Deeming Regulations have been released!!!!

[The Ocelot]

I haven't read what's on this site yet, but it looks interesting:

Freedom from the FDA

 

[teemae]

Okay, no debate. Can you name a few recent films that fit your description? I'd like to look them up and review them.

The Resurrection of Jake the Snake is doing pretty good world wide and started out with only being released on ITunes and Amazon. Is now available on DVD, but wasn't in the beginning

 

[Coldrake]

Well I kinda knew that would be her stance

It was a joke.

Most vendors, even major ones, wouldn't have the cash flow for applications for even one product or eliquid. They may collectively have money toward lawsuits but in 90 days they will have to close shop - not enough time to get too far into a lawsuit, unless there's an injunction to stop closing.

No one has to close shop in 90 days

Now i am really confused. My understanding is if the product you are making now or will be
physically for sale on the market here within 90 of publication of the regs in the Federal Register
you are automatically grandfathered ( a word along with substantially I am beginning to hate)
into the pre-market approval process with the 2 year application time limit. The 90 day
time limit introduces all under age sales restrictions and requires new products introduced
after 90 days to to remain off the market until approved by the FDA as being compliant with
the regulations.(no grace period after 90 days)

No need to be confused, you are correct.

 

[retired1]

I haven't read what's on this site yet, but it looks interesting:

Freedom from the FDA

I'd be more impressed if the individual writing that had a professional medical background. The author has a degree in International Relations. Hardly something I'd be willing to hitch my wagon to.

 

[mightymen]

Teaser Trailer “You Are Being Lied To”
Here’s a sneak peek at the upcoming film!

It will premiere in early 2016 and be in theaters mid-year.
Teaser Trailer “You Are Being Lied To”

A Billion Lives

 

[Kent C]

Now i am really confused. My understanding is if the product you are making now or will be
physically for sale on the market here within 90 of publication of the regs in the Federal Register
you are automatically grandfathered

Just to be clear, while it is true that IF a manufacturer submits an application, that 2 year period (one if there is no sign of progress - as someone else mentioned), isn't really 'grandfathered', but just an allowed period for the application to be approved (or not).

What I was saying is that most vendors/manufacturers won't have the cash for applications. So that 2 year grace period means nothing to them. Only the tobacco companies, IF they decide to submit applications will benefit.

 

[The Ocelot]

I agree - total BS - or a desire to be part of the regulatory process. I suspect many of us will be contributing toward a lawsuit - perhaps brought by pro-vape lawyer Azim Chowdhury.

Keller Heckman | Professionals | Azim Chowdhury

" Mr. Chowdhury has also developed expertise in tobacco and e-vapor product regulation relating to the implementation of the Family Smoking Prevention and Tobacco Control Act, and spearheaded the FDA Tobacco and Electronic Cigarette practice at Keller and Heckman. Specifically, Mr. Chowdhury has experience representing tobacco, e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance."

Q&A: Keller Heckman's Azim Chowdhury on FDA e-cigarette rules
password protected for full access of the link

Don't forget Greg Conley. American Vaping Association | Vaping to Quit Smoking

My name is Gregory Conley. I served as CASAA's volunteer Legislative Director for approximately three years while I was getting my JD / MBA from Rutgers University and clerking for a NJ Superior Court judge. I am now the President of the American Vaping Association, which was formed to get truthful and accurate information about vaping products out to the media. I am also a research fellow with the Heartland Institute, a think tank based in Chicago, where I work exclusively on nicotine and tobacco issues.

 

[mcol]

Bernie, answering a follow-up question, said he does not oppose tobacco taxes. He said that tobacco taxes are different. Also, Hillary's support of Philadelphia's proposed soda tax is worse than at first glance.

People here have pointed out how recently, vaping and tobacco tax proposals have been omitting any reasons other than budget crises for the need for the taxes or tax increases. This reflects a new strategy for pushing sin taxes. The sin taxers feel like there's too much being leveraged against them politically from the nanny state arguments, and they blame that for the legislative failures they encounter.

Philadelphia isn't tying their soda tax request to any public health problems from soda and sugary drinks. Neither did Hillary Clinton make any connection in her support for the tax.

Here's an article discussing the new strategy, by a group who's been posting articles promoting sugar taxes:

Will the Bay Area Get Another Soda Tax in the Fall?



Clinton and Sanders' comments:

Kenney's soda tax gets national attention: Clinton likes it, Sanders hates it



Hillary:

https://www.youtube.com/watch?v=UPf6eFyFuKU

(Link broken, so that Hillary's face doesn't appear on this thread.)

Thanks for the clarification!

 

[Kent C]

Who voted yes to what bill?

Supposing that they meant Hillary and Bernie voted for the Family Smoking Prevention and Tobacco Control Act. Actually Hillary wasn't in the Senate for that vote but Bernie voted for the FSPTCA.

 

[MacTechVpr]

I think you are right, for now. Nicotine, VG, and PG have all been given the status of GRAS by the FDA. Nicotine, up to a strength of 100mg/ml has been an over the counter sale item for many years. So I see no problem with it the way it stands now.

But I also believe this will be one of the FDAs first "further actions" to the deeming regs. And I think they won't wait very long after the first 90 days to move on that. They will certainly replace the GRAS recommendation and replace it with something much more stringent. I wouldn't be surprised to see it changed to a controlled substance.

In the words of Frank Herbert, Dune "He who controls the spice, controls the universe"

Unfortunately, I think you're probably right.

This is a copy and paste from another person at FB.

Quick and dirty notes from the SFATA teleconference:
1) 0mg juice does not count as tobacco, and is basically therefor not affected by these new regs
2) because of #1, the ban on samples and testers will also not apply to 0mg juice. No more free juice giveaways or testers in store unless its 0mg, but 0mg is ok for the time being until the devices are regulated in 2 years
3) online selling of juice seems to be regulated less than face to face sales. This does not affect anyone who makes their own juice or hardware, as you are still held to the standard of a tobacco manufacturer. But for those who simply buy and resell, its ok. This point is unclear and will require more study of the regulations.
4) Clarification has been made that state laws that specifically say that ecigs are not tobacco are superseded by the new regulations. The Federal Government says its tobacco, so it doesn't matter what the states say.
5) clarification that if stores tell customers "you can add nicotine to this 0mg juice", that 0mg juice then becomes a tobacco accessory and falls under the FDA's regulatory power.
6) non tobacco extracted nicotine (such as eggplant nicotine or synthetic nicotine) will most likely not count as tobacco, but SFATA expects that the FDA would respond by saying that nicotine itself is a drug and close the loophole by regulating it as a drug delivery device.
7) SFATA will be releasing a "FDA regs for dummys" document next week, explaining all these shenanigans to those of us who are not lawyers or politicians. Even though the regs state that ecig juice and hardware is classified as tobacco, the states will all have to specifically tax and license retailers for ecig stuff. It is not included automatically.
9) out of country hardware manufacturers are still required to get FDA approval for ecig stuff. Generic items like batteries are exempt since they're not specifically made for ecig use.
10) If you are a straight retailer, who only buys product from other companies to resell, the only things the regs means to you is that you must ID everyone, and cannot alter products, and will most likely have to register as a tobacco retailer in your state. Also there will be no sampling. So you can't let the customer sample the juice before they buy it.
11) Building coils counts as altering a product, which makes it a new product, and since it's a tobacco accessory, building coils makes you a tobacco manufacturer.
12) 90 days starts the law, any products not for sale in the market will require a PMTA
13) No free samples
14) 2 years to file your PMTA, 1 year to get an approval, if no approval is received within the 12 months following you will have to remove your product from the market while you wait for FDA approval
15) Mandatory ID, Child Proof Caps, Warning Labels and Marketing Ban go into effect in 90 days
16) Litigation is HIGHLY unlikely to be successful and SFATA strongly suggests against it.
17) Software upgrades to mods would need a PMTA
18) Verbiage on how we talk about e-cigarettes have to change: no longer healthier, not smokeless, not a way to quit smoking, etc..

This isn't a vaping ban…it's a new religion! Good luck all.

 

[nicnik]

I was playing 6 Degrees of Deeming last night. The software to update my mod was transmitted over a WiFi connection, which I also use for my phone. I phoned in a pizza order last night, which made my pizza a tobacco product.

I have some cotton I bought for making wicks. Shortly after, I bought some organic cotton to use, instead.

It's very complicated to try and figure out how I might be allowed to use that first box of cotton I bought. Is it still a tobacco product, now that its intended use has changed? Once it becomes illegal for me to use for vaping, can I still use it for other things? Can I give it away to someone who doesn't vape, and therefore would have no vaping intended use? If not, I'll recycle the box, but is the cotton condemned to the landfill?

 

[ZeroedIn]

Now i am really confused. My understanding is if the product you are making now or will be
physically for sale on the market here within 90 of publication of the regs in the Federal Register
you are automatically grandfathered ( a word along with substantially I am beginning to hate)
into the pre-market approval process with the 2 year application time limit. The 90 day
time limit introduces all under age sales restrictions and requires new products introduced
after 90 days to to remain off the market until approved by the FDA as being compliant with
the regulations.(no grace period after 90 days)

I haven't read the whole 499 pages yet but,I have seen some quotes posted here
from parts I haven't read that are in direct contradictions of what is stated in parts
that I have read. If i can recall specifics I will point them out here. As i recall after the
proposed deeming regs were released there were more than a few confusing and or
definite contradictory statements. This seems to be the case with the release of the
official release. In hindsight I believe then and now this is a deliberate tactical ploy to
sew confusion in our ranks and split us into different factions fighting for different
things. If it is not a deliberate ploy the only other thing that would account for
this lack of cohesion is it is a deliberate tactical ploy to sew confusion in our ranks
and split us into different opposing factions. If anyone notes these types of contradictions
please point them out here so we can hash them out.

Regards
Mike

I think I see what you did not do there?

 

[skoony]

However, on page 222:

"Also, as stated earlier, nicotine-free e-liquid that is intended or reasonably expected to be used with or for the human consumption of tobacco products in most cases would be a component or part of a tobacco product and, therefore, within the scope of this rule. These products will be evaluated on a case-by-case basis."

At some point the FDA could "reasonably expect" that vapers addicted to nicotine might add nicotine to nicotine-free e-liquid, making it a "covered tobacco product."

Thanks for pointing these out. Although not contradictory the sure would sew seeds of confusion.
In one part the state that juice with out nicotine doesn't far under the scope of the regulations.
the other statement is their go around to get most if not all zero nicotine juice under regulatory
control because the are sole arbitrators of what would be reasonably be expected.

If you are selling nic base and zero nic base one could reasonably assume the customer
would buy both and mix them himself avoiding the regulatory burden other wise imposed
by buying pre-nic'ed base. so you only sell one or the other to a particular customer.
But wait,there's more. What kind of weirdo would buy just nic base? that stuff is unvapeable.
Two customers must be colluding to avoid buying juice and nic thus circumventing the FDA's
ability to regulate and control the market. Well i guess no one can sell nic base because the
only purpose is to avoid regulatory authority even though the nic base is under regulatory
control. Well ok, I'll just sell zero nic base and no nic base sales. I still have all of my pre nic'ed
juices that haven't been taxed to kingdom come and the sales are good enough,imight be ok after
all. Then your first customer walks back in and buys 60 ml of zero nic base and 60 liters
of 24 mg per ml base and he uses a tootle puffer. The FDA guy says,"Hmmmm?)

Remember as per the regs the FDA has reserved the right to change or modify or
add to them as they deem necessary to accomplish their task to put these tobacco products
under their regulatory control.
Regards
Mike

 

[Kent C]

Don't forget Greg Conley. American Vaping Association | Vaping to Quit Smoking

My name is Gregory Conley. I served as CASAA's volunteer Legislative Director for approximately three years while I was getting my JD / MBA from Rutgers University and clerking for a NJ Superior Court judge. I am now the President of the American Vaping Association, which was formed to get truthful and accurate information about vaping products out to the media. I am also a research fellow with the Heartland Institute, a think tank based in Chicago, where I work exclusively on nicotine and tobacco issues.

I haven't forgotten about Greg :- ) perhaps he and Azim will collaborate.

 

[nicnik]

Jes' you wait when dem FDA finds out that some vapers/makers use dihydrogenmonoxide to make their VG less viscous ...

Good point. Intended use. Clearly a tobacco product, now.

 

[ZeroedIn]

Bernie, answering a follow-up question, said he does not oppose tobacco taxes. He said that tobacco taxes are different. Also, Hillary's support of Philadelphia's proposed soda tax is worse than at first glance.

People here have pointed out how recently, vaping and tobacco tax proposals have been omitting any reasons other than budget crises for the need for the taxes or tax increases. This reflects a new strategy for pushing sin taxes. The sin taxers feel like there's too much being leveraged against them politically from the nanny state arguments, and they blame that for the legislative failures they encounter.

Philadelphia isn't tying their soda tax request to any public health problems from soda and sugary drinks. Neither did Hillary Clinton make any connection in her support for the tax.

Here's an article discussing the new strategy, by a group who's been posting articles promoting sugar taxes:

Will the Bay Area Get Another Soda Tax in the Fall?



Clinton and Sanders' comments:

Kenney's soda tax gets national attention: Clinton likes it, Sanders hates it



Hillary:

https://www.youtube.com/watch?v=UPf6eFyFuKU

(Link broken, so that Hillary's face doesn't appear on this thread.)

Maybe it's time to consider filling Boston Harbor with VG?

 

[LoriP1702]

I have some cotton I bought for making wicks. Shortly after, I bought some organic cotton to use, instead.
Can I give it away to someone who doesn't vape, and therefore would have no vaping intended use? If not, I'll recycle the box, but is the cotton condemned to the landfill?

...since we're both in IL, you better check the EPA regulations first, that may no longer be a permissible item.

 

[The Ocelot]

Electronic
Nicotine
Delivery
System

FDA ENDS vaping.

 

[skoony]

Just to be clear, while it is true that IF a manufacturer submits an application, that 2 year period (one if there is no sign of progress - as someone else mentioned), isn't really 'grandfathered', but just an allowed period for the application to be approved (or not).

What I was saying is that most vendors/manufacturers won't have the cash for applications. So that 2 year grace period means nothing to them. Only the tobacco companies, IF they decide to submit applications will benefit.

Thanks for clarifying that. The ones that can't hack got 2 years and out the door.
roger wilco,
mike

 

[The Ocelot]

Hey Randy!

Most vendors, even major ones, wouldn't have the cash flow for applications for even one product or eliquid. They may collectively have money toward lawsuits but in 90 days they will have to close shop - not enough time to get too far into a lawsuit, unless there's an injunction to stop closing.

Don't know about Joyetech USA or Kanger USA. Joyetech and Kanger have many vendors in the US - whether they'll step up to the plate, via vendors (don't think a Chinese company could do anything directly). who knows. I doubt it. While the US is a major market for them, it isn't the only one.

This was posted on another forum:

Shenzhen Mingjietong Technology Co., Ltd.
Guangdong, China

Shenzhen Joyetech Co.,Ltd.
Address: 9th Blvd.Changxing High New Tech. Industry Zone, Shajing Town, Baoan District, ShenZhen China.
Tel: 0086 755 81737161 Fax: 0086 755 81737094

Dear honorable sirs,

The United States Food and Drug Administration has openly declared economic war upon your businesses. They have done this via means of regulations which carry force of law. These new regulations would require any new vaping, electronic product to submit to the authority of the United States Food and Drug Administration for review. The United States Food and Drug Administration will also require approximately 3- 20 million dollars per each new product review prior to any product being approved for sale in United States markets.

This will decimate many smaller vendors of your products. It will also mean you loose [sic] a vast market share in the electronic cigarette and vaping industry. Through your creation of this industry, more employment has been gained by vendors in the United States. Customers in the United States feel very good about your industry, realizing its potential to save lives and have great positive environmental and social impact. The United States Food and Drug Administration has chosen to side to side with the big tobacco industry which only seeks profit as an end game.

We the consumers, the vaping shop vendors, the family members glad of harm reduction offered by your products, seek assistance. We understand that you appreciate the value of business. Also at stake is reputations and honor of being socially responsible. To the end users of your products there is no redress against the United States Food and Drug Administration's actions. The political system in the United States has been eroded by greed, profit replacing human life as the key to happy consumers, a happy planet. Any aid you may offer would be greatly appreciated. It would demonstrate you commitment to the consumers, who no doubt would offer commitment to your products in return.

Thank you kindly sirs,

The Vaping Community of the United States

Note: I still don't understand why that forum only has 3 pages in their deeming thread and most of it is Don't panic, there are people in the background working on this.