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Deeming Regulations For Vaping: Policy Maker Files Suit Against FDA

 

According to their own calculations, the FDA’s deeming regulations of the electronic cigarette/vaping industry will destroy in excess of 99% of the current market.

While the British Government is advising their citizenry to switch to vaping as a 95% less harmful alternative to smoking, the FDA has enacted a defacto ban — essentially handing a blossoming industry to the Tobacco giants that many millions of people are looking to escape.  The countdown clock has begun, by August 8th, 2016 all innovation in the industry will have ceased until such time as companies decide to part with millions of dollars or close their doors for good.

No-one is against sensible regulation of this industry.  In fact, some of the points the FDA made on a press release attached to the regulation made so much sense that vape shop owners had already enacted most of them without the need of federal oversight.  Unfortunately, the FDA is demanding that all devices and liquids not on the market before an arbitrary date in 2007, in essence before this technology had gained a foothold in the USA, go through a lengthy and extremely expensive process in the hopes of being allowed to remain available to the public — a process in which, if left unchanged, will be physically impossible for anyone to complete.

Individual companies and advocacy organisations are already in the process of bringing the federal agency to task over its blatant over reach of power and ignoring scientific guidance from The Royal College Of Physicians; the very body who initially declared war on smoking in the 1960’s.


Larry W Faircloth Vs The FDA

Larry W FairclothEarlier today, Larry Faircloth, a West Virginia delegate who has spent the last several months doing everything in his power to prevent the Governor of that state enacting sin taxes on life changing products, handed me a document to share with the world.  The vaping community was aware that he was planning to file suit against the FDA, but the various details have been with-held from public view…  until now.

I had the chance to sit down and talk with him after reading the document.  We here at GuideToVaping are pleased to share the interview and lawsuit, which are both available below.

The Lawsuit

Quietly filed on June 10th, some aspects of the suit are already familiar to the vaping community.  Named as defendants are Deputy Commissioner of the United States Food and Drug Administration’s Office of Medical Products and Tobacco, Robert Callif M.D and Secretary of Health and Human services, Sylvia Mathews Burwell.

In essence, Mr. Faircloth is requesting the court “sets aside” the FDA’s deeming regulations, using the following reasoning to make the case:

  1. Violation Of APA – Unlawful Statutory Interpretations
  2. Violation Of APA – Arbitrary and Capricious Agency Action
  3. Violation Of APA – Unlawful Cost-Benefit Analysis
  4. Violation of The First Amendment
  5. Violation of The Tenth Amendment

Each point within the suit has been carefully considered before entry, and Mr. Faircloth went into some great details as we spoke about the case.

The paperwork for the lawsuit can be viewed and downloaded here.


 The Interview

Q. Why did you decide to take it upon yourself to file a suit against the FDA? 

A. Being an elected official, I saw the importance of a Policy Maker challenging Policy.  The biggest impact of that will be the fact that it will raise brows with other elected officials nationwide seeing that one of their own is challenging the policy written.


Q. What specifically are your challenging in your suit as argument? 

A. We know that the FDA has definitely, without doubt, over reached its jurisdiction on the Constitution. We were able to directly cite violation in not only the 1st Amendment Rights of the Constitution, but more importantly, the 10th Amendment.  Let’s keep in mind, the 10th Amendment is the article that protects State’s Rights.  Each state has an Attorney General, and to this point their hands have been tied with filing suit against the FDA as well.  This can open the door for requests for them to follow suit for State’s Rights.

We also cited the cancer research, which the FDA used as a basis for their deeming regulations. If they are truly concerned (which in my opinion they are not), they have to acknowledge the fact of the extended health care costs to each person who uses a vaping device.  The healthcare costs for each person can reach nearly 800,000 dollars, which should then fall back on the FDA, as their responsibility for shutting the industry down. If they deny those costs, they are in essence, denying their own data is accurate (which is the basis of their deeming regulations).

There is also the illegal action of the FDA not applying a cost benefit analysis to their regulations. This is a big issue, as it is a clear over reach from an agency that has no jurisdiction to do such.


Q. We have heard that lawsuits can number into the millions of dollars, however you are saying that your suit will be far less and in the neighborhood of around 100-150 thousand dollars. Can we ask why such a difference? 

A. Absolutely, as this is a point that has many people scratching their heads at this point.
Lawsuits can be very expensive, and I do not want to discredit the amounts stated by other suits at this point.  I am a firm supporter of the Right to Be Smoke Free coalition lawsuit, and definitely want to see it successful in its efforts.  What puts a twist on my suit is this:

As a policy maker, we deal with these types of agencies everyday and we see the maneuvers they make to bring things together to put them forward.  One of the most interesting parts of the deeming regulations is the fact that the FDA held them in their possession for a period of approximately two years.

The question is why did they do that?

Nobody seems to know.  But if you look very closely at their deeming regulations, one of the first things you will notice is the fact they have collaborated with Health and Human Services.  This was the first thing I noticed as a policy maker when I saw the deeming regs.  It is a political maneuver used by an agency when they can not complete a task.  In this case, enforcement of their own regulations.

So with that one point being said, I think it is important that people understand the discovery process of a lawsuit is where the expenses can accrue very quickly.  Being a policy maker, and using a legal team that specializes in not only Constitutional Issues, but Regulatory Over reach, can create something that will eliminate many costs of discovery by simply knowing exactly which agencies, as well what documents to subpoena and FOIA.

This will dramatically cut down on costs, but will also in turn add some other benefits for the vaping industry.


Q. What exactly are those benefits? 

A. Those benefits are numerous.  First, if we look at how the lawsuit opens the door for Attorney Generals, it can add that avenue in the fight against the FDA.  Secondly, if we look at the documents we attain and make public, by entering them into the court process, it makes them readily available to the R2B Smoke Free suit as well as other suits.  Finally, it will give lawmakers an argument on Capitol Hill something to use as argument for the push of HR 2058 with the Cole Bishop Amendment, as the suit was brought forward by one of their own (an elected official).  So at the end of the day, it is important to remember the most important thing in all of this — each aspect of not only our suit, but other suits, as well as avenues and pathways that policy makers and elected officials have; become many tools in the toolbox for this fight. In my opinion, we need all those tools, and we need all hands on deck.  This industry is facing what will be a complete shutdown at the end of the day if this fight can not be won.


Q. On another note, you have been pretty quiet about the suit publicly to this point. Why not just come out weeks ago and lay all this out for public? 

A. That has been one issue that has driven me crazy in all of this.  Please keep in mind, when you are dealing with legal issues, as well as policy issues, there are things that must be kept quiet, no matter how much you hate it.

I was advised by legal counsel to keep details of the case quiet as it could prove harmful to the case itself.  Even now, there are certain matters in the case that we can not discuss on points of discovery, details of findings that are in process, and even mediating the suit, should we get it to that point.

There have been some days that I have been beat on pretty hard by some in the industry, and I completely understand their frustrations, truly.  This industry is the livelihood for thousands, and they are on the verge of watching it all be taken away overnight by an agency that has no rights to do such.  As much as I wanted to sit down and explain it all to them, it was and has been easier just to take their beatings to this point.


Q. There has been some rumor that your suit will become part of the R2B coalition suit at some point. Are you able to elaborate on that, or is there any validity to it? 

A. Let me say this much about that rumor. I will not elaborate, nor can I speak to it, but I will say this much. If that in fact would be the case, and it helps protect this industry, I am more than willing to do whatever is necessary to keep this industry alive. So at the end of the day, if putting our suits together (at the right time) would be what is best for the vaping industry, you would not see me think about it twice.  You would see me taking and doing the necessary steps for it to happen.  I can also say, at this point, the work we are doing is still in process and there has to be a great deal done first before we can even speak to that rumor.


Q. What is your outlook on how this will all end, if in fact you have an outlook?

A. I think my outlook is very similar to other vapers.  I am scared as well.  While I do not own a brick and mortar, nor do I have any vested financial interests in the industry, I am looking ahead at the future of my children and grandchildren.  I do not want them stuck with a Tobacco Only option. I want to see this industry survive and continue to offer a less harmful solution to them, as well as millions of others.

Right now we have 42 million Americans that are tobacco users, and here is technology that can help each of them escape.

How will it end though?

Knowing the judicial system we have in place in this country, the odds, and the fight is definitely there. We have an uphill battle, and everybody needs to do their part. We are all jigsaw pieces in a puzzle that has to come together perfectly to have a fighting chance to keep this industry alive.


Q. Finally, there are people rallying behind you, and you have picked up a ton of momentum along the way. Is there anything that you would like to say to that? 

A. Yes, I would definitely like to say something.  I think it is great to have the support, but I want to make it clear that I am just like everybody else. There is nothing special about me, and I am only one tool in the toolbox of this fight.  I am in no way a savior to this industry, or some type of vape god for that matter.

I hear those things, and it actually takes away from the point I have tried to push.  Each person is just as important as the next in this fight.  I am nothing more than a fighter; a worker bee.

Hell, to be honest, if it wasn’t for some amazing advocates out there, I wouldn’t even be here doing this interview today. There are some true heroes out here in this industry that are fighting, and I do not consider myself worthy of being where they are at.

They are the people who deserve the credit for the countless hours they have given over the years. All the late night meetings, traveling, lack of sleep, time away from families… they are the ones that deserve respect from this industry, and I know each of them have earned my respect.


The paperwork for the lawsuit can be viewed and downloaded here.

About the author

Daniel Hall

Avid Vaper, advocate and cloud chaser. Writer for 3 vaping websites and broadcaster/presenter as Vapin Demon on Coast 2 Coast Vapers.
Originally from Manchester, England, I got bored one day and moved to the USA.
Vaping saved my life and my aim is to save as many others as I can.

19 Comments

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  • I have yet to see anyone post that had smoked more than 54 years, 2 yrs and 3 months smoke free I’m Down to a 2 nic now in a mini Natilus tank. I had tried everything to quit, vaping has work i even opened a vapor store I have got lot of customers off cig Thank You

    • fifty two years for me. .06 real tobacco juice. Chems is what I escaped. The benefits are numerous. I got my singing voice back.

    • You’ve got me, Mike Watt. I smoked for approx (maybe a bit more, casually) 44 years. I am now 2 years and 1 month smoke free. If it weren’t for vaping, I would still be smoking and undergoing some serious nasty treatments for polycythemia, because of it. I am now no longer considered a patient with any polycythemia and I have a fairly good chance of being around for my grandchilren’s weddings and maybe, with luck, the birth of a great grandchild or two in the future. Vaping literally saved my life and I will fight with my last, now strong breath for that!

  • The fight is on, we must not become complacent by the idea of victory, we must in fact continue to be vigilant and determined as ever. Just because we all know something is wrong doesn’t mean it will right itself, our calls to our representatives, meetings with peers, and perseverance must go on if we seek the outcome we all want. Thank you to all who have contributed their time or money to get this where its at. This is one step in a long journey.

  • Smoked for about 40 years. At the time that I quit my health was quickly going downhill. COPD big time.
    Been vaping for over 7 years and almost immediately after making the switch, I started rebounding. Now I’m alive and COPD is gone. I’m healthy because of vaping.

  • I don’t understand. See “introduction” item 3 which states, “Eliquids contain nicotine derived from nontobacco sources.” Either there’s a typo or your lawyers are stupid. Doesn’t anyone proof read this stuff?

    • Nicotine is also found naturally in other things like tomatoes, arguing that the nicotine is not a definite and exclusive product of tobacco is legit.

  • I just read the full text of the lawsuit. It looks well founded to me. Many thanks to Rep. Faircloth for stepping up and initiating litigation from an elected official.

  • Thank you so very much Rep. Faircloth! The vaping industry has saved so many lives from the dangers of smoking cigarettes, and I’m willing to fight till the day that I die to keep the vaping industries in business and saving lives! I started smoking when I was 12 and I know I’m only 19 now but I started vaping as soon as I turned 18 and instantly the urge to smoke vanished! I only smoked for 6 years but it was taking its toll on me, I noticed it, my friends and family noticed it and when I started vaping my whole life changed! I felt way better than I ever did smoking, I could breathe easier and could be more active with less complications. I used to smoke 3 packs a day and now I vape with 0 nicotine, just enjoying the flavor and chucking clouds! So thank you to the vaping industry and thank you Rep. Faircloth for fighting to save others!

  • I smoked for 30 years and have been completely smoke free for 2.5 years. Thanks to vaping.. literally saved my life within 6 months lung function improved to the point where I had no need for medication or oxygen even my inhaler. From 76 % lung function to 96.7. That of a non smoker it’s amazing. My sons, sisters, nephew and countless friends have followed suit. I’ve tried all of the gum patches chantex horrible side effects.. vaping saved my life!!!!!! Please don’t let them take that away!!

  • Kudos to Representative Faircloth! I smoked from twelve years old until approximately four years ago (is it five now? Hunh…no matter…). From my first cigarette I was ‘hooked’. I worked my way up to 2-3 packs/day. None of that “light” stuff for me, oh no, I had to do the super strong menthols all the time and I would “suck down” two cigarettes to everyone else’s one!! I did quit for two out of three pregnancies but as soon as I was back on my feet i was smoking again! (What an idiot I was!). I guess that makes it approximately 51 (?) years of smoking?
    The only reason I was able to quit and start on 24 mg cigalikes (plus 4 mg nicotine replacement lozenges as needed for intense cravings) is because my earthy-crunchy, au naturelle daughter wouldn’t let me touch her babies without a serious hand scrubbing, tooth brushing, and changing out of my “chemical filled shirt”! I couldn’t disagree with her cuz she was right! She’s been very conscientious about good organic (most often right from the organically farmed farms!)
    Anyway one day when they were living in South Carolina she mentioned a vapor shop right down the street and the man that took care of me was fantastic!! This was my first knowledge of Vaping and I had no idea what it was about. I bought my first Nemesis and was dripping those little 510 drippers – atomizers(?). I barely remember them now… He spent hours explaining things to me, letting me taste every mint or menthol juice in the shop. Finally, although it was the most expensive juice at the time, we hit upon JVapes’ Minthol and I was sold!! That was it for me! I ultimately bought a tank and learned how to slot my own cartomizers as well as a vv/vw stick that went up to 8(?) 13(?) Watts! I’ve always loved learning and teaching and whenever I had a few extra dollars I’d buy 4-5 ego sticks online with whatever tanks were around at the time and I eventually got all my smoking friends and family hooked up with good juice and some type of decent set up and they’ve all either quit everything or still vape. I know every one of them feel healthier and all agree that Vaping has saved them from the certain death of cigarettes. I still vape a lot and have stayed on top of the changes in Vaping. Still watch a million YouTube videos a week and often sneak a new piece of equipment into my overflowing collection of vape gear. If they were to pass this ridiculous legislation in August I know I would ultimately end up smoking again! (Ughhhh) but I’ve only been able to get down to 18mg (occasionally 12 if I love the juice and have no choice) but I still know that I can still breath better, never get sick, heal faster and just generally feel better overall vaping than when I was smoking. I write letters, make phone calls, and definitely DONATE money to CASAA and other organizations that are fighting for us as often as possible even though I am disabled and no longer able to work and live on a ridiculously small SS check. So Kudos Representative Faircloth and thank you from the bottom of my heart for trying to help us fight this fight. And I hope anyone reading this extensive comment has made donations to our cause no matter how small because every little bit adds up!! VAPE ON AND F~%K THE FDA!!!

    • Kathi, it is people like yourself that get me out of bed and writing everyday as well as fighting tooth and nail for this industry and the community that surrounds it. If we had 10,000,000 people willing to put in a couple of phone calls a day, a couple of emails a week and a little bit of effort to educate the man standing next to them at the bus stop this fight would be a hell of a lot easier. Although I will never put it in print, your final sentence is one that comes out of my mouth at least 100 times a day, even though truth be told be are the ones on the receiving end.

  • I do own a small Vape Shop in Baker City Oregon. I never thought this is what I would be doing at this age helping People quit smoking. However I used to break my friends cigarettes years back and then I became a smoker myserlf at age 37! I am a college graduate and almost 50 years old. I hated cigarettes but I smoked. One day I met a couple that introduced me to the Vape world. The stick pen style mind you. LOL!! They left a card and said call when I am ready. Well in 2 months I called them and I got my first vapor Ecig. I quit in less then 3 months and have been smoke free for nearly 3 1/2 years and would never touch a tobacco cigarette again. For sure For sure never been more Sure!! I vape lightly and vape more when I have social hour. I am not a cloud buster/ chaser person but I can have fun with my vape if I choose too. I am usually to busy working to even vape these days and now I can’t vape indoors! 🙁 at my vape shop! As a smoker I always took that smoke break! I am here today to basically say Thank you to everyone out there fighting to save the VAPES! I believe in my heart that I have saved so many people with this technology. People as old as 72 years old have started vaping and are so thankful to kick the nasty habit that held them hostage for so many years. By the way the 72 year old just quit nicotine and is on a zero now. Pretty awesome! It is such a great feeling to see someone quit so easily without medications or stress. The easiest thing ever and they want to take that away from people who will benefit from it so much. All the Government is putting us all through is way out of line and over done! I wanted to simply say Thank you and please keep supporting our voices do matter and we will be heard. I hope it is enough! We pay taxes we have a right to choose our fate,not the politicians, FDA ( by which make many mistakes all the time ) We have to stand tall and support and join together in what we believe.! They say listen to your body it knows best well ask any smoker who Vapes and what they say Will BLOW your mind right folks! Theresa/ Baker City Vape

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