104 
eliminate such risk. The Secretary may order notifi-
cation by any appropriate means, including public 
service announcements. Before issuing an order 
under this subsection, the Secretary shall consult 
with the persons who are to give notice under the 
order. 
‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.— 
Compliance with an order issued under this section shall 
not relieve any person from liability under Federal or 
State law. In awarding damages for economic loss in an 
action brought for the enforcement of any such liability, 
the value to the plaintiff in such action of any remedy 
provided under such order shall be taken into account. 
‘‘(c) RECALL AUTHORITY.— 
‘‘(1) IN GENERAL.—If the Secretary finds that 
there is a reasonable probability that a tobacco prod-
uct contains a manufacturing or other defect not or-
dinarily contained in tobacco products on the market 
that would cause serious, adverse health con-
sequences or death, the Secretary shall issue an 
order requiring the appropriate person (including 
the manufacturers, importers, distributors, or retail-
ers of the tobacco product) to immediately cease dis-
tribution of such tobacco product. The order shall 
provide the person subject to the order with an op-
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portunity for an informal hearing, to be held not 
later than 10 days after the date of the issuance of 
the order, on the actions required by the order and 
on whether the order should be amended to require 
a recall of such tobacco product. If, after providing 
an opportunity for such a hearing, the Secretary de-
termines that inadequate grounds exist to support 
the actions required by the order, the Secretary shall 
vacate the order. 
‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE-
CALL.— 
‘‘(A) IN GENERAL.—If, after providing an 
opportunity for an informal hearing under 
paragraph (1), the Secretary determines that 
the order should be amended to include a recall 
of the tobacco product with respect to which the 
order was issued, the Secretary shall, except as 
provided in subparagraph (B), amend the order 
to require a recall. The Secretary shall specify 
a timetable in which the tobacco product recall 
will occur and shall require periodic reports to 
the Secretary describing the progress of the re-
call. 
‘‘(B) NOTICE.—An amended order under 
subparagraph (A)— 
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‘‘(i) shall not include recall of a to-
bacco product from individuals; and 
‘‘(ii) shall provide for notice to per-
sons subject to the risks associated with 
the use of such tobacco product. 
In providing the notice required by clause (ii), 
the Secretary may use the assistance of retail-
ers and other persons who distributed such to-
bacco product. If a significant number of such 
persons cannot be identified, the Secretary shall 
notify such persons under section 705(b). 
‘‘(3) REMEDY
NOT
EXCLUSIVE.—The remedy 
provided by this subsection shall be in addition to 
remedies provided by subsection (a) of this section. 
‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD-
UCTS. 
‘‘(a) IN GENERAL.—Every person who is a tobacco 
product manufacturer or importer of a tobacco product 
shall establish and maintain such records, make such re-
ports, and provide such information, as the Secretary may 
by regulation reasonably require to assure that such to-
bacco product is not adulterated or misbranded and to 
otherwise protect public health. Regulations prescribed 
under the preceding sentence— 
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‘‘(1) may require a tobacco product manufac-
turer or importer to report to the Secretary when-
ever the manufacturer or importer receives or other-
wise becomes aware of information that reasonably 
suggests that one of its marketed tobacco products 
may have caused or contributed to a serious unex-
pected adverse experience associated with the use of 
the product or any significant increase in the fre-
quency of a serious, expected adverse product experi-
ence; 
‘‘(2) shall require reporting of other significant 
adverse tobacco product experiences as determined 
by the Secretary to be necessary to be reported; 
‘‘(3) shall not impose requirements unduly bur-
densome to a tobacco product manufacturer or im-
porter, taking into account the cost of complying 
with such requirements and the need for the protec-
tion of the public health and the implementation of 
this chapter; 
‘‘(4) when prescribing the procedure for making 
requests for reports or information, shall require 
that each request made under such regulations for 
submission of a report or information to the Sec-
retary state the reason or purpose for such request 
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and identify to the fullest extent practicable such re-
port or information; 
‘‘(5) when requiring submission of a report or 
information to the Secretary, shall state the reason 
or purpose for the submission of such report or in-
formation and identify to the fullest extent prac-
ticable such report or information; and 
‘‘(6) may not require that the identity of any 
patient or user be disclosed in records, reports, or 
information required under this subsection unless re-
quired for the medical welfare of an individual, to 
determine risks to public health of a tobacco prod-
uct, or to verify a record, report, or information sub-
mitted under this chapter. 
In prescribing regulations under this subsection, the Sec-
retary shall have due regard for the professional ethics of 
the medical profession and the interests of patients. The 
prohibitions of paragraph (6) continue to apply to records, 
reports, and information concerning any individual who 
has been a patient, irrespective of whether or when he 
ceases to be a patient. 
‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), the Secretary shall by regulation require 
a tobacco product manufacturer or importer of a to-
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bacco product to report promptly to the Secretary 
any corrective action taken or removal from the 
market of a tobacco product undertaken by such 
manufacturer or importer if the removal or correc-
tion was undertaken— 
‘‘(A) to reduce a risk to health posed by 
the tobacco product; or 
‘‘(B) to remedy a violation of this chapter 
caused by the tobacco product which may 
present a risk to health. 
A tobacco product manufacturer or importer of a to-
bacco product who undertakes a corrective action or 
removal from the market of a tobacco product which 
is not required to be reported under this subsection 
shall keep a record of such correction or removal. 
‘‘(2) EXCEPTION.—No report of the corrective 
action or removal of a tobacco product may be re-
quired under paragraph (1) if a report of the correc-
tive action or removal is required and has been sub-
mitted under subsection (a). 
‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO-
BACCO PRODUCTS. 
‘‘(a) IN GENERAL.— 
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‘‘(1) NEW TOBACCO PRODUCT DEFINED.—For 
purposes of this section the term ‘new tobacco prod-
uct’ means— 
‘‘(A) any tobacco product (including those 
products in test markets) that was not commer-
cially marketed in the United States as of June 
1, 2003; 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 prod-
uct where the modified product was commer-
cially marketed in the United States after June 
1, 2003. 
‘‘(2) PREMARKET APPROVAL REQUIRED.— 
‘‘(A) NEW
PRODUCTS.—Approval under 
this section of an application for premarket ap-
proval for any new tobacco product is required 
unless— 
‘‘(i) the manufacturer has submitted a 
report under section 905(j); and 
‘‘(ii) the Secretary has issued an order 
that the tobacco product— 
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‘‘(I) is substantially equivalent to 
a tobacco product commercially mar-
keted (other than for test marketing) 
in the United States as of June 1, 
2003; and 
‘‘(II)(aa) is in compliance with 
the requirements of this Act; or 
‘‘(bb) is exempt from the require-
ments of section 905(j) pursuant to a 
regulation 
issued 
under 
section 
905(j)(3). 
‘‘(B) APPLICATION
TO
CERTAIN
POST 
JUNE
1, 2003
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 June 1, 2003, and 
prior to the date that is 15 months after 
the date of enactment of the Family Smok-
ing Prevention and Tobacco Control Act; 
and 
‘‘(ii) for which a report was submitted 
under section 905(j) within such 15-month 
period, until the Secretary issues an order 
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that the tobacco product is not substan-
tially equivalent. 
‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 
‘‘(A) IN
GENERAL.—In this section and 
section 905(j), the terms ‘substantially equiva-
lent’ or ‘substantial equivalence’ mean, with re-
spect to the tobacco product being compared to 
the predicate tobacco product, that the Sec-
retary 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 reg-
ulate the product under this section be-
cause the product does not raise different 
questions of public health. 
‘‘(B) 
CHARACTERISTICS.—In 
subpara-
graph (A), the term ‘characteristics’ means the 
materials, 
ingredients, 
design, 
composition, 
heating source, or other features of a tobacco 
product. 
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‘‘(C) LIMITATION.—A tobacco product may 
not be found to be substantially equivalent to a 
predicate tobacco product that has been re-
moved from the market at the initiative of the 
Secretary or that has been determined by a ju-
dicial 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 no-
tification under such section shall provide an 
adequate summary of any health information 
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.— 
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‘‘(1) CONTENTS.—An application for premarket 
approval 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 
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-
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115 
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) REFERENCE 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 initia-
tive; or 
‘‘(B) may, upon the request of an appli-
cant, refer such application to the Tobacco 
Products Scientific Advisory Committee for ref-
erence and for submission (within such period 
as the Secretary may establish) of a report and 
recommendation respecting approval of the ap-
plication, together with all underlying data and 
the reasons or basis for the recommendation. 
‘‘(c) ACTION ON APPLICATION.— 
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‘‘(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 para-
graph (2) of such subsection, shall— 
‘‘(i) issue an order approving the ap-
plication if the Secretary finds that none of 
the grounds for denying approval specified 
in paragraph (2) of this subsection applies; 
or 
‘‘(ii) deny approval of the application 
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 approving an application 
for a tobacco product may require as a condi-
tion to such approval that the sale and distribu-
tion of the tobacco product be restricted but 
only to the extent that the sale and distribution 
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of a tobacco product may be restricted under a 
regulation under section 906(d). 
‘‘(2) DENIAL
OF
APPROVAL.—The Secretary 
shall deny approval of an application for a tobacco 
product if, upon the basis of the information sub-
mitted 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, 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, compli-
ance with which is a condition to approval of 
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118 
the application, 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 
place such application in approvable 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 approval of a 
tobacco product 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.— 
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‘‘(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 an advisory committee, and after due 
notice and opportunity for informal hearing to the 
holder of an approved application for a tobacco 
product, issue an order withdrawing approval of the 
application if the Secretary finds— 
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120 
‘‘(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 
approved, 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-
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121 
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 approved, that the labeling of such to-
bacco product, based on a fair evaluation of all 
material facts, is false or misleading in any par-
ticular and was not corrected within a reason-
able time after receipt of written notice from 
the Secretary of such fact; or 
‘‘(F) on the basis of new information be-
fore the Secretary, evaluated together with the 
evidence before the Secretary when the applica-
tion was approved, that such tobacco product is 
not shown to conform in all respects to a to-
bacco product standard which is in effect under 
section 907, compliance with which was a con-
dition to approval of the application, and that 
there is a lack of adequate information to jus-
tify the deviation from such standard. 
‘‘(2) APPEAL.—The holder of an application 
subject to an order issued under paragraph (1) with-
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122 
drawing approval of the application may, by petition 
filed on or before the 30th day after the date upon 
which such holder receives notice of such with-
drawal, obtain review thereof in accordance with 
subsection (e). 
‘‘(3) TEMPORARY SUSPENSION.—If, after pro-
viding an opportunity for an informal hearing, the 
Secretary determines there is reasonable probability 
that the continuation of distribution of a tobacco 
product under an approved application would cause 
serious, adverse health consequences or death, that 
is greater than ordinarily caused by tobacco prod-
ucts on the market, the Secretary shall by order 
temporarily suspend the approval of the application 
approved under this section. If the Secretary issues 
such an order, the Secretary shall proceed expedi-
tiously under paragraph (1) to withdraw such appli-
cation. 
‘‘(e) SERVICE OF ORDER.—An order issued by the 
Secretary under this section shall be served— 
‘‘(1) in person by any officer or employee of the 
department designated by the Secretary; or 
‘‘(2) by mailing the order by registered mail or 
certified mail addressed to the applicant at the ap-
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123 
plicant’s last known address in the records of the 
Secretary. 
‘‘(f) RECORDS.— 
‘‘(1) ADDITIONAL INFORMATION.—In the case 
of any tobacco product for which an approval of an 
application filed under subsection (b) is in effect, the 
applicant shall establish and maintain such records, 
and make such reports to the Secretary, as the Sec-
retary may by regulation, or by order with respect 
to such application, prescribe on the basis of a find-
ing that such records and reports are necessary in 
order to enable the Secretary to determine, or facili-
tate a determination of, whether there is or may be 
grounds for withdrawing or temporarily suspending 
such approval. 
‘‘(2) ACCESS TO RECORDS.—Each person re-
quired under this section to maintain records, and 
each person in charge or custody thereof, shall, upon 
request of an officer or employee designated by the 
Secretary, permit such officer or employee at all rea-
sonable times to have access to and copy and verify 
such records. 
‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP-
TION FOR INVESTIGATIONAL USE.—The Secretary may 
exempt tobacco products intended for investigational use 
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from the provisions of this chapter under such conditions 
as the Secretary may by regulation prescribe. 
‘‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—No person may introduce or de-
liver for introduction into interstate commerce any modi-
fied risk tobacco product unless approval of an application 
filed pursuant to subsection (d) is effective with respect 
to such product. 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) MODIFIED RISK TOBACCO PRODUCT.—The 
term ‘modified risk tobacco product’ means any to-
bacco product that is sold or distributed for use to 
reduce harm or the risk of tobacco-related disease 
associated with commercially marketed tobacco prod-
ucts. 
‘‘(2) SOLD OR DISTRIBUTED.— 
‘‘(A) IN GENERAL.—With respect to a to-
bacco product, the term ‘sold or distributed for 
use to reduce harm or the risk of tobacco-re-
lated disease associated with commercially mar-
keted tobacco products’ means a tobacco prod-
uct— 
‘‘(i) the label, labeling, or advertising 
of which represents explicitly or implicitly 
that— 
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125 
‘‘(I) the tobacco product presents 
a lower risk of tobacco-related disease 
or is less harmful than one or more 
other commercially marketed tobacco 
products; 
‘‘(II) the tobacco product or its 
smoke contains a reduced level of a 
substance or presents a reduced expo-
sure to a substance; or 
‘‘(III) the tobacco product or its 
smoke does not contain or is free of a 
substance; 
‘‘(ii) the label, labeling, or advertising 
of which uses the descriptors ‘light’, ‘mild’, 
or ‘low’ or similar descriptors; or 
‘‘(iii) the tobacco product manufac-
turer of which has taken any action di-
rected to consumers through the media or 
otherwise, other than by means of the to-
bacco product’s label, labeling or adver-
tising, after the date of enactment of the 
Family Smoking Prevention and Tobacco 
Control Act, respecting the product that 
would be reasonably expected to result in 
consumers believing that the tobacco prod-
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uct or its smoke may present a lower risk 
of disease or is less harmful than one or 
more commercially marketed tobacco prod-
ucts, or presents a reduced exposure to, or 
does not contain or is free of, a substance 
or substances. 
‘‘(B) LIMITATION.—No tobacco product 
shall be considered to be ‘sold or distributed for 
use to reduce harm or the risk of tobacco-re-
lated disease associated with commercially mar-
keted tobacco products’, except as described in 
subparagraph (A). 
‘‘(c) TOBACCO DEPENDENCE PRODUCTS.—A product 
that is intended to be used for the treatment of tobacco 
dependence, including smoking cessation, is not a modified 
risk tobacco product under this section and is subject to 
the requirements of chapter V. 
‘‘(d) FILING.—Any person may file with the Sec-
retary an application for a modified risk tobacco product. 
Such application shall include— 
‘‘(1) a description of the proposed product and 
any proposed advertising and labeling; 
‘‘(2) the conditions for using the product; 
‘‘(3) the formulation of the product; 
‘‘(4) sample product labels and labeling; 
VerDate Aug 31 2005 
00:40 Aug 05, 2006
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