A SUGGESTION FROM LAWYER GREG CONLEY, A FORMER CASAA DIRECTOR…
By the time most of you read this, the FDA Center for Tobacco Products will have already released the several hundred page “deeming” regulation regarding electronic cigarettes and other nicotine and tobacco products.Please read this comment I quickly wrote earlier tonight on why vapers and vendors should OPPOSE deeming regulation. I have reproduced it below this e-mail.
Predictably, the news stories out right now are largely being told from the FDA’s point of view. The FDA is trying to sell this regulation to lawmakers, public health groups, and industry, so they are of course aiming to have their regulation portrayed in the most positive light possible in the media.Nonetheless, from what I can gather from these news articles and my knowledge of the Tobacco Control Act, the deeming regulation will be a disaster for e-cigarette product innovation, small and medium-sized businesses, and consumers. This is not a surprise to me, as people and groups like Bill Godshall, Dr. Michael Siegel, CASAA, SFATA, myself, etc. have long-noted that regulation of e-cigarettes under the Tobacco Control Act would likely do more harm than good, increase costs to consumers without benefits, and lead to products being removed from the market.Please do not accept interview requests by journalists and TV reporters on this subject until you fully understand the ramifications of these regulations. Simply tell the reporters that, like any rational business owner, you won’t be commenting until you have had the chance to actually read the proposed regulations.
For business owners and investors wishing to understand the subject more, I offer consulting services. Please call or email me for more details.Best,
Gregory Conley, JD, MBA231 Church Road
Medford, NJ 08055
Here is the comment from Greg on Reddit. I thought it important enough to re-post…
Two years after these regulations go into effect, any e-cigarette product then on the market containing nicotine or any e-cigarette product marketed to be used with nicotine will be BANNED if the manufacturer does not submit a costly application to the FDA. New products will not be permitted to enter the market without FDA approval. FDA is woefully and inadequately prepared to handle this.
This is NOT good news and vendors and vapers should vehemently OPPOSE these regulations, as they will only serve to benefit large tobacco and e-cigarette companies with Wall Street investors, none of whom make the products used by 98% of this subreddit’s users. At the same time, this will potentially shut down hundreds or thousands of small and medium-sized businesses thanks to an extremely expensive, resource-heavy, and arbitrary system setup by the Family Smoking Prevention & Tobacco Control Act.
This is actually worse than I expected.
Two years after the regulation is written, e-cigarette companies will have to put in ‘new tobacco product’ applications for any product released to the market after February 25, 2007.*** This is not mere registration. This is a lengthy and expensive process. If you don’t file an application, your product is banned. If you file an application and the FDA finds that your product shouldn’t be on the market for one of a variety of reasons (including their favorite, ‘You failed to submit adequate evidence of x, y, and z.’), it can be pulled from the market.
After that 2 year date, any new e-cigarette product must be approved by the FDA before it goes to market. If the FDA does not approve your product, it cannot be brought to market. This is not a fast process, as evidenced by a Government Accountability Office report that was highly critical of huge delays that were and still are happening at the FDA Center for Tobacco Products. http://www.gao.gov/assets/660/657451.pdf
For just a sample of what a “new tobacco product” application is like, see here. This a document from when the FDA refused to even file (let alone approve) four “new tobacco product” applications : http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM389515.pdf
Also see this snippet from a Lancet article (behind a paywall) by Dr. Lawrence Deyton, the former Director of the Center for Tobacco Products, in which the burden that will be put on e-cigarette and e-liquid companies is outlined: http://pastebin.com/5nGxZYac
This is bad news for e-cigarette consumers. The chance of a flavor ban or an online sales ban from the start was never really an option. This prospect was here all along and is not positive.
*** There is also something called “substantial equivalence” which is a smaller, but still expensive, loop to jump through. However, FDA guidance on substantial equivalence, and their past decisions on other applications, indicate that it would be a fruitless effort to prove substantial equivalence for a 2016 e-cig product vs. a 2007 product.
Vapers should not only oppose this deeming regulation, but also support vendors that stick up for their businesses and consumers.
A BREAKDOWN OF THE PROPOSED FDA REGULATIONS
Here is another good breakdown of the proposed FDA Regulations:
FDA Gives Huge Gift to Combustible Tobacco, and to Cancer
THANK YOU EROCK!
A Big THANK YOU to my buddy Erock for decorating my site for my birthday. It was an unexpected and pleasant surprise!
FDA REGULATIONS – HERE THEY ARE
Posted with permission of Dimitris and Vape Team Media.
FDA released “deeming regulations” today. Dimitris is joined by Dr. Gilbert Ross to discuss the chilling effects of these regulations and what you can do to make your voice heard.
Dr. Gilbert Ross is the Medical Director at the American Council for Science and Health.
The Video:
THE DNA-30 & THE CONTEST WINNERS ANNOUNCED
A PBusardo Review & Contest Winners – THE DNA 30
In this video we take a look at the DNA-30 and see how it compares to the DNA-20. We also pick the winners of the V3Tronics Flip and Seven-22 devices.
The Links:
EvolVapor – The DNA-30
V3Tronix – The Flip
Pioneer4You – The Seven-22
Vapor Ware Store – The meter
The Video:
The Photos:
Note that the DNA-20 is pictured in the photos below. The DNA-30 is the same size and format.
An interview with Jeff Stier by Dimitris
Posted with permission of Dimitris and Vape Team Media.
In this episode of It’s Political we discuss with Jeff Stier, Senior Fellow at the National Center for Public Policy Research (https://twitter.com/JeffaStier) what went down at the FDA Seminar held in San Diego April 5th as well as some interesting things stated at a press conference held at the same place! We also dive in why vapers should wake up and stand up for their right to vape!
The Video:
NEW IN THE QUEUE – 04/19/14
With this New In The Queue update, the review queue is now closed for the summer, although a few more items may trickle in.
DON’T PANIC! 🙂
I’ll still be doing review videos over the summer, but this will allow me to catch up a bit and spend some much needed time with family and friends.
You may continue to submit items for review, but unless they are “Vape Shattering” they will probably not be accepted until after the summer is over.
Thanks for your understanding and continued support!
- The Radix V1
- The Vapor Shark DNA-30
- New items from Clean Tanks
- The Arnold RTA – Website coming soon
- The D-Eagle RTA
- The Eye APV
- The Mechano Double M Mechanical
THE SEVEN-22 REVIEW & CONTEST!
A PBusardo Review & Contest – The Seven 22
In this video we take a full look at the Seven 22, we do a show & tell on the Vapor Ware resistance and voltage meter, we go over contest rules and how to enter, and we kick off a new contest for a Seven-22 and a Vaper Ware meter!
The Links:
Alibaba Product Page
Poneer4U Website
Distribution Contact Email
Vapor Ware Store – For the meter
The Video:
The Photos:
SHOW RESPECT, BE CONSIDERATE, AND REPRESENT OURSELVES WELL
Being who I am and how I am, I can appreciate this… well some of it. I don’t like the word “weirdos”. People are people… all human beings at their core. But it’s an interesting read and I’m quite sure Russ Wishtart’s show will be interesting as well.
I’ve felt the same way. I feel the hotel could have handled things better. I even made the comment to several people that I felt like we were being treated like animals, but the more I reflect on it, the more I can understand it (but still not how they went about it). I guess I felt at the time like the good kid in the class. Remember? When the entire class was punished because of a few bad individuals?
One thing that really stood out to me…
A father walking his little daughter through the hall the night before the event. There was vape everywhere. There were “interesting” people everywhere. The little girl put her head down into her arm and breathed into her shirt.
Without knowing what we were doing, without knowing how and who we are, I could only imagine how that little girl and her father felt about us.
I hear it all the time. We should have the right to vape anywhere we want! Really? I dare you to vape in the maternity ward of a hospital. No, we don’t have that right, and we shouldn’t. However, we also shouldn’t be forced into smoking sections, where we KNOW second hand exposure is dangerous. We need our own set of rules.
But we also need to show respect, be considerate, and represent ourselves well.
Why do I vape? I vape NOT to smoke. I personally don’t see the need for my PV to produce any more vapor than my cigarette did smoke. However, I think you can be this kind of vaper and still be a hobbyist & enthusiast… searching for consistency, flavor, a device you really like, and overall vape quality.
And I’m not even saying this is the right way, nor do I dislike those who don’t do things this way… but it is my way.
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