--- kind: "section" citation: "21 U.S.C. § 387t" title: "21" title_heading: "Food and Drugs" number: "387t" heading: "Labeling, recordkeeping, records inspection" release: "119-102" date: "2026-07-12" url: "https://uscodex.org/usc/21/387t" units: - "Chapter 9 — Federal Food, Drug, and Cosmetic Act" - "Subchapter IX — Tobacco Products" --- # §387t. Labeling, recordkeeping, records inspection - (a) **Origin labeling—** - (1) **Requirement—** Beginning 1 year after June 22, 2009, the [label](/usc/21/321.md?p=k), packaging, and shipping containers of [tobacco products](/usc/21/321.md?p=rr-1) other than [cigarettes](/usc/21/387.md?p=3) for introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) in the [United States](/usc/21/387.md?p=22) shall bear the statement “sale only allowed in the [United States](/usc/21/387.md?p=22)”. Beginning 15 months after the issuance of the regulations required by [section 1333(d) of title 15](/usc/15/1333.md?p=d), as amended by [section 201](/usc/21/201.md) of Family[^1] Smoking Prevention and Tobacco Control Act, the [label](/usc/21/321.md?p=k), packaging, and shipping containers of [cigarettes](/usc/21/387.md?p=3) for introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) in the [United States](/usc/21/387.md?p=22) shall bear the statement “Sale only allowed in the [United States](/usc/21/387.md?p=22)”. - (2) **Effective date—** The effective date specified in [paragraph (1)](#a-1) shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a [manufacturer](/usc/21/360hh.md?p=3) shall not introduce into the domestic [commerce](/usc/21/387.md?p=5) of the [United States](/usc/21/387.md?p=22) any [product](/usc/21/360eee.md?p=13), 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](/usc/21/321.md?p=d) shall promulgate regulations regarding the establishment and maintenance of records by any [person](/usc/21/321.md?p=e) who manufactures, processes, transports, [distributes](/usc/21/360eee.md?p=5), receives, [packages](/usc/21/387.md?p=13), holds, exports, or imports [tobacco products](/usc/21/321.md?p=rr-1). - (2) **Inspection—** In promulgating the regulations described in [paragraph (1)](#b-1), the [Secretary](/usc/21/321.md?p=d) shall consider which records are needed for inspection to monitor the movement of [tobacco products](/usc/21/321.md?p=rr-1) from the point of manufacture through [distribution](/usc/21/360eee.md?p=5) to retail outlets to assist in investigating potential [illicit trade](/usc/21/387.md?p=8), smuggling, or counterfeiting of [tobacco products](/usc/21/321.md?p=rr-1). - (3) **Codes—** The [Secretary](/usc/21/321.md?p=d) may require codes on the [labels](/usc/21/321.md?p=k) of [tobacco products](/usc/21/321.md?p=rr-1) or other designs or [devices](/usc/21/321.md?p=h-1) for the purpose of tracking or tracing the [tobacco product](/usc/21/321.md?p=rr-1) through the [distribution](/usc/21/360eee.md?p=5) system. - (4) **Size of business—** The [Secretary](/usc/21/321.md?p=d) shall take into account the size of a business in promulgating regulations under this section. - (5) **Recordkeeping by retailers—** The [Secretary](/usc/21/321.md?p=d) shall not require any [retailer](/usc/21/387.md?p=14) to maintain records relating to individual purchasers of [tobacco products](/usc/21/321.md?p=rr-1) for personal consumption. - (c) **Records inspection—** If the [Secretary](/usc/21/321.md?p=d) has a reasonable belief that a [tobacco product](/usc/21/321.md?p=rr-1) is part of an [illicit trade](/usc/21/387.md?p=8) or smuggling or is a counterfeit [product](/usc/21/360eee.md?p=13), each [person](/usc/21/321.md?p=e) who manufactures, processes, transports, [distributes](/usc/21/360eee.md?p=5), receives, holds, [packages](/usc/21/387.md?p=13), exports, or imports [tobacco products](/usc/21/321.md?p=rr-1) shall, at the request of an officer or employee duly designated by the [Secretary](/usc/21/321.md?p=d), 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](/usc/21/321.md?p=e), to have access to and copy all records (including financial records) relating to such article that are needed to assist the [Secretary](/usc/21/321.md?p=d) in investigating potential [illicit trade](/usc/21/387.md?p=8), smuggling, or counterfeiting of [tobacco products](/usc/21/321.md?p=rr-1). The [Secretary](/usc/21/321.md?p=d) shall not authorize an officer or employee of the government of any of the several [States](/usc/21/387.md?p=19) to exercise authority under the preceding sentence on [Indian country](/usc/21/387.md?p=9) without the express written consent of the [Indian tribe](/usc/21/387.md?p=10) involved. - (d) **Knowledge of illegal transaction—** - (1) **Notification—** If the [manufacturer](/usc/21/360hh.md?p=3) or [distributor](/usc/21/387.md?p=7) of a [tobacco product](/usc/21/321.md?p=rr-1) has knowledge which reasonably supports the conclusion that a [tobacco product](/usc/21/321.md?p=rr-1) manufactured or distributed by such [manufacturer](/usc/21/360hh.md?p=3) or [distributor](/usc/21/387.md?p=7) that has left the control of such [person](/usc/21/321.md?p=e) may be or has been— - (A) imported, exported, distributed, or offered for sale in [interstate commerce](/usc/21/321.md?p=b) by a [person](/usc/21/321.md?p=e) without paying duties or taxes required by law; or - (B) imported, exported, distributed, or diverted for possible illicit marketing, the [manufacturer](/usc/21/360hh.md?p=3) or [distributor](/usc/21/387.md?p=7) shall promptly notify the Attorney General and the [Secretary](/usc/21/321.md?p=d) of the Treasury of such knowledge. - (2) **Knowledge defined—** For purposes of this subsection, the term “knowledge” as applied to a [manufacturer](/usc/21/360hh.md?p=3) or [distributor](/usc/21/387.md?p=7) means— - (A) the actual knowledge that the [manufacturer](/usc/21/360hh.md?p=3) or [distributor](/usc/21/387.md?p=7) had; or - (B) the knowledge which a reasonable [person](/usc/21/321.md?p=e) 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](/usc/21/321.md?p=d) shall consult with the Attorney General of the [United States](/usc/21/387.md?p=22) and the [Secretary](/usc/21/321.md?p=d) of the Treasury, as appropriate. ## Footnotes [^1]: So in original. Probably should be “the Family”. ## Source credit (June 25, 1938, ch. 675, § 920, as added Pub. L. 111–31, div. A, title III, § 301, June 22, 2009, 123 Stat. 1850.) ## Notes ### Editorial Notes ### References in Text Section 201 of the Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (a)(1), is section 201 of div. A of Pub. L. 111–31.