Deeming Regulations have been released!!!!

[crxess]

EDIT: If HR 2058 passes then my post above is null and void.

Sadly, I believe this is the only Congressional route that would protect e-liquid manufacturers.
I Believe the Cole-bishop bill would have little or no effect on protecting e-liquid manufacturing. However it is a Mass Casualty Triage before Legal Treatment of the critical injury to our Industry and the Customers it supports.

 

[DC2]

I wish. I'll try throughout the day. The feeder is just a foot on the other side of the kitchen window so I should have a decent chance. Whether I can get that same hummingbird again is another question. There are a mess of different ones and they're always fighting.

Our birdbath is a very popular local attraction.
We've seen some amazing things watching what goes on out there.

 

[Bob Chill]

I find myself in the unfortunate position of being more pessimistic than others here...

I am not sure ANYONE can realistically get a PMTA through the process as it currently stands.
Therefore, I think that a few will be granted by special favor.

It will be fun to watch the tortured language and justifications the FDA uses...
For granting those few, while not granting others.
Assuming, of course, there are any others.

Also, it sounds like Zeller is saying that once you get something through...
It may be easier to get others through by Substantial Equivalence or special exemptions...

I don't see more than a handful of eliquids being available.
And most certainly in the end there will only be "tobacco" flavors, whatever that means.

And none of them will be in a bottle.


EDIT: By the way, I'm starting to wonder if posts should be qualified going forward?
EDIT: Is the underlying assumption of a given post in an HR 2058 world, or deeming as is?
EDIT: My post above was with the underlying assumption of deeming as is.
EDIT: If HR 2058 passes then my post above is null and void.

I tend to agree with you. We are looking at a preset time line of short/med/long term changes. The short term (august 8th) is coming quickly. Our only chance at things not changing quickly for the worse at both the national and state level is an injunction. It will require uncovering a legal or serious technical snafu in the reg language that none of us really understand enough about to make definitive statements. Do I believe one exists? I would say yes. Do I think it will come to light before 8/8? Not really.

Then we have the 2 year window. It's going to be a cage match. I do believe there is opportunity to get some modifications or concessions. There is also potential for e-cigs to be required to be classified separately from tobacco products that actually contain organic leaf matter. We really need that to happen or we're never winning anything meaningful.

The thing that stinks during the 2 year window is that indiv States are going to have a field day. It won't be pretty. It won't happen immediately after Aug 8th but it's going to happen faster than any of us want. Even if the GF date changes, it's almost a given that the States will be formidable opposition. WV could become vape nirvana though. Lol

 

[Lessifer]

None. And furthermore I'm not sure it's even possible...
Premarket Tobacco Applications

You know, I tried to find actual manufacturing standards for tobacco products, and I can't. I believe they are out there, and they include things like every cigarette has to be within a very small range as far as nicotine content for that brand, etc.

I keep finding links to statements that say that the FDA now has the authority to regulate the manufacturing standards, but nothing with the actual standards. I still think there are many shops that believe that if HR 2058 passes, they'll still be able to mix in their shops, to order, or at all, and I just don't think that is the case.

 

[Bob Chill]

You know, I tried to find actual manufacturing standards for tobacco products, and I can't. I believe they are out there, and they include things like every cigarette has to be within a very small range as far as nicotine content for that brand, etc.

I keep finding links to statements that say that the FDA now has the authority to regulate the manufacturing standards, but nothing with the actual standards. I still think there are many shops that believe that if HR 2058 passes, they'll still be able to mix in their shops, to order, or at all, and I just don't think that is the case.

I agree with this as well. The only way small eliquid mixers stand a chance is if eliquid gets a separate classification with separate rules. Similar to my last post.

A good analogy is a baker or bartender. They both mix end use consumable products. All the ingredients are already approved. Cookie makers don't need to get their cookie approved because they already used approved ingredients and baked in a regulated commercial kitchen. Bartenders have to follow rules like age verification and not serving wasted people but have free reign to mix whatever is on the shelf.

Logically, the same rules should apply. But I havent seen much logic applied to anything in the 499 pages of doom so...

 

[crxess]

Mr. Zeller should answer to the Deputy Commissioner for The Office of Medical Products and Tobacco. But I think that seat is still Vacant? So I believe he answers directly to Califf.

And Califf answers ultimately to the HHS Secretary, Burwell.

So shouldn't we Also be Blasting our friends Califf and Burwell?

Yes we should(to RED)
However, as in the Military - one placed in power is left alone so long as one follows intended guidelines for operation and in this instance - CTP is a Free Range division of the FDA. So long as they stay on LEGAL land they are Free to Roam as they Please - to the pleasure of the Goals of the current Administration.
The CTA has proven to be a Weak enactment to the Reduction of Health Risk.......with highest achievement in Reducing Tobacco use being increasing TAX.

Regulation to Reduce Teen/Child Smoking - The #1 form of Tobacco Health Risk by Magnitudes - has, IMO, been a total Disaster and a waste of Millions in Advertisement.

$48 Million in 1 quarter 2012, estimating $480 cost per Quitter.

[QUOTEA previous study of the effort determined that more than 100,000 people gave up smoking for six months or more, considered permanent abstinence for the purposes of the research. Another 100,000 quit for shorter periods of time and 1.6 million tried to quit after seeing the ads./QUOTE]

Although often longer term Quitters return to smoking and that $480 does not account for Short term Failed quits.

That Actual Campaign was also a Target toward Long Term Smokers, not Teens/Children - <Their Prime objective.

Government anti-smoking campaign cost just $480 per quitter, study finds

So, Everyone is Making money,
People are being made to suffer(us) to the satisfaction of others - while the GOAL, Reducing Health Risk, continues to be placed on Simmer.

 

[bobwho77]

Exactly.

It kinda like Voting for a Candidate.

Are there More things that I like about a Candidate than I Don't Like? And are the things I like More Important than the things I Don't Like? And Visa Visa.

Exactly!
While it's nice to see some elected officials standing up for vaping I'm not a single issue voter, nor do I plan on becoming one.

 

[DC2]

I thought you'd like that. We're the FDA! We don't need no stinking badges!

That's an extremely accurate summary of the FDA's reply to comments.

As pessimistic as I am about the deeming, I am possibly more optimistic about the courts.
I have a hard time seeing how the FDA will not get smacked down again.

The regulations are illogical, circular, and nearly impossible to comply with.
They have distorted or ignored economic impacts, and mandates to explore modified risk.

They even took a clean shot at the First Amendment.

 

[KODIAK (TM)]

I emailed Marco Rubio three times..the next two got canned form replies
indicating that his staff had no clue what I was referring to,
apparently they thought I was talking about the cost of prescription meds.

This is why I feel legislation like HR2058 and even cole-bishop has a snowball's chance of going anywhere. We are simply a gnat on an elephant's azz. The issue simply doesn't have enough political or media capital like pay inequality, birth control costs, LGBT rights or transgenders flipping a coin to see which public crapper to use.

It all comes down to a sympathetic judge who might take a 2nd look at the detrimental damage this will create with small businesses and how the FDA decided in god-like fashion that these regulations are worth it to save humanity. But even if litigation is somewhat successful, there will surely be FDA appeals (unlike in 2010). The FDA is hanging their hat on this one folks. By then I fear the industry will have suffered too much damage and the only options will be Vuse/Blu lookalikes.

I hope you all are stocking up because I don't see an injunction on the horizon either. At best we're looking at a potentially long dry spell with supply lines popping up and folding weekly. My issue now is DIY'ing the right flavors that will keep my compadres from "falling off the wagon" when they find they can't order their own ADV anymore.

So, I'm done signing petitions, talking to vape shops, writing silly-assed letters and making calls to a do-nothing congress. Instead I've set aside 1/2 of my savings from when I stopped smoking over 4 years ago. (I was 2-3 packs per day there at the end). It certainly ain't much but I'm waiting to see which "legal" horse to back in all of this. At this point, anyone whose damages include seeking prison sentences is a very viable candidate.

 

[zoiDman]

Yes we should(to RED)
However, as in the Military - one placed in power is left alone so long as one follows intended guidelines for operation and in this instance - CTP is a Free Range division of the FDA. So long as they stay on LEGAL land they are Free to Roam as they Please - to the pleasure of the Goals of the current Administration. ...

I don't think I would say that the CTP is in anyway "Free Range" with respect to the FDA Commissionaire.

The CTP answers Directly to the FDA Commissionaire. And I don't think there is very much that the CTP can do/propose without the Full Buy-Off from Califf (and previously Hamburg).

Especially when something like the "Deeming" is going to have such a Ginormous effect on Individuals, Businesses, and Taxes.

Like I said in another Thread, Mr. Zeller isn't on my Christmas Card list. But directing All Anger/Blame on Mr. Zeller is like cutting the leaves off a Weed in the Garden. It Doesn't do Anything. Because the Problem/Cause still remains. You have to Pull a weed out Roots and All.

If things are Ever going to Change in this Country, we have got to Start holding those who are behind things accountable. And not just those who are the Front Men/Women for things.

 

[bobwho77]

Since no one else will say it I will. You need to vote Republican. In general as a party they are for smaller government. Trump has said time and time again that he will reign in the FDA, IRS, DOE, and EPA. A vote for Hillary is just a vote for 4 more years of Obama. Since Obama has taken office he has invoked over 20,000 new regulatory rules. Wake the hell up vapers. Time to cross party lines and give up those broken political beliefs.

Sent from my SAMSUNG-SM-N915A using Tapatalk

While they claim to be for "Smaller government" and pay lip service to some personal choice issues, their record of curtailing freedom on numerous other issues, support for military intervention, big business over individuals....
makes them unsupportable in my PERSONAL opinion

 

[HazyShades]

This is why I feel legislation like HR2058 and even cole-bishop has a snowball's chance of going anywhere. We are simply a gnat on an elephant's azz. The issue simply doesn't have enough political or media capital like pay inequality, birth control costs, LGBT rights or transgenders flipping a coin to see which public crapper to use.

It all comes down to a sympathetic judge who might take a 2nd look at the detrimental damage this will create with small businesses and how the FDA decided in god-like fashion that these regulations are worth it to save humanity. But even if litigation is somewhat successful, there will surely be FDA appeals (unlike in 2010). The FDA is hanging their hat on this one folks. By then I fear the industry will have suffered too much damage and the only options will be Vuse/Blu lookalikes.

I hope you all are stocking up because I don't see an injunction on the horizon either. At best we're looking at a potentially long dry spell with supply lines popping up and folding weekly. My issue now is DIY'ing the right flavors that will keep my compadres from "falling off the wagon" when they find they can't order their own ADV anymore.

So, I'm done signing petitions, talking to vape shops, writing silly-assed letters and making calls to a do-nothing congress. Instead I've set aside 1/2 of my savings from when I stopped smoking over 4 years ago. (I was 2-3 packs per day there at the end). It certainly ain't much but I'm waiting to see which "legal" horse to back in all of this. At this point, anyone whose damages include seeking prison sentences is a very viable candidate.

Perhaps I haven't become as cynical just yet...but I agree more than I'd like to.
For most of my adult years I've been repeating the mantra;
"It's all BS" when trying to not discuss politics with my liberal friends.

My perspective is that "My Kingdom is not of this world"
and in order to run for political office one has to have sold one's soul to the devil or one of his representative cabals.
But I do know that those politicians respond to two things:
a. Money
b. Public opinion.

Experience has taught me that the pup who whines the loudest gets the
mammary gland...And it would seem that at this point all we have left to do is scream and whine louder

 

[Oliver]

Let's be totally clear here. What the FDA does or doesn't do going forward is going to entirely depend on which way the wider political wind blows.

The best case scenario is that manufacturers find their products tolerated, but illegal. The worst case scenario is that everything is taken off the shelves.

Flavors, in particular, are going to remain in huge danger as long as the "US teens are suffering an epidemics of nicotine addiction" lie stays in place. This is being contrived by the CDC, and reaffirmed by Matt Myers and the CTFK. The FDA doesn't need to change its course while those lies hold dominance and are believed by millions of Americans.

 

[bobwho77]

This is why I feel legislation like HR2058 and even cole-bishop has a snowball's chance of going anywhere. We are simply a gnat on an elephant's azz. The issue simply doesn't have enough political or media capital like pay inequality, birth control costs, LGBT rights or transgenders flipping a coin to see which public crapper to use.

It all comes down to a sympathetic judge who might take a 2nd look at the detrimental damage this will create with small businesses and how the FDA decided in god-like fashion that these regulations are worth it to save humanity. But even if litigation is somewhat successful, there will surely be FDA appeals (unlike in 2010). The FDA is hanging their hat on this one folks. By then I fear the industry will have suffered too much damage and the only options will be Vuse/Blu lookalikes.

I hope you all are stocking up because I don't see an injunction on the horizon either. At best we're looking at a potentially long dry spell with supply lines popping up and folding weekly. My issue now is DIY'ing the right flavors that will keep my compadres from "falling off the wagon" when they find they can't order their own ADV anymore.

So, I'm done signing petitions, talking to vape shops, writing silly-assed letters and making calls to a do-nothing congress. Instead I've set aside 1/2 of my savings from when I stopped smoking over 4 years ago. (I was 2-3 packs per day there at the end). It certainly ain't much but I'm waiting to see which "legal" horse to back in all of this. At this point, anyone whose damages include seeking prison sentences is a very viable candidate.

A preliminary injunction barring enforcement of the Deeming regulations will almost certainly be granted.

 

[bobwho77]

You can hire experts to manipulate what appears in the media. If we vapers had enough money and organization we could have hired those people and seeded the media with pro-vaping stories. We didn't, but the other side did.

The media goes where the money is.

We should STILL be doing it.
Don't we have any vapers that work for ad agencies?

 

[Mazinny]

Setting aside the PMTA/grandfather issue. How many liquid lines out there do you think meet the other standards required to be a manufactured tobacco product?

I think Azim Chowdhuri was saying that at the very least they expect the type of toxicity testing that Flavourart is doing. I don't think a tobacco flavored product will have the upper hand over other flavors absent toxicity testing ( and probably more ). The flavor ( kiddie magnets ) issue, is something they will revisit at a later date.

They view safety of flavors for inhalation, and appeal to kids, as two separate issues.

 

[HazyShades]

Flavors, in particular, are going to remain in huge danger as long as the "US teens are suffering an epidemics of nicotine addiction

Which is precisely why my research presently is using naturally available flavors.extracts.
and food flavors. Whether because of the "threat to teens" or the diacetyl nonsense
flavors are possibly less likely to be available than nicotine.

Regards,
Hazy

 

[Rossum]

That's an extremely accurate summary of the FDA's reply to comments.

As pessimistic as I am about the deeming, I am possibly more optimistic about the courts.
I have a hard time seeing how the FDA will not get smacked down again.

The regulations are illogical, circular, and nearly impossible to comply with.
They have distorted or ignored economic impacts, and mandates to explore modified risk.

They even took a clean shot at the First Amendment.

Let's hope there are some honest judges left.

 

[Rossum]

While they claim to be for "Smaller government" and pay lip service to some personal choice issues, their record of curtailing freedom on numerous other issues, support for military intervention, big business over individuals....
makes them unsupportable in my PERSONAL opinion

Some of us find BOTH wings of the political establishment unsupportable.

 

[Bronze]

This is why I feel legislation like HR2058 and even cole-bishop has a snowball's chance of going anywhere. We are simply a gnat on an elephant's azz. The issue simply doesn't have enough political or media capital like pay inequality, birth control costs, LGBT rights or transgenders flipping a coin to see which public crapper to use.

It all comes down to a sympathetic judge who might take a 2nd look at the detrimental damage this will create with small businesses and how the FDA decided in god-like fashion that these regulations are worth it to save humanity. But even if litigation is somewhat successful, there will surely be FDA appeals (unlike in 2010). The FDA is hanging their hat on this one folks. By then I fear the industry will have suffered too much damage and the only options will be Vuse/Blu lookalikes.

I hope you all are stocking up because I don't see an injunction on the horizon either. At best we're looking at a potentially long dry spell with supply lines popping up and folding weekly. My issue now is DIY'ing the right flavors that will keep my compadres from "falling off the wagon" when they find they can't order their own ADV anymore.

So, I'm done signing petitions, talking to vape shops, writing silly-assed letters and making calls to a do-nothing congress. Instead I've set aside 1/2 of my savings from when I stopped smoking over 4 years ago. (I was 2-3 packs per day there at the end). It certainly ain't much but I'm waiting to see which "legal" horse to back in all of this. At this point, anyone whose damages include seeking prison sentences is a very viable candidate.

While I totally agree the vape community has nowhere near the backing or force of the leftwing groups you mention, I also do not share your doom and gloom forecast as it relates to HR2058 and/or Cole-Bishop. Does this mean I think those measures will pass as of today? No. I think they have at best less than a 50/50 chance. But I also have followed politics for many decades and know how quickly the landscape can change. We don't know what November will bring. We don't know the powers that will be. For this reason, forecasting the death of 2058 and/or Cole-Bishop or similar measures going forward is entirely premature and raising the white flag as you are subscribing to would be a major mistake in my estimation. If you want to surrender that is your choice. I will not. And I will also support to the best of my ability any legal action that stops this insanity. There are multiple ways of attacking most problems. I will not forfeit any of them. That includes holding out hope we get an administration in January that has a Secretary of DHHS with a head that is screwed on straight. So there are three viable paths where if each of them had only a 20% chance of succeeding we would still have a better than 50% chance of saving our industry. I will not retreat from ANYTHING!