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21 U.S.C. § 391 — Separability clause
Federal law — U.S. Code and appendices · legal_authorities
If any provision of this chapter is declared unconstitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the chapter and the applicability thereof to other persons and circumstances shall not be affected thereby.
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Source location: Title 21, Chapter 9, § 391; chapter-009-federal-food-drug-and-cosmetic-act.md
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If any provision of this chapter is declared unconstitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the chapter and the applicability thereof to other persons and circumstances shall not be affected thereby.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** Tobacco products, including modified risk tobacco products for which an order has been issued in accordance with [section 387k of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387k&num=0&edition=prelim), shall be regulated by the Secretary under this subchapter and shall not be subject to the provisions of subchapter V.
**(b) Applicability** This subchapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this subchapter. This subchapter shall also apply to any tobacco product containing nicotine that is not made or derived from tobacco.
**(c) Scope**
(1) **In general** — Nothing in this subchapter, or any policy issued or regulation promulgated thereunder, or in sections 101(a), 102, or 103 of title I, title II, or title III of the Family Smoking Prevention and Tobacco Control Act, shall be construed to affect, expand, or limit the Secretary’s authority over (including the authority to determine whether products may be regulated), or the regulation of, products under this chapter that are not tobacco products under subchapter V or any other subchapter.
(2) **Limitation of authority**
(A) *In general* — The provisions of this subchapter shall not apply to tobacco leaf that is not in the possession of a manufacturer of tobacco products, or to the producers of tobacco leaf, including tobacco growers, tobacco warehouses, and tobacco grower cooperatives, nor shall any employee of the Food and Drug Administration have any authority to enter onto a farm owned by a producer of tobacco leaf without the written consent of such producer.
(B) *Exception* — Notwithstanding subpa
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387a
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Federal law — U.S. Code and appendices · legal_authorities
Page 700
TITLE 21—FOOD AND DRUGS
§ 391
(D) Communications.
(E) Leadership, management oversight,
and administrative services.
(F) Related overhead activities.
(5) The numbers of applications, categorized
by class of tobacco product and review path-
way under sections 387e, 387j, and 387k of this
title, that were—
(A) submitted;
(B) pending;
(C) accepted;
(D) refused to file;
(E) withdrawn;
(F) denied;
(G) authorized for marketing under an
order;
(H) issued a deficiency letter or environ-
mental information request letter; or
(I) referred to the Tobacco Products Sci-
entific Advisory Committee.
(6) The number and titles of draft and final
guidance documents and proposed and final
regulations issued on topics related to the
process for the review of tobacco product ap-
plications, whether such regulations and guid-
ance documents were issued as required by
statute or by other legal or regulatory re-
quirements, and whether the issuance met the
deadlines set forth by the applicable statute or
other requirements.
(7) The number and titles of public meetings
related to the review of tobacco product appli-
cations by the Center for Tobacco Products or
other offices or centers within the Food and
Drug Administration.
(8) The number of pre-submission meetings
relating to applications under section 387j of
this title, including the number of meeting re-
quests received, the number of meetings held,
and the median amount of time between when
such meeting requests were made and when
the requests were granted or denied.
(9) The number of full-time equivalent em-
ployees funded pursuant to fees collected
under section 387s of this title, including iden-
tification of the centers and offices within the
Food and Drug Administration in which such
posit
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 391
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