How will FDA regs effect new mod products

[jonny w]

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

 

[retired1]

ALL products made since 2007 must go through the process. The significance of the August 8th date is e-cigarettes and associated items (e-liquid, mods, software, chips, atomizers, etc.) will be officially deemed as a tobacco product.

 

[Eskie]

Roughly correct. No new items may be released after 8/8. All products will have to file an application for approval by 8/8/2018 to remain on the market. If they file an application, they may continue to sell for up to one more year, or until the application is approved or denied.

Also, as of 8/8, all products can only be sold to people over the age of 18, certain warnings must be on packaging, and restrictions on advertising kicks in. Oh, and child safety caps as well.

 

[jonny w]

Thank you for your reply. Aren't the current models on the market exempt from the process until 2018? Otherwise they would have to be taken off the market until the testing is done.

Also, a connected question, can you link me to the details of the exact testing process?

Thank you again

 

[retired1]

Current models can stay on the market, but they have to go through the approval process. No approval, no sales after 2018. There's no "exemptions" anywhere.

 

[Eskie]

Also, a connected question, can you link me to the details of the exact testing process?

Thank you again

Here you go https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

It's just a little shy of 500 pages. To save you a bit of effort, after reading all 499 pages, you will still not truly know the exact testing process as it's never exactly stated, only required.

 

[Two_Bears]

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

If the deeming regulations are allowed to stand that means no new mods, juices, attys can come to market without undergoing PMTA MULTI $MILLION SCAM.

If tge deeming regulations are allowed to stand in 3 years or less 99% of all vaping products will be GONE.

A colection of four groups are working together to destroy vaping.

1. The FDA
2. Big Pharma
3. Big tobacco
4. States that are greedy for more taxes.

I have been telling abd screaming for 13 months for people to invest $500 or more and prep before the axe falls.

Now the axe falls tomorrow.

Tomorrow just about everything vaping related will be classified as a tobacco product. This means new rules and taxes are involved, abd even more taxes coming on in the next few months.

Myself and other old timers begged you vapers to...

1. Prep
2. Get involved in advocacy
3. Contact your Senators and representative.

I had hoped tge congress would pass HR2058 OR the Cole Bishop ammendment. They havent yet not that i know of, and TOMORROW IS D DAY. Once a law goes into effect; it almost takes an act of God to get it over turned.

For those of you that didn't prep i'm sorry but you only have three options.

1. Do what ever it takes to break your addiction to nicotine.

2. Buy your vaping supplies off the black market and pay big Bucks doing it.

3. Go back to the stinkies.

 

[jonny w]

Thank you so much. So... we should expect to see NO NEW DEVICES in the near future? What we have is what we have (assuming that the FDA approval process is too expensive and time consuming for most manufacturers)?

 

[retired1]

Depending on the existing court cases, you're correct. Hopefully the courts will spank the FDA into submission and toss the whole thing out. Only time will tell, though.

 

[Rule62]

The side effect of this is, if past history is any indication, the industry has moved so fast in the last few years that a lot of vape gear becomes obsolete in a matter of a few months; sometimes in a matter of weeks. This is especially true with regulated mods. Why would a maker go through the lengthy and expensive application process, to introduce a product that is already obsolete by the time it's approved, if it ever is approved, which is doubtful?

 

[Two_Bears]

Pennsylvania has prooosed a 40% tax on all vaping products,

And some States in tge north east have proposed to tax 2 mls of eJuice the same level of taxation as a full pack of cigarettes. If that level of taxation goes through how would you like to pay $20-50 tax on a 10 ml bottle of ejuice?

These greedy States....

Never have tge backbone to say NO!

Never learn Tax the rich and the Rich PULL up stakes and move to a place with lower taxes.

Excessive taxation leads to lower income off the taxes because high taxation leads to a black market. I saw a report that in New York city 75-80% of the cigarettes were black market cigarettes bought in lower taxes States and Indian reservations.

These greedy States are literally killing the goose that lays golden eggs.

Both JFK and Ronald Reagan prooved lower taxes and watch the revenue go up.

The revolutionary war was started by a 1 or 2 cent tax on tea

Kanesian (SP) doesnt work on free citizens who can pick up and move to a lower tax state or country.

 

[Two_Bears]

Depending on the existing court cases, you're correct. Hopefully the courts will spank the FDA into submission and toss the whole thing out. Only time will tell, though.

From your keyboard to God's ear!

 

[Eskie]

If the deeming regulations are allowed to stand that means no new mods, juices, attys can come to market without undergoing PMTA MULTI $MILLION SCAM.

Oh, and the really good part? You can spend a million on testing and filing an application with absolutely no way of knowing it will approved.

 

[Two_Bears]

Oh, and the really good part? You can spend a million on testing and filing an application with absolutely no way of knowing it will approved.

Thats exactly why i called it a scam.

Another reason i called it a scam is the FDA demanding a PMTA for each and every level of nicotine

0 mg, 3 mg, 6 mg, 12 mg, 18 mg, 24 mg, 30, and 36 mg.

Meaning it could cost $8 million+ just to get 1 Juice aporoved.

It becomes obvious they have NO intention of approving anything. To me it is obvious they want to destroy vaping.

 

[Eskie]

It becomes obvious they have NO intention of approving anything. To me it is obvious they want to destroy vaping.

I might reword that. They likely have no intention of approving any open system for vaping as we currently know it. They will likely end up approving closed system cigalikes from BT. Of course that's just speculation on my part, but more than one analyst has referred to these rules as a gift to BT, so there's that.

 

[Two_Bears]

Thank you so much. So... we should expect to see NO NEW DEVICES in the near future? What we have is what we have (assuming that the FDA approval process is too expensive and time consuming for most manufacturers)?

That is correct unless....

1. HR2058 is passed.
2. The Cole Bishop ammendment passes
3. One of the court Cases slaps down this overeach.
4. All vapers unite and deluge all 535 members of congress (100 Senators 435 representatives), and the president.

Tomorrow is D DAY.

 

[Two_Bears]

I might reword that. They likely have no intention of approving any open system for vaping as we currently know it. They will likely end up approving closed system cigalikes from BT. Of course that's just speculation on my part, but more than one analyst has referred to these rules as a gift to BT, so there's that.

The FDA aporoved 1 device ib the last few years and it was by big tobbaco with deep pockets.

I still say it is best to deluge Congress with letters and make them do the right thing.

 

[Str8vision]

Products that were on the market prior to 2007 are grandfathered in, problem is nothing usable or relevant was on the market back then. Products that hit the market between 2007 and August 8th 2016 (tomorrow) can remain on the market until late 2018 but manufacturers are required to make "good faith" efforts to file applications for approval with the FDA within that timeframe or withdraw their products. If/after manufacturers file an application their product may remain on the market another year while the FDA ponders approval. After tomorrow (Aug 8th) no "new" product may be offered without -first- being approved by the FDA, a process the FDA estimates can take over a year to complete. Problem is the FDA itself doesn't yet know what criteria must be met to gain approval so manufacturers are completely in the dark. According to the FDA each application will cost -well- over $300k and take around a year to process so don't any "new" products in 2017, the industry will be static.

Since the FDA itself hasn't a clue what kind of data, criteria, reports, tests or scientific evaluations will be required to gain approval there are only two types of people willing to risk millions of dollars -blindly- seeking it. First will be politically connected large corporations (think BT, BP) who regularly lobby ($$$$) members of congress "buying" political influence, they'll be guaranteed access to the FDA's fast lane and receive "special" treatment. The second type of person willing to seek FDA approval -without knowing what is actually required to gain it- are optimistic fools who manage to beg or borrow enough cash to blindly submit an application. A phrase that originated back in the 1500's comes to mind; "A fool and his money are soon parted". Since not many "successful" business owners are fools I suspect they'll wait (however long it takes) until the FDA submits detailed guidance and a list of requirements before attempting to file and even then it could take a year before they are granted approval. In a nutshell it may be 1 1/2 years before we see any viable "new" products on the market with the possible exception of those offered by BT or other large politically connected corporate entities.

 

[Robino1]

The only thing, tobacco wise, that the FDA has approved in the last few years are different types of Snus. That was just recently. Other than that, the FDA has approved 0 (zero) devices.

The FDA has said that there is 1 (one) product they have found the predates the 2007 date and they have not released any information on what that product is.

All of this is new territory for both the FDA and us. The FDA have not been able to answer any questions that we have asked outright.

 

[WharfRat1976]

The side effect of this is, if past history is any indication, the industry has moved so fast in the last few years that a lot of vape gear becomes obsolete in a matter of a few months; sometimes in a matter of weeks. This is especially true with regulated mods. Why would a maker go through the lengthy and expensive application process, to introduce a product that is already obsolete by the time it's approved, if it ever is approved, which is doubtful?

(Sarcasm button on)Did you actually attempt to inject reason in a discussion of the FDA and our Federal Government?
Tsk, Tsk.