Deeming Regulations have been released!!!!

[drum747]

Yourstruli, There is obviously a lot of passion on our side and frankly, anger. It may not be helping but people are venting and with every tweet there is the opportunity to expose people to the issue and hopefully further our cause.

Here is the link directly to the comments for people who want to see them:

fda tobacco - Twitter Search

Check out Dimitris "Come get this White Lotus" tweet,...

 

[Lessifer]

Same reason I refuse to Shut up!
To many chances for a young person to do something miraculous......given the opportunity. Healthier, extended life is an opportunity.

*Note: Reading the original deeming Act, it seems FDA is combining 901 and 911 in their reasoning for approval. However 911 is MRTP.

from MRTP:
FDA can issue an order authorizing the marketing of a product only if the evidence submitted in the application meets the requirements of Section 911, including, among other things, showing that the product will or is expected to benefit the health of the population as a whole.

Question - Who is the Referred to - Secretary - in many of these Rules?

Nothing in this subparagraph shall be construed to limit the Secretary's authority to take action under this section or other sections of this Act

Secretary of Health and Human Services I believe. Currently Sylvia Burwell.

 

[leftyandsparky]

Thanks SG...

@leftyandsparky

When I bought bulk nic 5L from Decadent Vapours back in 2013, I consulted with Kurt and ended up with these from amazon: (now out of stock)

16oz/500ml
http://www.amazon.com/Kimble-Soda-L...&redirect=true&ref_=oh_aui_detailpage_o01_s00

32oz/1L
Kimble Type III Soda-Lime Glass Narrow Mouth Bottle with Solid PE Cap, Amber: Amazon.com: Industrial & Scientific

At the time Kurt recommended the PE caps and 'No Rubber'. :- )

Each time I access the nic from DV - who at the time had the highest quality nic (now others have joined in)... still as clear as the day I put them in the freezer.

Thanks! I'm hold off on bottles, I was mainly worried about nic. And got that ordered this morning!

 

[MyMagicMist]

Yes, 72ml of 100mg concentrate will make 4 liters of 1.8mg final juice. At 1.8mg it goes a long way

Yes, I can see this doing a quick estimation. I could do ~14 batches of 4 L to sum 56 L.

 1 Batch = 4L/1G

1000 ml / 72ml = 13.88 ~ 14 Batches

I vape 2ml a day. 2 ml * 365 days = 730 ml per year

56,000 ml / 730 ml = 76.71  ~ 77 years

If my algebra is correct here too, holy fat cows wearing skates on ice!

 

[Lessifer]

It doesn't matter what we think. I could make the logical argument that it's not yet a 'finished' tobacco product, but who knows what the FDA thinks of it? They're certainly not talking as far as I know, unless it's to say "If they contain nicotine derived from tobacco, ecigs meet the definition of a 'tobacco product' and are regulated accordingly." =or= "Ecig regulations aren’t a ban; they allow manufacturers to apply to have ecigs brought to, or stay on, the market."

Well, this is what the deeming regs have to say about it:

"In this context, a finished
tobacco product refers to a tobacco product, including all components and parts, sealed in final
packaging intended for consumer use (e.g., filters or filter tubes sold separately to consumers or
as part of kits). For example, an e-liquid sealed in final packaging that is to be sold or distributed
to a consumer for use in a finished tobacco product will be subject to enforcement if it is on the
market without authorization. In contrast, an e-liquid that is sold or distributed for further
83
manufacturing into a finished ENDS product is not itself a finished tobacco product. At this
time, FDA does not intend to enforce the premarket authorization requirements against such eliquids
or other components and parts of newly deemed products that are sold or distributed
solely for further manufacturing without a marketing order."

I don't believe DIY strictly for personal use constitutes manufacturing, so I'm fairly certain that bulk nicotine would be considered just another e-liquid, and if its sold to a consumer, it's subject to market authorization. That's just my interpretation though.

 

[MyMagicMist]

I'm so glad I lived at least the beginning of my life before the term Political Correctness was invented. That IMHO is the root of all our evils. That was when 1984 started to become reality and it is chilling to consider how close that moment was to 1984....

Oh it's all double plus good and in your better interest for sure.

 

[Lessifer]

I've got, hopefully, another half century ahead of me and no plans to leave the country. So, to all you old goats fighting for the other guy, THANK YOU!

 

[VNeil]

Well, this is what the deeming regs have to say about it:

"In this context, a finished
tobacco product refers to a tobacco product, including all components and parts, sealed in final
packaging intended for consumer use (e.g., filters or filter tubes sold separately to consumers or
as part of kits). For example, an e-liquid sealed in final packaging that is to be sold or distributed
to a consumer for use in a finished tobacco product will be subject to enforcement if it is on the
market without authorization. In contrast, an e-liquid that is sold or distributed for further
83
manufacturing into a finished ENDS product is not itself a finished tobacco product. At this
time, FDA does not intend to enforce the premarket authorization requirements against such eliquids
or other components and parts of newly deemed products that are sold or distributed
solely for further manufacturing without a marketing order."

I don't believe DIY strictly for personal use constitutes manufacturing, so I'm fairly certain that bulk nicotine would be considered just another e-liquid, and if its sold to a consumer, it's subject to market authorization. That's just my interpretation though.

My considered opinion:. Stock up on nic sooner than later

 

[Bronze]

I've got, hopefully, another half century ahead of me and no plans to leave the country. So, to all you old goats fighting for the other guy, THANK YOU!

Us old goats saw this country when it was a hell of a lot better than what it is now. Sadly, it is our generation who is killing it. It's the "Me" generation now. Ask not what you can do for your country, but what can your country do for you".

 

[Steamix]

I like how these regulators and lawmakers put "Family" in front of all their proposals. It's designed to make the idiot public think they actually care about families (whether their proposal has anything to do with families or not). And trust me, there are a lot of idiots in the general public who can and will be hoodwinked by such titles.

Remember the "Affordable Care Act"? It's anything BUT affordable. We Americans are suckers for marketing ploys.

Family - la familia - Mafia - organized crime

If fits alright - they do care about 'family'. Theirs. Not yours.

 

[drum747]

I don't know if this was ever posted but its worth a look:
It’s Just the Science – Royal College of Physicians’ John Britton Talks e-Cigarette Benefits & Regulation (RegWatch Exclusive)

 

[zoiDman]

I don't know if this was ever posted but its worth a look:
It’s Just the Science – Royal College of Physicians’ John Britton Talks e-Cigarette Benefits & Regulation (RegWatch Exclusive)

Great Link drum747 !

 

[Kent C]

Okay, Next Question:

Will the 2016 Update Deeming include and effect All Producers of Nicotine?(Manufacturers/refiners)

i.e. are they now Required to register as Tobacco Manufacturers?
Are they now subject to PMTA policy?

I think it gets down to the 'catch all' phrase: "if it is intended or reasonably expected to be used with or for the human consumption". And that would entail to whom the nic producer was selling. Not just directly to the consumer but to any wholesaler that would sell to a business that sold to the consumer.

 

[bigdancehawk]

Where is the Portal for Positive Comments?
Could we Flood the Problems reporting system with positives?

Vaping Saved my Life

"Electronic cigarettes have caused big problems for me. First off, I had planned my retirement based on the assumption that smoking cigarettes would result in my premature demise. However, I was able to stop smoking with e-cigarettes and my lifespan has probably been extended to the point that my retirement fund will not be sufficient to cover my basic living expenses in my final years on Earth.
"Secondly, I find that I have a great deal more energy and endurance than when I smoked. This had led me to want to travel more, go out to dinner more (especially now that I can taste food so much better), engage in physical exercise, and so forth. So, I have had to join a fitness club and have several more vacations planned. All of these activities cost significant sums money and, again, are eating into my retirement fund.
"Third, non-smokers seem seem more inclined to be around me now that my breath and clothing don't smell like an ashtray. This has led to a variety of social activities, parties and such. But people expect me to reciprocate, and so I find myself throwing parties from time to time and those can get quite expensive.
"I am reporting these problems to you because I had hoped you would have taken a more stringent approach to e-cigarette regulation than the current deeming regulation. It will only result in the elimination of 99.9% of existing products. Although it will result in the elimination of all the products I currently use, there might still be a few available, so I worry about the economic impact on current smokers switching over to e-cigarettes who, just as I have, will have difficulty providing adequate funds to cover their retirement.
"I can only hope that the few remaining products will be similar to BT's current cig-alike offerings, and will thus be so unappealing and unsatisfying that very few smokers will find them effective as cessation devices."

 

[bigdancehawk]

It

I simply don't understand how it could NOT require a PMTA when sold directly to consumers. Some people have talked about its "other" uses but I have not been able to find nicotine suspended in PG or VG for sale for any other use, and when it is sold from a site that also sells other vaping supplies, or even just flavorings, the intent is clear.

It's hard to "like" this, but I did so anyway because it's accurate.

 

[mikepetro]

That's the Only Reason I'm Fighting all this. For that Poor Smuck out there somewhere, that I would like to see have the Same Chance of Quitting Smoking that I Did.

Agreed, wholeheartedly.

I am all set, I wont need to worry. Its those poor souls that have yet hit bottom with the stoggies, and become willing to give vaping a shot. They may not have the same chance at kicking the addiction that we got!

 

[crxess]

United States Secretary of Health and Human Services would be my guess. DHHS.

Ahh..........Protection of Collusion

Yourstruli, There is obviously a lot of passion on our side and frankly, anger. It may not be helping but people are venting and with every tweet there is the opportunity to expose people to the issue and hopefully further our cause.

Here is the link directly to the comments for people who want to see them:

fda tobacco - Twitter Search

Check out Dimitris "Come get this White Lotus" tweet,...

Truli may(or not) be miffed at some of my post. I try to be clear, but 2 lines isn't much room for expression.

In contrast, an e-liquid that is sold or distributed for further
83
manufacturing into a finished ENDS product is not itself a finished tobacco product. At this
time, FDA does not intend to enforce the premarket authorization requirements against such eliquids

As to Nicotine:
So at 100mg/ml - Sales are likely safe
At 24mg/ml, 50/50 mi<<<<<<<May be considered finished product>>> Vapeable

 

[zoiDman]

Agreed, wholeheartedly.

I am all set, I wont need to worry. Its those poor souls that have yet hit bottom with the stoggies, and become willing to give vaping a shot. They may not have the same chance at kicking the addiction that we got!

I think that is a Great Way to put it.

Because for Many, like myself, nothing I tried worked when I wanted to Quit. (Except Chantix. Wasn't going to go there after seeing someone want to jump out of a Window).

 

[Lessifer]

As to Nicotine:
So at 100mg/ml - Sales are likely safe
At 24mg/ml, 50/50 mi<<<<<<<May be considered finished product>>> Vapeable

Why do you think 100mg/ml is safe? Because it isn't directly vapeable? I'm not sure that matters. RYO tobacco can't be smoked without the use of something else, either a pipe or papers/tube. If it's being sold directly to a consumer, I believe it is considered a "finished" product.

The distinction is so that a company that makes the liquid for vuse doesn't have to submit a PMTA because vuse will.

 

[crxess]

Why do you think 100mg/ml is safe? Because it isn't directly vapeable? I'm not sure that matters. RYO tobacco can't be smoked without the use of something else, either a pipe or papers/tube. If it's being sold directly to a consumer, I believe it is considered a "finished" product.

The distinction is so that a company that makes the liquid for vuse doesn't have to submit a PMTA because vuse will.

While I did RYO for almost 2 years, and felt it was much less polluted than BT Products, I don't remember ever seeing RYO on any of my tobacco packaging. Also this was a Whole Leaf Product.

I'm just thinking 100mg/ml is not intended for direct use and therefor not a finished product.