WARNING: Your Government Loves You So Much, The Covid Show Was Better On TV, Vaccines Are Super Cool And LoL For You, Only Support Transgender Biracial Businesses Because That Totally Makes Sense To Mention On Every Website That Isn't, Cancel Netflix And Shopify Sucks.

Historical lawsuit slams FDA e-cig regulations with 8 violations

On June 20, 2016, eleven advocacy groups for users of electronic cigarettes and vaping devices united to file a single lawsuit over the recently announced FDA e-cig regulations.  The case was filed in the District Court of Washington, D.C. and lists eight possible points of contention that the plaintiffs believe are either unconstitutional or downright illegal.  While this is not the first lawsuit of its kind, it appears to be one of the most promising, according to many industry insiders.

Issue #1:  The Predicate Date

The lawsuit questions the legality of the February 15, 2007 predicate date for the Pre-Market Tobacco Applications process (PMTA).  By back-dating this predicate date, nearly 100% of the entire vaping industry’s products would fall victim to the million-dollar and time-consuming approval process within the next two years.  The lawsuit suggests moving the predicate date forward to the date that the FDA e-cig regulations take effect.


Issue #2:  The PMTA Process

Under the U.S. Administrative Procedures Act, the PMTA process is reserved to only “tobacco products.” Since vaping devices and e-cigs are 100% tobacco-free, the lawsuit claims that the FDA does not have the legal authority to require manufacturers of the vaping industry to adhere to a federal approval process that is typically only reserved for Big Tobacco.  With an estimated price tag of $1 million per product, the PMTA process will essentially wipe out the entire industry. The plaintiffs propose an alternative – the submission of a Substantial Equivalence (SE) Report.


Issue #3:  Unconstitutional

The U.S. Tobacco Control Act, of which the FDA regulations are partially based, makes it very clear that different products present different health risks.  But the legislation does not provide clear instructions for how to regulate new products that center the marketplace that are significantly safer than traditional tobacco products, like e-cigs, for example.  Therefore, the entire U.S. Tobacco Control Act is unconstitutional, and the FDA e-cig regulations should be nullified.

Issue #4:  Ban on Free Samples

A ban on free samples essentially violates the U.S. Administrative Procedures Act and the First Amendment of the U.S. Constitution, which states, “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the government for a redress of grievances.”

Issue #5:  Smoke vs. Vapor

Under the U.S. Administrative Procedures Act, there is a special provision called The Modified Risk Tobacco Product (MRTP) which discusses the different levels of health risks associated with tobacco products.  This provision seems to focus largely on the harmful substances found in tobacco smoke.  But vaping devices and e-cigs do not contain tobacco and do not produce “smoke.”  Therefore, the U.S. Administrative Procedures Act, does not apply to the vaping industry, and the new FDA e-cig regulations should be nullified.


Issue #6: “Tobacco Product” Classification

By following the chain of issues outlined so far, the plaintiffs take the time to clearly point out with laser-like focus that e-cigs and vaping devices are 100% tobacco-free.  Based on this single point of contention alone, the plaintiffs claim that the FDA e-cig regulations do not apply. 

Issue #7:  Impacts to Small Business

Under the U.S. Regulatory Flexibility Act, all federal agencies must take into consideration the possible effects that their regulatory actions have on small businesses.  The predicate date comes into play again, because nearly 100% of today’s e-cigs and vaping devices were placed on the market after the predicate date of February 15, 2007.  As a result, all retailers would be required to obtain FDA approval through the PMTA process, which most business owners cannot afford.  This is also one of the main issues that Sen. Ron Johnson is questioning by sending those letters to the FDA in the recent past.


Issue #8:  Wiping out the E-cig and Vaping Industry

According to the U.S. Tobacco Control Act, the FDA is required to consider the costs and benefits of their legislative actions.  And under the U.S. Regulatory Flexibility Act, the FDA failed to consider other regulatory alternatives to the PMTA process that would be less costly and perhaps less time-consuming for small business owners.  The lawsuit alleges that the FDA essentially went for a one-size-fits-all solution, grabbing the already written regulations for Big Tobacco, and slapping them onto the vaping industry without a second thought. 

Moving Forward

Of course, the legal language used in the court documents filed for the eleven plaintiffs is much more elaborate than the above breakdown of eight different points.  But for members of the vaping community who are only now hearing about the potentially devastating FDA e-cig regulations, this latest lawsuit seems to hit nearly every major argument that threatens the very existence of the vaping industry.

Vape shop owners love what they do, and they also want to keep selling their products and e-liquids to millions of happy customers.  However, if the FDA e-cig regulations are not overturned, consumers may see thousands of their favorite e-juice flavors, vape mods, and even wicks and batteries disappear almost overnight.  These eleven advocacy groups are fighting for the rights of all vapers and e-cig users in America.



Special Edit from Matt:  I corrected a slight error in the wording of point #7 based on readers' comments.  Thanks so much for pointing this out.  The last thing that we want to do is confuse the vaping community even further.  Fighting the FDA Deeming Regulations is a very important issue that needs everyone's support.  I apologize for the error.  And thanks again! 


  • And once again BIG GOVERNMENT! trying to rule our lives. It has to stop!

    Kay Livezey
  • I started smoking cigarettes I stole from my dad when I was 13 years old. I had tried quitting, probably a hundred times since then. Each time was time wasted, that I could have been smoking. I was a smoker, there’s no two ways about it. I smoked for 36 years. Also, being a truck driver who smoked, I was killing myself to the tune of 2 1/2 to 3 packs a day. The Sunday before Thanksgiving, 2013, I bought my very first vape starter kit. I still smoked, occasionally for only 3 days after I started vaping. Since then, I have been cigarette-free for almost 3 years. I cannot express enough, the positive affects that vaping has had on, not just mine, but also my family’s quality of life. All in all, I just simply feel better, and I owe it all to vaping, and the vaping community. Thanks for getting me pointed in the right direction, and the help and support you’ve given me in the last, almost, 3 years.
    God bless you all, and Vape long and Prosper !!! VAPE ON !!!

  • I smoked for 30 years of my life finally after doing vape I quit 3 weeks ago and won’t turn back don’t ban vape it’s actually helping a lot of people to quit smoking.

    Grant michaelis
  • Altria, a big tobacco company, sat in with the fda and helped craft this legislation. Furthermore, the former head of the fda was charged under the rico act for corruption and racketeering…only to be replaced by a man that bernie sanders tried to block for his extensive ties to big pharma. This is an assualt against the american public by the fda, we see what theyre doing, and will not be fooled by orwellian doublespeak that pretends to protect citizens while destroying their health and handing the industry over to big tobacco

  • Vaping saved my life. Vaping is saving my coworkers lives.

    I went from a 2 pack a day smoker to Vaping overnight. I started at 18MG 3 years ago. I am now down to 3MG. I could not breath and was constantly sick with chest colds. Sometimes I would be sick for weeks. Since switching to Vaping my health is amazing. I have not been sick any breathing issues since I made the switch. I went from running out of breath walking up a flight of stairs to hiking 15 miles a week.

    We had 8 smokers at work and I was the first to make the switch. All but one switched from smoking to Vaping and 3 have quit both completely.

    They decided to make the switch after seeing my health improvements and increased energy at work.

    I’ve also lost 40lbs Since I quit because I can actually get up and move.

    To vaping away from us away from us and to cripple the industry is a crime! You will be responsible for killing millions of people vaping will save!


Leave a comment

Please note, comments must be approved before they are published