U.S Code last checked for updates: Oct 17, 2024
All TitlesTitle 21Chapter 9Subchapter IX
§ 387g.
Tobacco product standards
(a)
In general
(1)
Special rules
(A)
Special rule for cigarettes
(B)
Additional special rule
(2)
Revision of tobacco product standards
(3)
Tobacco product standards
(A)
In general
(B)
Determinations
(i)
Considerations
In making a finding described in subparagraph (A), the Secretary shall consider 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
(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, components, 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;
(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 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 387f(d) of this title;
(C)
shall, where appropriate, require the use and prescribe 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 standards
(6)
Involvement of other agencies; informed 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 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 Secretary’s judgment can make a significant contribution.
(b)
Considerations by Secretary
(1)
Technical achievability
(2)
Other considerations
(c)
Proposed standards
(1)
In general
(2)
Requirements of notice
A notice of proposed rulemaking 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
(4)
Comment
(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
(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 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 chapter.
(4)
Amendment; revocation
(A)
Authority
(B)
Effective date
(5)
Referral to Advisory Committee
(A)
In general
(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 regulation.
(C)
Provision of data
(D)
Report and recommendation
(E)
Public availability
(e)
Menthol cigarettes
(1)
Referral; considerations
(2)
Report and recommendation
(3)
Rule of construction
(f)
Dissolvable tobacco products
(1)
Referral; considerations
(2)
Report and recommendation
(3)
Rule of construction
(June 25, 1938, ch. 675, § 907, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1799; amended Pub. L. 117–103, div. P, title I, § 111(f), Mar. 15, 2022, 136 Stat. 790.)
cite as: 21 USC 387g
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