The final countdown to August 8th - your FDA comments NEEDED

[xena222]

Oh I just got done reading the CASAA response...so glad someone posted it!! The one thing that came up in there that I never thought of was the comparison of ecigs to Chantix!! I took that stuff and it nearly killed me!! It was like try number 18 for me Thank you to the CASSA for writing things i think they HAVE to read.....I am really worried now.....just got the hang of this and smoke free for the first time in my life....I could not use the cigalikes (LOL, if anyone remembers me insisting it MUST look like a cigarette!) and if it goes back that way, I am doomed....

 

[pamdis]

I'm glad you posted this. I was at my local vape store yesterday. I asked the owner about the pending regulations and what it would do to his juice lab. He said he's prepared to pay the price of certification imposed and he only uses the purest ingredients. Of course he said he'd have to raise juice prices, but that's inevitable to begin with.


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So, in essence, he is prepared to raise his prices based on things that are not even addressed in the regulations - certification and purity of ingredients.

You should print a copy of this:

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM273425.pdf

And then ask him if he is prepared to pay the price for sections V and VI.

Oh, and tell him that this document was written in 2011, is still in draft status, and will probably change significantly to address the newly deemed products. And probably not for the better, I would imagine. And probably not within the two year window he will be given to submit his applications either.

 

[pamdis]

One thing that is Kinda Funny about the Entire Hardware thing is that if it is Marketed as something to Use for the Things we can Not Talk about, there doesn't seem to be any Problems.

And the FDA has No Authority over it.

Go Figure.

They will get the authority by claiming since they CAN be used for nicotine liquids, it SHOULD fall under their jurisdiction. Problem solved.

The AG letter already addressed this from the opposite direction in their letter:

Another reason components and parts should not be limited to those containing nicotine is that e-cigarettes, such as vape pens and tanks, can be customized by the user to smoke liquid ........., {MODERATED}, shisha, oils, whole tobacco, herbs and other drug products. A lifelong ......... user confessed to using a vapor pen to smoke liquid ......... on a train commute from New York to Baltimore undetected.126 The Konyo complete 3-in-One Vaporizer portable vape pen127 has been described by Susanne E. Tanski, MD, MPH, FAAP, a pediatrician with the American Academy of Pediatrics, as the ......... vape pen.128

 

[pamdis]

I think the Act says that the FDA can not ban or eliminate a tobacco "category" like ecigs. I think an agreement was made for tobacco to buy placeholder ecig companies because the FDA figured it would be better to work with one or two of them than with us. That way the FDA wasn't banning the entire category. .

I didn't think it was possible to find someone even more cynical than me. Congrats!

 

[rbrylawski]

So, in essence, he is prepared to raise his prices based on things that are not even addressed in the regulations - certification and purity of ingredients.

You should print a copy of this:

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM273425.pdf

And then ask him if he is prepared to pay the price for sections V and VI.

Oh, and tell him that this document was written in 2011, is still in draft status, and will probably change significantly to address the newly deemed products. And probably not for the better, I would imagine. And probably not within the two year window he will be given to submit his applications either.

I think you're taking his comments a bit too literally. Of course he doesn't know the exact process or cost he'll have to go through, but his position is he'll make the investment required to comply "IF" or "WHEN" new guidelines are adopted. As to raising prices, I think he's just realistic. If his cost of doing business goes up, it's only natural "we" consumers will end up paying more.

A little cynical are we?

 

[pamdis]

A little cynical are we?

Just a tad. But I just noticed I have some formidable competition from aikanae1. I need to step up my game.

 

[sonicdsl]

I think you're taking his comments a bit too literally. Of course he doesn't know the exact process or cost he'll have to go through, but his position is he'll make the investment required to comply "IF" or "WHEN" new guidelines are adopted. As to raising prices, I think he's just realistic. If his cost of doing business goes up, it's only natural "we" consumers will end up paying more.

A little cynical are we?

Not cynicism, analysis. There's a whole thread on the economic impact report the FDA issued here: http://www.e-cigarette-forum.com/forum/fda-regulations/557605-economic-impact-analysis.html

Bottom line: Each product (that means each individual type: flavor, nicotine level, etc.) will have to have an application, and the applications will run about ~$300,000 EACH (not a typo). So if they offer Strawberry in 6 different nic strengths, that will be 6 applications for about $1.8 million.

If he has that kind of money, he's running a hell of a business.

 

[zoiDman]

They will get the authority by claiming since they CAN be used for nicotine liquids, it SHOULD fall under their jurisdiction. Problem solved.

The AG letter already addressed this from the opposite direction in their letter:

Not saying that the FDA could Not Considered this Approach.

But they know as well as we know that if I make No Marketing Statements that an Item is to be Used with Nicotine that has been Derived from Tobacco Plants, and if my Product has Other Uses (ie: 0mg, "The Stuff we can Not Talk About") besides what the FDA Does have Authority over, that if they Restrict or Impede my Sale of the Item, that they will be Sued.

 

[Rickajho]

Kristin just put this up in the CASAA forum:

CASAA is doing an FDA Comment Survey. It's short and very easy. We would greatly appreciate people completing the survey and sharing their comment with us "for the record."

More information here: CASAA: Call to Action: FDA Comments Survey

 

[inswva]

Kristin just put this up in the CASAA forum:

Just completed the survey. Any and all additional information CASAA collects can only help.

 

[rbrylawski]

Not cynicism, analysis. There's a whole thread on the economic impact report the FDA issued here: http://www.e-cigarette-forum.com/forum/fda-regulations/557605-economic-impact-analysis.html

Bottom line: Each product (that means each individual type: flavor, nicotine level, etc.) will have to have an application, and the applications will run about ~$300,000 EACH (not a typo). So if they offer Strawberry in 6 different nic strengths, that will be 6 applications for about $1.8 million.

If he has that kind of money, he's running a hell of a business.

You're speaking in absolutes at this point. Nothing has been put in place yet, so we'll just have to at this point take a wait and see perspective.

 

[Megan Kogijiki Ratchford]

Oh I just got done reading the CASAA response...so glad someone posted it!! The one thing that came up in there that I never thought of was the comparison of ecigs to Chantix!! I took that stuff and it nearly killed me!! It was like try number 18 for me Thank you to the CASSA for writing things i think they HAVE to read.....I am really worried now.....just got the hang of this and smoke free for the first time in my life....I could not use the cigalikes (LOL, if anyone remembers me insisting it MUST look like a cigarette!) and if it goes back that way, I am doomed....

My PCP refuses to prescribe Chantix. She says "it is the very worst drug on the market today. I would rather see my patients smoke than take this poison!"

 

[Megan Kogijiki Ratchford]

Just a tad. But I just noticed I have some formidable competition from aikanae1. I need to step up my game.

Personally I think it's just being realistic not cynical. I'm sitting on a dragon's hoard of gear and juice. A cynic would be moving to the woods and placing land mines around the cabin which has enough food, water, juice, batteries, wicking materials and kanthal to survive the coming vapocolypse.

I'm only missing the land mines and the cabin in the woods....

 

[Megan Kogijiki Ratchford]

Kristin just put this up in the CASAA forum:

I tried but could never get the survey to load...

 

[Megan Kogijiki Ratchford]

I tried but could never get the survey to load...

Never mind...I got it done!

 

[skoony]

whew,i actually read this whole thread. to all those i didn't get to liking their comments heres my official like to each and every poster in this thread.




regards
mike

 

[zoiDman]

Kristin just put this up in the CASAA forum:

Thank you for posting this Rick.

Here is the Lin to the Thread if Anyone has not seen it yet.

http://www.e-cigarette-forum.com/forum/casaa/592629-call-action-fda-comment-survey.html

 

[Rickajho]

I think you're taking his comments a bit too literally. Of course he doesn't know the exact process or cost he'll have to go through, but his position is he'll make the investment required to comply "IF" or "WHEN" new guidelines are adopted. As to raising prices, I think he's just realistic. If his cost of doing business goes up, it's only natural "we" consumers will end up paying more.

A little cynical are we?

Not cynicism, analysis. There's a whole thread on the economic impact report the FDA issued here: http://www.e-cigarette-forum.com/forum/fda-regulations/557605-economic-impact-analysis.html

Bottom line: Each product (that means each individual type: flavor, nicotine level, etc.) will have to have an application, and the applications will run about ~$300,000 EACH (not a typo). So if they offer Strawberry in 6 different nic strengths, that will be 6 applications for about $1.8 million.

If he has that kind of money, he's running a hell of a business.

"A little cynical are we?"

Am I the only person who picked up what it says right there, on the docket scummary^* page:

Regulations.gov

Priority: Economically Significant

You don't have to read the entire economic impact analysis to figure this one out, just read between the lines those two words. The economical significance isn't going to be about saving the consumers any money over this one.

^*The wonky ECF message editor made that typo. I was gonna fix it, but I decided to leave that one alone.

 

[marlight]

Survey done and comment and tracking number included.

 

[charly1954]

Big Tobacco Co., FDA, Politicians, all sleep in the same bad and scratch each others back..

So why R they agains us(Vapors)

Gov is looseing tax dollars from smoker switching to E-Cigs
Tobacco Co. loosing cig sales.

To me it looks like the FEDS are wanting to SLOW down the USE of e-cigs, behind closed doors they like the smokers taxes and don't want to give those dollars up.