Proposed FDA Regulations

18 May, 2014

CASAA's first Call to Action regarding the proposed FDA regulations on #ecigs is out. This is simple--just request that the FDA extend the amount of time people have to submit official comments. CASAA has provided an easy outline of steps to follow here on their blog.

There's a lot to understand about these regulations. We want to make sure that when we all finally get down to the work of giving our opinions that we offer appropriate, logical, specific comments. Knowing exactly what the FDA wants to do will make our comments more effective. So let's start here,#ssvapers!

 

Vaping as we know it today would cease to exist if these regulations go into effect 2 years from now. That's 2016. The only products immediately allowed on the market at that point would be those that were around before February 2007. The vaping industry would be set back TEN YEARS. A decade of innovation and improvement and creativity would be wiped out. Most vapers have only been introduced to the concept of a "smokeless cigarette" within the last few years. Many have no clue how inefficient and awkward the technology once was and how quickly a lack of pointless restrictions has allowed it to continually improve. Trying to obtain approvals for "newer" technology would be so expensive that even medium-sized businesses couldn't handle the financial or temporal burden. That just hands over the whole industry to large tobacco companies, and mom-and-pop vape shops and online vendors would disappear overnight.

 

If vaping has changed your life or the life of someone you care about, then let's not allow the industry to go down like this. If you understand that there is an even bigger ideal that is being threatened, then we ask you participate in this fight as well. Vaping is a blatant reminder of how easily a free market can transform a product with a legacy of disease and death into something exciting, refreshing, and literally life-changing and spawn an entire new business sector. So many passionate smokers have come together to create and share and have inadvertently revolutionized an ancient product in less than a decade. This type of growth should never be stifled in our country.

 

Below is Kevin's original post on Facebook after the FDA announced their proposal. Please read all that you can on this matter. There are great links below it as well. Thank you.

 

We're sure by now many of you have heard about the proposed deeming regulation from the FDA. We want to take a moment and address this. I'm going to try not to make this a long winded soapbox post but I do think it is very important for all of us as vapors to watch this situation as closely as possible.

Please don't get lulled in to a lot of the hype coming from the media that says "it's not that bad". Without a doubt it is not as "bad" as we originally anticipated but in our opinion this regulation should not and cannot pass as proposed. If it does it is essentially handing the industry over to big tobacco. 

While we're all excited that flavors are not being banned, online sales will be able to continue, age restrictions are officially being put in place and manufacturing standards are being set, that's not the entire story.

When reading through the rules pay close attention to the part that states that all products not produced before 2007 will have to undergo an approval process from the FDA or pass a substantial equivalency process proving that a product is more or less equivalent to an existing product that was on the market then. What that means is that your favorite juice maker - be it local or online - will have to submit an application for approval for every flavor and variation (strength, sweetness, amount of flavoring, etc) of that flavor they want to sell. The paperwork, testing and cost involved in this process will be out of reach for 99% of small and most medium sized vendors. Your favorite mod or device will have to go through the same process. Keep in mind, most of our devices are made in another country. The FDA is already backlogged and has yet to approve a single substantial equivalence application since the act that they are trying to lump E-cigs in with passed in 2007. There is no evidence that this new regulation will speed that process up. 

While there are some good parts to this regulation we have to remember that as all things the government does it's all or nothing. 

Everyone, please take the time to send comments to the FDA giving them your honest thoughts on this BUT don't rush to do it. The 240+ pages of the rule are still being vetted. Use resources like casaa.org and ECF and make sure you fully understand what you are commenting on. We have until July 9th to have our comments in. Let's make them count. 

Here's a few links that I found interesting. Check them out and if you find more, please share them with us here. 

Thank you everyone for your business but more than that thank you for supporting vaping and what it does now and will continue to do for smokers everywhere.

-Kevin 

http://www.e-cigarette-forum.com/forum/legislation-news/556086-bill-godshall-urges-opposition-fda-deeming-reg-fdli-conference-because-would-give-e-cig-industry-big-tobacco.html

http://blog.casaa.org/2014/04/casaa-assessment-of-fda-deeming.html

http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm198169.htm

And lastly - Grimm Green gets it right again -http://www.youtube.com/watch?v=MAa60mWNzXY

 

 

 

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