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Has FDA abandoned its efforts to make fake-cigar cigarettes comply with federal tobacco control laws that apply to cigarettes but not cigars?
  1. Eric N Lindblom1,
  2. Darren Mays2,
  3. Kevin R J Schroth3,
  4. Cristine Delnevo3
  1. 1O'Neill Institute for National & Global Health Law, Georgetown University Law Center, Washington, District of Columbia, USA
  2. 2Department of Oncology, Georgetown University Medical Center, Lombardi Comprehensive Cancer Center, Washington, District of Columbia, USA
  3. 3Center for Tobacco Studies, Rutgers School of Public Health, New Brunswick, New Jersey, USA
  1. Correspondence to Eric N Lindblom, O'Neill Institute for National & Global Health Law, Georgetown University Law Center, Washington, DC 20001, USA; enl27{at}law.georgetown.edu

Abstract

In the USA, legal definitions of cigarettes and cigars are critical to tobacco control policy because federal, state and local laws typically tax and regulate cigarettes more strictly than cigars. In 2016, near the end of the Obama Administration, the US Food and Drug Administration (FDA) sent warning letters to four filtered ‘little cigar’ manufacturers stating that their so-called ‘cigars’ were cigarettes and, therefore, subject to more stringent public health restrictions. Documents produced in response to a Freedom of Information Act request show that without explanation or public notice FDA has abandoned its prior determination that the manufacturers’ ‘little cigars’ were actually cigarettes and, consequently, were violating the ban on flavoured cigarettes in the Family Smoking Prevention and Tobacco Control Act (TCA). The documents also present the manufacturers’ arguments against FDA’s original position. However, those industry arguments are inconsistent with the research, other evidence and legal analysis indicating that filtered ‘little cigars’ meet the legal definition of cigarettes under the TCA and other similar federal, state and local definitions. To protect the public health, FDA must renew its efforts to ensure that these filtered ‘little cigars’ do not continue to evade compliance with the many important restrictions and requirements that apply to cigarettes but not cigars. Other government regulatory and tax-collection agencies with similar definitions need to follow suit.

  • packaging and labelling
  • public policy
  • tobacco industry
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Footnotes

  • Twitter @kevinschroth, @crisdelnevo

  • Contributors No substantive contributions to the paper were made by anyone other than the four listed authors. The four informally discussed the paper and what it would contain. ENL wrote the initial draft which the others reviewed, leading to numerous additions and revisions, followed by several more rounds of redrafting, comments and revisions from all four until all agreed that the final draft was accurate, complete and ready for submission. Upon receiving the revise and resubmit with comments from reviewers and the subsequent request for final changes, the same basic process repeated to produce the revised draft and then the final draft.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available in a public, open access repository.

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