§387j. Application for review of certain tobacco products — Inbound Citations

Code of Federal Regulations Citations

Cited by 1 regulation in the Code of Federal Regulations.

• 21 C.F.R. § 1107.1(a) — Exemptions.

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  (a) Under section 905(j)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387e(j)(3)), FDA may exempt from the requirements relating to the demonstration that a tobacco product is substantially equivalent within the meaning of section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j), tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, if FDA determines that:

  (1) Such modification would be a minor modification of a tobacco product that can be sold under the Federal Food, Drug, and Cosmetic Act (a legally marketed tobacco product);

  (2) A report under section 905(j)(1) intended to demonstrate substantial equivalence is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; and

Citations to 21 U.S.C. § 387j as a whole

• 21 U.S.C. § 387e(i)(1)(A)

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  (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 or which is subject to section 387j of this title, a reference to the authority for the marketing of such tobacco product and a copy of all labeling for such tobacco product;

• 21 U.S.C. § 387e(j)(1)(A)(i)

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  (i) the tobacco product is substantially equivalent, within the meaning of section 387j of this title, 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, is substantially equivalent and that is in compliance with the requirements of this chapter; or

• 21 U.S.C. § 387e(j)(3)(A)

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  (A) 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, 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.

• 21 U.S.C. § 387f(a)

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  (a) Any requirement established by or under section 387b, 387c, 387e, or 387i of this title applicable to a tobacco product shall apply to such tobacco product until the applicability of the requirement to the tobacco product has been changed by action taken under section 387g of this title, section 387j of this title, section 387k of this title, or subsection (d) of this section, and any requirement established by or under section 387b, 387c, 387e, or 387i of this title which is inconsistent with a requirement imposed on such tobacco product under section 387g of this title, section 387j of this title, section 387k of this title, or subsection (d) of this section shall not apply to such tobacco product.

• 21 U.S.C. § 387f(b)

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  (b) Each notice of proposed rulemaking or other notification under section 387g, 387h, 387i, 387j, or 387k of this title or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth—

  (1) the manner in which interested persons may examine data and other information on which the notice or findings is¹ based; and

  (2) the period within which interested persons may present their comments on the notice or findings (including the need therefore) orally or in writing, which period shall be at least 60 days but may not exceed 90 days unless the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefore.

• 21 U.S.C. § 387f(c)

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  (c) Any information reported to or otherwise obtained by the Secretary or the Secretary’s representative under section 387c, 387d, 387g, 387h, 387i, 387j, 387k, or 374 of this title, or under subsection (e) or (f) of this section, which is exempt from disclosure under subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of that section shall be considered confidential and shall not be disclosed, except that the information may be disclosed to other officers or employees concerned with carrying out this subchapter, or when relevant in any proceeding under this subchapter.

• 21 U.S.C. § 387k(l)(4)

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  (4) Not later than 2 years after June 22, 2009, the Secretary shall issue a regulation or guidance that permits the filing of a single application for any tobacco product that is a new tobacco product under section 387j of this title and which the applicant seeks to commercially market under this section.

• 21 U.S.C. § 387l(e)

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  (e) To facilitate judicial review, a regulation or order issued under section 387f, 387g, 387h, 387i, 387j, or 387p of this title shall contain a statement of the reasons for the issuance of such regulation or order in the record of the proceedings held in connection with its issuance.

• 21 U.S.C. § 387u(a)(3)

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  (3) data on the number of new product applications received under section 387j of this title and modified risk product applications received under section 387k of this title, and the number of applications acted on under each category; and

• 21 U.S.C. § 387v(b)(5)

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  (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.

• 21 U.S.C. § 387v(b)(8)

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  (8) The number of pre-submission meetings relating to applications under section 387j of this title, including the number of meeting requests received, the number of meetings held, and the median amount of time between when such meeting requests were made and when the requests were granted or denied.

Citations to §387j(a)

• 21 U.S.C. § 387b(6)(A)

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  (A) it is required by section 387j(a) of this title to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i) of this title; or

Citations to §387j(a)(1)(B)

• 21 U.S.C. § 387o(d)(3)

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  (3) The regulations promulgated under subsection (a) shall provide that, with respect to any subsequent or additional testing and reporting of tobacco products required under this section, such testing and reporting by a small tobacco product manufacturer shall be conducted in accordance with the timeframes described in paragraph (2)(A), except that, in the case of a new product, or if there has been a modification described in section 387j(a)(1)(B) of this title of any product of a small tobacco product manufacturer since the last testing and reporting required under this section, the Secretary shall require that any subsequent or additional testing and reporting be conducted in accordance with the same timeframe applicable to manufacturers that are not small tobacco product manufacturers.

Citations to §387j(c)

• 21 U.S.C. § 387l(a)(1)(B)

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  (B) a denial of an application under section 387j(c) of this title,

Citations to §387j(c)(1)(A)

• 21 U.S.C. § 387b(6)(B)

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  (B) it is in violation of an order under section 387j(c)(1)(A) of this title;

Citations to §387j(c)(1)(A)(i)

• 21 U.S.C. § 387b(6)(A)

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  (A) it is required by section 387j(a) of this title to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i) of this title; or