H. R. 1256—21 
‘‘(2) the period within which interested persons may present 
their comments on the notice or findings (including the need 
therefore) orally or in writing, which period shall be at least 
60 days but may not exceed 90 days unless the time is extended 
by the Secretary by a notice published in the Federal Register 
stating good cause therefore. 
‘‘(c) LIMITED CONFIDENTIALITY OF INFORMATION.—Any informa-
tion reported to or otherwise obtained by the Secretary or the 
Secretary’s representative under section 903, 904, 907, 908, 909, 
910, 911, or 704, or under subsection (e) or (f) of this section, 
which is exempt from disclosure under subsection (a) of section 
552 of title 5, United States Code, by reason of subsection (b)(4) 
of that section shall be considered confidential and shall not be 
disclosed, except that the information may be disclosed to other 
officers or employees concerned with carrying out this chapter, 
or when relevant in any proceeding under this chapter. 
‘‘(d) RESTRICTIONS.— 
‘‘(1) IN GENERAL.—The Secretary may by regulation require 
restrictions on the sale and distribution of a tobacco product, 
including restrictions on the access to, and the advertising 
and promotion of, the tobacco product, if the Secretary deter-
mines that such regulation would be appropriate for the protec-
tion of the public health. The Secretary may by regulation 
impose restrictions on the advertising and promotion of a 
tobacco product consistent with and to full extent permitted 
by the first amendment to the Constitution. The finding as 
to whether such regulation would be appropriate for the protec-
tion 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. 
No such regulation may require that the sale or distribution 
of a tobacco product be limited to the written or oral authoriza-
tion of a practitioner licensed by law to prescribe medical 
products. 
‘‘(2) LABEL STATEMENTS.—The label of a tobacco product 
shall bear such appropriate statements 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
H. R. 1256—22 
of tobacco products, shall be considered as adult-written 
publications which shall be permitted to contain adver-
tising. Notwithstanding the preceding sentence, if the Sec-
retary finds that such treatment of matchbooks is not 
appropriate for the protection of the public health, the 
Secretary may determine by regulation that matchbooks 
shall not be considered adult-written publications. 
‘‘(4) REMOTE SALES.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) within 18 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control 
Act, promulgate 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 estab-
lished by applicable law for the purchase of such prod-
ucts, including requirements for age verification; and 
‘‘(ii) within 2 years after such date of enactment, 
issue regulations to address the promotion and mar-
keting of tobacco products that are sold or distributed 
through means other than a direct, face-to-face 
exchange between a retailer and a consumer in order 
to protect individuals who have not attained the min-
imum age established by applicable law for the pur-
chase 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 sub-
section. 
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIREMENTS.— 
‘‘(1) METHODS, FACILITIES, AND CONTROLS TO CONFORM.— 
‘‘(A) IN GENERAL.—In applying manufacturing restric-
tions to tobacco, the Secretary shall, in accordance with 
subparagraph (B), prescribe regulations (which may differ 
based on the type of tobacco product involved) requiring 
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 point methodology, as prescribed in 
such regulations to assure that the public health is pro-
tected and that the tobacco product is in compliance with 
this chapter. Such regulations may provide for the testing 
of raw tobacco for pesticide chemical residues regardless 
of whether a tolerance for such chemical residues has been 
established. 
‘‘(B) REQUIREMENTS.—The Secretary shall— 
‘‘(i) before promulgating any regulation under 
subparagraph (A), afford the Tobacco Products Sci-
entific Advisory Committee an opportunity to submit 
recommendations with respect to the regulation pro-
posed to be promulgated;
H. R. 1256—23 
‘‘(ii) before promulgating any regulation under 
subparagraph (A), afford opportunity for an oral 
hearing; 
‘‘(iii) provide the Tobacco Products Scientific 
Advisory Committee a reasonable time to make its 
recommendation with respect to proposed regulations 
under subparagraph (A); 
‘‘(iv) in establishing the effective date of a regula-
tion promulgated under this subsection, take into 
account the differences in the manner in which the 
different types of tobacco products have historically 
been produced, the financial resources of the different 
tobacco product manufacturers, and the state of their 
existing manufacturing facilities, and shall provide for 
a reasonable period of time for such manufacturers 
to conform to good manufacturing practices; and 
‘‘(v) not require any small tobacco product manu-
facturer to comply with a regulation under subpara-
graph (A) for at least 4 years following the effective 
date established by the Secretary for such regulation. 
‘‘(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 to 
the Secretary in such form and manner as the Secretary 
shall prescribe and shall— 
‘‘(i) in the case of a petition for an exemption 
from a requirement, set forth the basis for the peti-
tioner’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 methods, facilities, 
and controls prescribed by the requirement; and 
‘‘(iii) contain such other information as the Sec-
retary shall prescribe. 
‘‘(B) REFERRAL TO THE TOBACCO PRODUCTS SCIENTIFIC 
ADVISORY
COMMITTEE.—The Secretary may refer to the 
Tobacco Products Scientific Advisory Committee any peti-
tion submitted under subparagraph (A). The Tobacco Prod-
ucts Scientific Advisory Committee shall report its rec-
ommendations to the Secretary with respect to a petition 
referred to it within 60 days after the date of the petition’s 
referral. Within 60 days after— 
‘‘(i) the date the petition was submitted to the 
Secretary under subparagraph (A); or 
‘‘(ii) the day after the petition was referred to 
the Tobacco Products Scientific Advisory Committee, 
whichever occurs later, the Secretary shall by order either 
deny the petition or approve it. 
‘‘(C) APPROVAL.—The Secretary may approve— 
‘‘(i) a petition for an exemption for a tobacco 
product from a requirement if the Secretary determines
H. R. 1256—24 
that compliance with such requirement is not required 
to assure that the tobacco product will be in compliance 
with this chapter; and 
‘‘(ii) a petition for a variance for a tobacco product 
from a requirement if the Secretary determines that 
the methods to be used in, and the facilities and con-
trols to be used for, the manufacture, packing, and 
storage of the tobacco product in lieu of the methods, 
facilities, and controls prescribed by the requirement 
are sufficient to assure that the tobacco product will 
be in compliance with this chapter. 
‘‘(D) CONDITIONS.—An order of the Secretary approving 
a petition for a variance shall prescribe such conditions 
respecting the methods used in, and the facilities and con-
trols used for, the manufacture, packing, and storage of 
the tobacco product to be granted the variance under the 
petition as may be necessary to assure that the tobacco 
product will be in compliance with this chapter. 
‘‘(E) HEARING.—After the issuance of an order under 
subparagraph (B) respecting a petition, the petitioner shall 
have an opportunity for an informal hearing on such order. 
‘‘(3) COMPLIANCE.—Compliance with requirements under 
this subsection shall not be required before 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 demonstrations 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 enactment 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 (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, pine-
apple, 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 subparagraph. 
‘‘(B) ADDITIONAL
SPECIAL
RULE.—Beginning 2 years 
after the date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act, a tobacco product manufac-
turer shall not use tobacco, including foreign grown tobacco, 
that contains a pesticide chemical residue that is at a 
level greater than is specified by any tolerance applicable 
under Federal law to domestically grown tobacco.
H. R. 1256—25 
‘‘(2) REVISION OF TOBACCO PRODUCT STANDARDS.—The Sec-
retary may revise the tobacco product 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 con-
sider scientific evidence concerning— 
‘‘(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 tobacco 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
CONSIDERATIONS.—In the event 
that the Secretary makes a determination, set forth 
in a proposed tobacco product standard in a proposed 
rule, that it is appropriate for the protection of public 
health to require the reduction or elimination of an 
additive, constituent (including a smoke constituent), 
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 on the ground that 
the proposed standard will not reduce or eliminate 
the risk of illness or injury may provide for the Sec-
retary’s consideration scientific evidence that dem-
onstrates that the proposed standard will not reduce 
or eliminate the risk of illness or injury. 
‘‘(4) CONTENT OF TOBACCO PRODUCT STANDARDS.—A tobacco 
product standard established under this section for a tobacco 
product— 
‘‘(A) shall include provisions that are appropriate 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 constituents, or harmful 
components of the product; or 
‘‘(iii) relating to any other requirement under 
subparagraph (B); 
‘‘(B) shall, where appropriate for the protection of the 
public health, include— 
‘‘(i) provisions respecting the construction, compo-
nents, ingredients, additives, constituents, including 
smoke constituents, and properties of the tobacco 
product; 
‘‘(ii) provisions for the testing (on a sample basis 
or, if necessary, on an individual basis) of the tobacco 
product;
H. R. 1256—26 
‘‘(iii) provisions for the measurement of the tobacco 
product characteristics of the tobacco product; 
‘‘(iv) provisions requiring that the results 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 dis-
tribution 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); 
‘‘(C) shall, where appropriate, require the use and pre-
scribe the form and content of labeling for the proper 
use of the tobacco product; and 
‘‘(D) shall require tobacco products containing foreign- 
grown tobacco to meet the same standards applicable to 
tobacco products containing domestically grown tobacco. 
‘‘(5) PERIODIC REEVALUATION OF TOBACCO PRODUCT STAND-
ARDS.—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 Sec-
retary may provide for testing under paragraph (4)(B) by any 
person. 
‘‘(6) INVOLVEMENT
OF
OTHER
AGENCIES; INFORMED
PER-
SONS.—In carrying out duties under this section, the Secretary 
shall endeavor to— 
‘‘(A) use personnel, facilities, and other technical sup-
port available in other Federal agencies; 
‘‘(B) consult with other Federal agencies concerned with 
standard setting and other nationally or internationally 
recognized standard-setting entities; and 
‘‘(C) invite appropriate participation, through joint or 
other conferences, workshops, or other means, by informed 
persons representative of scientific, professional, industry, 
agricultural, or consumer organizations who in the Sec-
retary’s judgment can make a significant contribution. 
‘‘(b) CONSIDERATIONS BY SECRETARY.— 
‘‘(1) TECHNICAL ACHIEVABILITY.—The Secretary shall con-
sider information submitted in connection with a proposed 
standard regarding the technical achievability of compliance 
with such standard. 
‘‘(2) OTHER CONSIDERATIONS.—The Secretary shall consider 
all other information submitted in connection with a proposed 
standard, including information concerning the countervailing 
effects of the tobacco product standard on the health of adoles-
cent tobacco users, adult tobacco users, or nontobacco 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 Fed-
eral Register a notice of proposed rulemaking for the establish-
ment, amendment, or revocation of any tobacco product 
standard.
H. R. 1256—27 
‘‘(2) REQUIREMENTS OF NOTICE.—A notice of proposed rule-
making for the establishment or amendment of a tobacco 
product standard for a tobacco 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 rulemaking 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. 
‘‘(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 rulemaking 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 protection of the public health, 
promulgate a regulation 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 proceeding for 
the development of the standard together with the reasons 
for such termination. 
‘‘(2) EFFECTIVE DATE.—A regulation establishing 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 nec-
essary 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. In establishing such effec-
tive date or dates, the Secretary shall consider information 
submitted in connection with a proposed product standard by 
interested parties, including manufacturers and tobacco 
growers, regarding the technical achievability of compliance 
with the standard, and including information concerning the 
existence of patents that make it impossible to comply in the 
timeframe envisioned in the proposed standard. If the Secretary 
determines, based on the Secretary’s evaluation of submitted 
comments, that a product standard can be met only by manufac-
turers requiring substantial changes to the methods of farming 
the domestically grown tobacco used by the manufacturer, the
H. R. 1256—28 
effective date of that product standard shall be not less than 
2 years after the date of publication of the final regulation 
establishing the standard. 
‘‘(3) LIMITATION
ON
POWER
GRANTED
TO
THE
FOOD
AND 
DRUG ADMINISTRATION.—Because of the importance of a decision 
of the Secretary to issue a regulation— 
‘‘(A) banning all cigarettes, all smokeless tobacco prod-
ucts, 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 
requirements 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 tobacco 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 interest. 
‘‘(5) REFERRAL TO ADVISORY COMMITTEE.— 
‘‘(A) IN GENERAL.—The Secretary may refer a proposed 
regulation for the establishment, amendment, or revocation 
of a tobacco product standard to the Tobacco Products 
Scientific Advisory Committee for a report and rec-
ommendation with respect to any matter involved in the 
proposed regulation which requires the exercise of scientific 
judgment. 
‘‘(B) INITIATION
OF
REFERRAL.—The Secretary may 
make a referral under this paragraph— 
‘‘(i) on the Secretary’s own initiative; or 
‘‘(ii) upon the request of an interested person 
that— 
‘‘(I) demonstrates good cause for the referral; 
and 
‘‘(II) is made before the expiration of the period 
for submission of comments on the proposed regu-
lation. 
‘‘(C) PROVISION OF DATA.—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. 
‘‘(D) REPORT
AND
RECOMMENDATION.—The Tobacco 
Products Scientific Advisory Committee shall, within 60 
days after the referral of a proposed regulation under this 
paragraph and after independent study of the data and 
information furnished to it by the Secretary and other 
data and information before it, submit to the Secretary 
a report and recommendation respecting such regulation, 
together with all underlying data and information and 
a statement of the reason or basis for the recommendation.
H. R. 1256—29 
‘‘(E) PUBLIC AVAILABILITY.—The Secretary shall make 
a copy of each report and recommendation under subpara-
graph (D) publicly available. 
‘‘(e) MENTHOL CIGARETTES.— 
‘‘(1) REFERRAL; CONSIDERATIONS.—Immediately upon the 
establishment of the Tobacco Products Scientific Advisory Com-
mittee under section 917(a), the Secretary shall refer to the 
Committee for report and recommendation, under section 
917(c)(4), the issue of the impact of the use of menthol in 
cigarettes on the public health, including such use among chil-
dren, 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 Tobacco Product Scientific Advisory 
Committee shall submit to the Secretary the report and rec-
ommendations required pursuant to paragraph (1). 
‘‘(3) RULE OF CONSTRUCTION.—Nothing in this subsection 
shall be construed to limit the Secretary’s authority to take 
action under this section or other sections of this Act applicable 
to menthol. 
‘‘(f) DISSOLVABLE TOBACCO PRODUCTS.— 
‘‘(1) REFERRAL; CONSIDERATIONS.—The Secretary shall refer 
to the Tobacco Products Scientific Advisory Committee for 
report and recommendation, under section 917(c)(4), the issue 
of the nature and impact of the use of dissolvable tobacco 
products on the public health, including such use among chil-
dren. In its review, the Tobacco Products Scientific Advisory 
Committee shall address the considerations listed in subsection 
(a)(3)(B)(i). 
‘‘(2) REPORT
AND
RECOMMENDATION.—Not later than 2 
years after its establishment, the Tobacco Product Scientific 
Advisory Committee shall submit to the Secretary the report 
and recommendations required pursuant to paragraph (1). 
‘‘(3) RULE OF CONSTRUCTION.—Nothing in this subsection 
shall be construed to limit the Secretary’s authority to take 
action under this section or other sections of this Act at any 
time applicable to any dissolvable tobacco product. 
‘‘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 dis-
tribution presents an unreasonable risk of substantial harm 
to the public health; and 
‘‘(2) notification under this subsection is necessary to elimi-
nate the unreasonable risk of such harm and no more prac-
ticable 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 eliminate such risk. The Secretary may order notification 
by any appropriate means, including public service announcements.