Advertisement

Federal Approaches to the Regulation of Noncigarette Tobacco Products

  • Michael J.A. Freiberg
    Correspondence
    Address correspondence to: Michael J. A. Freiberg, JD, Public Health Law Center, William Mitchell College of Law, 875 Summit Avenue, St. Paul MN 55105
    Affiliations
    Public Health Law Center, William Mitchell College of Law, St. Paul, Minnesota
    Search for articles by this author

      Context

      Under a grant funded by ClearWay MinnesotaSM and in partnership with nationally recognized experts in tobacco product regulation, the Public Health Law Center investigated how laws at every level apply, or fail to apply, to noncigarette tobacco products—also called “other tobacco products.”

      Evidence acquisition

      During the years 2010–2011, standard legal research techniques were used to identify and compile relevant statutes, regulations, decisions, pleadings, proposals, and related materials. Sources included standard commercial legal databases such as LexisNexis and Westlaw, online sources for pending rules and legislation, and direct contact with courts for legal pleadings and unpublished decisions. These legal authorities related to many aspects of the regulation, including price, flavorants, youth access, marketing restrictions, and product design of other tobacco products. Five of these products were used as case studies: dissolvable tobacco products, electronic cigarettes, little cigars, snus, and water pipes.

      Evidence synthesis

      Research during the years 2010–2011 revealed that the federal regulation of other tobacco products lags behind the regulation of more “traditional” tobacco products, such as cigarettes and moist snuff. Federal regulatory options to expand regulation of these products were identified.

      Conclusions

      The article highlights several federal policy interventions that would address gaps in the regulation of other tobacco products. The FDA must determine whether these interventions will benefit public health and, if so, to what extent—the legal criteria for intervention under the federal Family Smoking Prevention and Tobacco Control Act.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to American Journal of Preventive Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

      1. Family Smoking Prevention and Tobacco Control Act, 21 U.S.C.A. §§ 387–387u (West 2009); Pub. L. No. 111-31, 123 Stat. 1776 (2009); 21 C.F.R. §§ 1140.30, 1140.32 (2010).
        • Remarks by the President at the Signing of the Family Smoking Prevention and Tobacco Control Act (June 22, 2009)
        • CDC
        Smoking-attributable mortality, years of potential life lost, and productivity losses—U.S., 2000–2004.
        MMWR Morb Mortal Wkly Rep. 2008; 57: 1226-1228
      2. 21 U.S.C. § 387a(b) (2010).

      3. 21 C.F.R. § 1140 (2010).

      4. 21 U.S.C. § 387g(a)(1)(A) (2010).

        • Zellers L.
        • McLaughlin I.
        State and local policy as a tool to complement and supplement the FDA law.
        Hastings Sci Technol Law J. 2010; 2: 117-130
      5. Freiberg M. Options for state and local governments to regulate non-cigarette tobacco products. Ann Health Law, Vol. 21, Issue 2 (Winter 2012).

      6. 21 U.S.C. § 387f(d)(1) (2010).

      7. 21 U.S.C. § 387j (2010).

        • Connolly G.N.
        • Richter P.
        • Aleguas Jr, A.
        • Pechacek T.F.
        • Stanfill S.B.
        • Alpert H.R.
        Unintentional child poisonings through ingestion of conventional and novel tobacco products.
        Pediatrics. 2010; 125: 896-899
        • Trtchounian A.
        • Talbot P.
        Electronic nicotine delivery systems: is there a need for regulation?.
        Tob Control. 2011; 20: 47-52
        • Delnevo C.D.
        • Hrywna M.
        “A whole 'nother smoke” or a cigarette in disguise: how RJ Reynolds reframed the image of little cigars.
        Am J Public Health. 2007; 97: 1368-1375
        • Mejia A.B.
        • Ling P.M.
        • Glantz S.A.
        Quantifying the effects of promoting smokeless tobacco as a harm reduction strategy in the USA.
        Tob Control. 2010; 19: 297-305
        • Martinasek M.P.
        • McDermott R.J.
        • Martini L.
        Waterpipe (hookah) tobacco smoking among youth.
        Curr Probl Pediatr Adolesc Health Care. 2011; 41: 34-57
        • Associated Press
        Virginia tobacco maker seeks new FDA designation.
        Fox News. 2011 January 4;
      8. 21 U.S.C. § 387k (2010).

        • Peterson M.
        Star Scientific's tobacco lozenges get favorable FDA ruling.
        Bloomberg. 2011 March 23;
      9. 21 U.S.C. § 387(18) (2010).

        • Deyton L.R.
        • Woodcock J.
        Regulation of e-cigarettes and other tobacco products, letter to stakeholders.
      10. 21 U.S.C. § 387g(a)(3) (2010).

      11. 21 U.S.C. § 387g(d)(3)(A) (2010).

      12. 21 U.S.C. § 387j(a)(2)(A)(i) (2010).

      13. 21 U.S.C. § 387j(a)(3)(A)(i) (2010).

      14. 21 U.S.C. § 387j(a)(3)(B) (2010).

        • Wilson D.
        Flavored tobacco pellets are denounced as a lure to young users.
        New York Times. 2010, Apr 19;
        • Stanfill S.B.
        • Zhang L.
        • Lawler T.S.
        • Watson C.H.
        • Ashley D.L.
        Camel Orbs: nicotine, pH, tobacco-specific nitrosamines, and select flavor analysis.
        • Star Scientific, Inc
        Comment on FDA Docket No. FDA-2010-N-0123 (Impact of dissolvable tobacco use on public health), 2010.
        • Kurtenbach E.
        China probes safety of nicotine inhalers.
        Associated Press Financial Wire. 2006, Dec 4;
        • Skatssoon J.
        Running out of puff.
        Townsville Bulletin/Townsville Sun. 2003, Apr 19;
        • Landwehr A.
        “Healthy cigarette” inventor hopes device will make a killing.
        The Patriot Ledger. 1995, Nov 13;
        • Hobart R.
        Preemption: taking the local out of tobacco control.
      15. 21 U.S.C. § 387p(a)(2)(B) (2010).

        • White House Office of the Press Secretary, Memorandum for the Heads of Executive Departments and Agencies
        • Chaloupka F.J.
        • Straif K.
        • Leon M.E.
        Effectiveness of tax and price policies in tobacco control.
        Tob Control. 2011; 20: 235-238
      16. 21 U.S.C. § 387p(a)(1) (2010).

      17. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, § 102(a)(2)(G).

      18. FDA, Draft guidance for industry: compliance with regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents.
      19. 21 C.F.R. § 1140.16(d)(2) (2010).

        • Federal Trade Commission
        Cigarette report for 2006.
      20. 21 C.F.R. § 1140.16(b) (2010).

        • Landrine H.
        • Klonoff E.A.
        • Alcaraz R.
        Minors' access to single cigarettes in California.
        Prev Med. 1998; 27: 503-505
      21. 21 U.S.C. § 387g(a)(1)(A) (2010).

        • Dachille K.
        Pick your poison: responses to the marketing and sale of flavored tobacco products.
      22. Required warnings for cigarette packages and advertisements, 76 Fed. Reg. 36,628, 36,676 (June 22, 2011) (to be codified at 21 C.F.R. pt. 1141).

        • Hammond D.
        • Fong G.T.
        • Borland R.
        • Cummings K.M.
        • McNeill A.
        • Driezen P.
        Text and graphic warnings on cigarette packages: findings from the international tobacco control four country study.
        Am J Prev Med. 2007; 32: 202-209
        • Stein R.
        Graphic cigarette warning labels blocked by judge.
        Washington Post. 2011, Nov 7;
      23. Discount Tobacco City & Lottery, Inc. v. United States, 2012 WL 899073 (6th Cir. March 19, 2012).

      24. 15 U.S.C. § 4402(a)(2)(A) (2010).

      25. 21 U.S.C. § 387k(a) (2010).

      26. 21 U.S.C. § 387k(b)(2)(A)(ii) (2010).

      27. 21 U.S.C. § 387k(b)(1) (2010).

      28. 21 U.S.C. § 387a(b) (2010).

      29. 21 C.F.R. § 1140.14 (2010).

      30. 21 C.F.R. § 1140.16(c) (2010).

      31. 21 C.F.R. §§ 1140.14(a), 1140.30, 1140.32, 1140.34 (2010).