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 shipping containers of cigarettes for intro- duction or delivery for introduction into inter- state 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 manufac- ture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic com- merce of the United States any product, irre- spective 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 dis- tribution to retail outlets to assist in inves- tigating potential illicit trade, smuggling, or counterfeiting of tobacco products. (3) Codes The Secretary may require codes on the la- bels 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 pur- chasers of tobacco products for personal con- sumption. (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 per- son who manufactures, processes, transports, distributes, receives, holds, packages, exports, or imports tobacco products shall, at the re- quest of an officer or employee duly designated by the Secretary, permit such officer or em- ployee, at reasonable times and within reason- able 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 poten- tial illicit trade, smuggling, or counterfeiting of tobacco products. The Secretary shall not au- thorize an officer or employee of the govern- ment of any of the several States to exercise au- thority 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 to- bacco product has knowledge which reason- ably 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 of- fered for sale in interstate commerce by a person without paying duties or taxes re- quired by law; or (B) imported, exported, distributed, or di- verted for possible illicit marketing, the manufacturer or distributor shall prompt- ly notify the Attorney General and the Sec- retary 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— Page 699 TITLE 21—FOOD AND DRUGS § 387v 1 So in original. Probably should be plural. (A) the actual knowledge that the manu- facturer or distributor had; or (B) the knowledge which a reasonable per- son would have had under like cir- cumstances or which would have been ob- tained 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 Treas- ury, as appropriate. (June 25, 1938, ch. 675, § 920, as added Pub. L. 111–31, div. A, title III, § 301, June 22, 2009, 123 Stat. 1850.) 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. § 387u. Studies of progress and effectiveness (a) FDA report Not later than 3 years after June 22, 2009, and not less than every 2 years thereafter, the Sec- retary of Health and Human Services shall sub- mit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Com- mittee on Energy and Commerce of the House of Representatives, a report concerning— (1) the progress of the Food and Drug Admin- istration in implementing this division, in- cluding major accomplishments, objective measurements of progress, and the identifica- tion of any areas that have not been fully im- plemented; (2) impediments identified by the Food and Drug Administration to progress in imple- menting this division and to meeting statu- tory timeframes; (3) data on the number of new product appli- cations received under section 387j of this title and modified risk product applications re- ceived under section 387k of this title, and the number of applications acted on under each category; and (4) data on the number of full time equiva- lents engaged in implementing this division. (b) GAO report Not later than 5 years after June 22, 2009, the Comptroller General of the United States shall conduct a study of, and submit to the Commit- tees described in subsection (a) a report con- cerning— (1) the adequacy of the authority and re- sources provided to the Secretary of Health and Human Services for this division to carry out its goals and purposes; and (2) any recommendations for strengthening that authority to more effectively protect the public health with respect to the manufacture, marketing, and distribution of tobacco prod- ucts. (c) Public availability The Secretary of Health and Human Services and the Comptroller General of the United States, respectively, shall make the reports re- quired under subsection 1 (a) and (b) available to the public, including by posting such reports on the respective Internet websites of the Food and Drug Administration and the Government Ac- countability Office. (Pub. L. 111–31, div. A, title I, § 106, June 22, 2009, 123 Stat. 1841.) Editorial Notes REFERENCES IN TEXT This division, referred to in subsecs. (a)(1), (2), (4) and (b)(1), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776, known as Family Smoking Prevention and To- bacco Control Act. For complete classification of divi- sion A to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables. CODIFICATION Section was enacted as part of the Family Smoking Prevention and Tobacco Control Act, and not as part of the Federal Food, Drug, and Cosmetic Act which com- prises this chapter. Statutory Notes and Related Subsidiaries MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION With respect to any time periods specified in div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fis- cal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title. § 387v. Reporting on tobacco regulation activities (a) In general For fiscal year 2022 and each subsequent fiscal year for which fees are collected under section 387s of this title, the Secretary of Health and Human Services shall, not later than 180 days after the end of the fiscal year, prepare and sub- mit to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, an annual report that contains the information re- quired under subsection (b). (b) Required information Each report submitted under subsection (a) shall contain the following information for the previous fiscal year: (1) Total annual user fee collections. (2) Total amount of fees obligated. (3) The amount of unobligated carryover bal- ance from fees collected. (4) The amount obligated by the Center for Tobacco Products for each of the following ac- tivities: (A) Compliance and enforcement. (B) Public education campaigns. (C) Scientific research and research infra- structure.