ten or oral authorization of a practitioner licensed 
by law to prescribe medical products. 
‘‘(2) LABEL STATEMENTS.—The label of a to-
bacco product shall bear such appropriate state-
ments of the restrictions required by a regulation 
under subsection (a) as the Secretary may in such 
regulation prescribe. 
‘‘(3) LIMITATIONS.— 
‘‘(A) IN GENERAL.—No restrictions under 
paragraph (1) may— 
‘‘(i) prohibit the sale of any tobacco 
product in face-to-face transactions by a 
specific category of retail outlets; or 
‘‘(ii) establish a minimum age of sale 
of tobacco products to any person older 
than 18 years of age. 
‘‘(B) MATCHBOOKS.—For purposes of any 
regulations issued by the Secretary, matchbooks 
of conventional size containing not more than 
20 paper matches, and which are customarily 
given away for free with the purchase of to-
bacco products, shall be considered as adult- 
written publications which shall be permitted to 
contain advertising. Notwithstanding the pre-
ceding sentence, if the Secretary finds that such 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00055
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
treatment of matchbooks is not appropriate for 
the protection of the public health, the Sec-
retary may determine by regulation that match-
books shall not be considered adult-written pub-
lications. 
‘‘(4) REMOTE SALES.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) within 18 months after the date 
of enactment of the Family Smoking Pre-
vention and Tobacco Control Act, promul-
gate regulations regarding the sale and 
distribution of tobacco products that occur 
through means other than a direct, face-to- 
face exchange between a retailer and a 
consumer in order to prevent the sale and 
distribution of tobacco products to individ-
uals who have not attained the minimum 
age established by applicable law for the 
purchase of such products, including re-
quirements for age verification; and 
‘‘(ii) within 2 years after such date of 
enactment, issue regulations to address the 
promotion and marketing of tobacco prod-
ucts that are sold or distributed through 
means other than a direct, face-to-face ex-
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00056
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
change between a retailer and a consumer 
in order to protect individuals who have 
not attained the minimum age established 
by applicable law for the purchase of such 
products. 
‘‘(B) RELATION TO OTHER AUTHORITY.— 
Nothing in this paragraph limits the authority 
of the Secretary to take additional actions 
under the other paragraphs of this subsection. 
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE-
MENTS.— 
‘‘(1) METHODS, FACILITIES, AND CONTROLS TO 
CONFORM.— 
‘‘(A) IN GENERAL.—In applying manufac-
turing restrictions to tobacco, the Secretary 
shall, in accordance with subparagraph (B), 
prescribe regulations (which may differ based 
on the type of tobacco product involved) requir-
ing that the methods used in, and the facilities 
and controls used for, the manufacture, 
preproduction design validation (including a 
process to assess the performance of a tobacco 
product), packing, and storage of a tobacco 
product conform to current good manufacturing 
practice, or hazard analysis and critical control 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00057
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
point methodology, as prescribed in such regu-
lations to assure that the public health is pro-
tected and that the tobacco product is in com-
pliance with this chapter. Such regulations may 
provide for the testing of raw tobacco for pes-
ticide chemical residues regardless of whether a 
tolerance for such chemical residues has been 
established. 
‘‘(B) 
REQUIREMENTS.—The 
Secretary 
shall— 
‘‘(i) before promulgating any regula-
tion under subparagraph (A), afford the 
Tobacco Products Scientific Advisory Com-
mittee an opportunity to submit rec-
ommendations with respect to the regula-
tion proposed to be promulgated; 
‘‘(ii) before promulgating any regula-
tion under subparagraph (A), afford oppor-
tunity for an oral hearing; 
‘‘(iii) provide the Tobacco Products 
Scientific Advisory Committee a reasonable 
time to make its recommendation with re-
spect to proposed regulations under sub-
paragraph (A); 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00058
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
‘‘(iv) in establishing the effective date 
of a regulation promulgated under this 
subsection, take into account the dif-
ferences in the manner in which the dif-
ferent types of tobacco products have his-
torically been produced, the financial re-
sources of the different tobacco product 
manufacturers, and the state of their exist-
ing manufacturing facilities, and shall pro-
vide for a reasonable period of time for 
such manufacturers to conform to good 
manufacturing practices; and 
‘‘(v) not require any small tobacco 
product manufacturer to comply with a 
regulation under subparagraph (A) for at 
least 4 years following the effective date 
established by the Secretary for such regu-
lation. 
‘‘(2) EXEMPTIONS; VARIANCES.— 
‘‘(A) PETITION.—Any person subject to 
any requirement prescribed under paragraph 
(1) may petition the Secretary for a permanent 
or temporary exemption or variance from such 
requirement. Such a petition shall be submitted 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00059
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
to the Secretary in such form and manner as 
the Secretary shall prescribe and shall— 
‘‘(i) in the case of a petition for an ex-
emption from a requirement, set forth the 
basis for the petitioner’s determination 
that compliance with the requirement is 
not required to assure that the tobacco 
product will be in compliance with this 
chapter; 
‘‘(ii) in the case of a petition for a 
variance from a requirement, set forth the 
methods proposed to be used in, and the 
facilities and controls proposed to be used 
for, the manufacture, packing, and storage 
of the tobacco product in lieu of the meth-
ods, facilities, and controls prescribed by 
the requirement; and 
‘‘(iii) contain such other information 
as the Secretary shall prescribe. 
‘‘(B) REFERRAL TO THE TOBACCO PROD-
UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 
Secretary may refer to the Tobacco Products 
Scientific Advisory Committee any petition sub-
mitted under subparagraph (A). The Tobacco 
Products Scientific Advisory Committee shall 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00060
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
and storage of the tobacco product in lieu 
of the methods, facilities, and controls pre-
scribed by the requirement are sufficient to 
assure that the tobacco product will be in 
compliance with this chapter. 
‘‘(D) CONDITIONS.—An order of the Sec-
retary approving a petition for a variance shall 
prescribe such conditions respecting the meth-
ods used in, and the facilities and controls used 
for, the manufacture, packing, and storage of 
the tobacco product to be granted the variance 
under the petition as may be necessary to as-
sure that the tobacco product will be in compli-
ance with this chapter. 
‘‘(E) HEARING.—After the issuance of an 
order under subparagraph (B) respecting a pe-
tition, the petitioner shall have an opportunity 
for an informal hearing on such order. 
‘‘(3) COMPLIANCE.—Compliance with require-
ments under this subsection shall not be required be-
fore the end of the 3-year period following the date 
of enactment of the Family Smoking Prevention and 
Tobacco Control Act. 
‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary 
may enter into contracts for research, testing, and dem-
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00062
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
onstrations respecting tobacco products and may obtain 
tobacco products for research, testing, and demonstration 
purposes. 
‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 
‘‘(a) IN GENERAL.— 
‘‘(1) SPECIAL RULES.— 
‘‘(A) SPECIAL RULE FOR CIGARETTES.— 
Beginning 3 months after the date of enact-
ment of the Family Smoking Prevention and 
Tobacco Control Act, a cigarette or any of its 
component parts (including the tobacco, filter, 
or paper) shall not contain, as a constituent (in-
cluding a smoke constituent) or additive, an ar-
tificial or natural flavor (other than tobacco or 
menthol) or an herb or spice, including straw-
berry, grape, orange, clove, cinnamon, pine-
apple, vanilla, coconut, licorice, cocoa, chocolate, 
cherry, or coffee, that is a characterizing flavor 
of the tobacco product or tobacco smoke. Noth-
ing in this subparagraph shall be construed to 
limit the Secretary’s authority to take action 
under this section or other sections of this Act 
applicable to menthol or any artificial or nat-
ural flavor, herb, or spice not specified in this 
subparagraph. 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00063
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
‘‘(B) ADDITIONAL SPECIAL RULE.—Begin-
ning 2 years after the date of enactment of the 
Family Smoking Prevention and Tobacco Con-
trol Act, a tobacco product manufacturer shall 
not use tobacco, including foreign grown to-
bacco, that contains a pesticide chemical res-
idue that is at a level greater than is specified 
by any tolerance applicable under Federal law 
to domestically grown tobacco. 
‘‘(2) REVISION OF TOBACCO PRODUCT STAND-
ARDS.—The Secretary may revise the tobacco prod-
uct standards in paragraph (1) in accordance with 
subsection (c). 
‘‘(3) TOBACCO PRODUCT STANDARDS.— 
‘‘(A) IN
GENERAL.—The Secretary may 
adopt tobacco product standards in addition to 
those in paragraph (1) if the Secretary finds 
that a tobacco product standard is appropriate 
for the protection of the public health. 
‘‘(B) DETERMINATIONS.— 
‘‘(i) CONSIDERATIONS.—In making a 
finding described in subparagraph (A), the 
Secretary shall consider scientific evidence 
concerning— 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00064
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
‘‘(I) the risks and benefits to the 
population as a whole, including users 
and nonusers of tobacco products, of 
the proposed standard; 
‘‘(II) the increased or decreased 
likelihood that existing users of to-
bacco products will stop using such 
products; and 
‘‘(III) the increased or decreased 
likelihood that those who do not use 
tobacco products will start using such 
products. 
‘‘(ii) 
ADDITIONAL
CONSIDER-
ATIONS.—In the event that the Secretary 
makes a determination, set forth in a pro-
posed tobacco product standard in a pro-
posed rule, that it is appropriate for the 
protection of public health to require the 
reduction or elimination of an additive, 
constituent (including a smoke constitu-
ent), or other component of a tobacco 
product because the Secretary has found 
that the additive, constituent, or other 
component is or may be harmful, any 
party objecting to the proposed standard 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00065
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
on the ground that the proposed standard 
will not reduce or eliminate the risk of ill-
ness or injury may provide for the Sec-
retary’s consideration scientific evidence 
that demonstrates that the proposed stand-
ard will not reduce or eliminate the risk of 
illness or injury. 
‘‘(4) CONTENT OF TOBACCO PRODUCT STAND-
ARDS.—A tobacco product standard established 
under this section for a tobacco product— 
‘‘(A) shall include provisions that are ap-
propriate for the protection of the public health, 
including provisions, where appropriate— 
‘‘(i) for nicotine yields of the product; 
‘‘(ii) for the reduction or elimination 
of other constituents, including smoke con-
stituents, or harmful components of the 
product; or 
‘‘(iii) relating to any other require-
ment under subparagraph (B); 
‘‘(B) shall, where appropriate for the pro-
tection of the public health, include— 
‘‘(i) provisions respecting the con-
struction, components, ingredients, addi-
tives, constituents, including smoke con-
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00066
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
stituents, and properties of the tobacco 
product; 
‘‘(ii) provisions for the testing (on a 
sample basis or, if necessary, on an indi-
vidual basis) of the tobacco product; 
‘‘(iii) provisions for the measurement 
of the tobacco product characteristics of 
the tobacco product; 
‘‘(iv) provisions requiring that the re-
sults of each or of certain of the tests of 
the tobacco product required to be made 
under clause (ii) show that the tobacco 
product is in conformity with the portions 
of the standard for which the test or tests 
were required; and 
‘‘(v) a provision requiring that the 
sale and distribution of the tobacco prod-
uct be restricted but only to the extent 
that the sale and distribution of a tobacco 
product may be restricted under a regula-
tion under section 906(d); 
‘‘(C) shall, where appropriate, require the 
use and prescribe the form and content of label-
ing for the proper use of the tobacco product; 
and 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00067
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
‘‘(D) shall require tobacco products con-
taining foreign-grown tobacco to meet the same 
standards applicable to tobacco products con-
taining domestically grown tobacco. 
‘‘(5) PERIODIC
REEVALUATION
OF
TOBACCO 
PRODUCT STANDARDS.—The Secretary shall provide 
for periodic evaluation of tobacco product standards 
established under this section to determine whether 
such standards should be changed to reflect new 
medical, scientific, or other technological data. The 
Secretary may provide for testing under paragraph 
(4)(B) by any person. 
‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN-
FORMED
PERSONS.—In carrying out duties under 
this section, the Secretary shall endeavor to— 
‘‘(A) use personnel, facilities, and other 
technical support available in other Federal 
agencies; 
‘‘(B) consult with other Federal agencies 
concerned with standard setting and other na-
tionally or internationally recognized standard- 
setting entities; and 
‘‘(C) 
invite 
appropriate 
participation, 
through joint or other conferences, workshops, 
or other means, by informed persons represent-
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00068
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
ative of scientific, professional, industry, agri-
cultural, or consumer organizations who in the 
Secretary’s judgment can make a significant 
contribution. 
‘‘(b) CONSIDERATIONS BY SECRETARY.— 
‘‘(1) TECHNICAL
ACHIEVABILITY.—The Sec-
retary shall consider information submitted in con-
nection with a proposed standard regarding the tech-
nical achievability of compliance with such standard. 
‘‘(2) OTHER CONSIDERATIONS.—The Secretary 
shall consider all other information submitted in 
connection with a proposed standard, including in-
formation concerning the countervailing effects of 
the tobacco product standard on the health of ado-
lescent tobacco users, adult tobacco users, or non-
tobacco users, such as the creation of a significant 
demand for contraband or other tobacco products 
that do not meet the requirements of this chapter 
and the significance of such demand. 
‘‘(c) PROPOSED STANDARDS.— 
‘‘(1) IN GENERAL.—The Secretary shall publish 
in the Federal Register a notice of proposed rule-
making for the establishment, amendment, or rev-
ocation of any tobacco product standard. 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00069
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
‘‘(2) REQUIREMENTS OF NOTICE.—A notice of 
proposed rulemaking for the establishment or 
amendment of a tobacco product standard for a to-
bacco product shall— 
‘‘(A) set forth a finding with supporting 
justification that the tobacco product standard 
is appropriate for the protection of the public 
health; 
‘‘(B) invite interested persons to submit a 
draft or proposed tobacco product standard for 
consideration by the Secretary; 
‘‘(C) invite interested persons to submit 
comments on structuring the standard so that 
it does not advantage foreign-grown tobacco 
over domestically grown tobacco; and 
‘‘(D) invite the Secretary of Agriculture to 
provide any information or analysis which the 
Secretary of Agriculture believes is relevant to 
the proposed tobacco product standard. 
‘‘(3) FINDING.—A notice of proposed rule-
making for the revocation of a tobacco product 
standard shall set forth a finding with supporting 
justification that the tobacco product standard is no 
longer appropriate for the protection of the public 
health. 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00070
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
‘‘(4) COMMENT.—The Secretary shall provide 
for a comment period of not less than 60 days. 
‘‘(d) PROMULGATION.— 
‘‘(1) IN GENERAL.—After the expiration of the 
period for comment on a notice of proposed rule-
making published under subsection (c) respecting a 
tobacco product standard and after consideration of 
comments submitted under subsections (b) and (c) 
and any report from the Tobacco Products Scientific 
Advisory Committee, the Secretary shall— 
‘‘(A) if the Secretary determines that the 
standard would be appropriate for the protec-
tion of the public health, promulgate a regula-
tion establishing a tobacco product standard 
and publish in the Federal Register findings on 
the matters referred to in subsection (c); or 
‘‘(B) publish a notice terminating the pro-
ceeding for the development of the standard to-
gether with the reasons for such termination. 
‘‘(2) EFFECTIVE
DATE.—A regulation estab-
lishing a tobacco product standard shall set forth 
the date or dates upon which the standard shall take 
effect, but no such regulation may take effect before 
1 year after the date of its publication unless the 
Secretary determines that an earlier effective date is 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00071
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
necessary for the protection of the public health. 
Such date or dates shall be established so as to min-
imize, consistent with the public health, economic 
loss to, and disruption or dislocation of, domestic 
and international trade. In establishing such effec-
tive date or dates, the Secretary shall consider infor-
mation submitted in connection with a proposed 
product standard by interested parties, including 
manufacturers and tobacco growers, regarding the 
technical achievability of compliance with the stand-
ard, and including information concerning the exist-
ence of patents that make it impossible to comply in 
the timeframe envisioned in the proposed standard. 
If the Secretary determines, based on the Sec-
retary’s evaluation of submitted comments, that a 
product standard can be met only by manufacturers 
requiring substantial changes to the methods of 
farming the domestically grown tobacco used by the 
manufacturer, the effective date of that product 
standard shall be not less than 2 years after the 
date of publication of the final regulation estab-
lishing the standard. 
‘‘(3) LIMITATION ON POWER GRANTED TO THE 
FOOD AND DRUG ADMINISTRATION.—Because of the 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00072
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
importance of a decision of the Secretary to issue a 
regulation— 
‘‘(A) banning all cigarettes, all smokeless 
tobacco products, all little cigars, all cigars 
other than little cigars, all pipe tobacco, or all 
roll-your-own tobacco products; or 
‘‘(B) requiring the reduction of nicotine 
yields of a tobacco product to zero, 
the Secretary is prohibited from taking such actions 
under this Act. 
‘‘(4) AMENDMENT; REVOCATION.— 
‘‘(A) AUTHORITY.—The Secretary, upon 
the Secretary’s own initiative or upon petition 
of an interested person, may by a regulation, 
promulgated in accordance with the require-
ments of subsection (c) and paragraph (2), 
amend or revoke a tobacco product standard. 
‘‘(B) EFFECTIVE
DATE.—The Secretary 
may declare a proposed amendment of a to-
bacco product standard to be effective on and 
after its publication in the Federal Register and 
until the effective date of any final action taken 
on such amendment if the Secretary determines 
that making it so effective is in the public inter-
est. 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00073
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
such use among African Americans, Hispanics, and 
other racial and ethnic minorities. In its review, the 
Tobacco Products Scientific Advisory Committee 
shall address the considerations listed in subsections 
(a)(3)(B)(i) and (b). 
‘‘(2) REPORT
AND
RECOMMENDATION.—Not 
later than 1 year after its establishment, the To-
bacco Product Scientific Advisory Committee shall 
submit to the Secretary the report and recommenda-
tions required pursuant to paragraph (1). 
‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to limit the Sec-
retary’s authority to take action under this section 
or other sections of this Act applicable to menthol. 
‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES. 
‘‘(a) NOTIFICATION.—If the Secretary determines 
that— 
‘‘(1) a tobacco product which is introduced or 
delivered for introduction into interstate commerce 
for commercial distribution presents an unreasonable 
risk of substantial harm to the public health; and 
‘‘(2) notification under this subsection is nec-
essary to eliminate the unreasonable risk of such 
harm and no more practicable means is available 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00076
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
under the provisions of this chapter (other than this 
section) to eliminate such risk, 
the Secretary may issue such order as may be necessary 
to assure that adequate notification is provided in an ap-
propriate form, by the persons and means best suited 
under the circumstances involved, to all persons who 
should properly receive such notification in order to elimi-
nate such risk. The Secretary may order notification by 
any appropriate means, including public service announce-
ments. 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-
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00077
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
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-
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 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00078
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
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)— 
‘‘(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). 
‘‘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-
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00079
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
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— 
‘‘(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; 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00080
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
‘‘(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 
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 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00081
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
Smoking Prevention 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 equiva-
lent’ or ‘substantial equivalence’ 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— 
‘‘(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-
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00085
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
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. 
‘‘(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 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00086
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
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 
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; 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00087
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
‘‘(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 
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, 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00088
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
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 
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-
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00089
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
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 
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); 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00090
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS
109 
‘‘(2) COMPARATIVE CLAIMS.— 
‘‘(A) IN GENERAL.—The Secretary may re-
quire for the marketing of a product under this 
subsection that a claim comparing a tobacco 
product to 1 or more other commercially mar-
keted tobacco products shall compare the to-
bacco product to a commercially marketed to-
bacco product that is representative of that type 
of tobacco product on the market (for example 
the average value of the top 3 brands of an es-
tablished regular tobacco product). 
‘‘(B) QUANTITATIVE
COMPARISONS.—The 
Secretary may also require, for purposes of sub-
paragraph (A), that the percent (or fraction) of 
change and identity of the reference tobacco 
product and a quantitative comparison of the 
amount of the substance claimed to be reduced 
shall be stated in immediate proximity to the 
most prominent claim. 
‘‘(3) LABEL DISCLOSURE.— 
‘‘(A) IN GENERAL.—The Secretary may re-
quire the disclosure on the label of other sub-
stances in the tobacco product, or substances 
that may be produced by the consumption of 
that tobacco product, that may affect a disease 
VerDate Nov 24 2008 
23:29 Mar 27, 2009
Jkt 079200
PO 00000
Frm 00109
Fmt 6652
Sfmt 6201
E:\BILLS\H1256.RH
H1256
jbell on PROD1PC69 with BILLS