Just over a week ago, the United States Food and Drug Administration announced what new FDA chief Dr. Scott Gottileb called “a cornerstone of our new and more comprehensive approach to effective tobacco regulation”: an initiative to reduce the nicotine content in cigarettes to “minimally or nonaddictive” levels. The 2009 Tobacco Control Act gave FDA authority to reduce any “additives, constituents…, or other component of a tobacco product.”
President Barack Obama signing the Tobacco Control Act
Public health historian Robert Proctor was thrilled. “This is exceptionally good news for tobacco control, and for human health,” he wrote last week in the New York Times. Not so for companies like Altria and British American Tobacco, whose stock value fell within an hour of the statement (and recovered somewhat before the closing bell).
Big Tobacco was reeling for good reason: nicotine is the primary addictive component of cigarette smoking, not incidentally the leading cause of preventable deaths in the U.S. The addictive capacity of nicotine is now practically indisputable. For over sixty years, government regulators, independent researchers, and tobacco company scientists have investigated the extent of that capacity and the danger it poses when delivered via tar-laden cigarettes. Continue reading →
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.
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Editor’s Note: Today’s post is brought to you by Camille Higham, a patent attorney in Jacksonville, Florida, with extensive experience researching e-cigarettes.
About a year ago, I wrote about e-cigarettes in a blog that is woefully neglected now. At that time, I thought e-cigarettes may fall between a novelty and a passing fad. Now I am still skeptical that e-cigarettes will ever supplant traditional cigarettes, primarily because of how deeply tobacco is entrenched in our history, for better or worse. E-cigarettes are undeniably increasing in popularity, and if they do edge out tobacco-based cigarettes, ironically, it is the Big Tobacco companies, with their deep pockets and market influence, who may be best equipped to make that happen.
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