H. R. 1256—30 
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 product contains a manu-
facturing or other defect not ordinarily contained in tobacco 
products on the market that would cause serious, adverse 
health consequences or death, the Secretary shall issue an 
order requiring the appropriate person (including the manufac-
turers, importers, distributors, or retailers of the tobacco 
product) to immediately cease distribution of such tobacco 
product. The order shall provide the person subject to the 
order with an opportunity 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 determines that inadequate grounds exist to sup-
port the actions required by the order, the Secretary shall 
vacate the order. 
‘‘(2) AMENDMENT OF ORDER TO REQUIRE RECALL.— 
‘‘(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 recall. 
‘‘(B) NOTICE.—An amended order under subparagraph 
(A)— 
‘‘(i) shall not include recall of a tobacco product 
from individuals; and 
‘‘(ii) shall provide for notice to persons 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 retailers and other persons who 
distributed such tobacco 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 sub-
section (a). 
‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—Every person who is a tobacco product manu-
facturer or importer of a tobacco product shall establish and main-
tain such records, make such reports, and provide such information, 
as the Secretary may by regulation reasonably require to assure
H. R. 1256—31 
that such tobacco product is not adulterated or misbranded and 
to otherwise protect public health. Regulations prescribed under 
the preceding sentence— 
‘‘(1) may require a tobacco product manufacturer or 
importer to report to the Secretary whenever the manufacturer 
or importer receives or otherwise becomes aware of information 
that reasonably suggests that one of its marketed tobacco prod-
ucts may have caused or contributed to a serious unexpected 
adverse experience associated with the use of the product or 
any significant increase in the frequency of a serious, expected 
adverse product experience; 
‘‘(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 burdensome to 
a tobacco product manufacturer or importer, taking into account 
the cost of complying with such requirements and the need 
for the protection 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 Secretary state the reason or purpose for such request 
and identify to the fullest extent practicable such report 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 information and identify to the 
fullest extent practicable 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 required for the medical welfare 
of an individual, to determine risks to public health of a tobacco 
product, or to verify a record, report, or information submitted 
under this chapter. 
In prescribing regulations under this subsection, the Secretary 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 paragraph (2), 
the Secretary shall by regulation require a tobacco product 
manufacturer or importer of a tobacco 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 correction 
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 tobacco 
product who undertakes a corrective action or removal from 
the market of a tobacco product which is not required to be
H. R. 1256—32 
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 required under paragraph 
(1) if a report of the corrective action or removal is required 
and has been submitted under subsection (a). 
‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PROD-
UCTS. 
‘‘(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 commercially marketed in the 
United States as of February 15, 2007; or 
‘‘(B) any modification (including a change in design, 
any component, any part, or any constituent, 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 mar-
keted in the United States after February 15, 2007. 
‘‘(2) PREMARKET REVIEW REQUIRED.— 
‘‘(A) NEW
PRODUCTS.—An order under subsection 
(c)(1)(A)(i) for a new tobacco product is required unless— 
‘‘(i) the manufacturer has submitted a report under 
section 905(j); and the Secretary has issued an order 
that the tobacco product— 
‘‘(I) is substantially equivalent to a tobacco 
product commercially marketed (other than for test 
marketing) in the United States as of February 
15, 2007; and 
‘‘(II) is in compliance with the requirements 
of this Act; or 
‘‘(ii) the tobacco product is exempt from the 
requirements of section 905(j) pursuant to a regulation 
issued under section 905(j)(3). 
‘‘(B) APPLICATION TO CERTAIN POST-FEBRUARY 15, 2007, 
PRODUCTS.—Subparagraph (A) shall not apply to a tobacco 
product— 
‘‘(i) 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 Preven-
tion and Tobacco Control Act; and 
‘‘(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 section 905(j), 
the term ‘substantially equivalent’ or ‘substantial equiva-
lence’ means, with respect to the tobacco product being 
compared to the predicate tobacco product, that the Sec-
retary by order has found that the tobacco product—
H. R. 1256—33 
‘‘(i) has the same characteristics as the predicate 
tobacco product; or 
‘‘(ii) has different characteristics and the informa-
tion submitted contains information, including clinical 
data if deemed necessary by the Secretary, that dem-
onstrates that it is not appropriate to regulate the 
product under this section because the product does 
not raise different questions of public health. 
‘‘(B) CHARACTERISTICS.—In subparagraph (A), the term 
‘characteristics’ means the materials, 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 product, the person required 
to file a premarket notification under such section shall 
provide an adequate summary of any health information 
related to the tobacco product or state that such informa-
tion will be made available upon request by any person. 
‘‘(B) REQUIRED
INFORMATION.—Any summary under 
subparagraph (A) respecting a tobacco 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 deter-
mination that such tobacco product is substantially equiva-
lent to another tobacco product. 
‘‘(b) APPLICATION.— 
‘‘(1) CONTENTS.—An application under this section shall 
contain— 
‘‘(A) full reports of all information, published or known 
to, or which should reasonably be known to, the applicant, 
concerning investigations which have been made to show 
the health risks of such tobacco product and whether such 
tobacco product presents less risk than other tobacco prod-
ucts; 
‘‘(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, proc-
essing, and, when relevant, packing and installation of, 
such tobacco product; 
‘‘(D) an identifying reference to any tobacco product 
standard under section 907 which would be applicable to 
any aspect of such tobacco product, and either adequate 
information to show that such aspect of such tobacco 
product fully meets such tobacco product standard or ade-
quate 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;
H. R. 1256—34 
‘‘(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 SCIENTIFIC 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 Scientific 
Advisory Committee for reference and for submission (within 
such period as the Secretary may establish) of a report and 
recommendation respecting the application, together with all 
underlying data and the reasons or basis for the recommenda-
tion. 
‘‘(c) ACTION ON APPLICATION.— 
‘‘(1) DEADLINE.— 
‘‘(A) IN GENERAL.—As promptly as possible, 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 product may be 
introduced or delivered for introduction 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 product 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
DISTRIBUTION.—An 
order under subparagraph (A)(i) may require that the sale 
and distribution 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 Sec-
retary with respect to such tobacco product, the Secretary finds 
that— 
‘‘(A) there is a lack of a showing that permitting 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 material facts, 
the proposed labeling is false or misleading in any par-
ticular; or 
‘‘(D) such tobacco product is not shown to conform 
in all respects to a tobacco product standard in effect under
H. R. 1256—35 
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 informing the applicant of 
the measures required to remove such application from deniable 
form (which measures may include further research by the 
applicant in accordance with 1 or more protocols prescribed 
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 include 1 or more 
clinical investigations by experts qualified by training and 
experience to evaluate the tobacco product. 
‘‘(B) OTHER
EVIDENCE.—If the Secretary determines 
that there exists valid scientific evidence (other than evi-
dence derived from investigations described in subpara-
graph (A)) which is sufficient to evaluate the tobacco 
product, the Secretary may authorize that the determina-
tion 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 Advisory 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), issue an order withdrawing the order if the Sec-
retary 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 material 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 
applicable regulation under section 909;
H. R. 1256—36 
‘‘(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 requirements of 
section 905; 
‘‘(D) on the basis of new information before the Sec-
retary 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 facilities and controls used for, the manufacture, proc-
essing, packing, or installation of such tobacco product 
do not conform with the requirements of section 906(e) 
and were not brought into conformity with such require-
ments within a reasonable time after receipt of written 
notice from the Secretary of nonconformity; 
‘‘(E) on the basis of new information before the Sec-
retary, evaluated together with the evidence before the 
Secretary when the application was reviewed, that the 
labeling of such tobacco product, based on a fair evaluation 
of all material facts, is false or misleading in any particular 
and was not corrected within a reasonable time after receipt 
of written notice from the Secretary of such fact; or 
‘‘(F) on the basis of new information before the Sec-
retary, evaluated together with the evidence before the 
Secretary when such order was issued, that such tobacco 
product is not shown to conform in all respects to a tobacco 
product standard which is in effect under section 907, 
compliance with which was a condition to the issuance 
of an order relating to the application, and that there 
is a lack of adequate information to justify the deviation 
from such standard. 
‘‘(2) APPEAL.—The holder of an application subject to an 
order issued under paragraph (1) withdrawing an order issued 
pursuant to subsection (c)(1)(A)(i) may, by petition filed on 
or before the 30th day after the date upon which such holder 
receives notice of such withdrawal, obtain review thereof in 
accordance with section 912. 
‘‘(3) TEMPORARY SUSPENSION.—If, after providing an oppor-
tunity for an informal hearing, the Secretary determines there 
is reasonable probability that the continuation of distribution 
of a tobacco product under an order would cause serious, 
adverse health consequences or death, that is greater than 
ordinarily caused by tobacco products on the market, the Sec-
retary shall by order temporarily suspend the authority of 
the manufacturer to market the product. If the Secretary issues 
such an order, the Secretary shall proceed expeditiously under 
paragraph (1) to withdraw such application. 
‘‘(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 applicant’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 order issued pursuant to subsection
H. R. 1256—37 
(c)(1)(A)(i) for 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 Secretary may 
by regulation, or by order with respect to such application, 
prescribe on the basis of a finding that such records and reports 
are necessary in order to enable the Secretary to determine, 
or facilitate a determination of, whether there is or may be 
grounds for withdrawing or temporarily suspending such order. 
‘‘(2) ACCESS TO RECORDS.—Each person required under this 
section to maintain records, and each person in charge of cus-
tody thereof, shall, upon request of an officer or employee 
designated by the Secretary, permit such officer or employee 
at all reasonable times to have access to and copy and verify 
such records. 
‘‘(g) INVESTIGATIONAL
TOBACCO
PRODUCT
EXEMPTION
FOR 
INVESTIGATIONAL USE.—The Secretary may exempt tobacco prod-
ucts intended for investigational use 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 deliver for 
introduction into interstate commerce any modified risk tobacco 
product unless an order issued pursuant to subsection (g) 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 tobacco product that is sold 
or distributed for use to reduce harm or the risk of tobacco- 
related disease associated with commercially marketed tobacco 
products. 
‘‘(2) SOLD OR DISTRIBUTED.— 
‘‘(A) IN GENERAL.—With respect to a tobacco product, 
the term ‘sold or distributed for use to reduce harm or 
the risk of tobacco-related disease associated with commer-
cially marketed tobacco products’ means a tobacco 
product— 
‘‘(i) the label, labeling, or advertising of which rep-
resents explicitly or implicitly that— 
‘‘(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 exposure 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 manufacturer of which 
has taken any action directed to consumers through 
the media or otherwise, other than by means of the 
tobacco product’s label, labeling, or advertising, after 
the date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act, respecting the product
H. R. 1256—38 
that would be reasonably expected to result in con-
sumers believing that the tobacco product 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 consid-
ered to be ‘sold or distributed for use to reduce harm 
or the risk of tobacco-related disease associated with 
commercially marketed tobacco products’, except as 
described in subparagraph (A). 
‘‘(C) SMOKELESS
TOBACCO
PRODUCT.—No smokeless 
tobacco product shall be considered to be ‘sold or distributed 
for use to reduce harm or the risk of tobacco-related disease 
associated with commercially marketed tobacco products’ 
solely because its label, labeling, or advertising uses the 
following phrases to describe such product and its use: 
‘smokeless tobacco’, ‘smokeless tobacco product’, ‘not con-
sumed by smoking’, ‘does not produce smoke’, ‘smokefree’, 
‘smoke-free’, ‘without smoke’, ‘no smoke’, or ‘not smoke’. 
‘‘(3) 
EFFECTIVE
DATE.—The 
provisions 
of 
paragraph 
(2)(A)(ii) shall take effect 12 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act 
for those products whose label, labeling, or advertising contains 
the terms described in such paragraph on such date of enact-
ment. The effective date shall be with respect to the date 
of manufacture, provided that, in any case, beginning 30 days 
after such effective date, a manufacturer shall not introduce 
into the domestic commerce of the United States any product, 
irrespective of the date of manufacture, that is not in conform-
ance with paragraph (2)(A)(ii). 
‘‘(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 if it has been approved as a drug or device 
by the Food and Drug Administration and is subject to the require-
ments of chapter V. 
‘‘(d) FILING.—Any person may file with the Secretary an applica-
tion 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; 
‘‘(5) all documents (including underlying scientific informa-
tion) relating to research findings conducted, supported, or 
possessed by the tobacco product manufacturer relating to the 
effect of the product on tobacco-related diseases and health- 
related conditions, including information both favorable and 
unfavorable to the ability of the product to reduce risk or 
exposure and relating to human health; 
‘‘(6) data and information on how consumers actually use 
the tobacco product; and 
‘‘(7) such other information as the Secretary may require. 
‘‘(e) PUBLIC
AVAILABILITY.—The Secretary shall make the 
application described in subsection (d) publicly available (except