VAPOR TECHNOLOGY ASSOCIATION FILES MOTION FOR PRELIMINARY INJUNCTION IN LAWSUIT AGAINST FDA TO DEMAND PMTA RULE AND APPROPRIATE SMALL BUSINESS DEADLINE
September 11, 2019
WASHINGTON D.C. – September 10, 2019 – Today, the Vapor Technology Association (VTA) and Vapor Stockroom (VSR) announced that they filed their motion seeking a preliminary injunction in their lawsuit against the Food & Drug Administration (FDA). The VTA and VSR have requested, and FDA has agreed, to an expedited briefing schedule on the motion.
There are two primary goals to the motion and lawsuit: (1) demand that FDA publish the actual proposed Pre-Market Tobacco Application rule (“PMTA Rule”) that industry has been waiting on for 3 years; and (2) establish a deadline that allows companies, particularly small businesses, the chance to comply with the still unwritten PMTA Rule.
Last month, the VTA and VSR filed a federal lawsuit against FDA over the constantly changing PMTA deadline and process. The industry should never have had to file a lawsuit to demand that FDA engage in the legally required notice and comment period regarding the creation of a PMTA Rule, before imposing the deadline for compliance with the same rule.
The Motion explains through expert testimony that without an injunction, the vapor industry – an industry that is the size of the iron and steel forging and the commercial fishing industries in the U.S. – faces a near-complete shutdown in May of 2020. Scientific expert testimony also explains that there are at least ten reasons why companies cannot conduct and complete the myriad tests, research studies, and surveys that FDA is demanding within the arbitrarily selected ten-month deadline. A link to the preliminary injunction motion and supporting brief can be found here.
Maintaining a May 2020 deadline for filing PMTAs will result in the dangerous scenario that the FDA itself has said “should be avoided if at all possible.” “What makes this motion so compelling is that the FDA already has warned that ‘dramatically and precipitously’ removing vapor products from the market will lead to the ‘mass market exit’ of vapor products which, according to FDA, will lead to an increase in smoking, something that FDA testified is a public health outcome that ‘should be avoided if at all possible,’” explained Tony Abboud, Executive Director of the Vapor Technology Association.
“Our company, and our industry in general, has for the past three years been complying with every regulation and every deadline set by the FDA. As a result, FDA already knows the ingredients that are found in each and every one of our products. But, when FDA has failed to even publish the draft, much less final, PMTA regulation, and is imposing an impossible 10-month deadline for complying with that still unwritten rule, we had to ask the Court to intervene,” said Tony Florence, President of Vapor Stockroom.
Anyone advocating for the ‘mass market” removal of vapor products should heed the FDA’s own sworn testimony. The preliminary injunction motion, if granted, would prevent a mass exit of vapor products from the U.S. market, the closure of thousands of businesses nationwide, and the loss of tens of thousands of jobs. Even worse, the devastating threat of increased smoking if vapor products are removed from the market, is compounded by the very real dangers of the black market activity which public health experts have predicted would follow the removal of vapor products.
Yesterday, Juul Labs announced that it would not be renewing its membership with the Vapor Technology Association (VTA) citing the lawsuit that VTA recently filed against FDA and policy differences.
VTA is surprised by Juul’s stated opposition to the filing of VTA’s complaint against FDA because Juul recently opposed the efforts of the American Academy of Pediatrics to grossly accelerate the PMTA deadline in another lawsuit and sought similar relief in that federal lawsuit. In addition, Juul’s designated VTA Board member participated in the VTA Board meeting held to consider the lawsuit against FDA, but never objected. In fact, the vote to move forward with the lawsuit was unanimous. Prior to the meeting, Juul had the relevant documents relating to VTA’s consideration of a potential lawsuit against FDA, but never objected or expressed opposition to the action.
From its inception, VTA policies have consistently focused on creating and preserving a diverse marketplace of products for adult consumers desiring an alternative to smoking cigarettes. A diverse marketplace includes both open system devices and closed system or “pod” devices. A diverse marketplace includes vape shop small business and convenience store options for adult smokers to access products. A diverse marketplace includes the many flavor options adult smokers have been purchasing in lieu of the same old tobacco and menthol flavors that are sold by Big Tobacco. A diverse marketplace includes e-liquids containing a variety of nicotine levels, including zero nicotine, to provide adult smokers with the option to reduce their nicotine intake.
We appreciate Juul’s past attempts to collaborate with VTA. We recognize that some decisions made by VTA on behalf of the industry may not perfectly align with the interests of every one of our members. However, we believe our strength as a trade association is our diverse membership.
VTA is organized so that no single member, no matter how large, can dictate policy. We put our decisions through a regimented process to make sure they are based on sound and strategic rationale. We avoid taking reactionary positions based on transitional moments or the news of the day and remain focused on securing the long-term future of a diverse and well-regulated vapor industry.
As a reminder of what is at stake, the FDA recently warned that a precipitously accelerated PMTA deadline would lead to the “mass market exit of ENDS products” and cause adults who have quit to return to smoking - a "public health outcome which should be avoided if at all possible.” VTA’s and Vapor Stockroom’s lawsuit against the FDA was filed to avoid that “mass market exit” about which FDA warned and to preserve the diverse and vibrant industry of companies dedicated to providing adult smokers an alternative to deadly cigarettes. VTA stands by its decision to defend the interests of all vapor companies, and the thousands of small businesses in the U.S. that will be put out of business without the relief requested in our lawsuit.
VTA is proud of its rapidly growing membership. We are committed more than ever to advocating for rational regulations that will ensure the availability of a diverse array of product options for adult smokers. We simply ask that all other vapor companies which believe in our vision of a diverse and vibrant marketplace join us in our fight.
Thank you for all that each of you do everyday to defend the promise of vapor!
Sen. Paul is taking issue with the March 2019 FDA decision to change the compliance deadlines from 2022 to 2021, claiming the change was not in compliance with the Administrative Procedures Act and the industry had detrimentally relied upon the 2022 dates.
May 31st, 2019 (Columbus, OH.)
The OHVTA is in the process of notifying the U.S. Federal Court of it's intentions to intervene in the ruling set forth by Judge Grimm (Grimm, P.W., 2019). Interested parties (who claim aggrieved status or standing) are allowed to file notice with the U.S. District Court in order to conjoin themselves to the lawsuit; when the outcome of the suit, would have significant impact upon them.
The letter of intent to intervene was presented on behalf of OHVTA (et al) by Keller and Heckman LLP. This notice will be followed by an amicus brief which will outline how the ruling by Judge Grimm has or will affect the parties listed. By conjoining with the lawsuit the OHVTA and other state organizations will become party to the action and should be given standing by Judge Grimm.
The outcome of this intervention would be to allow the Judge to hear arguments by The OHVTA (et al) on why his ruling is would be in contravention to public health. At this time the official response by the FDA has not been made public but is expected next week. The OHVTA will continue to monitor the response by Judge and the FDA.
Grimm, P.W., 2019. UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND, Case 8:18-cv-00883-PWG.
By Dimitris Agrafiotis/Guest Column
Today, the Food & Drug Administration announced numerous actions related to tobacco control and the vapor industry. VTA leadership has met with FDA and worked relentlessly on your behalf to advocate for our industry. Today's announcement makes one thing abundantly clear: FDA has heard our message. Click here to read our full response to the FDA announcement: https://bit.ly/2PsihZo
People have asked me “What does 08-08-18 mean to me?” I honestly do not have just a simple, one sentence answer. (Imagine that)
08-08-18 is a date that will live in infamy as the day that shook the vape industry to its very core! On 5-10-16, we had a very real and direct wake up call that threatened our very existence as we were told we were being regulated like tobacco of all things! On 08-08-16 we were officially under the tobacco umbrella with the FDA, and our regulatory pathway was unleashed upon an industry that was more concerned with selling cartoon labels, huge clouds, and devices that could power a small vehicle. It was a call to the industry to WAKE UP and learn how to become a professional business. Its funny, how an industry that for the most part started at the kitchen table for many, was now going to be regulated by a federal agency –– The FDA! We certainly didn’t need the federal government to start it, teach it or show us how to do it, but that didn’t stop them.
Since that day, people have been looking for “loopholes” or “ways around or to cheat” the system because they think that they are either bigger than the industry or rules don’t apply to them since there were no rules when they started into it. Some people used the fear of uncertainty to manipulate consumers and make them think the rules didn’t apply. All you have to do is look at the amount of liquids and salt liquids that were NOT on market prior to 08-08-16. Its enough to make someone who fights for the very existence and future of this industry to puke, want to pack up and go home.
Its at that point, I look to what the industry has done for me personally and it makes it all go away. For every “bad actor” in the industry, there are “good actors”. These are the people that give me hope for this industry! They give everything they have to the industry, they invest, they broker meetings with companies, they actually have proof that their products were not only on the market prior to 08-08-16, but they have proof of their registration info and their product numbers. These are the folks who market responsibly, call out the ones who don’t, and effect positive changes for the industry. We have national associations like VTA (Vapor Technology Association), State Associations like OHVTA (Ohio Vapor Trade Association), TSFA (Tennessee Smoke-Free Association), and KSFA (Kentucky Smoke-Free Association) that are comprised of vapor business that are investing in the future of the industry for their states and elect board members that are volunteers. We have leaders like Dimitris Agrafiotis, Fig Ramsey, and Phil Busardo that are out on the front lines and set the standard for what an advocate is and should be.
The most important piece of all of this is our consumer. They are the very reason we even exist, they are who we want to help and show the way to a successful transition to a tobacco free life. When at times the industry looked bleak at best, it was the consumer that came out to the shop to show their support for the industry and it’s the consumer that we need to be there to support in times of adversity within this industry. As a shop owner, it’s the consumer that builds the community. This community is amazing. No matter what you are going through, the community is always there to lend a hand, an ear or extend their feelings of support for whatever it is you are doing or going through. That is something that the FDA will never be able to replace! We are #vapefamily
So what did 08-08-16 give me? It gave me the opportunity to continue to do what I love by being able to positively effect someone’s life. What does 08-08-18 mean to me? It means that I am able to continue to do this, hopefully save lives, advocate for a life saving technology, advocate for the consumer, advocate for the community, and continue to spread the message that vapor is at least 95% safer than combustible tobacco!
WE ARE VAPE FAMILY!!
Hundreds of thousands of fake comment submissions have ground FDA’s regulatory process over the proposed regulation of flavors in vaping products to a halt.
As RegWatch first reported, a minimum of 250,000 bot submitted fake form-letters that are anti-flavors and anti-vaping in nature overwhelmed servers at Regulations.gov putting the entire public consultation process at risk. FDA could decide to throw out all submissions, including legitimate testimonials, provided by tens of thousands of vapers. Read more.
" Advertising for electronic cigarettes that deliver nicotine via vapor is a growing category for out of home advertising. Effective August 10, ads for e-cigarettes must include a warning that nicotine is addictive. New rules from the Food & Drug Administration (FDA) require the warning to occupy 20 percent of the ad space. OAAA attorney Kerry Yoakum explains this new requirement and what it means for OOH ads. Advertising for electronic cigarettes that deliver nicotine via vapor is a growing category for out of home advertising. Effective August 10, ads for e-cigarettes must include a warning that nicotine is addictive. New rules from the Food & Drug Administration (FDA) require the warning to occupy 20 percent of the ad space. OAAA attorney Kerry Yoakum explains this new requirement and what it means for OOH ads.
Since 2009, under the Tobacco Control Act, the US Food and Drug Administration (FDA) has regulated cigarettes, smokeless, and roll-your-own tobacco. A recent rule, affectionately called the “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” (aka the Deeming rule) extends FDA’s regulatory authority to “deem” other “tobacco products” subject to its regulation, too. Under the act, a “tobacco product” is:
… any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).
With its “deeming rule,” the FDA has effectively declared e-cigarettes and other forms of electronic nicotine delivery systems (ENDS), in addition to their parts and components, to be subject to regulation under the Tobacco Act.
The deeming rule also requires that advertisements, including billboards, for all covered tobacco products bear an addictiveness warning statement. Effective August 10, 2018, the tobacco product advertisement must bear the following required warning label statement: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”