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21 U.S.C. § 387u — Studies of progress and effectiveness
Federal law — U.S. Code and appendices · legal_authorities
**(a) FDA report** Not later than 3 years after June 22, 2009, and not less than every 2 years thereafter, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning—
(1) the progress of the Food and Drug Administration in implementing this division, including major accomplishments, objective measurements of progress, and the identification of any areas that have not been fully implemented;
(2) impediments identified by the Food and Drug Administration to progress in implementing this division and to meeting statutory timeframes;
(3) data on the number of new product applications received under [section 387j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j&num=0&edition=prelim) and modified risk product applications received under [section 387k of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387k&num=0&edition=prelim), and the number of applications acted on under each category; and
(4) data on the number of full time equivalents 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 Committees described in subsection (a) a report concerning—
(1) the adequacy of the authority and resources 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 product
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Source file: Laws/federal/codes/united-states-code/title-21/section-387u-studies-of-progress-and-effectiveness--0b89dd429e.md
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Source location: Title 21, Chapter 9, § 387u; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) FDA report** Not later than 3 years after June 22, 2009, and not less than every 2 years thereafter, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning—
(1) the progress of the Food and Drug Administration in implementing this division, including major accomplishments, objective measurements of progress, and the identification of any areas that have not been fully implemented;
(2) impediments identified by the Food and Drug Administration to progress in implementing this division and to meeting statutory timeframes;
(3) data on the number of new product applications received under [section 387j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j&num=0&edition=prelim) and modified risk product applications received under [section 387k of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387k&num=0&edition=prelim), and the number of applications acted on under each category; and
(4) data on the number of full time equivalents 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 Committees described in subsection (a) a report concerning—
(1) the adequacy of the authority and resources 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 products.
**(c) Public availability** The Secretary of Health and Human Services and the Comptroller General of the United States, respectively, shall make the reports required under subsection 11 So in original. Probably should be plural. (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 Accountability Office.
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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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387j
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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.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product.
**(b) Definitions** In this section:
(1) **Modified risk tobacco product** — The term “modified risk tobacco product” means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
(2) **Sold or distributed**
(A) *In general* — With respect to a tobacco product, the term “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products” means a tobacco product—
(i) the label, labeling, or advertising of which represents explicitly or implicitly that—
(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;
(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or
(III) the tobacco product or its smoke does not contain or is free of a substance;
(ii) the label, labeling, or advertising of which uses the descriptors “light”, “mild”, or “low” or similar descriptors; or
(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product’s label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than
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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 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 unde
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