Tobacco product regulation
Federal Approaches to the Regulation of Noncigarette Tobacco Products

https://doi.org/10.1016/j.amepre.2012.07.036Get rights and content

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and Westlaw, online sources for pending rules and legislation, and direct contact with courts for legal pleadings and unpublished decisions.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.

Section snippets

Context

In 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act1 (TCA)—far-reaching legislation giving the Food and Drug Administration (FDA) the authority to regulate tobacco products. In his signing statement, the President stated that “the decades-long effort to protect our children from the harmful effects of tobacco has emerged victorious.”2 Yet, despite this optimism, tobacco remains the leading cause of preventable death in the U.S.3

At least in part,

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 of other tobacco products,

Evidence Synthesis

Research during the years 2010–2011 revealed that the federal regulation of these other 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.

Category Prohibition

The first regulatory option available to the FDA is perhaps the most dramatic. The FDA has the authority to issue tobacco product standards which it determines would protect public health.21 These standards could include the prohibition of entire classes of tobacco products with certain exceptions, including all cigarettes, all smokeless tobacco products, all little cigars, and all pipe tobacco.22

Moreover, the FDA has the authority to require premarket review for products that are not

Summary

Because many tobacco products are not currently regulated in the same manner as cigarettes, there is a need to consider new federal regulation of the products. This regulation could take many forms: prohibiting an entire category of tobacco products; price regulation, including regulations related to free samples, coupons, and minimum pack size; a prohibition on characterizing flavors; expanded warning labels, potentially including graphic warnings; a prohibition on health descriptors; and

References (56)

  • Freiberg M. Options for state and local governments to regulate non-cigarette tobacco products. Ann Health Law, Vol....
  • 21 U.S.C. § 387f(d)(1)...
  • 21 U.S.C. § 387j...
  • G.N. Connolly et al.

    Unintentional child poisonings through ingestion of conventional and novel tobacco products

    Pediatrics

    (2010)
  • A. Trtchounian et al.

    Electronic nicotine delivery systems: is there a need for regulation?

    Tob Control

    (2011)
  • C.D. Delnevo et al.

    “A whole 'nother smoke” or a cigarette in disguise: how RJ Reynolds reframed the image of little cigars

    Am J Public Health

    (2007)
  • A.B. Mejia et al.

    Quantifying the effects of promoting smokeless tobacco as a harm reduction strategy in the USA

    Tob Control

    (2010)
  • Virginia tobacco maker seeks new FDA designation

    Fox News

    (2011 January 4)
  • 21 U.S.C. § 387k...
  • M. Peterson

    Star Scientific's tobacco lozenges get favorable FDA ruling

    Bloomberg

    (2011 March 23)
  • 21 U.S.C. § 387(18)...
  • L.R. Deyton et al.

    Regulation of e-cigarettes and other tobacco products, letter to stakeholders

  • 21 U.S.C. § 387g(a)(3)...
  • 21 U.S.C. § 387g(d)(3)(A)...
  • 21 U.S.C. § 387j(a)(2)(A)(i)...
  • 21 U.S.C. § 387j(a)(3)(A)(i)...
  • 21 U.S.C. § 387j(a)(3)(B)...
  • D. Wilson

    Flavored tobacco pellets are denounced as a lure to young users

    New York Times

    (2010, Apr 19)
  • Cited by (22)

    • Claims in vapour device (e-cigarette) regulation: A Narrative Policy Framework analysis

      2017, International Journal of Drug Policy
      Citation Excerpt :

      A 2015 national survey of students reported that 16.0% of high school and 5.3% of middle school students had used a vapour device in the past 30 days (Singh et al., 2016). It appears that no vapour devices were marketed in the US prior to February 15, 2007 (Freiberg, 2012). From 2008 to 2010, the Food and Drug Administration (FDA) attempted to regulate vapour devices as an unapproved medical drug/device (US Food and Drug Aministration, 2011, April 25) and took steps to interdict their importation and distribution (Washington Legal Foundation, 2010, July 21).

    • Overview of Electronic Nicotine Delivery Systems: A Systematic Review

      2017, American Journal of Preventive Medicine
      Citation Excerpt :

      Reviews have been published on ENDS in general10–21 or on specific topics, including health effects22–58; impact on smoking cessation29,40–43,45,47,48,51,59–73; product features22,39,41–43,45,47,74–77; potential to induce dependence28,45,47,78,79; consumer perceptions26,48,80,81; patterns of use8,26,43,48,51,82–90; and policies.8,48,91–98 Two conducted a bibliometric review of the ENDS literature86,99 and 46% of the reviews were systematic.11,13,15,16,22–28,33,34,36,39,46,48,53–58,60,61,66,68,70–75,79–82,85,86,88–90,93,97,100–104 The dramatically changing product landscape warrants frequent updates and synthesis of the rapidly growing evidence to inform prudent practice, policy, and regulation.9,105,106

    • Trends in medical malpractice claims in patients with cleft or craniofacial abnormalities in the United States

      2016, International Journal of Pediatric Otorhinolaryngology
      Citation Excerpt :

      However, this commercial and computerized database does not suffer from the geographic and socioeconomic homogeneity limitations inherent to using private insurer closed claims databases. In addition, WestLawNext and its predecessor, WestLaw, have previously been used in studies ranging across many fields of study and thus were deemed acceptable for use [13–15,32–43]. International organizations have cited healthcare cost analysis as a research priority in patients with craniofacial abnormalities and thus our research contributes to this mandate [7,44].

    • Patterns of alternative tobacco product use: Emergence of hookah and E-cigarettes as preferred products amongst youth

      2016, Journal of Adolescent Health
      Citation Excerpt :

      Furthermore, our results also indicate that another group of teens, overrepresented by boys, may benefit from interventions targeting all types of tobacco products. Current regulations related to tobacco products do not meaningfully impact three of the five products examined in this study (cigars, e-cigarettes, and hookah) [26]. The regulation of flavoring, youth access, and secondhand exposure are topics that should continue to receive careful consideration.

    • Trends in cigarette, cigar, and smokeless tobacco use among New York City public high school youth smokers, 2001-2013

      2015, Preventive Medicine Reports
      Citation Excerpt :

      Ultimately, these data emphasize the need for public health efforts focus on consumption of other tobacco products, such as cigars and smokeless tobacco (Freiberg, 2012). To address this issue, in August 2014, NYC introduced a policy equalizing the price of little cigars to that of cigarettes, making it more difficult for youth to gain access to these products (Freiberg, 2012; The New York State Department of Taxation and Finance, 2014). Future studies will be needed to assess the impact of such legislation.

    View all citing articles on Scopus
    View full text