tion or removal is required and has been submitted 
under subsection (a). 
‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO-
BACCO PRODUCTS. 
‘‘(a) IN GENERAL.— 
‘‘(1) NEW
TOBACCO
PRODUCT
DEFINED.—For 
purposes of this section the term ‘new tobacco product’ 
means— 
‘‘(A) any tobacco product (including those 
products in test markets) that was not commer-
cially marketed in the United States as of Feb-
ruary 15, 2007; or 
‘‘(B) any modification (including a change 
in design, any component, any part, or any con-
stituent, including a smoke constituent, or in the 
content, delivery or form of nicotine, or any 
other additive or ingredient) of a tobacco product 
where the modified product was commercially 
marketed in the United States after February 15, 
2007. 
‘‘(2) PREMARKET REVIEW REQUIRED.— 
‘‘(A) NEW PRODUCTS.—An order under sub-
section (c)(1)(A)(i) for a new tobacco product is 
required unless— 
VerDate Aug 31 2005 
23:01 Jul 17, 2008
Jkt 069200
PO 00000
Frm 00081
Fmt 6652
Sfmt 6203
E:\BILLS\H1108.RH
H1108
erowe on PROD1PC71 with BILLS
‘‘(i) the manufacturer has submitted a 
report under section 905(j); and the Sec-
retary has issued an order that the tobacco 
product— 
‘‘(I) is substantially equivalent to 
a tobacco product commercially mar-
keted (other than for test marketing) in 
the United States as of February 15, 
2007; and 
‘‘(II) is in compliance with the re-
quirements of this Act; or 
‘‘(ii) the tobacco product is exempt 
from the requirements of section 905(j) pur-
suant to a regulation issued under section 
905(j)(3). 
‘‘(B) APPLICATION TO CERTAIN POST-FEB-
RUARY 15, 2007, PRODUCTS.—Subparagraph (A) 
shall not apply to a tobacco product— 
‘‘(i) that was first introduced or deliv-
ered for introduction into interstate com-
merce 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; and 
VerDate Aug 31 2005 
23:01 Jul 17, 2008
Jkt 069200
PO 00000
Frm 00082
Fmt 6652
Sfmt 6203
E:\BILLS\H1108.RH
H1108
erowe on PROD1PC71 with BILLS
‘‘(ii) for which a report was submitted 
under section 905(j) within such 21-month 
period, 
except that subparagraph (A) shall apply to the 
tobacco product if the Secretary issues an order 
that the tobacco product is not substantially 
equivalent. 
‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 
‘‘(A) IN GENERAL.—In this section and sec-
tion 905(j), the term ‘substantially equivalent’ or 
‘substantial equivalence’ means, with respect to 
the tobacco product being compared to the predi-
cate tobacco product, that the Secretary by order 
has found that the tobacco product— 
‘‘(i) has the same characteristics as the 
predicate tobacco product; or 
‘‘(ii) has different characteristics and 
the information submitted contains infor-
mation, including clinical data if deemed 
necessary by the Secretary, that dem-
onstrates that it is not appropriate to regu-
late the product under this section because 
the product does not raise different ques-
tions of public health. 
VerDate Aug 31 2005 
23:01 Jul 17, 2008
Jkt 069200
PO 00000
Frm 00083
Fmt 6652
Sfmt 6203
E:\BILLS\H1108.RH
H1108
erowe on PROD1PC71 with BILLS
‘‘(B) CHARACTERISTICS.—In subparagraph 
(A), the term ‘characteristics’ means the mate-
rials, ingredients, design, composition, heating 
source, or other features of a tobacco product. 
‘‘(C) LIMITATION.—A tobacco product may 
not be found to be substantially equivalent to a 
predicate tobacco product that has been removed 
from the market at the initiative of the Secretary 
or that has been determined by a judicial order 
to be misbranded or adulterated. 
‘‘(4) HEALTH INFORMATION.— 
‘‘(A) SUMMARY.—As part of a submission 
under section 905(j) respecting a tobacco prod-
uct, the person required to file a premarket noti-
fication under such section shall provide an ade-
quate summary of any health information re-
lated to the tobacco product or state that such in-
formation will be made available upon request 
by any person. 
‘‘(B) REQUIRED INFORMATION.—Any sum-
mary under subparagraph (A) respecting a to-
bacco product shall contain detailed information 
regarding data concerning adverse health effects 
and shall be made available to the public by the 
Secretary within 30 days of the issuance of a de-
VerDate Aug 31 2005 
23:01 Jul 17, 2008
Jkt 069200
PO 00000
Frm 00084
Fmt 6652
Sfmt 6203
E:\BILLS\H1108.RH
H1108
erowe on PROD1PC71 with BILLS
termination that such tobacco product is sub-
stantially equivalent to another tobacco product. 
‘‘(b) APPLICATION.— 
‘‘(1) CONTENTS.—An application under this sec-
tion shall contain— 
‘‘(A) full reports of all information, pub-
lished or known to, or which should reasonably 
be known to, the applicant, concerning investiga-
tions which have been made to show the health 
risks of such tobacco product and whether such 
tobacco product presents less risk than other to-
bacco products; 
‘‘(B) a full statement of the components, in-
gredients, additives, and properties, and of the 
principle or principles of operation, of such to-
bacco product; 
‘‘(C) a full description of the methods used 
in, and the facilities and controls used for, the 
manufacture, processing, and, when relevant, 
packing and installation of, such tobacco prod-
uct; 
‘‘(D) an identifying reference to any tobacco 
product standard under section 907 which would 
be applicable to any aspect of such tobacco prod-
uct, and either adequate information to show 
VerDate Aug 31 2005 
23:01 Jul 17, 2008
Jkt 069200
PO 00000
Frm 00085
Fmt 6652
Sfmt 6203
E:\BILLS\H1108.RH
H1108
erowe on PROD1PC71 with BILLS
that such aspect of such tobacco product fully 
meets such tobacco product standard or adequate 
information to justify any deviation from such 
standard; 
‘‘(E) such samples of such tobacco product 
and of components thereof as the Secretary may 
reasonably require; 
‘‘(F) specimens of the labeling proposed to 
be used for such tobacco product; and 
‘‘(G) such other information relevant to the 
subject matter of the application as the Secretary 
may require. 
‘‘(2) REFERRAL
TO
TOBACCO
PRODUCTS
SCI-
ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 
application meeting the requirements set forth in 
paragraph (1), the Secretary— 
‘‘(A) may, on the Secretary’s own initiative; 
or 
‘‘(B) may, upon the request of an applicant, 
refer such application to the Tobacco Products Sci-
entific Advisory Committee for reference and for sub-
mission (within such period as the Secretary may es-
tablish) of a report and recommendation respecting 
the application, together with all underlying data 
and the reasons or basis for the recommendation. 
VerDate Aug 31 2005 
23:01 Jul 17, 2008
Jkt 069200
PO 00000
Frm 00086
Fmt 6652
Sfmt 6203
E:\BILLS\H1108.RH
H1108
erowe on PROD1PC71 with BILLS
‘‘(c) ACTION ON APPLICATION.— 
‘‘(1) DEADLINE.— 
‘‘(A) IN
GENERAL.—As promptly as pos-
sible, but in no event later than 180 days after 
the receipt of an application under subsection 
(b), the Secretary, after considering the report 
and recommendation submitted under subsection 
(b)(2), shall— 
‘‘(i) issue an order that the new prod-
uct may be introduced or delivered for in-
troduction into interstate commerce if the 
Secretary finds that none of the grounds 
specified in paragraph (2) of this subsection 
applies; or 
‘‘(ii) issue an order that the new prod-
uct may not be introduced or delivered for 
introduction into interstate commerce if the 
Secretary finds (and sets forth the basis for 
such finding as part of or accompanying 
such denial) that 1 or more grounds for de-
nial specified in paragraph (2) of this sub-
section apply. 
‘‘(B) RESTRICTIONS
ON
SALE
AND
DIS-
TRIBUTION.—An 
order 
under 
subparagraph 
(A)(i) may require that the sale and distribution 
VerDate Aug 31 2005 
23:01 Jul 17, 2008
Jkt 069200
PO 00000
Frm 00087
Fmt 6652
Sfmt 6203
E:\BILLS\H1108.RH
H1108
erowe on PROD1PC71 with BILLS
of the tobacco product be restricted but only to 
the extent that the sale and distribution of a to-
bacco product may be restricted under a regula-
tion under section 906(d). 
‘‘(2) DENIAL OF APPLICATION.—The Secretary 
shall deny an application submitted under subsection 
(b) if, upon the basis of the information submitted to 
the Secretary as part of the application and any 
other information before the Secretary with respect to 
such tobacco product, the Secretary finds that— 
‘‘(A) there is a lack of a showing that per-
mitting such tobacco product to be marketed 
would be appropriate for the protection of the 
public health; 
‘‘(B) the methods used in, or the facilities or 
controls used for, the manufacture, processing, or 
packing of such tobacco product do not conform 
to the requirements of section 906(e); 
‘‘(C) based on a fair evaluation of all mate-
rial facts, the proposed labeling is false or mis-
leading in any particular; or 
‘‘(D) such tobacco product is not shown to 
conform in all respects to a tobacco product 
standard in effect under section 907, and there 
VerDate Aug 31 2005 
23:01 Jul 17, 2008
Jkt 069200
PO 00000
Frm 00088
Fmt 6652
Sfmt 6203
E:\BILLS\H1108.RH
H1108
erowe on PROD1PC71 with BILLS
is a lack of adequate information to justify the 
deviation from such standard. 
‘‘(3) DENIAL INFORMATION.—Any denial of an 
application shall, insofar as the Secretary determines 
to be practicable, be accompanied by a statement in-
forming the applicant of the measures required to re-
move such application from deniable form (which 
measures may include further research by the appli-
cant in accordance with 1 or more protocols pre-
scribed by the Secretary). 
‘‘(4) BASIS FOR FINDING.—For purposes of this 
section, the finding as to whether the marketing of a 
tobacco product for which an application has been 
submitted is appropriate for the protection of the pub-
lic 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. 
‘‘(5) BASIS FOR ACTION.— 
VerDate Aug 31 2005 
23:01 Jul 17, 2008
Jkt 069200
PO 00000
Frm 00089
Fmt 6652
Sfmt 6203
E:\BILLS\H1108.RH
H1108
erowe on PROD1PC71 with BILLS
‘‘(A) INVESTIGATIONS.—For purposes of 
paragraph (2)(A), whether permitting a tobacco 
product to be marketed would be appropriate for 
the protection of the public health shall, when 
appropriate, be determined on the basis of well- 
controlled investigations, which may include 1 or 
more clinical investigations by experts qualified 
by training and experience to evaluate the to-
bacco product. 
‘‘(B) OTHER EVIDENCE.—If the Secretary 
determines that there exists valid scientific evi-
dence (other than evidence derived from inves-
tigations described in subparagraph (A)) which 
is sufficient to evaluate the tobacco product, the 
Secretary may authorize that the determination 
for purposes of paragraph (2)(A) be made on the 
basis of such evidence. 
‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.— 
‘‘(1) IN GENERAL.—The Secretary shall, upon 
obtaining, where appropriate, advice on scientific 
matters from the Tobacco Products Scientific Advi-
sory Committee, and after due notice and opportunity 
for informal hearing for a tobacco product for which 
an order was issued under subsection (c)(1)(A)(i), 
VerDate Aug 31 2005 
23:01 Jul 17, 2008
Jkt 069200
PO 00000
Frm 00090
Fmt 6652
Sfmt 6203
E:\BILLS\H1108.RH
H1108
erowe on PROD1PC71 with BILLS