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21 U.S.C. § 387e — Annual registration
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section:
(1) **Manufacture, preparation, compounding, or processing** — The term “manufacture, preparation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user.
(2) **Name** — The term “name” shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation.
**(b) Registration by owners and operators** On or before December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products shall register with the Secretary the name, places of business, and all such establishments of that person. If enactment of the Family Smoking Prevention and Tobacco Control Act occurs in the second half of the calendar year, the Secretary shall designate a date no later than 6 months into the subsequent calendar year by which registration pursuant to this subsection shall occur.
**(c) Registration by new owners and operators** Every person upon first engaging in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person’s name, place of business, and such establishment.
**(d) Registration of added establishments** Every person required to register under subsection (b) or (c) shall immediatel
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Source location: Title 21, Chapter 9, § 387e; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Definitions** In this section:
(1) **Manufacture, preparation, compounding, or processing** — The term “manufacture, preparation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user.
(2) **Name** — The term “name” shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation.
**(b) Registration by owners and operators** On or before December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products shall register with the Secretary the name, places of business, and all such establishments of that person. If enactment of the Family Smoking Prevention and Tobacco Control Act occurs in the second half of the calendar year, the Secretary shall designate a date no later than 6 months into the subsequent calendar year by which registration pursuant to this subsection shall occur.
**(c) Registration by new owners and operators** Every person upon first engaging in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person’s name, place of business, and such establishment.
**(d) Registration of added establishments** Every person required to register under subsection (b) or (c) shall immediately register with the Secretary any additional establishment which that person owns or operates in any State and in which that person begins the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products.
**(e) Uniform product identification system** The Secretary may by regulation prescribe a uniform system for the identification of tobacco products and may require that persons who are required to list such tobacco products under subsection (i) shall list such tobacco products in accordance with such system.
**(f) Public access to registration information** The Secretary shall make available for inspection, to any person so requesting, any registration filed under this section.
**(g) Biennial inspection of registered establishments** Every establishment registered with the Secretary under this section shall be subject to inspection under [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim) or subsection (h), and every such establishment engaged in the manufacture, compounding, or processing of a tobacco product or tobacco products shall be so inspected by 1 or more officers or employees duly designated by the Secretary at least once in the 2-year period beginning with the date of registration of such establishment under this section and at least once in every successive 2-year period thereafter.
**(h) Registration by foreign establishments** Any establishment within any foreign country engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products, shall register under this section under regulations promulgated by the Secretary. Such regulations shall require such establishment to provide the information required by subsection (i) and shall include provisions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the Secretary to determine from time to time whether tobacco products manufactured, prepared, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in [section 381(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/a&num=0&edition=prelim).
**(i) Registration information**
(1) **Product list** — Every person who registers with the Secretary under subsection (b), (c), (d), or (h) shall, at the time of registration under any such subsection, file with the Secretary a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution and which have not been included in any list of tobacco products filed by that person with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by—
(A) in the case of a tobacco product contained in the applicable list with respect to which a tobacco product standard has been established under [section 387g of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387g&num=0&edition=prelim) or which is subject to [section 387j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j&num=0&edition=prelim), a reference to the authority for the marketing of such tobacco product and a copy of all labeling for such tobacco product;
(B) in the case of any other tobacco product contained in an applicable list, a copy of all consumer information and other labeling for such tobacco product, a representative sampling of advertisements for such tobacco product, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular tobacco product; and
(C) if the registrant filing a list has determined that a tobacco product contained in such list is not subject to a tobacco product standard established under [section 387g of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387g&num=0&edition=prelim), a brief statement of the basis upon which the registrant made such determination if the Secretary requests such a statement with respect to that particular tobacco product.
(2) **Consultation with respect to forms** — The Secretary shall consult with the Secretary of the Treasury in developing the forms to be used for registration under this section to minimize the burden on those persons required to register with both the Secretary and the Tax and Trade Bureau of the Department of the Treasury.
(3) **Biannual report of any change in product list** — Each person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following:
(A) A list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the Secretary under this subparagraph or paragraph (1). A list under this subparagraph shall list a tobacco product by its established name and shall be accompanied by the other information required by paragraph (1).
(B) If since the date the registrant last made a report under this paragraph that person has discontinued the manufacture, preparation, compounding, or processing for commercial distribution of a tobacco product included in a list filed under subparagraph (A) or paragraph (1), notice of such discontinuance, the date of such discontinuance, and the identity of its established name.
(C) If since the date the registrant reported under subparagraph (B) a notice of discontinuance that person has resumed the manufacture, preparation, compounding, or processing for commercial distribution of the tobacco product with respect to which such notice of discontinuance was reported, notice of such resumption, the date of such resumption, the identity of such tobacco product by established name, and other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary under this subparagraph.
(D) Any material change in any information previously submitted under this paragraph or paragraph (1).
**(j) Report preceding introduction of certain substantially equivalent products into interstate commerce**
(1) **In general** — Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a tobacco product intended for human use that was not commercially marketed (other than for test marketing) in the United States as of February 15, 2007, shall, at least 90 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)—
(A) the basis for such person’s determination that—
(i) the tobacco product is substantially equivalent, within the meaning of [section 387j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j&num=0&edition=prelim), to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of [section 387j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j&num=0&edition=prelim), is substantially equivalent and that is in compliance with the requirements of this chapter; or
(ii) the tobacco product is modified within the meaning of paragraph (3), the modifications are to a product that is commercially marketed and in compliance with the requirements of this chapter, and all of the modifications are covered by exemptions granted by the Secretary pursuant to paragraph (3); and
(B) action taken by such person to comply with the requirements under [section 387g of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387g&num=0&edition=prelim) that are applicable to the tobacco product.
(2) **Application to certain post–February 15, 2007, products** — A report under this subsection for a tobacco product that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after June 22, 2009, shall be submitted to the Secretary not later than 21 months after June 22, 2009.
(3) **Exemptions**
(A) *In general* — The Secretary may exempt from the requirements of this subsection relating to the demonstration that a tobacco product is substantially equivalent within the meaning of [section 387j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j&num=0&edition=prelim), tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, if the Secretary determines that—
(i) such modification would be a minor modification of a tobacco product that can be sold under this chapter;
(ii) a report under this subsection is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; and
(iii) an exemption is otherwise appropriate.
(B) *Regulations* — Not later than 15 months after June 22, 2009, the Secretary shall issue regulations to implement this paragraph.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment of quarterly fee** Beginning on June 22, 2009, the Secretary shall in accordance with this section assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to this subchapter. The fees shall be assessed and collected with respect to each quarter of each fiscal year, and the total amount assessed and collected for a fiscal year shall be the amount specified in subsection (b)(1) for such year, subject to subsection (c).
**(b) Assessment of user fee**
(1) **Amount of assessment** — The total amount of user fees authorized to be assessed and collected under subsection (a) for a fiscal year is the following, as applicable to the fiscal year involved:
(A) For fiscal year 2009, $85,000,000 (subject to subsection (e)).
(B) For fiscal year 2010, $235,000,000.
(C) For fiscal year 2011, $450,000,000.
(D) For fiscal year 2012, $477,000,000.
(E) For fiscal year 2013, $505,000,000.
(F) For fiscal year 2014, $534,000,000.
(G) For fiscal year 2015, $566,000,000.
(H) For fiscal year 2016, $599,000,000.
(I) For fiscal year 2017, $635,000,000.
(J) For fiscal year 2018, $672,000,000.
(K) For fiscal year 2019 and each subsequent fiscal year, $712,000,000.
(2) **Allocations of assessment by class of tobacco products**
(A) *In general* — The total user fees assessed and collected under subsection (a) each fiscal year with respect to each class of tobacco products shall be an amount that is equal to the applicable percentage of each class for the fiscal year multiplied by the amount specified in paragraph (1) for the fiscal year.
(B) *Applicable percentage*
(i) *In general* — For purposes of subparagraph (A), the applicable percentage for a fiscal year for each of the following
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387s
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general**
(1) **New tobacco product defined** — For purposes of this section the term “new tobacco product” means—
(A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
(B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.
(2) **Premarket review required**
(A) *New products* — An order under subsection (c)(1)(A)(i) for a new tobacco product is required unless—
(i) the manufacturer has submitted a report under [section 387e(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/j&num=0&edition=prelim); and the Secretary has issued an order that the tobacco product—
(I) is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007; and
(II) is in compliance with the requirements of this chapter; or
(ii) the tobacco product is exempt from the requirements of [section 387e(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/j&num=0&edition=prelim) pursuant to a regulation issued under [section 387e(j)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/j/3&num=0&edition=prelim).
(B) *Application to certain post-February 15, 2007, products* — Subparagraph (A) shall not apply to a tobacco product—
(i) that was first introduced or deliv
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general**
(1) **Authority for program** — Subject to paragraph (2), the Secretary shall carry out a program of entering into contracts with appropriately qualified health professionals under which such health professionals agree to conduct research, as employees of the Food and Drug Administration, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $20,000 of the principal and interest of the educational loans of such health professionals.
(2) **Limitation** — The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—
(A) has a substantial amount of educational loans relative to income; and
(B) agrees to serve as an employee of the Food and Drug Administration for purposes of paragraph (1) for a period of not less than 3 years.
**(b) Applicability of certain provisions** With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III of the Public Health Service Act [[42 U.S.C. 254](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section254&num=0&edition=prelim)l et seq.], the provisions of such subpart shall, except as inconsistent with subsection (a) of this section, apply to the program established in such subsection in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.
**(c) Authorization of appropriations** For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1996.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general**
(1) **Special rules**
(A) *Special rule for cigarettes* — Beginning 3 months after June 22, 2009, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. Nothing in this subparagraph shall be construed to limit the Secretary’s authority to take action under this section or other sections of this chapter applicable to menthol or any artificial or natural flavor, herb, or spice not specified in this subparagraph.
(B) *Additional special rule* — Beginning 2 years after June 22, 2009, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.
(2) **Revision of tobacco product standards** — The Secretary may revise the tobacco product standards in paragraph (1) in accordance with subsection (c).
(3) **Tobacco product standards**
(A) *In general* — The Secretary may adopt tobacco product standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health.
(B) *Determinations*
(i) *Considerations* — In making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning—
(I) the risks and benefits to the population as a whole,
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Federal law — U.S. Code and appendices · legal_authorities
In this subchapter:
(1) **Additive** — The term “additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical.
(2) **Brand** — The term “brand” means a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration, packaging, logo, registered trademark, brand name, identifiable pattern of colors, or any combination of such attributes.
(3) **Cigarette** — The term “cigarette”—
(A) means a product that—
(i) is a tobacco product; and
(ii) meets the definition of the term “cigarette” in [section 1332(1) of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1332/1&num=0&edition=prelim); and
(B) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.
(4) **Cigarette tobacco** — The term “cigarette tobacco” means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements applicable to cigarettes under this subchapter shall also apply to cigarette tobacco.
(5) **Commerce** — The term “commerce” has the meaning giv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions**
(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in [section 350c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c&num=0&edition=prelim), when the standard for records inspection under paragraph (1) or (2) of [section 350c(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/a&num=0&edition=prelim) applies, subject to the limitations established in [section 350c(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/d&num=0&edition=prelim). In the case of a facility (as defined in [section 364 of this title](https://uscode.house.gov/vi
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 374
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** For fiscal year 2022 and each subsequent fiscal year for which fees are collected under [section 387s of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387s&num=0&edition=prelim), the Secretary of Health and Human Services shall, not later than 180 days after the end of the fiscal year, prepare and submit 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 required 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 balance from fees collected.
(4) The amount obligated by the Center for Tobacco Products for each of the following activities:
(A) Compliance and enforcement.
(B) Public education campaigns.
(C) Scientific research and research infrastructure.
(D) Communications.
(E) Leadership, management oversight, and administrative services.
(F) Related overhead activities.
(5) The numbers of applications, categorized by class of tobacco product and review pathway under sections 387e, 387j, and 387k of this title, that were—
(A) submitted;
(B) pending;
(C) accepted;
(D) refused to file;
(E) withdrawn;
(F) denied;
(G) authorized for marketing under an order;
(H) issued a deficiency letter or environmental information request letter; or
(I) referred to the Tobacco Products Scientific Advisory Committee.
(6) The number and titles
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Federal law — U.S. Code and appendices · legal_authorities
Page 674
TITLE 21—FOOD AND DRUGS
§ 387e
by brand and by quantity in each brand and
subbrand. The Secretary shall publish a public
notice requesting the submission by interested
persons of scientific and other information con-
cerning the harmful and potentially harmful
constituents in tobacco products and tobacco
smoke.
(June 25, 1938, ch. 675, § 904, as added Pub. L.
111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123
Stat. 1790.)
Editorial Notes
PRIOR PROVISIONS
A prior section 904 of act June 25, 1938, was renum-
bered section 1004 and is classified to section 394 of this
title.
Statutory Notes and Related Subsidiaries
MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION
With respect to any time periods specified in an
amendment by 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 cal-
culation of such time periods shall commence on the
first day of the first fiscal 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 re-
duce the duration of one or more such time periods, ex-
cept 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.
§ 387e. Annual registration
(a) Definitions
In this section:
(1) Manufacture, preparation, compounding, or
processing
The
term
‘‘manufacture,
preparation,
compounding, or processing’’ shall include re-
packaging or otherwise changing the con-
tainer, wrapper, or labeling of any tobacco
product package in furtherance of the dis-
tri
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 387e
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