would be appropriate for the protection of the 
public health; 
‘‘(B) the methods used in, or the facilities 
or controls used for, the manufacture, proc-
essing, 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 
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 
remove 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 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. 
‘‘(5) BASIS FOR ACTION.— 
‘‘(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 in-
clude 1 or more clinical investigations by ex-
perts qualified by training and experience to 
evaluate the tobacco 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 oppor-
tunity for informal hearing for a tobacco product for 
which an order was issued under subsection 
(c)(1)(A)(i), issue an order withdrawing the order if 
the Secretary finds— 
‘‘(A) that the continued marketing of such 
tobacco product no longer is appropriate for the 
protection of the public health; 
‘‘(B) that the application contained or was 
accompanied by an untrue statement of a mate-
rial fact; 
‘‘(C) that the applicant— 
‘‘(i) has failed to establish a system 
for maintaining records, or has repeatedly 
or deliberately failed to maintain records
or to make reports, required by an applica-
ble regulation under section 909; 
‘‘(ii) has refused to permit access to, 
or copying or verification of, such records 
as required by section 704; or 
‘‘(iii) has not complied with the re-
quirements of section 905; 
‘‘(D) on the basis of new information be-
fore the Secretary with respect to such tobacco 
product, evaluated together with the evidence 
before the Secretary when the application was 
reviewed, that the methods used in, or the fa-
cilities and controls used for, the manufacture, 
processing, packing, or installation of such to-
bacco product do not conform with the require-
ments of section 906(e) and were not brought 
into conformity with such requirements within a 
reasonable time after receipt of written notice 
from the Secretary of nonconformity; 
‘‘(E) on the basis of new information be-
fore the Secretary, evaluated together with the 
evidence before the Secretary when the applica-
tion was reviewed, that the labeling of such to-
bacco product, based on a fair evaluation of all 
material facts, is false or misleading in any par-