Title 21Food and DrugsRelease 119-73

§387t Labeling, recordkeeping, records inspection

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

Last updated Apr 6, 2026|Official source

Summary

Labels, packaging, and shipping boxes for tobacco products other than cigarettes must say that sales are allowed only in the United States starting one year after June 22, 2009. For cigarettes, the same statement must appear 15 months after the issuance of the regulations required by section 1333(d) of title 15 (as amended by section 201). The rule applies by date of manufacture, and 30 days after each effective date manufacturers may not put any products into U.S. commerce that do not meet the rule, no matter when they were made. The Secretary must write rules about what records people who make, move, store, sell, import, or export tobacco must keep. The rules must focus on tracking products from the factory to the retailer to help find smuggling, illicit trade, or counterfeits. The Secretary can require codes or marks on labels to trace products and must consider business size. Retailers do not have to keep records about individual buyers. If the Secretary reasonably believes a product is involved in smuggling, illicit trade, or is counterfeit, designated federal officers may, with ID and written notice and at reasonable times, inspect and copy needed records (including financial). State officers need written tribal consent to act on Indian country. "Knowledge" for manufacturers or distributors means what they actually knew or what a reasonable person would have known. The Secretary must consult the Attorney General and the Secretary of the Treasury.

Full Legal Text

Title 21, §387t

Food and Drugs — Source: USLM XML via OLRC

(a)(1)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 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)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)(1)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)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)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)The Secretary shall take into account the size of a business in promulgating regulations under this section.
(5)The Secretary shall not require any retailer to maintain records relating to individual purchasers of tobacco products for personal consumption.
(c)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)(1)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,
(2)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)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 21Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73