HR 1108 RFS 
related to the tobacco product or state that 
such information 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 ef-
fects and shall be made available to the public 
by the Secretary within 30 days of the issuance 
of a determination that such tobacco product is 
substantially equivalent to another tobacco 
product. 
‘‘(b) APPLICATION.— 
‘‘(1) CONTENTS.—An application under this 
section shall contain— 
‘‘(A) full reports of all information, pub-
lished or known to, or which should reasonably 
be known to, the applicant, concerning inves-
tigations which have been made to show the 
health risks of such tobacco product and wheth-
er such tobacco product presents less risk than 
other tobacco products; 
‘‘(B) a full statement of the components, 
ingredients, additives, and properties, and of 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00086
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
HR 1108 RFS 
the principle or principles of operation, of such 
tobacco 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 to-
bacco product standard under section 907 
which would be applicable to any aspect of such 
tobacco product, and either adequate informa-
tion to show that such aspect of such tobacco 
product fully meets such tobacco product stand-
ard or adequate information to justify any devi-
ation 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 Sec-
retary may require. 
‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCI-
ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00087
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
HR 1108 RFS 
application meeting the requirements set forth in 
paragraph (1), the Secretary— 
‘‘(A) may, on the Secretary’s own initia-
tive; or 
‘‘(B) may, upon the request of an appli-
cant, 
refer such application to the Tobacco Products Sci-
entific Advisory Committee for reference and for 
submission (within such period as the Secretary may 
establish) of a report and recommendation respect-
ing the application, together with all underlying data 
and the reasons or basis for the recommendation. 
‘‘(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 sub-
section (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 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00088
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS
HR 1108 RFS 
specified in paragraph (2) of this sub-
section 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 accom-
panying such denial) that 1 or more 
grounds for denial specified in paragraph 
(2) of this subsection apply. 
‘‘(B) RESTRICTIONS
ON
SALE
AND
DIS-
TRIBUTION.—An order under subparagraph 
(A)(i) may require that the sale and distribu-
tion of the tobacco product be restricted but 
only to the extent that the sale and distribution 
of a tobacco product may be restricted under a 
regulation 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 
VerDate Aug 31 2005 
03:52 Aug 02, 2008
Jkt 069002
PO 00000
Frm 00089
Fmt 6652
Sfmt 6201
E:\BILLS\H1108.RFS
H1108
erowe on PRODPC61 with BILLS