Hostname: page-component-84b7d79bbc-c654p Total loading time: 0 Render date: 2024-07-25T14:50:50.255Z Has data issue: false hasContentIssue false
  • English
  • Français

D.C. Circuit Rules FDA Cannot Block E-cigarette Imports – Sottera, Inc. v. FDA

Published online by Cambridge University Press:  06 January 2021

Laura Kirshner
Get access Rights & Permissions [Opens in a new window]

Abstract

An abstract is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.
Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Recent Case Developments
Information
American Journal of Law & Medicine , Volume 37 , Issue 1 , March 2011 , pp. 194 - 198
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2011

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 Sottera, Inc. v. FDA, 627 F.3d 891 (D.C. Cir. 2010), aff’g Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62 (D.D.C. 2010).

2 Family Smoking Prevention & Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009).

3 Federal Food, Drug, & Cosmetic Act (FDCA), 21 U.S.C. §§ 301-399 (2006).

4 Sottera, 627 F.3d at 893.

5 Id.

6 Id.

7 Id. at 892. Sottera does business as NJOY. Smoking Everywhere, another e-cigarette distributor, was an additional plaintiff in the original suit but voluntarily dismissed its claims against the FDA prior to the FDA's appeal. Id. at 893.

8 Id.

9 Id. at 891.

10 Id. at 893, 900-01; see Federal Food, Drug, & Cosmetic Act (FDCA), 21 U.S.C. §§ 321(g)(1), 321(h)(2), 353(g)(1) (2006).

11 FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 144 (2000).

12 Sottera, 627 F.3d at 893.

13 Id.; see also Deborah M. Shelton & Allie Frumin, E-Cigarettes Get a “Smoking” Break: D.C. Circuit Clarifies Scope of FDA's Authority Over E-Cigarettes, Nat’l L. Rev., Jan. 4, 2011, http://www.natlawreview.com/printpdf/3479.

14 Sottera, 627 F.3d at 895.

15 Id. at 894-95. Under the Chevron doctrine, when an implementing agency interprets an ambiguous statute, a federal court must defer to the agency's interpretation of the statute if the agency's interpretation is reasonable, even if the agency's interpretation of the statute differs from the court's interpretation. See Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984).

16 Smoking Everywhere v. FDA, 680 F. Supp. 2d 62, 73 (D.D.C. 2010).

17 Sottera, 627 F.3d at 898-99.

18 Id. at 895-96.

19 Id. at 897.

20 Id. at 899 (“[T]he district court noted that the factual record on [Sottera] is meager and that the FDA may establish that [Sottera] does in fact make therapeutic claims regarding its electronic cigarettes.”).

21 Id. at 898.

22 Id.

23 Id.

24 Id. at 899 (Garland, J., concurring).

25 Id. at 900-01.

26 Id. at 902 (quoting Family Smoking Prevention & Tobacco Control Act sec. 101(a), § 201, 123 Stat. 1776, 1783 (2009)).

27 Id. (citing sec. 101(a), § 201, 123 Stat. 1776, 1783).

28 Id. at 899.

29 Id. at 903. To receive Chevron deference, an agency's statutory interpretation must carry “the force of law,” usually in the form of a regulation. Id. Litigation documents, such as court briefs, do not carry the force of law and, therefore, do not qualify for Chevron deference. See id. (“Other than its briefs, which do not qualify, the only expression of the FDA's view regarding electronic cigarettes is the agency's 2008 detention order barring the importation of [Sottera’s] products.”).

30 See id. at 903.

31 The FDA's authority over tobacco products allows the FDA to restrict how the products are marketed, manufactured, and distributed. Shelton & Frumin, supra note 13. The FDA's authority over drug/device products is more expansive and includes a pre-marketing approval requirement. Id.

32 Alicia Gallegos, FDA Regulation of E-cigarettes Rebuffed Again, Am. Med. News, Feb. 14, 2011, http://www.ama-assn.org/amednews/2011/02/14/gvsb0214.htm; see also Motion to Reinstate Stay of Preliminary Injunction Pending Disposition of Petition for Rehearing and Rehearing En Banc at 5, Sottera, 627 F.3d 891 (D.C. Cir. Dec. 20, 2010) (No. 10-5032), 2010 U.S. D.C. Cir. Motions LEXIS 82, at *5-6 [hereinafter FDA Motion to Reinstate].

33 Id.; Shelton & Frumin, supra note 13.

34 Dellorto, Danielle, FDA Hazy on E-cigarettes’ Safety, CNN, Mar. 13, 2009, http://articles.cnn.com/2009-03-13/health/ecigarettes.smoking.Google Scholar

35 While the Tobacco Act allows the FDA to regulate the marketing and manufacturing of e-cigarettes, the Act does not allow the FDA to outright ban e-cigarettes or to require ecigarette manufacturers to reduce nicotine levels to zero. See Family Smoking Prevention & Tobacco Control Act, sec. 101(b)(3), § 907(d)(3), 123 Stat. 1776, 1803 (2009).

36 See generally An Electronic Cigarette Ban: What Would Users Do?, E Cigarette Direct, http://www.ecigarettedirect.co.uk/research/ecig-user-survey/results.html (last visited Feb 26, 2011) (U.K. survey found that 67.8% of e-cigarette users “completely replaced tobacco cigarettes with electronic cigarettes”).

37 Sarah Reinecke, Popularity Surges for E-cigarettes, but Health Questions Unanswered, ArgusLeader.com, Feb. 14, 2011, http://www.argusleader.com/article/20110214/NEWS/102140318.

38 See id.; see also Dellorto, supra note 34.

39 To regulate e-cigarettes under the Tobacco Act, the FDA must “draft regulatory language and conduct a public proposal process.” Alicia Gallegos, FDA Barred from Regulating E-cigarettes as Medical Devices, Am. Med. News, Dec. 29, 2010, http://www.amaassn.org/amednews/2010/12/27/prsd1229.htm.

40 Preliminary FDA tests raised concerns about “inconsistent or non-existent” quality control among some e-cigarette manufacturers. FDA, Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted by FDA, July 22, 2009, http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.htm; see also Maggie Fox, FDA Cannot Block E-cigarette Imports, Court Rules, Westlaw News & Insight, Dec. 8, 2010, http://westlawnews.thomson.com/California_Litigation/News/2010/12_-_December/FDA_cannot_block_e-cigarette_imports,_court_rules.

41 Available flavors include menthol, tobacco, cherry, coffee, apple, chocolate, almond, and vanilla, among others. Electronic Cigarette Comparison Chart: Part 1, Electronic Cigarette Information, http://electroniccigaretteinformation.org/2010/06/28/electronic-cigarette-comparison-chart-part-1 (last visited Feb. 26, 2011).

42 Reinecke, supra note 37; Press Release, FDA, FDA and Public Health Experts Warn About Electronic Cigarettes (July 22, 2009), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm.

43 FDA Motion to Reinstate, supra note 32, at 5, 2010 U.S. D.C. Cir. Motions LEXIS 82, at *5-6; Press Release, supra note 42.