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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.

(Related Article: BREAKING NEWS: VAPING INDUSTRY FILES LANDMARK LAWSUIT OVER FDA DEEMING REGULATIONS)

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.

(Related Article: NEW FDA E-CIG REGULATIONS AND THE MILLION-DOLLAR PMTA PROCESS)

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.

(Related Article: NICOPURE MAKES HISTORY; FILES FIRST LAWSUIT OVER FDA E-CIG REGULATIONS)

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.

(Related Article: SEN. RON JOHNSON SENDS 2ND LETTER OVER FDA E-CIG REGULATIONS; THREATENS ‘OTHER MEANS’)

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.

(Related Article: WORLD-FIRST COURT CASE OVER ‘TOXIC CHEMICALS’ IN E-CIGS MAY BE NEXT ASSAULT ON U.S. E-CIG INDUSTRY)

 

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! 

56 comments

  • My husband and I both smoked for over 30 years. At the time we dropped the cigs and began vaping, he was smoking a little over one pack a dat but I was up to almost 3. Whilst smoking, I couldn’t lay down at night without coughing nor do any kind of exercise….even just walking to the mailbox was rough. I also had cronic bronchitis. …everytime the weather changed I would develop bronchitis. ..usually 3-4 times per year. Since dropping the cigs and taking up vaping I can now walk more steps and still breathe normally, take a deep breath for the doctor during routine checkups without coughing, lay down at night without coughing, and I haven’t had bronchitis at all….in the whole 4 1/2 years I’ve been vaping. E-cigs saved my life….I truly believe had I continued to smoke cigs I would have either been on full oxygen by now or very possibly dead!! It’s totally wrong of the FDA to consider vaping the same as smoking, and to even consider it a tobacco product is ludicrous!! There is NO tobacco in it!! Big Tobacco is simply ticked off because we vapers are no longer buying THEIR product and Big Pharma is ticked off because most if not all of us vapers no longer need THEIR products! We must fight for our right to vape….and to keep the equipment and liquids that are available now on the market!

    Beth McGee
  • Like most who use the electric cigarettes, we either stopped smoking for economic reasons and/or to save our lives.

    I have smoked over one pack of analog-tobacco cigarettes for FIFTEEN years each day of my life. I would have smoked until cigarettes killed me. Since I am a proud user of the e-cig, my chances to live a longer, healthier life has increased substantially.

    Since e-cig contains no tobacco, it should NOT be under the same label and have the same restrictions as the traditional cigarettes.

    Since we vape, certain establishments ARE losing revenue. With less smokers using the e-cig, it will save their lives. I know vaping should be worth more than a financial lost to them?

    I will never SMOKE, again. NEVER!
    Trina Moore (vaper of the e-cig)

    Trina Moore
  • I started vaping nearly three years ago after smoking for over forty plus years. When I was driving a truck for a living I was smoking one right after the other and coughing my head off now that I am smoke free my breathing is much better.

    Clifford Beatty
  • I am 47, started smoking at age 13. I was a pack a day smoker for more than 30 years. I use a subvod to vape & after starting with a 12nic, I am proudly at a 4nic. Vaping (not pre packaged ecigs) has given me a new lease on life. My daughter, now 21, quit smoking on the same day, & we vape together! The big pharm companies don’t want to lose money because we all are going to LIVE & not need oxygen tanks or chemo for lung cancer. Big Tobacco is losing money because not only have we dumped their deadly products, we are convincing others to do the same. Seems like the FDA is a puppet for the tobacco & the pharmaceutical business, rather than an entity that wants to make the world a safer, healthier place. Thank you, VAPING INDUSTRY, for helping my daughter & I drop a deadly habit.

    Tiffany
  • After smoking for over 30 years my friends opened a vape shop and said I had to try it. It took some time, but once I purchased my first ecig, I became a hugh advocate and started spreading the word! Within 2 years I was at zero milligram of nicotine and was slowly weaning myself of of it completely. I purchased units for my husband, my mom, my son, and was getting friends to purchase them to get off cigarettes. I am now completely cigarettes and ecig free and feel better than I have in many years! I never could have quit without this device!
    These laws must be over turned!

    Heidi Bennett

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