and storage of the tobacco product in lieu 
of the methods, controls, and facilities 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 period ending 3 years after the date of en-
actment of the Family Smoking Prevention and To-
bacco Control Act. 
‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary 
may enter into contracts for research, testing, and dem-
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onstrations respecting tobacco products and may obtain 
tobacco products for research, testing, and demonstration 
purposes without regard to section 3324(a) and (b) of title 
31, United States Code, and section 5 of title 41, United 
States Code. 
‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 
‘‘(a) IN GENERAL.— 
‘‘(1) SPECIAL RULE FOR CIGARETTES.—A ciga-
rette or any of its component parts (including the 
tobacco, filter, or paper) shall not contain, as a con-
stituent (including a smoke constituent) or additive, 
an artificial or natural flavor (other than tobacco or 
menthol) or an herb or spice, including strawberry, 
grape, orange, clove, cinnamon, pineapple, vanilla, 
coconut, licorice, cocoa, chocolate, cherry, or coffee, 
that is a characterizing flavor of the tobacco product 
or tobacco smoke. Nothing 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 
natural flavor, herb, or spice not specified in this 
paragraph. 
‘‘(2) REVISION OF TOBACCO PRODUCT STAND-
ARDS.—The Secretary may revise the tobacco prod-
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uct standards in paragraph (1) in accordance with 
subsection (b). 
‘‘(3) TOBACCO
PRODUCT
STANDARDS.—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. This finding 
shall be determined with respect to the risks and 
benefits to the population as a whole, including 
users and non-users of the tobacco product, and tak-
ing 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. 
‘‘(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 the reduction of nicotine 
yields of the product; 
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‘‘(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 (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-
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 
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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); and 
‘‘(C) shall, where appropriate, require the 
use and prescribe the form and content of label-
ing for the proper use of the tobacco product. 
‘‘(5) PERIODIC
RE-EVALUATION
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; 
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‘‘(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-
ative of scientific, professional, industry, agri-
cultural, or consumer organizations who in the 
Secretary’s judgment can make a significant 
contribution. 
‘‘(b) ESTABLISHMENT OF STANDARDS.— 
‘‘(1) NOTICE.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
publish in the Federal Register a notice of pro-
posed rulemaking for the establishment, amend-
ment, or revocation of any tobacco product 
standard. 
‘‘(B) REQUIREMENTS OF NOTICE.—A no-
tice of proposed rulemaking for the establish-
ment or amendment of a tobacco product stand-
ard for a tobacco product shall— 
‘‘(i) set forth a finding with sup-
porting justification that the tobacco prod-
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uct standard is appropriate for the protec-
tion of the public health; 
‘‘(ii) set forth proposed findings with 
respect to the risk of illness or injury that 
the tobacco product standard is intended 
to reduce or eliminate; and 
‘‘(iii) invite interested persons to sub-
mit an existing tobacco product standard 
for the tobacco product, including a draft 
or proposed tobacco product standard, for 
consideration by the Secretary. 
‘‘(C) STANDARD.—Upon a determination 
by the Secretary that an additive, constituent 
(including smoke constituent), or other compo-
nent of the product that is the subject of the 
proposed tobacco product standard is harmful, 
it shall be the burden of any party challenging 
the proposed standard to prove that the pro-
posed standard will not reduce or eliminate the 
risk of illness or injury. 
‘‘(D) FINDING.—A notice of proposed rule-
making for the revocation of a tobacco product 
standard shall set forth a finding with sup-
porting justification that the tobacco product 
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standard is no longer appropriate for the pro-
tection of the public health. 
‘‘(E) CONSIDERATION
BY
SECRETARY.— 
The Secretary shall consider all information 
submitted in connection with a proposed stand-
ard, including information concerning the coun-
tervailing effects of the tobacco product stand-
ard on the health of adolescent tobacco users, 
adult tobacco users, or non-tobacco users, such 
as the creation of a significant demand for con-
traband or other tobacco products that do not 
meet the requirements of this chapter and the 
significance of such demand, and shall issue the 
standard if the Secretary determines that the 
standard would be appropriate for the protec-
tion of the public health. 
‘‘(F) COMMENT.—The Secretary shall pro-
vide for a comment period of not less than 60 
days. 
‘‘(2) PROMULGATION.— 
‘‘(A) IN GENERAL.—After the expiration of 
the period for comment on a notice of proposed 
rulemaking published under paragraph (1) re-
specting a tobacco product standard and after 
consideration of such comments and any report 
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100 
from the Tobacco Products Scientific Advisory 
Committee, the Secretary shall— 
‘‘(i) promulgate a regulation estab-
lishing a tobacco product standard and 
publish in the Federal Register findings on 
the matters referred to in paragraph (1); 
or 
‘‘(ii) publish a notice terminating the 
proceeding for the development of the 
standard together with the reasons for 
such termination. 
‘‘(B) EFFECTIVE DATE.—A regulation es-
tablishing 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 necessary for 
the protection of the public health. Such date or 
dates shall be established so as to minimize, 
consistent with the public health, economic loss 
to, and disruption or dislocation of, domestic 
and international trade. 
‘‘(3) POWER
RESERVED
TO
CONGRESS.—Be-
cause of the importance of a decision of the Sec-
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101 
retary to issue a regulation establishing a tobacco 
product standard— 
‘‘(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, 
Congress expressly reserves to itself such power. 
‘‘(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 paragraphs (1) and (2)(B), 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. 
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102 
‘‘(5) REFERENCE TO ADVISORY COMMITTEE.— 
The Secretary may— 
‘‘(A) on the Secretary’s own initiative, 
refer a proposed regulation for the establish-
ment, amendment, or revocation of a tobacco 
product standard; or 
‘‘(B) upon the request of an interested per-
son which demonstrates good cause for referral 
and which is made before the expiration of the 
period for submission of comments on such pro-
posed regulation, refer such proposed regulation 
to the Tobacco Products Scientific Advisory 
Committee, for a report and recommendation 
with respect to any matter involved in the pro-
posed regulation which requires the exercise of 
scientific judgment. If a proposed regulation is 
referred under this paragraph to the Tobacco 
Products Scientific Advisory Committee, the 
Secretary shall provide the advisory committee 
with the data and information on which such 
proposed regulation is based. The Tobacco 
Products Scientific Advisory Committee shall, 
within 60 days after the referral of a proposed 
regulation and after independent study of the 
data and information furnished to it by the Sec-
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103 
retary and other data and information before it, 
submit to the Secretary a report and rec-
ommendation respecting such regulation, to-
gether with all underlying data and information 
and a statement of the reason or basis for the 
recommendation. A copy of such report and rec-
ommendation shall be made public by the Sec-
retary. 
‘‘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 
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 appropriate 
form, by the persons and means best suited under 
the circumstances involved, to all persons who 
should properly receive such notification in order to 
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