FDA Sen Johnson (R-Wis) demands answers from FDA RE deeming

[Jumpin' In...]

From his letter to Robert Califf :

According to Christian Berkey, the Chief Executive Officer of Johnson Creek Vapor Company located in Hartland, Wisconsin, the FDA e-cigarette regulations would “extinguish a multi-billion dollar industry and put tens of thousands of people out of business.” Mr. Berkey also stated that the new FDA rule would have more than just a burdensome impact on the e-cigarette industry, the effect of the rule would be “catastrophic.” In its regulatory analysis, the FDA itself acknowledged that the cost of the rule “would be high enough to expect additional product exit, consolidation, and reduction in variety compared with the baseline.”

This is the same Christian Berkey who had this to say a few days after the issuance of the proposed deemings ( a substantially similar document to the final version ) in April 2014 :

“It’s a great day,” says Christian Berkey, CEO of Johnson Creek, a leading maker of electronic cigarette liquid based in Wisconsin..... “People worried the regulations would be unreasonable and onerous,” says Berkey. “What we are seeing is they are not.” Upon seeing the FDA’s proposed rules today, the businesses are cheering. They see the proposal as a signal that the agency plans to take a business-friendly approach.

E-Cig Execs Are Actually Thrilled With New FDA Regulations

Heh. Two years is a long time in this ~#^%£* world.

 

[Katya]

From his letter to Robert Califf :

According to Christian Berkey, the Chief Executive Officer of Johnson Creek Vapor Company located in Hartland, Wisconsin, the FDA e-cigarette regulations would “extinguish a multi-billion dollar industry and put tens of thousands of people out of business.” Mr. Berkey also stated that the new FDA rule would have more than just a burdensome impact on the e-cigarette industry, the effect of the rule would be “catastrophic.” In its regulatory analysis, the FDA itself acknowledged that the cost of the rule “would be high enough to expect additional product exit, consolidation, and reduction in variety compared with the baseline.”

This is the same Christian Berkey who had this to say a few days after the issuance of the proposed deemings ( a substantially similar document to the final version ) in April 2014 :

“It’s a great day,” says Christian Berkey, CEO of Johnson Creek, a leading maker of electronic cigarette liquid based in Wisconsin..... “People worried the regulations would be unreasonable and onerous,” says Berkey. “What we are seeing is they are not.” Upon seeing the FDA’s proposed rules today, the businesses are cheering. They see the proposal as a signal that the agency plans to take a business-friendly approach.

E-Cig Execs Are Actually Thrilled With New FDA Regulations

 

[Katya]

My simple letter just sent to the Senator and Committee ...

Wonderful letter.

Would you mind posting it also in this thread? I'm sure it will inspire others to write their own letters. Thanks!

FORM LETTERS - For Congress, State, Commissioners

 

[Mazinny]

Heh. Two years is a long time in this ~#^%£* world.

Yeah enough time to realize selling 50% of your company to Republic tobacco might extend your distribution network into convenience stores, but it still doesn't give you the financial muscle to navigate your products through the PMTA procedure. When he thought he may be able to afford something his smaller competitors won't, he was all for the deemings. Singing a slightly different tune now.

 

[Katya]

Yeah enough time to realize selling 50% of your company to Republic Tobacco might extend your distribution network into convenience stores, but it still doesn't give you the financial muscle to navigate your products through the PMTA procedure. When he thought he may be able to afford something his smaller competitors won't, he was all for the deemings. Singing a slightly different tune now.

It never ceases to amaze me that some people still believe that if they feed an alligator they won't get eaten.

 

[Lessifer]

From his letter to Robert Califf :

According to Christian Berkey, the Chief Executive Officer of Johnson Creek Vapor Company located in Hartland, Wisconsin, the FDA e-cigarette regulations would “extinguish a multi-billion dollar industry and put tens of thousands of people out of business.” Mr. Berkey also stated that the new FDA rule would have more than just a burdensome impact on the e-cigarette industry, the effect of the rule would be “catastrophic.” In its regulatory analysis, the FDA itself acknowledged that the cost of the rule “would be high enough to expect additional product exit, consolidation, and reduction in variety compared with the baseline.”

This is the same Christian Berkey who had this to say a few days after the issuance of the proposed deemings ( a substantially similar document to the final version ) in April 2014 :

“It’s a great day,” says Christian Berkey, CEO of Johnson Creek, a leading maker of electronic cigarette liquid based in Wisconsin..... “People worried the regulations would be unreasonable and onerous,” says Berkey. “What we are seeing is they are not.” Upon seeing the FDA’s proposed rules today, the businesses are cheering. They see the proposal as a signal that the agency plans to take a business-friendly approach.

E-Cig Execs Are Actually Thrilled With New FDA Regulations

Yeah, two years ago there were a number of "big vapor" companies that thought they were big enough, and prepared enough to survive. The final regs though, they're pretty clear that anything other than closed system isn't going to make it through. It's been awhile since I've checked out JC, do they still have their VEA? It wasn't proprietary connection before, did they make it that way now?

 

[MacTechVpr]

Yeah enough time to realize selling 50% of your company to Republic Tobacco might extend your distribution network into convenience stores, but it still doesn't give you the financial muscle to navigate your products through the PMTA procedure. When he thought he may be able to afford something his smaller competitors won't, he was all for the deemings. Singing a slightly different tune now.

Fair enough Maz. Needed to be said. You know I like the co and products. And Im sure there's more that went on we won't know. Good reminder the commercial interest doesn't always coincide with the consumer. Good luck.

 

[redddog]

While I applaud this senator for requiring more from the fda, I wish his primary interest was the health benefits of vaping rather than the fact that it will cost jobs. It's a consideration for sure, but to me, convincing someone to change their tune about vaping lies in establishing the truth about the miraculous health benefits over cigarettes vaping gives us.

This fact has to be driven home: these regulations, come by from prejudicial force to further ones interests not in the best interests of the very constituency they are there to protect, will simply and with certainty lead directly to the deaths of countless Americans.

It's utterly incredible that this argument is met with indifference.

 

[Mazinny]

Fair enough Maz. Needed to be said. You know I like the co and products. And Im sure there's more that went on we won't know. Good reminder the commercial interest doesn't always coincide with the consumer. Good luck.

Yes, that was the point i was alluding to . I am glad Senator Johnson has stepped up, but a part of me wonders if he would have done so if he wasn't approached by Johnson Creek, who i assume is a campaign contributor.

I don't really have anything against Johnson Creek. I do realize however, that his primary concern is to do what's best for his company, not to be an advocate for consumers. To be fair, he was already backtracking (somewhat !) from his position by Oct 2014 :

aelmer2821

With ties to "big tobacco," how do you feel about the idea of regulation and limitation within the Vaping crowd? And since no one has said so yet, Thanks for doing this.

• 
  
• jcsmokejuiceJohnson Creek Vapor Company[S] 8 points 1 year ago
  
  There is no simple answer to this question, as I’m sure you know. It is obvious to us that the vaping community is getting much more involved in the self regulation of juices and equipment, and to that extent we’re impressed and proud. On the federal regulation side we are in favor of some reasonable regulations regarding juice manufacturing, after all, at the end of the day, we all make product that we ingest. As long as these regulations have a positive impact on not just the community but the industry, and ensure that the products we make and consume are as safe as possible, some regulation is needed. But the end goal should be to keep these products safe and keep vaping, as an alternative to smoking, around for as long as possible. Regulations should be productive and allow for innovation, as allowing for innovation is the best way to make the products safer and more enjoyable.
  
  As far as the “open/closed” system is concerned, open systems are something that we’ve found to be a powerful tool for vapers and we want nothing more than to ensure that the best experience is available to everyone. It’s also something that we’ve set our sights on as far as building our stable of products. - MG

Does Mr. Berkey still stand by his quote from this Time article regarding the FDA proposals as they stand?

This is a great question, because at that time the regulations as we saw them were not as bad as we had anticipated (banning flavors, banning web sales, restrictions on hardware, etc), and we still do see some reasonable regulation as a necessity in this growing industry, especially considering the product being discussed is a consumable product. That being said, we expressed some feelings on this in a previous question:

"It is obvious to us that the vaping community is getting much more involved in the self regulation of juices and equipment, and to that extent we’re impressed and proud. On the federal regulation side we are in favor of some reasonable regulations regarding juice manufacturing, after all, at the end of the day, we all make product that we ingest. As long as these regulations have a positive impact on not just the community but the industry, and ensure that the products we make and consume are as safe as possible, some regulation is needed. But the end goal should be to keep these products safe and keep vaping, as an alternative to smoking, around for as long as possible. Regulations should be productive and allow for innovation, as allowing for innovation is the best way to make the products safer and more enjoyable."

In addition to that, we're encourage smaller businesses, and as we've stated before and will always feel, we applaud the ingenuity and entrepreneurship of all small businesses, as the vaping industry is nothing without innovation and creativity.

Also, what are your thoughts on RJ Reynold's FDA comments regarding open systems?

This is another great topic and also something that we've touched on in a previous question. The short answer is that we support open systems fully.

We are Christian & Mike of Johnson Creek Smoke Juice - AMA • /r/electronic_cigarette

 

[DC2]

While I applaud this senator for requiring more from the fda, I wish his primary interest was the health benefits of vaping rather than the fact that it will cost jobs. It's a consideration for sure, but to me, convincing someone to change their tune about vaping lies in establishing the truth about the miraculous health benefits over cigarettes vaping gives us.

Regardless of what his primary interests may or may not be...
The committee he belongs to can only do what it is tasked to do...

And comparing health benefits of vaping to smoking is WELL outside of their purview.

Rather than fretting over that, we should throw our full support behind this effort.

And then after doing so maybe we should consider blaming those...
Who really ARE responsible for the health and science evaluations on this issue...

Folks like the FDA, the CDC and Health and Human Services.
They are distorting the truth at every opportunity.

For fun? Or for profit? Or does it even matter WHY they are lying?

 

[rwoodin]

Wonderful letter.

Would you mind posting it also in this thread? I'm sure it will inspire others to write their own letters. Thanks!

FORM LETTERS - For Congress, State, Commissioners

Sure, no problem reposting as long as that's not considered spamming!

 

[rwoodin]

Wonderful letter.

Would you mind posting it also in this thread? I'm sure it will inspire others to write their own letters. Thanks!

FORM LETTERS - For Congress, State, Commissioners

Oh, It already is posted on this thread - page 6

 

[Katya]

Oh, It already is posted on this thread - page 6

Sorry, not this thread.

I meant the thread linked below (and above ). Please click on the link in red:

FORM LETTERS - For Congress, State, Commissioners

The thread (linked above) was created especially for vapers' advocacy letters, so no, it's not spamming. The idea behind that thread was to have all the letters in one place for easy reference (and/or inspiration) for other letter writers. There's no chitchat allowed--just letters.

Thanks again.

ETA:
@retired1 @classwife @Robino1

I think that the title "Form letters" is somewhat misleading. Those are not form letters; "advocacy letters" or "inspirational advocacy letters" or something similar would be more accurate, methinks. Just a suggestion...

 

[Kent C]

Sen. Johnson's radio address. Keep Vapin', Vicki. Worth a listen.



From drum 747's post on the deeming thread....

 

[Katdarling]

Thanks, Kent (and DPL for letting me know)!

 

[DC2]

Well, first of all kudos to Vapin' Vicki for a very solid effort.

And kudos to my new favorite politician.
Ron Johnson.

EDIT: Yes, I realize that "favorite" and "politician" are rarely used in the same sentence.
EDIT:

 

[DPLongo22]

Well, first of all kudos to Vapin' Vicki for a very solid effort.

And kudos to my new favorite politician.
Ron Johnson.

EDIT: Yes, I realize that "favorite" and "politician" are rarely used in the same sentence.
EDIT:

Actually, I never thought I'd ever think such a thing -
but I do think I've got a bit of guy crush -
ON A POLITICIAN????

 

[nelsonm64]

signed. with a bogus email addy and said I live in Washington state! i'm only an hour or so from the border, that's close enough right plus, I spend 3-4 months a year in socal so, i'm a part time citizen haha.

 

[janiegrl]

Yesterday was the deadline Sen. Johnson gave the FDA to answer. I wonder if we'll find out if they did, and what happens next.

 

[retired1]

We'll have to give them a day or two to publish the response (if there was one).