FDA The day after the deeming - ?

[Sewnmachine]

Moderators, please move or merge this thread if appropriate.

Now that we are fast approaching August 8th, I'm trying to drill down as to what the new reality will be. After reading through pretty much all the topics and discussions here are a few bullet points I've burned into my brain. Please correct or comment as necessary to clear up some confusion.
* Age restrictions and verifications will be effective immediately.
* E-juice and hardware can continue to be sold within a one year grace period.
* New juice combinations and hardware are not permitted to be introduced within this grace period.
* At some point during this grace period vendors must submit a patent application for any/all iterations of ejuice and hardware they would like to continue to sell. These applications may or may not be approved by the FDA.
* Upon submission of the application, vendors may continue to sell their product until they receive a final determination by the FDA.
* Once a patent application has been rejected any future sale of that product would be subject to criminal prosecution.
* Any state may at any time impose their own restrictions, taxes and prohibitions to the sale of vaping products. This could be applied to brick and mortar stores as well as online vendors.
* Products purchased overseas and shipped into the US would need to be in compliance with current US and FDA regulations or else risk being confiscated by customs.
* By 2018 there will ( or should be ) a final established protocol defining legal vaping products for the vendor and consumer.

Ok. What have I missed - or misconstrued?

 

[Kent C]

What have I missed - or misconstrued?

Pretty good.

Vendors have to register their products by Aug 8th (see Zoidman's link on dates) (different than the PMTA's needed).

Vendors will be subject to undercover enforcement of those things mentioned on Aug 9th. Checking ID's, child proof caps, etc.

* By 2018 there will ( or should be - or might never be) a final established protocol defining legal vaping products for the vendor and consumer.

 

[zoiDman]

...

Ok. What have I missed - or misconstrued?

Not a Bad Summation of what we will Probably see. Barring any Legal or Congressional/FDA Changes.

Here is a Regulatory Calendar that VTA compiled. Note the February 8th 2017 and August 8th 2017 Deadlines for submitting "Tobacco Health Documentation" to the FDA.

Dropbox - VTA Guidance - Deeming Compliance Calendar - FINAL.pdf

This hasn't been Talked about much. But could put a Kibosh on a Seller thinking they can just Coast Out for 2 Years without having to do anything.

Also, after Aug 8th 2016, the FDA will have the Authority to Enter Any "Manufacture" of e-Liquids. And has the Power to Close them down if they do not meet "Sanitary Standards".

Of Course, the FDA Hasn't Published what Sanitary Standards an e-Liquid Manufacture is supposed to Comply to.

So I guess the Determining Factor of whether or not the FDA can Close your Business because it Doesn't Meet some Imaginary Sanitation Standard is what mood the FDA Inspector is in when he walks in your door.

 

[Sewnmachine]

Thank you, both of you. I wanted to make sure I had some valid understanding of what is to come. I have a few coworkers that I am going to try to explain all of this to. I have been stockpiling supplies for the past few months and should be ok for about 4 years. After that...... who knows? But I want to give my coworkers a heads up so they can begin to prepare also.
It might be that we can continue to buy what we need for at least the next year. I hope so.
Thanks again!

 

[Grimwald]

The one caveat is what happens on the state and local level. The whole deeming is pretty much a can of worms at this point.

 

[5150Marley]

Just saw this posted on the California Vaping Advocacy page .. not sure if it has been share yet.

Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products

 

[trying]

R & D budgets will be slashed, because why pay to develop new devices and liquids if they can't market them because they can't afford the required testing.

 

[seminolewind]

Where is the tobacco in a vaping product? How does one do testing on a tobacco product that has no tobacco? I hope congress can figure out that there's no tobacco in vaping products. No rat poison or antifreeze either.

 

[DaveP]

Old thread here, but still not closed.

So, 8-8-2017 is approaching. The end of a one year period where devices and vaping products can still be sold. What happens on 8-8-2017? Will we not be able to purchase new mods, existing stock, or e-liquids if Trump doesn't get his grandfather clause passed?

Looks like the Trump initiative and Duncan Hunter's bill have had some effect in easing the restrictions the FDA planned to implement.

It's hard to pin down what actually happens until 2018. I'm wondering how many manufacturers have submitted products for testing and approval. You don't hear much about individual brands and models or whether we will be able to buy hardware or juice products if the deeming rule outlaws anything introduced after 2010.

 

[zoiDman]

Old thread here, but still not closed.

So, 8-8-2017 is approaching. The end of a one year period where devices and vaping products can still be sold. What happens on 8-8-2017? Will we not be able to purchase new mods, existing stock, or e-liquids if Trump doesn't get his grandfather clause passed?

Looks like the Trump initiative and Duncan Hunter's bill have had some effect in easing the restrictions the FDA planned to implement.

It's hard to pin down what actually happens until 2018. I'm wondering how many manufacturers have submitted products for testing and approval. You don't hear much about individual brands and models or whether we will be able to buy hardware or juice products if the deeming rule outlaws anything introduced after 2010.

I believe this is an Up-to-Date Timeline for Compliance Dates.

Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf

 

[DaveP]

I believe this is an Up-to-Date Timeline for Compliance Dates.

Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf

It's so difficult to get a top view of what is going to be allowed and what is to be prohibited in 2018. Looks like a mod won't be since it contains no nicotine unless the user adds it by screwing on an atomizer with nic based juice.

Congress is sitting on the issue and it seems that no one is ready to reign in the FDA. The UK is recommending that smokers quit and switch to ecigs. The USA is ready to rip them out of the hands of vendors under the Deeming rule if they don't spend millions to get juice and devices approved. It's a sad situation, IMO.

Seems to me that the FDA would be better served by copying the UK 3.52 pound tax on a pack of cigs and let the cost deter smoking. Then, smokers who are left would turn to ecigs and live longer!

For me, all this says that I need to get on the ball and order a box full of mods and atomizers just for longevity. I already have a dozen or more of each, but who can say that more will be available for purchase after 8-10-2019? It's crazy.

 

[zoiDman]

It's so difficult to get a top view of what is going to be allowed and what is to be prohibited in 2018. Looks like a mod won't be since it contains no nicotine unless the user adds it by screwing on an atomizer with nic based juice.

Congress is sitting on the issue and it seems that no one is ready to reign in the FDA. The UK is recommending that smokers quit and switch to ecigs. The USA is ready to rip them out of the hands of vendors under the Deeming rule if they don't spend millions to get juice and devices approved. It's a sad situation, IMO.

Seems to me that the FDA would be better served by copying the UK 3.52 pound tax on a pack of cigs and let the cost deter smoking. Then, smokers who are left would turn to ecigs and live longer!

For me, all this says that I need to get on the ball and order a box full of mods and atomizers just for longevity. I already have a dozen of each, but who can say that more will be available for purchase after 8-10-2019? It's crazy.

I think an awful lot is going to depend on what Judge Jackson rules in the Nicopure et al lawsuit. And if the Ruling is for the Most Part favorable, if the FDA/Justice Department decides it wants to Appeal the Ruling?

I'm optimistic that things will go well (for the most part) on the Federal Level. But there are Also State Regs/Taxes to contend with.

 

[Rossum]

Seems to me that the FDA would be better served by copying the UK 3.52 pound tax on a pack of cigs and let the cost deter smoking.

The FDA does not have the power to do that.

Then, smokers who are left would turn to ecigs and live longer!

A few might, but I don't think most would. There are already places in the US that have taxes at least that high and many smokers simply find a way to cough up the dough.

 

[DaveP]

The FDA does not have the power to do that.

Yeah, I worded that weakly. The FDA would be better served if Congress told the FDA to stick to food and drugs and just ramped up cigarettes taxes incrementally over a few years and forced cigarettes out of the market.


That won't happen until after the Tobacco Settlement runs out.

 

[Rossum]

Yeah, I worded that weakly. The FDA would be better served if Congress told the FDA to stick to food and drugs and just ramped up cigarettes taxes incrementally over a few years and forced cigarettes out of the market.

That won't happen until after the Tobacco Settlement runs out.

I really don't think it will work. Oh, you might get smoking rates down somewhat more, but you'll never eliminate it. If taxes on a product are really excessive, the market for that product doesn't cease to exist, it just goes informal/underground.

 

[DaveP]

I really don't think it will work. Oh, you might get smoking rates down somewhat more, but you'll never eliminate it. If taxes on a product are really excessive, the market for that product doesn't cease to exist, it just goes informal/underground.

FDA has already hit on the roll your own market. It all gets to a point where meddling just creates more confusion.

I bought two more dual battery mods last week. I wonder how many it will take to ensure my vaping hardware doesn't all die for another couple of decades. My old eGo from 2010 still works, but the battery life is dismal.