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. Food & Drug Administration et al., 1:16-cv-21967 (S.D. Fla. June 1, 2016)

Nicopure Labs, LLC. V. Food & Drug Administration et al., 1:16-cv-00878 (D.D.C. May 10, 2016)

Right to Be Smoke-Free, et al. vs. Food & Drug Administration 1:16-cv-01210 (D.D.C. June 20, 2016)

Lost Art Liquids, LLC v. U.S. Food & Drug Administration 2:16-cv-3468 (C.D. Cal. May 19, 2016)

John Middleton Company LLC v. U.S. Food & Drug Administration et al. 1:16-cv-996 (D.D.C. May 26, 2016)

Cigar Association of America, et al. v. U.S. Food & Drug Administration et al. 1:16-cv-1460 (D.D.C July 15, 2016)

Larry W. Faircloth v. U.S. Food & Drug Administration 2:16-cv-5267 (S.D.W.V. June 10, 2016)

Cyclops Vapor 2, Tiger Vapor and Karma S. v U.S. Food & Drug Administration 2:16-cv-556 (M.D. Ala. July 8, 2016)