H. R. 1256—17 
as appropriate, a list of harmful and potentially harmful constitu-
ents, including smoke constituents, to health in each tobacco product 
by brand and by quantity in each brand and subbrand. The Sec-
retary shall publish a public notice requesting the submission by 
interested persons of scientific and other information concerning 
the harmful and potentially harmful constituents in tobacco prod-
ucts and tobacco smoke. 
‘‘SEC. 905. ANNUAL REGISTRATION. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) MANUFACTURE, PREPARATION, COMPOUNDING, OR PROC-
ESSING.—The term ‘manufacture, preparation, compounding, or 
processing’ shall include repackaging or otherwise changing 
the container, wrapper, or labeling of any tobacco product pack-
age in furtherance of the distribution of the tobacco product 
from the original place of manufacture 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 incorporation. 
‘‘(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 processing of a tobacco product or 
tobacco products shall register with the Secretary the name, places 
of business, and all such establishments of that person. If enactment 
of the Family Smoking Prevention and Tobacco Control 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 registration pursuant to this subsection shall occur. 
‘‘(c) REGISTRATION BY NEW OWNERS AND OPERATORS.—Every 
person upon first engaging in the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco products 
in any establishment owned 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 additional establishment which 
that person owns or operates in any State and in which that 
person begins the manufacture, preparation, compounding, or proc-
essing of a tobacco product or tobacco products. 
‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYSTEM.—The Sec-
retary may by regulation prescribe a uniform system for the identi-
fication of tobacco products and may require that persons who 
are required to list such tobacco products under subsection (i) 
shall list such tobacco products in accordance with such system. 
‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMATION.—The Sec-
retary shall make available for inspection, to any person so 
requesting, any registration filed under this section. 
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTABLISHMENTS.— 
Every establishment registered with the Secretary under this sec-
tion shall be subject to inspection under section 704 or subsection 
(h), and every such establishment engaged in the manufacture, 
compounding, or processing of a tobacco product or tobacco products 
shall be so inspected by 1 or more officers or employees duly
H. R. 1256—18 
designated by the Secretary at least once in the 2-year period 
beginning with the date of registration of such establishment under 
this section and at least once in every successive 2-year period 
thereafter. 
‘‘(h) 
REGISTRATION
BY
FOREIGN
ESTABLISHMENTS.—Any 
establishment within any foreign country engaged in the manufac-
ture, preparation, compounding, or processing of a tobacco product 
or tobacco products, shall register under this section under regula-
tions promulgated by the Secretary. Such regulations shall require 
such establishment to provide the information required by sub-
section (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 tobacco 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 registers with the 
Secretary under subsection (b), (c), (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 manufac-
tured, 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 Sec-
retary 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 contained in 
the applicable list with respect to which a tobacco product 
standard has been established 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 product contained 
in an applicable list, a copy of all consumer information 
and other labeling for such tobacco product, a representa-
tive sampling of advertisements for such tobacco product, 
and, upon request made by the Secretary for good cause, 
a copy of all advertisements for a particular tobacco 
product; and 
‘‘(C) if the registrant filing a list has determined 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 Secretary requests 
such a statement with respect to that particular tobacco 
product. 
‘‘(2) CONSULTATION
WITH
RESPECT
TO
FORMS.—The Sec-
retary shall consult with the Secretary 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 Bureau 
of the Department of the Treasury.
H. R. 1256—19 
‘‘(3) BIANNUAL REPORT OF ANY CHANGE IN PRODUCT LIST.— 
Each person who registers with the Secretary under this section 
shall report to the Secretary 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 introduced by the 
registrant for commercial distribution which has not been 
included in any list previously filed by that person with 
the Secretary 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 distribution 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 established name. 
‘‘(C) If since the date the registrant reported under 
subparagraph (B) a notice of discontinuance that person 
has resumed the manufacture, preparation, compounding, 
or processing for commercial distribution of the tobacco 
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 estab-
lished name, and other information required by paragraph 
(1), unless the registrant has previously reported such 
resumption to the Secretary under this subparagraph. 
‘‘(D) Any material change in any information previously 
submitted under this paragraph or paragraph (1). 
‘‘(j) REPORT PRECEDING INTRODUCTION OF CERTAIN SUBSTAN-
TIALLY EQUIVALENT PRODUCTS INTO INTERSTATE COMMERCE.— 
‘‘(1) IN GENERAL.—Each person who is required to register 
under this section and who proposes to begin the introduction 
or delivery for introduction into interstate commerce for 
commercial distribution of a tobacco product intended for 
human use that was not commercially marketed (other than 
for test marketing) in the United States as of February 15, 
2007, shall, at least 90 days prior to making such introduction 
or delivery, report to the Secretary (in such form and manner 
as the Secretary shall prescribe)— 
‘‘(A) the basis for such person’s determination that— 
‘‘(i) the tobacco product is substantially equivalent, 
within the meaning of section 910, to a tobacco product 
commercially marketed (other than for test marketing) 
in the United States as of February 15, 2007, or to 
a tobacco product that the Secretary has previously 
determined, pursuant to subsection (a)(3) of section 
910, is substantially equivalent and that is in compli-
ance with the requirements of this Act; or 
‘‘(ii) the tobacco product is modified within the 
meaning of paragraph (3), the modifications are to 
a product that is commercially marketed and in compli-
ance with the requirements of this Act, and all of 
the modifications are covered by exemptions granted 
by the Secretary pursuant to paragraph (3); and
H. R. 1256—20 
‘‘(B) action taken by such person to comply with the 
requirements under section 907 that are applicable to the 
tobacco product. 
‘‘(2) APPLICATION TO CERTAIN POST-FEBRUARY 15, 2007, PROD-
UCTS.—A report under this subsection for a tobacco product 
that was first introduced or delivered for introduction into 
interstate commerce for commercial distribution in the United 
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 enact-
ment. 
‘‘(3) EXEMPTIONS.— 
‘‘(A) IN
GENERAL.—The Secretary may exempt from 
the requirements of this subsection relating to the dem-
onstration that a tobacco product is substantially equiva-
lent within the meaning of section 910, tobacco products 
that are modified by adding or deleting a tobacco additive, 
or increasing or decreasing the quantity of an existing 
tobacco additive, if the Secretary determines that— 
‘‘(i) such modification would be a minor modifica-
tion 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 appropriate. 
‘‘(B) REGULATIONS.—Not later than 15 months after 
the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, the Secretary shall issue regula-
tions to implement 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 require-
ment to the tobacco product has been changed by action taken 
under section 907, section 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, section 910, 
section 911, or subsection (d) of this section shall not apply to 
such tobacco product. 
‘‘(b) INFORMATION
ON PUBLIC ACCESS
AND COMMENT.—Each 
notice of proposed rulemaking or other notification 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 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