Editor’s Note: This post is brought to you by Camille Wilson, a patent attorney in Jacksonville, Florida, with extensive experience researching e-cigarettes. Enjoy!
Last January, in 2015, I wrote about the patent evolution of e-cigarettes up until that point. I also made some general predictions about the e-cigarette industry, mostly favoring Big Tobacco. Only a short twenty months later, the entire landscape is about to change…and it will most likely favor Big Tobacco, in one way or another.
But why the shift?
In May 2016, the FDA finalized a rule (a very dense 134 page rule, to be exact) extending their regulatory power established by the Tobacco Control Act in 2007 to cover all tobacco products, which now includes e-cigarettes. That rule officially went into effect on August 8, 2016, starting the clock for the entire industry to disprove that their products are “not appropriate for the protection of public health.” (“Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act”, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28975, May 10, 2016) (Amending 21 C.F.R. §§ 1100, 1140, and 1143). I use the term “disprove” because the entire rule seems to presume that all e-cigarette products do not protect public health; so, the onus is placed on the manufacturers to prove otherwise.