# USA FDA Deeming Regs published.



## method1 (5/5/16)

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

From what I've seen so far:

No moving of grandfather date.
E-Liquid manufacturers will be considered tobacco product manufacturers.
0mg products will exempt from some regulation.
Product samples will not be allowed.
3 Year period for implementing compliance.

Reactions: Thanks 3


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## NewOobY (5/5/16)

horry sheet, sounds hectic. However it could of been worse I guess. Thanks for the update bro. I don't know I don't really understand this though. Hopefully more insightful peeps will comment here.


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## Imperator (5/5/16)

Looks pretty bad, actually. 

Comment 287: "Some comments indicated that FDA equates the time and financial burden of preparing a PMTA with an SE application, but the PMTA requirements are significantly more burdensome than SE requirements, and it is completely unreasonable to allocate the same amount of man-hours needed to successfully complete a PMTA and an SE application. (Response) The Agency has revised the estimated burden per PMTA response to an average of 1,500 hours to complete a PMTA. In reaching this average, FDA considered efficiencies achieved through manufacturer experience, application overlap, economies of scale, incorporation of evidence by reference, and other means including availability of the SE FAQ"

Greg Conley, someone who is currently interpreting the legislation, estimates it will cost around $1 million per product to prepare a premarket tobacco application. 

Also, looks like you can't sell individual components for devices (batteries, atomizers etc.) 

Compliance costs will kill the industry within two years.

Reactions: Agree 1


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## rogue zombie (5/5/16)

From the Washington Post:

The Obama administration on Thursday announced controversial new rules for electronic cigarettes, cigars, hookahs and pipe tobacco, including barring the sales of the products to teens under 18 years old.

The new requirements, which go into effect in 90 days, mark the first time the Food and Drug Administration has regulated any of the items.

The rules compel retailers to verify the age of purchasers by photo identification and bar sales of the products in vending machines that are accessible to minors. They also ban the distribution of free samples.

In addition, the FDA is generally requiring manufacturers whose products went on sale after Feb. 15, 2007, to get approval from the agency to continue selling their products. These product reviews will allow the FDA to scrutinize ingredients, product design and health risks, the agency said. It added that it will allow the companies to keep selling their products for two years while they submit their applications and then for an additional year while the FDA reviews the submissions.

The requirements, which have been the focus of intense lobbying from the industry on one side and tobacco-control advocates on the other, are likely to only intensify the debate over whether the devices are a dangerous gateway to traditional tar-laden, chemical-filled cigarettes or a helpful smoking-cessation tool.

"As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap," said Sylvia Mathews Burwell, secretary of health and human services, in announcing the new rules. "All of this is creating a new generation of Americans who are at risk of addiction."

She said the new regulations were an "important step in the fight for a tobacco-free generation — it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions."


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## Stevape;) (5/5/16)

They just mentioned this on 5 fm


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## Alex (5/5/16)

Yup, all that's left now is the black market.

Reactions: Like 1 | Agree 1


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## Cruzz_33 (5/5/16)

In your opinions what does this mean for us in South Africa ? Will we follow US legislation or will we be going the way of the UK

Reactions: Optimistic 1


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## Neal (5/5/16)

Hey @Alex, as a man who keeps his finger on the pulse of these matters what is your take on all of this? Every time we seem to get some good news (Sky TV last week) we inevitably receive bad news shortly after. Do these people really want us all to go back to smoking cigarettes?


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## Alex (5/5/16)

Neal said:


> Hey @Alex, as a man who keeps his finger on the pulse of these matters what is your take on all of this? Every time we seem to get some good news (Sky TV last week) we inevitably receive bad news shortly after. Do these people really want us all to go back to smoking cigarettes?



Hi Neal, 

In my opinion, it's all about money and politics in the USA as far as ecigs are concerned. Regardless of the science that comes out in support of vaping, the money hungry scabs will always have the upper hand.

I'm really gutted right now, as I hoped that given recent events the grandfathered date of 2007 would at least be changed to something reasonable. But the fact remains that once the time limits set by the fda are up, every one of us are going to be screwed.

So sad


Sent from iPhone


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## BumbleBee (5/5/16)

Yip, SA will naturally follow USA like a wet lost puppy after some table scraps. The USA controls the world, so if some fat overpaid greedy bastard wants more money then we'll just die of cancer, no big deal.

Reactions: Agree 2


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## Imperator (5/5/16)

Cruzz_33 said:


> In your opinions what does this mean for us in South Africa ? Will we follow US legislation or will we be going the way of the UK



I don't think we will follow the US on this one. Our law, with a bunch of exceptions, is mainly derived from UK and EU laws. From what I can tell, e-cigs wouldn't be regulated under the Tobacco Products Control Act but rather under pharmaceutical regulations. The difference would be considerate (I think)

Reactions: Like 2 | Agree 1 | Thanks 1


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## Neal (5/5/16)

Alex said:


> Hi Neal,
> 
> In my opinion, it's all about money and politics in the USA as far as ecigs are concerned. Regardless of the science that comes out in support of vaping, the money hungry scabs will always have the upper hand.
> 
> ...


Thanks for your response mate, would normally post a like but given the subject did not think that would be fitting. I agree with your summary but still live in hope that the recent positive findings from UK may have some weight in any future legislation on our side of the world.

Reactions: Agree 1


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## andro (5/5/16)

lets say it pass as law.....whats gonna happen to people that already own mod etc that are not complaint with it? like walking around with a rolo and a griffin tank for example?


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## rogue zombie (5/5/16)

Here's a pretty good summary on what this all means http://www.vaporvanity.com/just-happened-fda-releases-vape-regulations/ 

Sorry I'm on a iPad so it's pretty difficult to copy and paste the whole article

Reactions: Thanks 1


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## Ezekiel (5/5/16)

Interestingly, tobacco products are generally considerably less regulated in SA than in either the US or the EU. We can still publicly display cigarettes in shops (even though we cannot advertise), we can have cigarette vending machines, we don't require graphic pictures on cigarette boxes, etc.... so maybe we won't start bottling ejuice in 10 ml bottles here for quite a while.

Reactions: Like 2


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## DaveH (5/5/16)

BumbleBee said:


> Yip, SA will naturally follow USA like a wet lost puppy after some table scraps.


Nope that will not happen, we do not have a political system that legally allows for bribery and corruption. Not sure what I am talking about .......... "lobbying" a term used to buy votes - part of the shameful politics of America.
Dave


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## YeOldeOke (6/5/16)

This is serious. Taken in conjunction with the EU regs it sounds the death knell for the industry as we know it and hands it to big tobacco on a silver platter.

So that is where your money is going to in future, big tobacco and governments in the form of excessive taxation, whether you keep on vaping or go back to cigs. Unless the black market explodes as in the prohibition years in the US. Time to start thinking along those lines, feck the corrupt governments and the greedy tobacco death merchants.

If the US sneezes the rest of the world catches a cold. If anyone thinks this won't propagate to SA they're sadly mistaken.

Reactions: Like 1 | Agree 2


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## YeOldeOke (6/5/16)

So who's up for becoming SA's Al Capone of vaping?

Reactions: Funny 1


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## Hardtail1969 (6/5/16)

From my days at law school...

South Africa, can and does, use international precedent to formulate legislation locally.

These precedents can be in many forms, one local example is e-tolls.

Further, one must bear in mind the anti-smoking lobby, who view vaping "as smoking". The fact that the people in this lobby are uneducated about vaping, and harbour outdated, outmoded and illogical ideas is a matter of concern.

Then, the tobacco companies, remember, the decline in sales for the traditional tobacco products, and the uptick in sales of vaping gear, will incentivize them, wrongly as always, to pursue methods designed to make vaping as similar to their products, or as can be seen in the "popcorn lung" scare, as more deadly than their products.

While we can debate this ad nauseam, one must always remember, that the only way to gain acceptance by the public of vaping, lies almost 99% in the hands, behaviour, attitude of each and every vaper in this world.

Our actions, when vaping, will always be the reason we are either applauded or vilified.

Reactions: Like 5 | Agree 2


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## Hardtail1969 (6/5/16)

YeOldeOke said:


> This is serious. Taken in conjunction with the EU regs it sounds the death knell for the industry as we know it and hands it to big tobacco on a silver platter.
> 
> So that is where your money is going to in future, big tobacco and governments in the form of excessive taxation, whether you keep on vaping or go back to cigs. Unless the black market explodes as in the prohibition years in the US. Time to start thinking along those lines, feck the corrupt governments and the greedy tobacco death merchants.
> 
> If the US sneezes the rest of the world catches a cold. If anyone thinks this won't propagate to SA they're sadly mistaken.



It is a sad state of affairs, however, one thing does spring to mind, and that is that this world of ours, is under revolutionary zeitgeist, which means that due to platforms like this, remember arab spring, i for one, do not see vaping as dying out for us, because we will always be able to sidestep, or circumvent legislation that is indeed morally wrong.

Again, take e-tolls for example.

Reactions: Like 1 | Agree 1


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## Stosta (6/5/16)

I'm not trolling here, and I understand that this legislation is about to put costs through the roof. But I did find it strange that I could buy a device that could take off my hand, fill it with liquid made of god knows what at god knows where, and then suck it up into my lungs. Only when I realised that it was a relatively new industry did I understand how this could happen.

Do I like seeing them label Ecigs as Tobacco products and whack them with legislation accordingly? No.

Should the production of Ecigs and and Eliquids be controlled and forced to conform to a set of standards. Yes.

Keep in mind though, I'm that asshole that will sit on my deck and watch the world burn, and complain about the fact that it's too hot and no-one is doing anything about it.

Reactions: Like 1


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## YeOldeOke (6/5/16)

Hardtail1969 said:


> While we can debate this ad nauseam, one must always remember, that the only way to gain acceptance by the public of vaping, lies almost 99% in the hands, behaviour, attitude of each and every vaper in this world.
> 
> Our actions, when vaping, will always be the reason we are either applauded or vilified.



I've disagreed with this sentiment before and I still disagree.

The public perception count for naught in the implementation of laws/regs where big bucks are involved. Only the bucks count. The idea that the public holds any sway in this is naive.

What we do as vapers has no impact whatsoever on the regulatory process. Hell, even health has no impact on it. Only money.

Reactions: Agree 1 | Winner 1


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## Stosta (6/5/16)

YeOldeOke said:


> So who's up for becoming SA's Al Capone of vaping?


@Zeki Hilmi is a bit of a wild child, sure he would be game. Can actually picture him forming a posse with @Gizmo and @Paulie , and they run around running numbers.


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## Hardtail1969 (6/5/16)

YeOldeOke said:


> I've disagreed with this sentiment before and I still disagree.
> 
> The public perception count for naught in the implementation of laws/regs where big bucks are involved. Only the bucks count. The idea that the public holds any sway in this is naive.


If that is how u see the public, please explain etolls to me? And how wonderfully solvent sanral is, and just how amazing the public uptake of their services have been.

Never ever discount what a group of people can accomplish when united in pursuit of a common goal.

Sent from my D6503 using Tapatalk

Reactions: Winner 1


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## YeOldeOke (6/5/16)

Stosta said:


> I'm not trolling here, and I understand that this legislation is about to put costs through the roof. But I did find it strange that I could buy a device that could take off my hand, fill it with liquid made of god knows what at god knows where, and then suck it up into my lungs. Only when I realised that it was a relatively new industry did I understand how this could happen.
> 
> Do I like seeing them label Ecigs as Tobacco products and whack them with legislation accordingly? No.
> 
> Should the production of Ecigs and and Eliquids be controlled and forced to conform to a set of standards. Yes.



Your cellphone battery could take off your hand, and ear. It uses the same technology.

It is not about regulation. Have you seen the FDA regulation. It is a de facto ban on any but the largest corporations producing vaping gear and juice.

Reactions: Agree 2


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## Stosta (6/5/16)

YeOldeOke said:


> Your cellphone battery could take off your hand, and ear. It uses the same technology.
> 
> It is not about regulation. Have you seen the FDA regulation. It is a de facto ban on any but the largest corporations producing vaping gear and juice.


Don't get me wrong, I'm not happy about _this_ piece of regulation, I'm just saying the industry could have been helped by it IF it had been done right, which it hasn't.


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## YeOldeOke (6/5/16)

Hardtail1969 said:


> If that is how u see the public, please explain etolls to me? And how wonderfully solvent sanral is, and just how amazing the public uptake of their services have been.
> 
> Never ever discount what a group of people can accomplish when united in pursuit of a common goal.
> 
> Sent from my D6503 using Tapatalk



The public can buck regulations. A la Al Capone. But what the public thinks is irrelevant to the implementation of strict regulation and taxation. What happens after that is moot.

My statement was that what the public thinks of vaping and vapers have no impact on laws. Money drives that.

Reactions: Agree 1


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## YeOldeOke (6/5/16)

Stosta said:


> Don't get me wrong, I'm not happy about _this_ piece of regulation, I'm just saying the industry could have been helped by it IF it had been done right, which it hasn't.



This is about Big Tabacco and governments losing great amounts of money. Everything else is but a smokescreen. Tepid regulation would never have satisfied these two players.

Reactions: Agree 1


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## JakesSA (6/5/16)

Let's hope the USA opposition takes this up as an electioneering point ..

Keep in mind these regulations are pertinent to products sold in three years time. Whatever is purchased in between is not affected e.g. it does not give anyone the right to take anything away from you purchased before the 'go-live' date.

The short term impact is that this will likely cause a feeding frenzy on vape related items in the land of the freely corrupt and not so brave. A massive uptake in demand normally leads to fast escalating prices but luckily we have no real need to import e-liquids since the local e-liquid quality now equals and often surpasses the best the international market has to offer.

On the hardware front the Chinese, unlike their western counterparts, understand the reality of the "people ARE the economy" principle and do not generally believe in limiting supply to escalate prices and increase margin but will rather ramp up production to meet demand. This, in turn, will keep prices steady and, very likely, will even drive pricing down.

In the longer term, to take a somewhat positive outlook, e-liquids will be tested based on the ingredients and in short order a good selection of flavourings etc. will be 'FDA' approved and, in time, remove a large burden for future entrants into the market.

The vape giants like KangerTech and the Joyetech conglomerate should easily be able to conform but it will probably lead to less frequent product releases e.g. swop a bit of R&D budget for FDA approval budget. Again these products are the sum of parts and it is rather likely that quite a few vaping electronics manufacturers will also set about having their components 'FDA approved' providing a base of approved parts for use in future developments. That is IF they face fair scrutiny in the process ... one wonders however if 'parties unrelated' will have undue influence in this process as well...

Do not underestimate the buying power of the vaping market, nor the explosion in size this legislation will cause in the near future. As such we can certainly rely on good old capitalist greed to ensure that many more than just the tobacco companies will bet a few dollars on the future of vaping...

Reactions: Like 6 | Agree 2 | Winner 1


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## rogue zombie (6/5/16)

Petition to Whitehouse to overturn the FDA's ruling on Ecigs being classified as tobacco products https://petitions.whitehouse.gov/pe...ing-ecigarette-classification-tobacco-product

Reactions: Winner 2 | Thanks 1


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## Andre (6/5/16)

rogue zombie said:


> Petition to Whitehouse to overturn the FDA's ruling on Ecigs being classified as tobacco products https://petitions.whitehouse.gov/pe...ing-ecigarette-classification-tobacco-product


Thanks. Done, verified and counted!

Reactions: Like 1 | Agree 1


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## Alex (6/5/16)

Andre said:


> Thanks. Done, verified and counted!


Same here.

Reactions: Like 1


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## Stevape;) (6/5/16)

Done

Reactions: Like 1


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## Yagya (6/5/16)

done!!

Reactions: Like 1


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## rogue zombie (6/5/16)

From what I gather, the 90 Day thing is a little deceptive.
As I understand, the industry folk cannot introduce NEW products after 90 days, but it the Grandfather date of 2007 will come into effect 2yrs after. So manufacturers will need to 'certify' their products within that period of two years.

So... nothing major will happen overnight. I think.


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## Neal (6/5/16)

Done


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## Cobrali (7/5/16)

Done


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## SAVaper (7/5/16)

Done
Also published the link on my facebook.

Reactions: Like 1


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## stevie g (7/5/16)

Apparently legal challenges will be brought forth towards the regulation which will push back the implementation date by a couple of years.

Reactions: Like 1


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## BubiSparks (7/5/16)

Done!!!


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## Lord Vetinari (7/5/16)

Alex said:


> Yup, all that's left now is the black market.


Nope. All thats left is to quit. Going to be my route. I was in this to stop cigarettes. I miss them. I will miss vaping too. Buf not going to complicate my life just to vape.

I know whats going on. It js about tax money. Well I am taxed enough already I need to rebel on this one.

Ultimate revenge on the regulators. Stop vaping. Sucks but how I will roll.


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## Lord Vetinari (7/5/16)

Hardtail1969 said:


> If that is how u see the public, please explain etolls to me? And how wonderfully solvent sanral is, and just how amazing the public uptake of their services have been.
> 
> Never ever discount what a group of people can accomplish when united in pursuit of a common goal.
> 
> Sent from my D6503 using Tapatalk


World War 2 was started by a single angry man. A small group can do even more. You never know. While there is still a chance I am goinf to be a walking ecigs advertisement.


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## BumbleBee (7/5/16)

rogue zombie said:


> Petition to Whitehouse to overturn the FDA's ruling on Ecigs being classified as tobacco products https://petitions.whitehouse.gov/pe...ing-ecigarette-classification-tobacco-product


Signed and Verified (for what it's worth)

https://wh.gov/iodIQ

Reactions: Like 1


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## Clouder (16/5/16)

Guys, we do not fall under the FDA regulations, So am I right in saying, that our local jooses does not need to meet all the requirements except those being exported?


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## JakesSA (16/5/16)

Correct.


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