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21 U.S.C. § 387t — Labeling, recordkeeping, records inspection

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 387t — Labeling, recordkeeping, records inspection

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Stable record: federal_law:legal_authorities:record_usc_4e7852c429207cb57ff23f33
Source file: Laws/federal/codes/united-states-code/title-21/section-387t-labeling-recordkeeping-records-inspection--592f59a59c.md
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Source location: Title 21, Chapter 9, § 387t; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) Origin labeling** (1) **Requirement** — Beginning 1 year after June 22, 2009, the label, packaging, and shipping containers of tobacco products other than cigarettes for introduction or delivery for introduction into interstate commerce in the United States shall bear the statement “sale only allowed in the United States”. Beginning 15 months after the issuance of the regulations required by [section 1333(d) of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1333/d&num=0&edition=prelim), as amended by section 201 of Family 11 So in original. Probably should be “the Family”. Smoking Prevention and Tobacco Control Act, the label, packaging, and shipping containers of cigarettes for introduction or delivery for introduction into interstate commerce in the United States shall bear the statement “Sale only allowed in the United States”. (2) **Effective date** — The effective date specified in paragraph (1) shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with such paragraph. **(b) Regulations concerning recordkeeping for tracking and tracing** (1) **In general** — The Secretary shall promulgate regulations regarding the establishment and maintenance of records by any person who manufactures, processes, transports, distributes, receives, packages, holds, exports, or imports tobacco products. (2) **Inspection** — In promulgating the regulations described in paragraph (1), the Secretary shall consider which records are needed for inspection to monitor the movement of tobacco products from the point of manufacture through distribution to retail outlets to assist in investigating potential illicit trade, smuggling, or counterfeiting of tobacco products. (3) **Codes** — The Secretary may require codes on the labels of tobacco products or other designs or devices for the purpose of tracking or tracing the tobacco product through the distribution system. (4) **Size of business** — The Secretary shall take into account the size of a business in promulgating regulations under this section. (5) **Recordkeeping by retailers** — The Secretary shall not require any retailer to maintain records relating to individual purchasers of tobacco products for personal consumption. **(c) Records inspection** If the Secretary has a reasonable belief that a tobacco product is part of an illicit trade or smuggling or is a counterfeit product, each person who manufactures, processes, transports, distributes, receives, holds, packages, exports, or imports tobacco products shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times and within reasonable limits and in a reasonable manner, upon the presentation of appropriate credentials and a written notice to such person, to have access to and copy all records (including financial records) relating to such article that are needed to assist the Secretary in investigating potential illicit trade, smuggling, or counterfeiting of tobacco products. The Secretary shall not authorize an officer or employee of the government of any of the several States to exercise authority under the preceding sentence on Indian country without the express written consent of the Indian tribe involved. **(d) Knowledge of illegal transaction** (1) **Notification** — If the manufacturer or distributor of a tobacco product has knowledge which reasonably supports the conclusion that a tobacco product manufactured or distributed by such manufacturer or distributor that has left the control of such person may be or has been— (A) imported, exported, distributed, or offered for sale in interstate commerce by a person without paying duties or taxes required by law; or (B) imported, exported, distributed, or diverted for possible illicit marketing, the manufacturer or distributor shall promptly notify the Attorney General and the Secretary of the Treasury of such knowledge. (2) **Knowledge defined** — For purposes of this subsection, the term “knowledge” as applied to a manufacturer or distributor means— (A) the actual knowledge that the manufacturer or distributor had; or (B) the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care. **(e) Consultation** In carrying out this section, the Secretary shall consult with the Attorney General of the United States and the Secretary of the Treasury, as appropriate.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 387a — FDA authority over tobacco products

**(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

21 U.S.C. § 387t — Labeling, recordkeeping, records inspec-

Page 698 TITLE 21—FOOD AND DRUGS § 387t 1 So in original. Probably should be ‘‘the Family’’. the quarter (including such date of enactment) and according to the daily equivalent of the quarterly fee amounts. Fees assessed under the preceding sentence shall not be collected until the next quarter. (3) For the quarter following the quarter to which paragraph (2) applies, the full quarterly fee amounts shall be assessed and collected, in addition to collection of the pro rata fees as- sessed under paragraph (2). (June 25, 1938, ch. 675, § 919, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1826.) Editorial Notes REFERENCES IN TEXT The Family Smoking Prevention and Tobacco Con- trol Act, referred to in subsec. (c)(2)(A), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title. The date of enactment of the Family Smoking Pre- vention and Tobacco Control Act and such date of en- actment, referred to in subsec. (e), is the date of enact- ment of Pub. L. 111–31, which was approved June 22, 2009. § 387t. Labeling, recordkeeping, records inspec- tion (a) Origin labeling (1) Requirement Beginning 1 year after June 22, 2009, the label, packaging, and shipping containers of tobacco products other than cigarettes for in- troduction or delivery for introduction into interstate commerce in the United States shall bear the statement ‘‘sale only allowed in the United States’’. Beginning 15 months after the issuance of the regulations required by section 1333(d) of title 15, as amended by sec- tion 201 of Family 1 Smoking Prevention and Tobacco Control Act, the label, packaging, and shippi

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 387t

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