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Tobacco Products

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Section 103 of the Tobacco Control Act - Conforming and Other Amendments to General Provisions

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Table of Contents

     

 


 

Related Resources for Section 103

 

Regulation: Final

 

Draft Guidance

 

Final Guidance

 

 


  

  1. Amendment of Federal Food, Drug, and Cosmetic Act. Except as otherwise expressly provided, whenever in this section an amendment is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference is to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
     
  2. Section 301. Section 301 (21 U.S.C. 331) is amended

    1. in subsection (a), by inserting "tobacco product," after "device,";
       
    2. in subsection (b), by inserting "tobacco product," after "device,";
       
    3. in subsection (c), by inserting "tobacco product," after "device,";
       
    4. in subsection (e)

      1. by striking the period after "572(i)"; and
         
      2. by striking "or 761 or the refusal to permit access to" and inserting "761, 909, or 920 or the refusal to permit access to";
         
    5. in subsection (g), by inserting "tobacco product," after "device,";
       
    6. in subsection (h), by inserting "tobacco product," after "device,";
       
    7. in subsection (j)

      1. by striking the period after "573"; and
         
      2. by striking "708, or 721" and inserting "708, 721, 904, 905, 906, 907, 908, 909, or 920(b)";
         
    8. in subsection (k), by inserting "tobacco product," after "device,";
       
    9. by striking subsection (p) and inserting the following:


      "(p) The failure to register in accordance with section 510 or 905, the failure to provide any information required by section 510(j), 510(k), 905(i), or 905(j), or the failure to provide a notice required by section 510(j)(2) or 905(i)(3).";
       
    10. by striking subsection (q)(1) and inserting the following:


      "(q)

      1. The failure or refusal

        1. to comply with any requirement prescribed under section 518, 520(g), 903(b), 907, 908, or 915;
           
        2. to furnish any notification or other material or information required by or under section 519, 520(g), 904, 909, or 920; or
           
        3. to comply with a requirement under section 522 or 913.";
           
    11. in subsection (q)(2), by striking "device," and inserting "device or tobacco product,";
       
    12. in subsection (r), by inserting "or tobacco product" after the term "device" each time that such term appears; and
       
    13. by adding at the end the following:

      "(oo) The sale of tobacco products in violation of a no-tobacco-sale order issued under section 303(f).

      (pp) The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 911.

      (qq)

      1. Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product.
         
      2. Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product.
         
      3. The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product.

      (rr) The charitable distribution of tobacco products.

      (ss) The failure of a manufacturer or distributor to notify the Attorney General and the Secretary of the Treasury of their knowledge of tobacco products used in illicit trade.

      (tt) Making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that

      1. the product is approved by the Food and Drug Administration;
         
      2. the Food and Drug Administration deems the product to be safe for use by consumers;
         
      3. the product is endorsed by the Food and Drug Administration for use by consumers; or
         
      4. the product is safe or less harmful by virtue of

        1. its regulation or inspection by the Food and Drug Administration; or
           
        2. its compliance with regulatory requirements set by the Food and Drug Administration;

          including any such statement or representation rendering the product misbranded under section 903."
           
  1. Section 303. Section 303(f) ( 21 U.S.C. 333(f)) is amended

    1. in paragraph (5)

      1. by striking "paragraph (1), (2), (3), or (4)" each place such appears and inserting "paragraph (1), (2), (3), (4), or (9)";
         
      2. in subparagraph (A)

        1. by striking "assessed" the first time it appears and inserting "assessed, or a no-tobacco-sale order may be imposed,"; and
           
        2. by striking "penalty" the second time it appears and inserting "penalty, or upon whom a no-tobacco-sale order is to be imposed,";
           
      3. in subparagraph (B)

        1. by inserting after "penalty," the following: "or the period to be covered by a no-tobacco-sale order,"; and
           
        2. by adding at the end the following: "A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order."; and
           
      4. by adding at the end the following:

        "(D) The Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order.";
         
    2. in paragraph (6)

      1. by inserting "or the imposition of a no-tobacco-sale order" after the term "penalty" each place such term appears; and
         
      2. by striking "issued." and inserting "issued, or on which the no-tobacco-sale order was imposed, as the case may be."; and
         
    3. by adding at the end the following:

      "(8) If the Secretary finds that a person has committed repeated violations of restrictions promulgated under section 906(d) 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."

      (9) Civil Monetary Penalties for Violation of Tobacco Product Requirements
       
      1. In General. Subject to subparagraph (B), any person who violates a requirement of this Act which relates to tobacco products shall be liable to the United States for a civil penalty in an amount not to exceed $ 15,000 for each such violation, and not to exceed $ 1,000,000 for all such violations adjudicated in a single proceeding.
         
      2. Enhanced Penalties

              1. Any person who intentionally violates a requirement of section 902(5), 902(6), 904, 908(c), or 911(a), shall be subject to a civil monetary penalty of

                1. not to exceed $ 250,000 per violation, and not to exceed $ 1,000,000 for all such violations adjudicated in a single proceeding; or
                   
                2. in the case of a violation that continues after the Secretary provides written notice to such person, $ 250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $ 1,000,000 for any 30-day period, and not to exceed $ 10,000,000 for all such violations adjudicated in a single proceeding.
                   
              2. Any person who violates a requirement of section 911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil monetary penalty of

                1. not to exceed $ 250,000 per violation, and not to exceed $ 1,000,000 for all such violations adjudicated in a single proceeding; or
                   
                2. in the case of a violation that continues after the Secretary provides written notice to such person, $ 250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $ 1,000,000 for any 30-day period, and not to exceed $ 10,000,000 for all such violations adjudicated in a single proceeding.
                   
                3. In determining the amount of a civil penalty under clause (i)(II) or (ii)(II), the Secretary shall take into consideration whether the person is making efforts toward correcting the violation of the requirements of the section for which such person is subject to such civil penalty."
                   
  2. Section 304. Section 304 ( 21 U.S.C. 334) is amended

    1. in subsection (a)(2)

      1. by striking "and" before "(D)"; and
         
      2. by striking "device." and inserting the following: "device, and (E) Any adulterated or misbranded tobacco product.";
         
    2. in subsection (d)(1), by inserting "tobacco product," after "device,";
       
    3. in subsection (g)(1), by inserting "or tobacco product" after the term "device" each place such term appears; and
       
    4. in subsection (g)(2)(A), by inserting "or tobacco product" after "device".
       
  3. Section 505. Section 505(n)(2) ( 21 U.S.C. 355(n)(2)) is amended by striking "section 904" and inserting "section 1004".
     
  4. Section 523. Section 523(b)(2)(D) ( 21 U.S.C. 360m(b)(2)(D)) is amended by striking "section 903(g)" and inserting "section 1003(g)".
     
  5. Section 702. Section 702(a)(1) (U.S.C. 372(a)(1)) is amended

    1. by striking "(a)(1)" and inserting "(a)(1)(A)"; and
       
    2. by adding at the end the following:


      "(B)

      1. For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this Act.
         
      2. The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this Act on Indian country without the express written consent of the Indian tribe involved."
         
  6. Section 703. Section 703 ( 21 U.S.C. 373) is amended

    1. by inserting "tobacco product," after the term "device," each place such term appears; and
       
    2. by inserting "tobacco products," after the term "devices," each place such term appears.
       
  7. Section 704. Section 704 ( 21 U.S.C. 374) is amended

    1. in subsection (a)(1)

      1. by striking "devices, or cosmetics" each place it appears and inserting "devices, tobacco products, or cosmetics";
         
      2. by striking "or restricted devices" each place it appears and inserting "restricted devices, or tobacco products"; and
         
      3. by striking "and devices and subject to" and all that follows through "other drugs or devices" and inserting "devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 505 (i) or (k), section 519, section 520(g), or chapter IX and data relating to other drugs, devices, or tobacco products";
         
    2. in subsection (b), by inserting "tobacco product," after "device,"; and
       
    3. in subsection (g)(13), by striking "section 903(g)" and inserting "section 1003(g)".
       
  8. Section 705. Section 705(b) ( 21 U.S.C. 375(b)) is amended by inserting "tobacco products," after "devices,".
     
  9. Section 709. Section 709 ( 21 U.S.C. 379a) is amended by inserting "tobacco product," after "device,".
     
  10. Section 801. Section 801 ( 21 U.S.C. 381) is amended

    1. in subsection (a)

      1. by inserting "tobacco products," after the term "devices,";
         
      2. by inserting "or section 905(h)" after "section 510"; and
         
      3. by striking the term "drugs or devices" each time such term appears and inserting "drugs, devices, or tobacco products";
         
    2. in subsection (e)(1)

      1. by inserting "tobacco product" after "drug, device,"; and
         
      2. by inserting ", and a tobacco product intended for export shall not be deemed to be in violation of section 906(e), 907, 911, or 920(a)," before "if it--"; and
         
    3. by adding at the end the following:


      "(p)

        1. Not later than 36 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, and annually thereafter, the Secretary 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 regarding

          1. the nature, extent, and destination of United States tobacco product exports that do not conform to tobacco product standards established pursuant to this Act;
             
          2. the public health implications of such exports, including any evidence of a negative public health impact; and
             
          3. recommendations or assessments of policy alternatives available to Congress and the executive branch to reduce any negative public health impact caused by such exports.
             
        2. The Secretary is authorized to establish appropriate information disclosure requirements to carry out this subsection."
           
  11. Section 1003. Section 1003(d)(2)(C) (as redesignated by section 101(b)) is amended

    1. by striking "and" after "cosmetics,"; and
       
    2. inserting ", and tobacco products" after "devices".
       
  12. Section 1009. Section 1009(b) (as redesignated by section 101(b)) is amended by striking "section 908" and inserting "section 1008".
     
  13. Section 409 of the Federal Meat Inspection Act. Section 409(a) of the Federal Meat Inspection Act ( 21 U.S.C. 679(a)) is amended by striking "section 902(b)" and inserting "section 1002(b)".
     
  14. Rule of Construction. Nothing in this section is intended or shall be construed to expand, contract, or otherwise modify or amend the existing limitations on State government authority over tribal restricted fee or trust lands.
     
  15. Guidance and Effective Dates

    1. In General. The Secretary of Health and Human Services shall issue guidance

      1. defining the term "repeated violation", as used in section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333(f)(8)) as amended by subsection (c), as including at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation and providing for civil penalties in accordance with paragraph (2);
         
      2. providing for timely and effective notice by certified or registered mail or personal delivery to the retailer of each alleged violation at a particular retail outlet prior to conducting a followup compliance check, such notice to be sent to the location specified on the retailer's registration or to the retailer's registered agent if the retailer has provider such agent information to the Food and Drug Administration prior to the violation;
         
      3. providing for 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, and providing for an expedited procedure for the administrative appeal of an alleged violation;
         
      4. providing that a person may not be charged with a violation at a particular retail outlet unless the Secretary has provided notice to the retailer of all previous violations at that outlet;
         
      5. establishing that civil money penalties for multiple violations shall increase from one violation to the next violation pursuant to paragraph (2) within the time periods provided for in such paragraph;
         
      6. providing that good faith reliance on the presentation of a false government-issued photographic identification that contains a date of birth does not constitute a violation of any minimum age requirement for the sale of tobacco products if the retailer has taken effective steps to prevent such violations, including

        1. adopting and enforcing a written policy against sales to minors;
           
        2. informing its employees of all applicable laws;
           
        3. establishing disciplinary sanctions for employee noncompliance; and
           
        4. requiring its employees to verify age by way of photographic identification or electronic scanning device; and
           
      7. providing for the Secretary, in determining whether to impose a no-tobacco-sale order and in determining whether to compromise, modify, or terminate such an order, to consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products, including the steps listed in subparagraph (F).
         
    2. Penalties for Violations

      1. In General. The amount of the civil penalty to be applied for violations of restrictions promulgated under section 906(d), as described in paragraph (1), shall be as follows:

        1. With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed

          1. in the case of the first violation, $0.00 together with the issuance of a warning letter to the retailer;
             
          2. in the case of a second violation within a 12-month period, $250;
             
          3. in the case of a third violation within a 24-month period, $500;
             
          4. in the case of a fourth violation within a 24-month period, $2,000;
             
          5. in the case of a fifth violation within a 36-month period, $5,000; and
             
          6. in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis.
             
        2. With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed

          1. in the case of the first violation, $250;
             
          2. in the case of a second violation within a 12-month period, $500;
             
          3. in the case of a third violation within a 24-month period, $1,000;
             
          4. in the case of a fourth violation within a 24-month period, $2,000;
             
          5. in the case of a fifth violation within a 36-month period, $5,000; and
             
          6. in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis.
             
      2. Training Program. For purposes of subparagraph (A), the term "approved training program" means a training program that complies with standards developed by the Food and Drug Administration for such programs.
         
      3. Consideration of State Penalties. The Secretary shall coordinate with the States in enforcing the provisions of this Act and, for purposes of mitigating a civil penalty to be applied for a violation by a retailer of any restriction promulgated under section 906(d), shall consider the amount of any penalties paid by the retailer to a State for the same violation.
         
    3. General Effective Date. The amendments made by paragraphs (2), (3), and (4) of subsection (c) shall take effect upon the issuance of guidance described in paragraph (1) of this subsection.
       
    4. Special Effective Date. The amendment made by subsection (c)(1) shall take effect on the date of enactment of this Act.
       
    5. Package Label Requirements. The package label requirements of paragraphs (3) and (4) of section 903(a) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act. The package label requirements of paragraph (2) of such section 903(a) for cigarettes shall take effect on the date that is 15 months after the issuance of the regulations required by section 4(d) of the Federal Cigarette Labeling and Advertising Act ( 15 U.S.C. 1333), as amended by section 201 of this division. The package label requirements of paragraph (2) of such section 903(a) for tobacco products other than cigarettes shall take effect on the date that is 12 months after the date of enactment of this Act. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 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.
       
    6. Advertising Requirements. The advertising requirements of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act.