Title 21, Food and DrugsRelease 119-110

§387t Labeling, Recordkeeping, Records Inspection

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER IX — TOBACCO PRODUCTS › § 387t

Last updated Sep 23, 2026|Official source

Summary

Tobacco products sold into U.S. interstate commerce must be labeled to show they are for sale only in the United States. For products other than cigarettes, that labeling had to start one year after June 22, 2009. For cigarettes, it must start 15 months after the federal regulations required by section 1333(d) of title 15, as amended by section 201 of the Family Smoking Prevention and Tobacco Control Act, are issued. The deadline applies to the date the product was made, and 30 days after the effective date manufacturers may not put any product into U.S. commerce unless it follows the rule. The Secretary must make rules requiring people in the tobacco supply chain (makers, processors, transporters, distributors, receivers, packagers, holders, exporters, importers) to keep records so products can be tracked from manufacture to retail. The rules can require codes on labels, must consider business size, and cannot force retailers to record individual buyers. If the Secretary suspects smuggling, illicit trade, or counterfeits, designated officers may inspect and copy needed records with proper ID and written notice. Manufacturers or distributors who know or should know a product left their control and may have been moved without required taxes or diverted for illicit marketing must promptly notify the Attorney General and the Secretary of the Treasury. The Secretary will consult with those officials as needed.

Full Legal Text

Title 21, §387t

Food and Drugs, Source: USLM XML via OLRC

(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, as amended by section 201 of 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.

Legislative History

Notes & Related Subsidiaries

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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 387t

Title 21, Food and Drugs

Last Updated

Sep 23, 2026

Release point: 119-110