§387f. General provisions respecting control of tobacco products — Inbound Citations

Code of Federal Regulations Citations

Cited by 1 regulation in the Code of Federal Regulations.

• 21 C.F.R. § 20.85 — Disclosure to other Federal Government departments and agencies.

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  Any Food and Drug Administration (FDA) record otherwise exempt from public disclosure may be disclosed to other Federal Government departments and agencies, except that trade secrets and confidential commercial or financial information prohibited from disclosure by 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 21 U.S.C. 360ll(d), 21 U.S.C. 360nn(e), and 21 U.S.C. 387f(c) may be released only as provided by those sections. Any disclosure under this section shall be pursuant to a written agreement that the record shall not be further disclosed by the other department or agency except with the written permission of FDA.

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

• 21 U.S.C. § 331(j)

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  (j) The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial proceeding under this chapter, any information acquired under authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c, 360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc–1, 360ccc–2, 374, 379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b) of this title concerning any method or process which as a trade secret is entitled to protection; or the violating of section 346a(i)(2) of this title or any regulation issued under that section..¹This paragraph does not authorize the withholding of information from either House of Congress or from, to the extent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint committee of Congress or any subcommittee of such joint committee.

• 21 U.S.C. § 387f–1(a)(1)

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  (1) Not later than 6 months after June 22, 2009, the Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall develop and publish an action plan to enforce restrictions adopted pursuant to section 387f of this title, as added by section 101(b) of this division, or pursuant to section 387a–1(a) of this title, on promotion and advertising of menthol and other cigarettes to youth.

• 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.

Citations to §387f(d)

• 21 U.S.C. § 333(f)(8)

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  (8) If the Secretary finds that a person has committed repeated violations of section 387f(d)(5) of this title or of restrictions promulgated under section 387f(d) of this title at a particular retail outlet then the Secretary may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). Prior to the entry of a no-sale order under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available.

• 21 U.S.C. § 387c(a)(7)(B)

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  (B) it is sold or distributed in violation of section 387f(d)(5) of this title or of regulations prescribed under section 387f(d) of this title;

• 21 U.S.C. § 387g(a)(4)(B)(v)

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  (v) a provision requiring that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 387f(d) of this title;

• 21 U.S.C. § 387j(c)(1)(B)

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  (B) An order under subparagraph (A)(i) may require that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 387f(d) of this title.

Citations to §387f(d)(5)

• 21 U.S.C. § 333(f)(8)

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  (8) If the Secretary finds that a person has committed repeated violations of section 387f(d)(5) of this title or of restrictions promulgated under section 387f(d) of this title at a particular retail outlet then the Secretary may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). Prior to the entry of a no-sale order under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available.

• 21 U.S.C. § 387c(a)(7)(B)

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  (B) it is sold or distributed in violation of section 387f(d)(5) of this title or of regulations prescribed under section 387f(d) of this title;

Citations to §387f(e)

• 21 U.S.C. § 381(e)(1)

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  (1) A food, drug, device, tobacco product or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this chapter, and a tobacco product intended for export shall not be deemed to be in violation of section 387f(e), 387g, 387k, or 387t(a) of this title, if it—

  (A) accords to the specifications of the foreign purchaser,

  (B) is not in conflict with the laws of the country to which it is intended for export,

  (C) is labeled on the outside of the shipping package that it is intended for export, and

  (D) is not sold or offered for sale in domestic commerce.

• 21 U.S.C. § 387j(c)(2)(B)

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  (B) the methods used in, or the facilities or controls used for, the manufacture, processing, or packing of such tobacco product do not conform to the requirements of section 387f(e) of this title;

• 21 U.S.C. § 387j(d)(1)(D)

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  (D) on the basis of new information before the Secretary with respect to such tobacco product, evaluated together with the evidence before the Secretary when the application was reviewed, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such tobacco product do not conform with the requirements of section 387f(e) of this title and were not brought into conformity with such requirements within a reasonable time after receipt of written notice from the Secretary of nonconformity;

Citations to §387f(e)(1)

• 21 U.S.C. § 387b(7)

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  (7) the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 387f(e)(1) of this title or an applicable condition prescribed by an order under section 387f(e)(2) of this title; or

Citations to §387f(e)(2)

• 21 U.S.C. § 387b(7)

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  (7) the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 387f(e)(1) of this title or an applicable condition prescribed by an order under section 387f(e)(2) of this title; or