Deeming Regulations have been released!!!!

[Buckeyevapen]

Just got home from work. Must admit that this news was a pleasant surprise.

My long term hope is that the voices of reason and scientific evidence grows louder and stronger.

As many have pointed out, this is just the start, not the destination.

 

[Rossum]

Watching China pour new products into the marketplace while they're either stifled or forced to outsource.

Right, but they are not supposed to produce and sell any product not on the market before 8/16
Even the US vendors are in violation selling products not available after 8/16.

Right, but none of that is any different than it was before today. And one might even get the impression that the FDA isn't real interested in enforcing that aspect of the Deeming right now, no?

 

[Shawn Hoefer]

Right, but none of that is any different than it was before today. And one might even get the impression that the FDA isn't real interested in enforcing that aspect of the Deeming right now, no?

Agreed. Just answering the question with one possible answer.

Sent from my SAMSUNG-SM-N910A using Tapatalk

 

[zoiDman]

What is the status of the "no new products after 8/16", is that still in effect?
Are they going to enforce the ban on these products?
Is the requirement to register products by this November still in effect?

While the Nicopure et al lawsuit was Pending, I think the FDA took a No Enforcement - Wait n' See approach to New Products. And I don't think that the FDA (or anyone else) thought a Ruling would take as Long as it did. But now they have a 100% Ruling.

And Now that they have Released a New Direction regarding TC and THR. And that will have It's Distractors.

So... JMO... I think the No New Products will be enforcement. Both to Appease the Anti e-Cigarette crowd. And to demonstrate that the FDA still has "Teeth" under this New Management.

 

[puffon]

Right, but none of that is any different than it was before today. And one might even get the impression that the FDA isn't real interested in enforcing that aspect of the Deeming right now, no?

True, but if I was in the business I would still be apprehensive about putting R+D and $ to bring a new product to market.

 

[mikepetro]

True, but if I was in the business I would still be apprehensive about putting R+D and $ to bring a new product to market.

Why not? Take the money they were going to spend on a PMTA and put it into R&D. Then worry about the PMTA when they actually post the clear rules.

 

[Opinionated]

While the Nicopure et al lawsuit was Pending, I think the FDA took a No Enforcement - Wait n' See approach to New Products. And I don't think that the FDA (or anyone else) thought a Ruling would take as Long as it did. But now they have a 100% Ruling.

And Now that they have Released a New Direction regarding TC and THR. And that will have It's Distractors.

So... JMO... I think the No New Products will be enforcement. Both to Appease the Anti e-Cigarette crowd. And to demonstrate that the FDA still has "Teeth" under this New Management.

Honestly, I think they will continue to crack down on underage sales etc. (As they have very recently been doing) but will probably let the no new product rule skate a while longer..

I honestly think that the whole for the kids thing is going to be their main concern.. they will wait til closer to product approval time to crack down on new product sales.

But - as this is just my opinion we could later find I'm wrong, I just think this is how it will go, unless too much light gets shed on the topic. Best really to pretend it's not happening to avoid shedding that light, imho.

 

[Opinionated]

Why not? Take the money they were going to spend on a PMTA and put it into R&D. Then worry about the PMTA when they actually post the clear rules.

I agree, even if you find later you cannot get approval here, you can always get approval overseas so it's not money lost.

 

[Alexander Mundy]

They got dinged for selling to minors. They should have been smarter.

Got a link? I was wondering what happened.

 

[zoiDman]

Honestly, I think they will continue to crack down on underage sales etc. (As they have very recently been doing) but will probably let the no new product rule skate a while longer..

I honestly think that the whole for the kids thing is going to be their main concern.. they will wait til closer to product approval time to crack down on new product sales.

But - as this is just my opinion we could later find I'm wrong, I just think this is how it will go, unless too much light gets shed on the topic. Best really to pretend it's not happening to avoid shedding that light, imho.

It's just kinda Hard to Say?

The Underage Sales thing, that is Full Steam Ahead.

Tobacco Retailer Warning Letters

Hardware? Well what is a Tobacco Component or a Part if the Intended Use judgment call is Removed? Judge Jackson sited that the FDA has the Authority to apply "Intended Use".

But after Listening to the FDA Commissionaire today, I'm not sure how much they will choose to use it?

I think for any New post August 2016 e-liquids that contain Nicotine they will. Absolutely. But more for Political Reasons. But this is just a Guesstimation.

 

[Opinionated]

Got a link? I was wondering what happened.

RTS LEASING, LLC 6/21/17

Quote from letter:

"FDA has determined that your RTS Vapes Flavorless Nicotine Liquid is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age."

But you can read the whole letter at the link.

 

[Alexander Mundy]

Got a link? I was wondering what happened.

Nevermind, found the warning letter on FDA site. Had to be a set up though, cause what minor would buy online and then voluntarily let the FDA know. And yes I know with the deeming they can use minors to set someone up legally but I don't think it's morally right.

 

[Alexander Mundy]

RTS LEASING, LLC 6/21/17

Quote from letter:

"FDA has determined that your RTS Vapes Flavorless Nicotine Liquid is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age."

But you can read the whole letter at the link.

Ninjaed

 

[Buckeyevapen]

Vape if you got'm.

At least for one night, maybe this community can believe that hope is still out there for us. And most importantly for current smokers who have not found that "first set up".

 

[smacuser]

(12:40)

Nightly Business Report – July 28, 2017

 

[DancingHeretik]

Just posted on youtube....

Thank you!

 

[coldgin96]

So for anyone on disability, they know whether or not you smoke

Only if you've ever admitted it....

 

[sofarsogood]

Gottlieb and Zeller were nervous. This was no routine announcement. The big news is not about ecigs, it's about going after the $1 trillion a year tobacco business. America has only a small percentage of the world's smokers but we can show leadership. This qualifies. Taking the nic out of cigarettes might work if there is a good alternative. We all agree that ecigs are a good alternative. I won't be without my stockpile but I'm hopeful.

 

[Eskie]

RTS LEASING, LLC 6/21/17

Quote from letter:

"FDA has determined that your RTS Vapes Flavorless Nicotine Liquid is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age."

But you can read the whole letter at the link.

Do remember a warning letter is not a finding of guilt and you're going to jail. They didn't even levy a fine, which can be done after the second or third offense. It doesn't drive someone out of business if they know what this is. BP gets hundreds of warning letters every year, and address them or refute the interpretation. The FDA did not walk in and shut them down. They chose to shut down, and if it was solely because of that letter, it was a way over the top response.

 

[Bonskibon]

Got a link? I was wondering what happened.

RTS LEASING, LLC 6/21/17