act; or 
‘‘(ii) the tobacco product is modified 
within the meaning of paragraph (3), the 
modifications are to a product that is com-
mercially marketed and in compliance with 
the requirements of this Act, and all of the 
modifications are covered by exemptions 
granted by the Secretary pursuant to para-
graph (3); and 
‘‘(B) action taken by such person to com-
ply with the requirements under section 907 
that are applicable to the tobacco product. 
‘‘(2) APPLICATION
TO
CERTAIN
POST-FEB-
RUARY 15, 2007, PRODUCTS.—A report under this 
subsection for a tobacco product that was first intro-
duced or delivered for introduction into interstate 
commerce for commercial distribution in the United 
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States after February 15, 2007, and prior to the 
date that is 21 months after the date of enactment 
of the Family Smoking Prevention and Tobacco 
Control Act shall be submitted to the Secretary not 
later than 21 months after such date of enactment. 
‘‘(3) EXEMPTIONS.— 
‘‘(A) IN
GENERAL.—The Secretary may 
exempt from the requirements of this sub-
section relating to the demonstration that a to-
bacco product is substantially equivalent within 
the meaning of section 910, tobacco products 
that are modified by adding or deleting a to-
bacco additive, or increasing or decreasing the 
quantity of an existing tobacco additive, if the 
Secretary determines that— 
‘‘(i) such modification would be a 
minor modification of a tobacco product 
that can be sold under this Act; 
‘‘(ii) a report under this subsection is 
not necessary to ensure that permitting the 
tobacco product to be marketed would be 
appropriate for protection of the public 
health; and 
‘‘(iii) an exemption is otherwise appro-
priate. 
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‘‘(B) REGULATIONS.—Not later than 15 
months after the date of enactment of the Fam-
ily Smoking Prevention and Tobacco Control 
Act, the Secretary shall issue regulations to im-
plement this paragraph. 
‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 
OF TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—Any requirement established by 
or under section 902, 903, 905, or 909 applicable to a 
tobacco product shall apply to such tobacco product until 
the applicability of the requirement to the tobacco product 
has been changed by action taken under section 907, sec-
tion 910, section 911, or subsection (d) of this section, 
and any requirement established by or under section 902, 
903, 905, or 909 which is inconsistent with a requirement 
imposed on such tobacco product under section 907, sec-
tion 910, section 911, or subsection (d) of this section 
shall not apply to such tobacco product. 
‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM-
MENT.—Each notice of proposed rulemaking or other noti-
fication under section 907, 908, 909, 910, or 911 or under 
this section, any other notice which is published in the 
Federal Register with respect to any other action taken 
under any such section and which states the reasons for 
such action, and each publication of findings required to 
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be made in connection with rulemaking under any such 
section shall set forth— 
‘‘(1) the manner in which interested persons 
may examine data and other information on which 
the notice or findings is based; and 
‘‘(2) the period within which interested persons 
may present their comments on the notice or find-
ings (including the need therefore) orally or in writ-
ing, which period shall be at least 60 days but may 
not exceed 90 days unless the time is extended by 
the Secretary by a notice published in the Federal 
Register stating good cause therefore. 
‘‘(c) LIMITED
CONFIDENTIALITY
OF
INFORMA-
TION.—Any information reported to or otherwise obtained 
by the Secretary or the Secretary’s representative under 
section 903, 904, 907, 908, 909, 910, 911, or 704, or 
under subsection (e) or (f) of this section, which is exempt 
from disclosure under subsection (a) of section 552 of title 
5, United States Code, by reason of subsection (b)(4) of 
that section shall be considered confidential and shall not 
be disclosed, except that the information may be disclosed 
to other officers or employees concerned with carrying out 
this chapter, or when relevant in any proceeding under 
this chapter. 
‘‘(d) RESTRICTIONS.— 
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‘‘(1) IN GENERAL.—The Secretary may by reg-
ulation require restrictions on the sale and distribu-
tion of a tobacco product, including restrictions on 
the access to, and the advertising and promotion of, 
the tobacco product, if the Secretary determines that 
such regulation would be appropriate for the protec-
tion of the public health. The Secretary may by reg-
ulation impose restrictions on the advertising and 
promotion of a tobacco product consistent with and 
to full extent permitted by the first amendment to 
the Constitution. The finding as to whether such 
regulation would be appropriate for the protection of 
the public health shall be determined with respect to 
the risks and benefits to the population as a whole, 
including users and nonusers of the tobacco product, 
and taking into account— 
‘‘(A) the increased or decreased likelihood 
that existing users of tobacco products will stop 
using such products; and 
‘‘(B) the increased or decreased likelihood 
that those who do not use tobacco products will 
start using such products. 
No such regulation may require that the sale or dis-
tribution of a tobacco product be limited to the writ-
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ten or oral authorization of a practitioner licensed 
by law to prescribe medical products. 
‘‘(2) LABEL STATEMENTS.—The label of a to-
bacco product shall bear such appropriate state-
ments of the restrictions required by a regulation 
under subsection (a) as the Secretary may in such 
regulation prescribe. 
‘‘(3) LIMITATIONS.— 
‘‘(A) IN GENERAL.—No restrictions under 
paragraph (1) may— 
‘‘(i) prohibit the sale of any tobacco 
product in face-to-face transactions by a 
specific category of retail outlets; or 
‘‘(ii) establish a minimum age of sale 
of tobacco products to any person older 
than 18 years of age. 
‘‘(B) MATCHBOOKS.—For purposes of any 
regulations issued by the Secretary, matchbooks 
of conventional size containing not more than 
20 paper matches, and which are customarily 
given away for free with the purchase of to-
bacco products, shall be considered as adult- 
written publications which shall be permitted to 
contain advertising. Notwithstanding the pre-
ceding sentence, if the Secretary finds that such 
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treatment of matchbooks is not appropriate for 
the protection of the public health, the Sec-
retary may determine by regulation that match-
books shall not be considered adult-written pub-
lications. 
‘‘(4) REMOTE SALES.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) within 18 months after the date 
of enactment of this chapter, promulgate 
regulations regarding the sale and distribu-
tion of tobacco products that occur 
through means other than a direct, face-to- 
face exchange between a retailer and a 
consumer in order to prevent the sale and 
distribution of tobacco products to individ-
uals who have not attained the minimum 
age established by applicable law for the 
purchase of such products, including re-
quirements for age verification; and 
‘‘(ii) within 2 years after such date of 
enactment, issue regulations to address the 
promotion and marketing of tobacco prod-
ucts that are sold or distributed through 
means other than a direct, face-to-face ex-
change between a retailer and a consumer 
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