Wow, Dawn here and this series has been a doozy. If you are one of the readers who have made it through parts I, II, III, IV, V, V.2, VI, VII, VII.2 VIII then I owe you a huge thank you! Heck if you have even made it through half of them I am truly impressed! The difference between this blog series and most of our blog series is that in this set of blogs I am reporting on a particular event I had the privilege to attend. The event I am talking about is, of course, the 2017 E-Cigarette Summit that was held on May 8th in Washington D.C.
Here is the thing, I am only reporting on the events that took place and the speakers that were gracious enough to present. Not all of the thoughts and opinions that were shared at the Summit are those of A Clean Cigarette brand electronic cigarettes. Remember, A Clean Cigarette brand e-cigarettes DO contain nicotine. Nicotine is an addictive chemical. A Clean Cigarette Brand e-cigarettes are not intended to treat, diagnose or cure any disease or illness. Since NOTHING you inhale into your lungs is as good for you as clean air, never smokers should never use A Clean Cigarette brand e-cigarette or ANY brand of nicotine containing e-cigarette. Really if you have never smoked, just don’t inhale anything into your lungs that you don’t have to.
Now onto the good stuff!
A Peek Inside the 2017 E-Cigarette Summit: Part IX
When we left off two weeks ago we were talking about Dr. Kevin Walton. Much like Dr. Walton our next speaker Mr. David Graham also works with regulatory end of things. He is President and managing partner of Reveritas Group, a multi-partner regulatory, clinical, and scientific consulting firm that supports ENDS companies in their efforts to comply with FDA regulations. They are currently focused on plan development and execution of programs for Premarket Tobacco Applications (PMTA) to FDA.
Wow, that is a lot of words to say that he and the Reveritas Group are actively seeking out ways to make the Premarket Tobacco Application a processes that more e-cigarette and vapor companies can traverse clearly. His lecture, which was titled “Addressing the Challenges of ENDS Regulation” focused on helping companies like A Clean Cigarette reduce the uncertainties involved in trying to comply with all of the regulations and paths that the FDA has set ahead of the industry. Much of what Mr. Graham spoke about was bridging the gap between what the industry can do, what it should do and what the best interest of public health would be. According to Mr. Graham believes that the best path to move forward starts with the regulatory agencies, public health agencies, and the industry to come together on some common ground to form common sense regulations to promote the best usage of ENDS units for the greatest public good.
According to Mr. Graham, a great place to start is NIDA’s SBIR project that is funding the research necessary to create a standardized product that can be used in a number of studies and clinicals in regards to electronic cigarettes. These standardized devices will focus on the questions of dosage, smoking cessation and possible risk reduction.
For my part: While we see things through different eyes, I tended to agree with much of Mr. Graham’s lecture. However, Mr. Graham has extensive ties to agencies such as Pfizer and Johnson and Johnson. His work has helped secure regulatory approval for a variety of NRTs (Nicotine Replacement Therapies) I worry that if big pharmacy has it’s hands in the regulatory pot to this degree the small mom and pop shops in this industry may be left in the dark once the dust settles. I hope I am wrong and I truly appreciated Mr. Graham for taking the time to come and speak at the 2017 E-Cigarette Summit.
Our next speaker, Eric N. Lindblom, JD, is the Director for Tobacco Control and Food and Drug Law at the O’Neill Institute for National and Global Health. Mr. Lindblom has extensive experience when it comes to tobacco regulation and reform both in the US and overseas. He is also the former director of office policy at the FDA’s center for tobacco products. Basically when it comes to tobacco laws and regulations few are more “in the know” then Mr. Lindblom. According to Mr. Linbloom, his goal is to help accelerate the development of new legal and policy analyses in an effort to influence the regulation of tobacco products, foods, and drugs (including legalized cannabis). Basically, he wants to make sure that the questions we are asking are the questions that the regulatory officials need answered to best do their jobs.
Take a quick peek at a few of Mr. Lindblom’s talking points:
- How can we help e-cigarettes compete?
- Since the only justification for e-cigarettes to be on the market is as smoking cessation tools (His words not mine!) wouldn’t e-cigarette be obsolete if tobacco is eradicated?
- Either way while tobacco is an epidemic it’s imperative that e-cigarettes be able to make reduced risk claims when compared to burning tobacco.
- E-Cigarettes should be on the market as smoking cessation tools.
- The UK has already made steps to accomplish this. (It’s at this point a man’s voice in the audience made a comment to the regards of “the only thing the UK has that the US FDA does not have is common sense!” (Again SOOO not my words!)
- We need to fast track the PMTA process to promote the creation of dosage measured e-cig and vapor products to combat the public harm that burning tobacco does.
Mr. Lindblom went on to say that e-cigarettes should only be on the market as a viable alternative to burning tobacco and there for regulations should to the degree that it is possible, work to prevent marketing to the youth markets as well as never smokers.
For my part: I agree! Yes! E-Cigarettes are not a toy. they should not be marketed to children and have no place as a never smokers new hobby of choice. They contain nicotine. Nicotine is addictive! Why start on an addiction?!?!?!? (duh)
All of that being said, Cary Lee, the founder of A Clean Cigarette and myself had a good chance to talk to Mr. Lindblom about these thoughts. We told him our story and the stories of some of our customers. We assured him that at A Clean Cigarette we go the extra mile to NOT market to kids and to NOT market to never smokers. In fact, it is even in our company policies that none of our team members are ever supposed to sell to non-smokers let alone market to them as a whole. For his part, Mr. Lindblom seemed intrigued with our business plan and corporate philosophy. He made a few suggestions to us that we are taking very seriously. Including one suggestion that we go to the FDA and actually tell them our story. Show them the work that we do. So when you see projects like our coin campaign to get 100K signatures and possible upcoming customer surveys please know that many of these projects are in direct response to the FDA and are our attempts to get the big picture to regulatory agencies that are trying to come up with the best possible policies. And the truth is, we can not fight this fight without you. Period.
Well, that’s almost 1300 words worth of e-cigarette summit. In an effort to get through the last 4 speakers(Yep that’s all that is left) I will try to do two blogs next week. So be on the lookout for part X and part X.2 which will be our final E-Cigarette Summit blogs! If in the meantime you have any questions or thoughts drop me a line to AccAnswers@gmail.com and I will do my best to get back a hold of you ASAP! Also, for more information regarding A Clean Cigarette brand electronic cigarettes, a Michigan-based company, stop by our website: www.acleancigarette.com. Have a great day and thank you for taking the time to be informed!