Wow! Dawn here again and can you believe we over half way through all of the speakers for this Summit! If you have not read parts I, II, III, IV, V, V.2, VI, and VII then consider doing so before going on. If you have (or just do not want to read the last parts) then we can move on after I remind you of a couple important facts. First, this blog series is meant to report on the thoughts and opinions of the speakers who were featured at the 2017 E-Cigarette Summit held in Washington D.C on May 8th. I can only report based on how I saw the event, The thoughts and opinions here do not necessarily represent the thoughts and opinions of A Clean Cigarette. Also, it’s important to note that A Clean Cigarette brand electronic cigarettes DO contain nicotine. Nicotine is an addictive chemical. Never smokers, should never start!!!!! In addition, A Clean Cigarette brand electronic cigarettes are not intended to treat, diagnose, or cure any disease or illness.
Okay now on to the good stuff!
A Peek Inside the 2017 E-Cigarette Summit: Part VII.2
In Part VII, I was only able to talk about a single speaker. In an effort to get this blog series done before you all get tired of it. (; I am going to try to get two speakers in versus the one speaker that I was not able to fit into Tuesday’s blog. The first of those two speakers is Professor Joanna Cohen Ph.D. Prof. Cohen is a Professor of Disease Prevention at Bloomberg and the Director of the Institute for Global Tobacco Control at Johns Hopkins School of Public Health. Her lecture at the Summit revolved around the tobacco industry and its influence on the e-cigarette regulatory decisions. It was hard to tell whether Prof. Cohen is more on the skeptic side of the issue or the enthusiast. You may recall from past parts of this series that at the Summit most speakers were either in one or the other category. In general, skeptic believes that e-cigarettes are nothing more then big tobacco’s way to hook the next generation on a nicotine dependency and “renormalize” the smoking habit, on the other hand, an enthusiast believes e-cigarettes are an alternative to deadly burning tobacco that could potentially save over a billion lives this century.
While Prof. Cohen did not claim to fit into either category, she certainly had a lot to say on how the government needs to regulate these products, or at least what the main focus of those regulations needs to be. Let’s look at her talking points and then you guys decide which category she should be in.
Prof. Cohen’s Talking Points:
- Agrees with responsible tobacco harm reduction, which she agree’s could be the case with ENDS products if regulated and studied properly. (electronic nicotine delivery systems.)
- ENDS products need a ton more evidence and that evidence needs objective independent oversight. (note that about here in the summit I overheard a number of the other speakers commenting on how much evidence is ALREADY available.)
- ENDS need to be regulated for safety standards such as battery safety and dosage label accuracy.
- Ends units should be regulated to make the devices more efficient.
- ENDS units need a standard for Dosing and accountability for mislabeled nicotine dosage.
- Believes the Current FDA deeming regulations are on the right track
While at face value it is hard to argue with most of these talking points, the fact that Prof. Cohen thinks that the current FDA deeming regulation is the right answer caused a large amount of alarm in the audience. Many of the post-lecture questions revolved around these concerns. For instance, if a hugely expensive pre-market application is required for EVERy minor improvement made to an ENDS unit, then how can companies afford to improve the quality and efficiency of their products, and why are there no safety standards for batteries? In fact, the only battery standard currently stated in the FDA Deeming Rule has nothing to do with the real dangers associated with lithium ion batteries. Instead, it requires a “Tobacco Product” warning label vs the more relevant warnings about fire and the batteries explosive properties.
Another point of concern for the audience was Prof. Cohan’s insistence that the Master Drug File required by the FDA on all ENDS units was affordable. She even went on to not there are special “protections” in place for small businesses. When these concerns were raised Prof. Cohen stated that the application is very do-able and that while Master Drug Files are complicated the FDA is available to answer questions at any time.
For my part: Prof. Cohan says she wants similar things as I do. Safety standards for ENDS and regulations to protect consumers from faulty low quality or mislabeled ENDS products. But then she points at the FDA Deeming as an example of a good way to do that. I can not agree. That rule was created to regulate a product that is completely different then ENDS products. How can standards and regulations that were made specifically to fit tobacco plant parts wrapped in paper then lit on fire be the same standards and regulations that fit metal and electric components that vaporize a fluid? Because they both deliver nicotine? Well the orange juice should be regulated like Vitamin C tabs…they both deliver Vitamin C, right? Plus, let’s get serious on the “help for small businesses she spoke about.” Even with the help, the cost to register our products will cost millions of dollars, other than BIG tobacco, who has that kind of funds? Certainly not the mom and pop shops that employ tens of thousands of people in our communities.
The next speaker at the event was Deborah Arnott, Chief Executive Officer, Action on Smoking and Health (Ash. She is also a recognized international expert on tobacco control and she works with WHO. (World Health Organization) Ms. Arnott comes to us from the other side of the pond ( The UK) and she had a fair amount to say on what they did regarding e-cigarettes and what we should do in regards to them as well.
If you have read some of my past blogs then you may recall that in the UK they have decided that since e-cigarettes are (in their words) “95% less harmful than burning tobacco” efforts should be made to license products that meet cerin standards as smoking cessation devices. Sounds good to the enthusiast on the surface, right? Not so fast, as of now, only one license has been granted and it was granted to BAT (British American Tobacco).
She shared her thoughts on how we could improve the FDA deeming rule by adding the ability for ENDS units to apply for medical licensing of some sort in order to avoid the premarket tobacco application and to receive the privilege of marketing said products as smoking cessation tools. In our case, she does think most products should be required to go through the premarket tobacco application process and that ENDS products should reach the standards set by the Deeming rule. That being said, she believes that they have done well over in the UK and since the FDA is better funded they should be able to revise and adapt regulations as the need arises.
Ms. Arnott also made comment on the feedback the UK was getting since the smoking cessation license was granted to BAT. According to her when smokers are asked 1/4th of them say they are not as satisfying as smoking. She indicated that overall the numbers were not as strong as they would have liked.
For my part: Goodness where to start. First off if we stay with the Deeming Rule most companies will be out of business due to the cost, but going pharmaceutical is not any cheaper than the Premarket Tobacco Application. Instead of handing the industry to big tobacco it risks handing this industry to big pharma. How is that any good for the smokers who need these products? How does taking an open market where there is a healthy competition that keeps the cost of ENDS lower on average than burning tobacco cigarettes and handing it to one or two giant corporations really benefit anyone? I mean anyone other than the CEOs of those corporations?
Second and really important. How can we meet the standards that the FDA has put out for this industry when those standards do not exist? That’s right there are no standards in the deeming rule. They have yet to set the standards at least in part because the laws these standards need to represent are written for an entirely different product. So then how can we comply with standards we do not have yet? Here’s the thing, I agree we need standards but shouldn’t those standards be based on this industry not just taged on to another industry? smh
All that being said I appreciate Ms. Arnott for coming the long distance that she did to not only speak but to listen. I hope stories like mine and the others will help put faces on the regulations she proposes. She spoke well and definitely, is passionate about wanting to help burning tobacco victims with approved alternatives. Her means may not see things from all points of view, but her point of view is still a valuable addition to forums like this.
Alright, that brings me to the end of part VII.2 and we are coming in at about 1600 words lol. Check back next week for part VIII where we will talk about a couple more speakers. If you have any thoughts or questions please feel free to reach out to me at AccAnswers@gmail.com. Also if you would like more information on A Clean Cigarette brand electronic cigarettes please visit our website at http://www.aclean cigarette.com. I really appreciate you for reading this blog. I hope the information is useful and that I am giving every speaker who attended this event a fair shake. Have a great day, guys. Please visit again!