How will FDA regs effect new mod products

[bigdancehawk]

I never said that. Here it is again.

Here us what will happen if the grandfather date is changed.

All products on the market as of the predicate date can stay on the market with no PMTA.

How it will help new market is the new product is. They can prove that item #98474 is equivalent to item #35 that was grandfathered in on or before the predicate date. Much less time consuming, much less paper work, ABS much less expensive to be aporoved

Johnny W said, “So… we should expect to see NO NEW devices in the near future.”

Your replied, “That is correct unless....
1. HR2058 is passed.”

I agree that if HR2058 passes, some products should have an easier time getting approved as substantial equivalents of existing products. However, I don’t agree that HR2058 will lead to new products in the “near future.” But we could have a different idea of what "new" means and what “near future” means:

“Between the enactment of the tobacco Control Act and February 2011, the FDA received only 26 SE reports. But in March of 2011, it received 3,491. To put it mildly, this created a mountain of paperwork for the FDA.

"It has now been four and a half years since March 2011, and the FDA has barely made a dent in the massive backlog of SE report. Of those filed by March 22, 2011 (referred to as “provisional SE reports”), the FDA has made final determinations on only 23 of them. (All 23 were determined to be not substantially equivalent, meaning that their manufacturers had to discontinue their sale.) [Update: The current number is now 27; see the update at the end of this post.]

"At this rate, it will take the FDA at least another 500 years to clear the backlog of provisional SE applications. And that is not counting the new avalanche of filings that will likely come when the “deeming rule” expands the FDA’s jurisdiction to new types of tobacco products.” LINK

IMO, if the FDA remains consistent in the way it treats SE applications, it will take a very long time, and nothing significantly different from what we have now will ever get SE approval.

 

[J.d. Roberts]

Johnny W said, “So… we should expect to see NO NEW DEVICES in the near future.”

Your replied, “That is correct unless....
1. HR2058 is passed.”

I agree that if HR2058 passes, some products should have an easier time getting approved as substantial equivalents of existing products. However, I don’t agree that HR2058 will lead to new products in the “near future.” But we could have a different idea of what "new" means and what “near future” means:

“Between the enactment of the Tobacco Control Act and February 2011, the FDA received only 26 SE reports. But in March of 2011, it received 3,491. To put it mildly, this created a mountain of paperwork for the FDA.

"It has now been four and a half years since March 2011, and the FDA has barely made a dent in the massive backlog of SE report. Of those filed by March 22, 2011 (referred to as “provisional SE reports”), the FDA has made final determinations on only 23 of them. (All 23 were determined to be not substantially equivalent, meaning that their manufacturers had to discontinue their sale.) [Update: The current number is now 27; see the update at the end of this post.]

"At this rate, it will take the FDA at least another 500 years to clear the backlog of provisional SE applications. And that is not counting the new avalanche of filings that will likely come when the “deeming rule” expands the FDA’s jurisdiction to new types of tobacco products.” LINK

IMO, if the FDA remains consistent in the way it treats SE applications, it will take a very long time, and nothing significantly different from what we have now will ever get SE approval.

I have a bad feeling, as I mentioned before, processes & responses will be as fast as..

 

[kbeam418]

Here's what I want to know. What happens if manufactures just plain and simple don't abide by these laws? Fines? Ok what happens if a shop is cash only? Can't seize cash UNLESS you arrest people. So the FDA is going to arrest people for selling an IPV5, this person files for litigation, calls ABC and says he going to serve 20 years because he sold e-liguid to a 30 year old pregnant woman who wanted to quit smoking. I can see the outrage already.

 

[Robino1]

It will be interesting times ahead, that's for sure.

 

[DixieDawn]

What I don't understand is the custom drip tip artists closing up shop. I understand they are classified as ENDS, but don't they have two years to continue "manufacturing", or are they supposed to be complying with the FDA and having each of their drip tip styles approved for sale as well... good grief. I'm so confused. Do they have to close?

 

[Robino1]

What I don't understand is the custom drip tip artists closing up shop. I understand they are classified as ENDS, but don't they have two years to continue "manufacturing", or are they supposed to be complying with the FDA and having each of their drip tip styles approved for sale as well... good grief. I'm so confused. Do they have to close?

Because no new products after 8-8-16. Each and Every drip tip is new and falls under that regulation.

If they were exactly the same, every single one, then they would be safe for a while.

 

[DixieDawn]

Oh good grief. I hate the government.

 

[Robino1]

Oh good grief. I hate the government.

You are not alone in that sentiment

 

[bigdancehawk]

Here's what I want to know. What happens if manufactures just plain and simple don't abide by these laws? Fines? Ok what happens if a shop is cash only? Can't seize cash UNLESS you arrest people. So the FDA is going to arrest people for selling an IPV5, this person files for litigation, calls ABC and says he going to serve 20 years because he sold e-liguid to a 30 year old pregnant woman who wanted to quit smoking. I can see the outrage already.

In addition to fines, seizures of non-compliant products and injunctions to shut down operations involving the sale of such products. LINK Civil disobedience is an option, but it might not generate much sympathy outside the vaping community. Hard to predict.

 

[Robino1]

Remember too, it usually just takes one take down by the government to scare everyone else into submission.

Depends then on how strong everyone else decides to be.... Stronger numbers and all that stuff....

 

[kbeam418]

In addition to fines, seizures of non-compliant products and injunctions to shut down operations involving the sale of such products. LINK Civil disobedience is an option, but it might not generate much sympathy outside the vaping community. Hard to predict.

Cool story, but as we know from prohibition and a better example; the other stuff, throwing people in jail is not going to work or heck even scare people. I'm not scared one bit, where I live drug abuse is rampant so somebody with a non-complaint PV is the least of the Police Department's concern. I know several vape shop owners and employees who said they'll continue on the black market. The one guy said he already makes un-regulated and regulated mods. He also designs RDAs. One vape shop owner here has a deep freezer stuffed full of nicotine for the black market. Toledo Ohio vapers are prepared but we're going to fight the FDA non-stop even do.

 

[Robert Cromwell]

Hello. I am trying to understand the impacts of the new regulations. Putting the voice regulations aside, I am interested on how this effects new vaping machines. As I understand it, as of Aug 8 2016 all new vaping products (or is it just mods) will have to undergo FDA testing before they are approved to go to market. Is this true? If so, does this mean that no new devices can come out? Then, after aug 8 2018 all existing products will need to go though that process?

Can anyone enlighten me on the specifics of how the deeming regs effects the caping hardware?

Thank you!

JonnyVermont

You are correct NO new vaping products after 8-8.
Mods, Tanks, coils, juice, etc.

 

[J.d. Roberts]

Oh good grief. I hate the government.

And we all have to remember, what caused the government to "get involved" in the first place? The people who are scared of things that they don't understand, like vaping, so they automatically hate it. What do I do when I don't know about something? I never immediately hate it, rather I listen and learn about the subject and see how it really has improved people's lives, will effect others, and how it'll be healthy for society in general in the long run. I can't stand that hating on vaping because I don't like new things bs. Anyways, about your message, I agree, I've seen really stupid official state government ads about vaping (Alaska for one) and other states/organizations (FOX News) that degrade vaping as worse than cigs. F- that kind of thinking. People will always complain about anything new that they don't understand in life; always negative, make up bogus reasons why it's bad even though it's not logical, made up, straight lying about it. That's the reason why I hate the government, when they do that kind of sh-, also the scrubs who pushed the FDA to get involved. The FDA needs to go back and stick with making sure my groceries from Whole Foods are legitimately organic, make my sure my foods don't contain E Coli, and do periodic visits to chicken farms or whatever the f- they do; instead of getting their hands on my juice, drip tips, atomizers, and devices.

 

[J.d. Roberts]

Wow. I'm sorry. I'm never that negative. I'm done beating this dead horse. You guys have a marvelous night..

 

[DixieDawn]

Wow. I'm sorry. I'm never that negative. I'm done beating this dead horse. You guys have a marvelous night..

No need to apologize, I think I started the negative train tonight - so it must be contagious.

 

[Tommy-Chi]

Hello. I am trying to understand the impacts of the new regulations. Putting the voice regulations aside, I am interested on how this effects new vaping machines. As I understand it, as of Aug 8 2016 all new vaping products (or is it just mods) will have to undergo FDA testing before they are approved to go to market. Is this true? If so, does this mean that no new devices can come out? Then, after aug 8 2018 all existing products will need to go though that process?

Can anyone enlighten me on the specifics of how the deeming regs effects the caping hardware?

Thank you!

JonnyVermont

Sure! Read and comment in this document. Everything is explained as well as what you might buy, with a 180 day stock up plan.

 

[Mowgli]

What I don't understand is the custom drip tip artists closing up shop. I understand they are classified as ENDS, but don't they have two years to continue "manufacturing", or are they supposed to be complying with the FDA and having each of their drip tip styles approved for sale as well... good grief. I'm so confused. Do they have to close?

510-style light pulls

 

[Mowgli]

Here's the 2.5 hour radio show on Monday night that Greg discussed the new regs and vaping in general.