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21 U.S.C. § 387d — Submission of health information to the Secretary
Federal law — U.S. Code and appendices · legal_authorities
**(a) Requirement** Each tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary the following information:
(1) Not later than 6 months after June 22, 2009, a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.
(2) A description of the content, delivery, and form of nicotine in each tobacco product measured in milligrams of nicotine in accordance with regulations promulgated by the Secretary in accordance with [section 1333(e) of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1333/e&num=0&edition=prelim).
(3) Beginning 3 years after June 22, 2009, a listing of all constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product, by brand and by quantity in each brand and subbrand. Effective beginning 3 years after June 22, 2009, the manufacturer, importer, or agent shall comply with regulations promulgated under section 387o of this title in reporting information under this paragraph, where applicable.
(4) Beginning 6 months after June 22, 2009, all documents developed after June 22, 2009 that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.
**(b) Data submission** At the request of the Secretary, each tobacco product manufacturer or importer of tobacco products, or agents thereof, shall submit the fo
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Stable record: federal_law:legal_authorities:record_usc_3a0579a99f45918eb535a9f4
Source file: Laws/federal/codes/united-states-code/title-21/section-387d-submission-of-health-information-to-the-secretary--418c58abeb.md
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Source location: Title 21, Chapter 9, § 387d; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Requirement** Each tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary the following information:
(1) Not later than 6 months after June 22, 2009, a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.
(2) A description of the content, delivery, and form of nicotine in each tobacco product measured in milligrams of nicotine in accordance with regulations promulgated by the Secretary in accordance with [section 1333(e) of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1333/e&num=0&edition=prelim).
(3) Beginning 3 years after June 22, 2009, a listing of all constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product, by brand and by quantity in each brand and subbrand. Effective beginning 3 years after June 22, 2009, the manufacturer, importer, or agent shall comply with regulations promulgated under section 387o of this title in reporting information under this paragraph, where applicable.
(4) Beginning 6 months after June 22, 2009, all documents developed after June 22, 2009 that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.
**(b) Data submission** At the request of the Secretary, each tobacco product manufacturer or importer of tobacco products, or agents thereof, shall submit the following:
(1) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) on the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents (including smoke constituents), ingredients, components, and additives.
(2) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) that relate to the issue of whether a reduction in risk to health from tobacco products can occur upon the employment of technology available or known to the manufacturer.
(3) Any or all documents (including underlying scientific or financial information) relating to marketing research involving the use of tobacco products or marketing practices and the effectiveness of such practices used by tobacco manufacturers and distributors.
An importer of a tobacco product not manufactured in the United States shall supply the information required of a tobacco product manufacturer under this subsection.
**(c) Time for submission**
(1) **In general** — At least 90 days prior to the delivery for introduction into interstate commerce of a tobacco product not on the market on June 22, 2009, the manufacturer of such product shall provide the information required under subsection (a).
(2) **Disclosure of additive** — If at any time a tobacco product manufacturer adds to its tobacco products a new tobacco additive or increases the quantity of an existing tobacco additive, the manufacturer shall, except as provided in paragraph (3), at least 90 days prior to such action so advise the Secretary in writing.
(3) **Disclosure of other actions** — If at any time a tobacco product manufacturer eliminates or decreases an existing additive, or adds or increases an additive that has by regulation been designated by the Secretary as an additive that is not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use, the manufacturer shall within 60 days of such action so advise the Secretary in writing.
**(d) Data list**
(1) **In general** — Not later than 3 years after June 22, 2009, and annually thereafter, the Secretary shall publish in a format that is understandable and not misleading to a lay person, and place on public display (in a manner determined by the Secretary) the list established under subsection (e).
(2) **Consumer research** — The Secretary shall conduct periodic consumer research to ensure that the list published under paragraph (1) is not misleading to lay persons. Not later than 5 years after June 22, 2009, the Secretary shall submit to the appropriate committees of Congress a report on the results of such research, together with recommendations on whether such publication should be continued or modified.
**(e) Data collection** Not later than 24 months after June 22, 2009, the Secretary shall establish, and periodically revise as appropriate, a list of harmful and potentially harmful constituents, including smoke constituents, to health in each tobacco product 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 concerning the harmful and potentially harmful constituents in tobacco products and tobacco smoke.
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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
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Federal law — U.S. Code and appendices · legal_authorities
Without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may—
(1) establish such technical and scientific review groups as are needed to carry out the functions of the Food and Drug Administration (including functions prescribed under this chapter); and
(2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.
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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
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Federal law — U.S. Code and appendices · legal_authorities
Page 673
TITLE 21—FOOD AND DRUGS
§ 387d
date of manufacture, provided that, in any case, begin-
ning 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 section
903(a)(2), (3), and (4) and section 920(a) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 387t(a)].
‘‘(6) ADVERTISING REQUIREMENTS.—The advertising re-
quirements of section 903(a)(8) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 387c(a)(8)] (as amend-
ed by this division) shall take effect on the date that
is 12 months after the date of enactment of this Act
[June 22, 2009].’’
§ 387d. Submission of health information to the
Secretary
(a) Requirement
Each tobacco product manufacturer or im-
porter, or agents thereof, shall submit to the
Secretary the following information:
(1) Not later than 6 months after June 22,
2009, a listing of all ingredients, including to-
bacco, substances, compounds, and additives
that are, as of such date, added by the manu-
facturer to the tobacco, paper, filter, or other
part of each tobacco product by brand and by
quantity in each brand and subbrand.
(2) A description of the content, delivery,
and form of nicotine in each tobacco product
measured in milligrams of nicotine in accord-
ance with regulations promulgated by the Sec-
retary in accordance with section 1333(e) of
title 15.
(3) Beginning 3 years after June 22, 2009, a
listing of all constituents, including smoke
constituents as applicable, identified by the
Secretary as harmful or potentially harmful
to health in each tobacco product, and as ap-
plicable in the smoke of each tobacco product,
by brand and by quantity in each brand
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