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Public Health Advocacy Institute

at Northeastern University School of Law

360 Huntington Avenue, 117CU

Boston, MA 02115


You are here: Home > Tobacco Control > Tobacco Litigation > FDA Deeming Rule

FDA Deeming Rule

In May of 2016, the U.S. Food and Drug Administration published its final “deeming” rule through which the agency extended its regulatory authority to all types of tobacco products, including e-cigarettes, cigars, hookah and others. The FDA may now regulate shisha (hookah tobacco), pipe tobacco, dissolvables, gels, all cigars (including premium cigars) and e-cigarettes. Newly deemed products were subject to certain sales restrictions as of August 8, 2016, while other regulations will be phased in.

As expected, several challenges were filed in federal courts across the country alleging in large part that the FDA had exceeded its authority, violated the rulemaking process and restricted rights protected by the U.S. Constitution. Click on a link below to read more about each case:

Icaza et al. v. F.D.A. et al., 1:16-cv-21967 (S.D. Fla. June 1, 2016)

Nicopure Labs, LLC. et al. v. F.D.A. et al., (D.C. Cir.)

Right to Be Smoke-Free, et al. vs. F.D.A., 1:16-cv-01210 (D.D.C. June 20, 2016)

Lost Art Liquids, LLC v. F.D.A. 2:16-cv-3468 (C.D. Cal. May 19, 2016)

John Middleton Company LLC v. FDA et al., 1:16-cv-996 (D.D.C. May 26, 2016)

Cigar Association of America, et al. v. F.D.A. et al., 1:16-cv-1460 (D.D.C July 15, 2016)

Larry W. Faircloth v. F.D.A., 2:16-cv-5267 (S.D.W.V. June 10, 2016)

Cyclops Vapor 2, Tiger Vapor and Karma S. v.  F.D.A., 2:16-cv-556 (M.D. Ala. July 8, 2016)

Masterpiece Vapors, et al. v. F.D.A., 2018 WL 626114 (D.Minn.)

Further, several health groups filed suit challenging FDA’s implementation of the deeming rule and seeking to vacate the agency’s 2017 Guidance extending premarket review deadlines for e-cigarette and cigar manufacturers. Click the link below to read more about the case: 

American Academy of Pediatrics, et al., v. Food and Drug Administration, et al., 8:18-cv-00883-PWG (D.Md. 2019)

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