FDA e-cig regulations attract two lawsuits from ‘Big Tobacco’

A total of four lawsuits has now been filed against the newly released FDA e-cig regulations, with two manufacturing companies of Big Tobacco products most recently joining in the legal wrangling.  While the vaping community is understandably concerned about the future of electronic cigarettes, they may or may not have found unlikely allies in the John Middleton Co. LLC, a subsidiary of the Altria Group, Inc., and Enrique Fernando Sanchez Icaza and Global Premium Cigars, LLC, manufacturers of the 1502 cigar brand.

The very first historical suit was filed by Nicopure labs on May 9, four days after the FDA’s announcement.  Nicopure essentially believes that the FDA e-cig regulations violate the Administrative Procedure Act of 1946 along with the First Amendment to the U.S. Constitution.  The second lawsuit came shortly afterward, filed by Lost Art Liquids who claims that the FDA’s recent actions to regulation electronic cigarettes in the same way as Big Tobacco is illegal and goes beyond its scope of authority.  But the two most recent lawsuits filed this week oppose the FDA e-cig regulations for very different reasons.

John Middleton Company files over ‘branding issues’

Altria bought John Middleton in 2007 for about $2.9 billion, due in part to the popularity of a brand of cigar called “Black & Mild.”  According to the lawsuit, Altria claims that the FDA is attempting to force the cigar manufacturer to remove the term “mild” from its brand name.  This stems from another 2010 regulation that bans the use of terms like “low-tar” and “light” from cigarette packaging. 


But Altria argues that “Black & Mild” is a trademark.  The FDA has no legal authority to use deeming regulations as an excuse to restrict company branding statues which are protected under the First Amendment of the U.S. Constitution.  Altria also goes on to say that the entire notion of banning terms like “mild” or “light” is capricious and arbitrary on the part of the FDA. 

Global Premium Cigars, LLC files over the predicate date

According to the company’s website, “Global Premium Cigars believes that the predicate date is a violation of substantive due process under the Fifth Amendment.”  And according to the newly released FDA e-cig regulations, this predicate date is April 15, 2007.  Any products released for sale before this date will not require the million-dollar PMTA approval process.  But those products released after this date must pay the massive fee and also prove to the FDA that the product is safe for public health. 


Global Premium Cigars essentially believes that the use of a predicate date is unfair and unjustifiable.  In other words, why should one cigar (or cigarette or e-juice or electronic cigarette) be required to follow very different approval regulations than another, based solely on the original date of sale?

Is the vaping industry heading down a dangerous path?

The PMTA process is more than just paying a hefty fee for the PMTA application.  There will also likely be lots of scientific documentation and required testing procedures that can cause the overall cost of FDA approval to skyrocket, which is a major fear of many small business owners in the vaping industry.  However, the news of the two most recent lawsuits filed by Big Tobacco may be setting a dangerous precedent.

If the vaping industry is trying to win a battle against the FDA e-cig regulations by arguing that e-cigs are not tobacco products, which is the very basis of the legislation, do e-cig retailers really want Big Tobacco “on their side?”  Or does the vaping industry need all the help that they can get?

Big Tobacco has been fighting the U.S. government for decades, and they know how to play the game.  But who are they fighting against now?  Is it the FDA?   Or is Big Tobacco secretly trying to place obstacles in the path to victory for the vaping industry by filing seemingly supportive lawsuits? Only time will tell.


1 comment

  • If you understood how BT has been demonized through out the years you would know the exact same thing is happening to the e-cigarette industry. I have been watching this circus for over 50 years. BT never once hid how they processed their tobacco from anyone. All of the after the fact accusations are just that. If I had three days and fourteen pages of content perhaps I could give everyone a little historical context. We as vapers should be fighting everything. The advertising. The flavors. The bans. That is what they did to BT. BT were not he supposed lying deceivers until after the bans and such. Not before. All this bad mouthing of what BT did or didn’t do is all post regulation not pre-regulation. I know. I smoked for 38 years. I am not saying smoking isn’t harmful. The problem is no one really knows how harmful and what harm it actually causes. At one time 44% of the adult population smoked. An additional 40% had tried smoking. Smoking was blamed for everything under the sun.today smoking rates are around 15% roughly. In all these intervening years the rate of illnesses blamed on smoking haven’t dropped a notch as a percentage of the total population. 480,000 deaths a year are blamed on smoking. That figure hasn’t changed since the mid 90’s. It’s becoming quite apparent there are not enough smokers to sustain that rate. Haven’t been for quite awhile.

    Michael Schoonover

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