FDA FDA deeming regulation proposals

[patkin]

In case it helps ...

1) Some of the items you've listed are covered under the Federal Drug Paraphernalia statute (google it, I don't want to post the link here, because of forum rules). That means DEA jurisdiction probably.

2) To the extent that syringes are medical devices, that's FDA. However a blunt-tipped syringe would probably not be. (A syringe that allows attachable needles which might be blunt or suitable for injection into people or animals? Dunno. But the attachable needles would be FDA if they could be used for injection and CPSC if not. Although hmm, maybe some designated for animal use might be USDA??).

3) I do not believe FDA has ever regulated tobacco pipes or even pipe tobacco. (But they could.)

4) Everything else is going to be CPSC (consumer product safety commission), and/or FCC (cell phones), and/or maybe OSHA (if used in the workplace) and/or FTC (regarding marketing).

To put it another way, FDA has two areas of jurisdition that concern us:

1) Tobacco products jurisdiction - anything derived from tobacco injested by consumers recreationally. (Not insecticides or some - say - fabric created from tobacco leaves intended to be used as clothing, etc.).

2) Approved medical therapies and devices. (Or UNaoproved ones, for that matter - which they can sieze and destroy as "adulterated or misbranded." FDA is always cracking down on the herbal supplements and homeopathic stuff on that basis.)

FDA also obviously does foods and cosmetics, but I don't think that matters for purposes of your Q, nor our interest here on ths forum.

My point being: I buy my syringes, including needles, at a feed store obviously used for animal injections and use them for many things neither with controlled substances nor ejuice. Though they CAN be used on humans as devices for usage with controlled substances, the FDA has NOT captured them as "components." They have many uses, controlled-substance delivery devices being ONLY one. For nic delivery they are trying to capture our setups which, obviously, have other usages just as syringes do. They should be regulated for safety as the other items I list falling under other depts/agencies but NOT exclusively by the FDA nor captured in their approval process. They are trying the net them and I'm trying to see what process the other items went through to avoid FDA exclusive control.

 

[DeeLeeKay]

The way I see it. If we can get zero flavor nic juice. The industry will change but vaping will still be available through mech mods and rba's.

This is a sad time to be alive in the USA.

 

[Myk]

What is to stop clone makers from producing all the hardware that demand is wanting?

Who are clone distributors currently registered with to make sure their product is considered legal and safe? If we are actually in a war going forward, then I don't see under what scenario that a clone maker would seek compliance from the FDA. And as the demand will be high, then it'll just be like war on any other substance that is banned. Clone distributors will make lots of money where they can, and some will be nabbed in the process. TCA doesn't give anyone the authority to ban a tobacco product, so clone makers wouldn't be subject to producing a product that is banned, but just one that may not be compliant with FDA. Who is going to keep track of all that? Surely not local and state jurisdictions. Vaping anywhere in that jurisdiction (in public) would have to be illegal for that to occur, for LEOs to have a chance to determine if product is non-compliant.

In the politics leading up to this moment, I see clone distribution as highly questionable and not something to support. But if we suddenly live in a world where only people with $5 million surplus can get into the hardware market for eCigs (and become FDA compliant), I would then have a different take on cloning. I would relish in the idea that innovation thru the black market is showing how utterly ridiculous the current set up for 'control' is destined to be, and how it'll be exploited as not workable.

Cost distributors out of the authorized market, and distributors will still find a way to make a profit. This won't be the first time humanity has encountered this sort of problem.

Clones would definitely stop being open about being fakes. They'd piggyback on someone else's approved status.

 

[patkin]

Been busy offline and just popped in to post this.... sorry if its already here... will catch up on thread later:

https://www.youtube.com/watch?v=InSCNdJKa0I

Pretty well, concisely sums it up.

 

[Sirius]

Those are two separate things (state law vs. FDA regulation.)

The states don't regulate tobacco products, they pass laws on use, marketing and sales. The FDA regulating e-liquid under its dfinintion of "tobacco product" has no effect on the states taxing it or not. The states aren't "required"by federal laws to tax tobacco products nor ban where they can be used. The only part of the proposed FDA rules that affect the state level are sales to minors and the advertising rules.

Bear in mind that even a lot of actual tobaco products, like snus and dissolvables, "are not combusting 1000s of addictive chemicals and the leaf of a plant." either.

Hi Kristin -- Thnx for chiming in. What FDA approved product on the market now containing nicotine for the cessation of smoking is different from e-liquid containing nicotine? The only difference in those and e-liquid is the delivery system. AND E-CIGS LOOK LIKE SMOKING..Some stories in the media even state, "Smoking e-cigarettes".
Some pretty big money has been paid to someone in the FDA by someone who would love to see us go away. BIG TOBACCO or PHARMACEUTICAL Co.s, or possibly both. The government no doubt has determined that they have lost revenue because of the taxes they loose by way of e-cigs but they can always just raise taxes on other things. But the revenue lost to BT and Pharm is really substantial.
Look at the cost of those pills and patches. Look at what a carton of cigarettes cost. IMO all CASAA has to do is find out who in the FDA pushed for these regulations to find the money trail and expose them. I would love to see an investigative reporter on one of these 60 Minutes type shows expose this thing! I doubt I will though. Nothing wrong with wishful thinking. lol

 

[patkin]

Just another possible angle for FDA handing the industry to BT: They are already used to dealing with them as they have been for years vs dealing with multiple new, unfamiliar and not in their ""standard operating procedures" (SOP) system, companies. All of govt creates those SOPs and when something doesn't fit, they go nuts. Of course the BT companies lobby and relationships are created over time but I'm really addressing the already existing bureaucratic paper work/computer systems. These are people who don't like to think too much nor adjust to new situations.

 

[StormFinch]

At least Demmi is trying. I haven't see one video from PBusardo or RipTrippers about this. Grimmgreen did one. Great post btw!

Don't hold me to it, but I believe PBusardo went on vacation the same day that the regs were released.

 

[aikanae1]

My point being: I buy my syringes, including needles, at a feed store obviously used for animal injections and use them for many things neither with controlled substances nor ejuice. Though they CAN be used on humans as devices for usage with controlled substances, the FDA has NOT captured them as "components." They have many uses, controlled-substance delivery devices being ONLY one. For nic delivery they are trying to capture our setups which, obviously, have other usages just as syringes do. They should be regulated for safety as the other items I list falling under other depts/agencies but NOT exclusively by the FDA nor captured in their approval process. They are trying the net them and I'm trying to see what process the other items went through to avoid FDA exclusive control.

There are some states who do ban syringes, including vet / pet med use, so I'm assuming it's up to the state. Even if syringes are not banned in the state, the pharmacy (most of them) may think they are and refuse to sell them but they'd be available in feed stores.

I think this deeming regulation covers pipes now, in addition to a number of things that hadn't been regulated under the FDA before; cigars, RYO, etc.

So looking for an answer to why they were exempted wouldn't really help since they are going through the same process that ecigs are.

There's a lot of this I don't understand. Can you imagine a mod with an ingredient listing? Stainless steel tube, wires, chip, brass spring, plastic button, brass 510 connection, 20x1 threading .... Or how about a drip tip, or clearo? Do they still have to get CE approval? This is just plain stoopid IMO.

 

[Myk]

There are some states who do ban syringes, including vet / pet med use, so I'm assuming it's up to the state. Even if syringes are not banned in the state, the pharmacy (most of them) may think they are and refuse to sell them but they'd be available in feed stores.

I think this deeming regulation covers pipes now, in addition to a number of things that hadn't been regulated under the FDA before; cigars, RYO, etc.

So looking for an answer to why they were exempted wouldn't really help since they are going through the same process that ecigs are.

There's a lot of this I don't understand. Can you imagine a mod with an ingredient listing? Stainless steel tube, wires, chip, brass spring, plastic button, brass 510 connection, 20x1 threading .... Or how about a drip tip, or clearo? Do they still have to get CE approval? This is just plain stoopid IMO.

View attachment 331670

That's why I've come to the conclusion the FDA really has no clue what they are trying to regulate.

That and the fact they're worried about killing big expensive cigars but don't seem to care the same would happen to ecigs and pipes. Doing that to ecigs won't help health, it will create a prohibition atmosphere and people's health will be harmed.

 

[DC2]

That's why I've come to the conclusion the FDA really has no clue what they are trying to regulate.

Nobody will ever be able to convince me that the FDA doesn't know what they are doing.
They've had listening sessions with CASAA and AEMSA and many others.

What they are doing right now is exactly what they always intended on doing.
For the very reasons they always intended on doing it.

They are aiming at eliminating the market as we know it, and handing everything over to Big Tobacco.
And Big Tobacco will only produce cigalikes in Tobacco and Menthol flavor.

 

[Bobbilly]

And that won't make it easier to backslide or become a dual use effortlessly. <sarcasm>

 

[Gato del Jugo]

Just watched a documentary on YouTube that has an interesting & not-so-kind look at the FDA...


Don't be turned off by the 5-minute intro (skip if you need to).. And at times the production value is a bit cheesy (& even comical)..

But the interviews with lawyers, doctors & consumer advocate types are well worth it, IMO..


And while it mainly focuses on how the FDA operates & their working relationship with Big Pharma (& a little with Big Agriculture), keep in the back of your mind while watching how it likely relates to vaping & Big Tobacco, as well..

About an hour & a half long...



War on Health - Gary Null's documentary exposing the FDA - YouTube

 

[DC2]

And that won't make it easier to backslide or become a dual use effortlessly. <sarcasm>

And once again, this is exactly as intended.

This is what the ANTZ want.
This is what Big Pharma wants.
This is what Big Tobacco wants.
This is what the government wants.

It's a perfect storm of screw us.

 

[Jman8]

Nobody will ever be able to convince me that the FDA doesn't know what they are doing.

It is interesting to me that you say this in response to the idea that FDA has no idea what they are trying to regulate.

For it reads like you give a lot of credit to their authority and (magic) power.

If they go in the direction they 'appear' to be (in terms of ridding all hardware, but BT), that could, theoretically, hurt many (advanced) eCig users. But if it hurts those same people for more than a couple years, it would be the first time in history of civilization that a black market didn't step up to 'ease the pain.' And not even a black market on banned products, but on non FDA compliant. Kinda like prescription drugs that are not bought by US citizens from US manufacturers.

A new market will surely be in play if this so called worst case scenario plays out. To not believe that would come about is, I would say, entirely implausible. There's already an underground market for smokes, which is legal and yet heavily regulated. If liquid were so easy to choke/cut off, then one would think, via reason, that war on drugs ought to be easy to win. If not, why not?

So, then you'd have to conclude that FDA, along with other entities, seeks to establish this black market, otherwise you would have to conclude, they really don't have a clue how to regulate, and/or the effect their heavy handed regulations could have.

On the children.

 

[Sirius]

Just watched a documentary on YouTube that has an interesting & not-so-kind look at the FDA...


Don't be turned off by the 5-minute intro (skip if you need to).. And at times the production value is a bit cheesy (& even comical)..

But the interviews with lawyers, doctors & consumer advocate types are well worth it, IMO..


And while it mainly focuses on how the FDA operates & their working relationship with Big Pharma (& a little with Big Agriculture), keep in the back of your mind while watching how it likely relates to vaping & Big Tobacco, as well..

About an hour & a half long...



War on Health - Gary Null's documentary exposing the FDA - YouTube

I'm going to watch this when I have time Gato. Part of the intro said,"FDA Cult Of Tyranny" Isn't that the truth?

 

[kristin]

This is what I am talking about. If Iowa can use it's own definition of "tobacco product," then so could any other state, or even Congress. FDA is just an executive agency, it is not the final authority. I could see the definition of "tobacco product" going all the way to the Supreme Court.

The states cannot supersede FDA regulations. They can add to sales and advertising, but they cannot create ANY of their own rules:
"The Tobacco Control Act preserves the authority of state, local, and tribal governments to regulate tobacco products in certain specific respects. It also prohibits, with certain exceptions, state and local requirements that are different from, or in addition to, requirements under the provisions of the FDCA relating to specified areas."

Hi Kristin -- Thnx for chiming in. What FDA approved product on the market now containing nicotine for the cessation of smoking is different from e-liquid containing nicotine? The only difference in those and e-liquid is the delivery system. AND E-CIGS LOOK LIKE SMOKING..Some stories in the media even state, "Smoking e-cigarettes".
Some pretty big money has been paid to someone in the FDA by someone who would love to see us go away. BIG TOBACCO or PHARMACEUTICAL Co.s, or possibly both. The government no doubt has determined that they have lost revenue because of the taxes they loose by way of e-cigs but they can always just raise taxes on other things. But the revenue lost to BT and Pharm is really substantial.
Look at the cost of those pills and patches. Look at what a carton of cigarettes cost. IMO all CASAA has to do is find out who in the FDA pushed for these regulations to find the money trail and expose them. I would love to see an investigative reporter on one of these 60 Minutes type shows expose this thing! I doubt I will though. Nothing wrong with wishful thinking. lol

The other nicotine products on the market have gone through the aproval proces to market as drug therapies. E-cigarette companies are not prohibited from applying as drug therapies. But if they do ot want to go through the drug approval proces, they will have to go through the tobacco product approval process.

The pharmaceutical industry lobbied years ago for the FDA to charge them fees to be approved. They knew that would chase away smaller competitiors and - just as the government relies on tobacco taxes and MSA payment - make the FDA dependant on those fees from the drug industry. A few years ago, an FDA official was quoted by a whistleblower as saying that the American people weren't the FDA's client, the drug industry is.

So, the "payoff" was from Congress, years ago, when it authorized the FDA to collect fees from the drug industry. Then there is the neotism between the FDA and pharma - a lot of people work at one, then go to the other and then back again. Not forgetting to mention that ythe FDA puts people with pharma ties on it's committees as "advisors." Add to that the number of genuine ANTZ who work for the FDA and there is your answer.

Unfortunately, there is no "smoking gun" to point to and if you attempt to tie it all together for people, they look at you like a conspiracy theorist. Unfortunately, a great many people, like myself 5 years ago, believe that the FDA is purely altruistic in its actions.

 

[patkin]

Black market ... blah, blah... what's the point? Has anyone bought anything from the black market? Do you know what it costs? The point is future smokers won't take the risks or pay the exorbitant prices if they can even find a dealer. They'll buy the BT products to try just as they do now and if not satisfied by them, they'll smoke. How many posts are seen by those who started that way and would have quite on vaping had there not been other alternatives? How many were able to leave smokes behind by vaping tobacco/menthol exclusively... maybe a few more... the majority of those are dualing. So the feds will be happy with that... The money will still flow into the govt from both and the medical establishment will continue its feast on smokers or dualers. Sorry to sound so snarky... the whole corrupt thing has me... well not wishing to go there... but, really, I'm sick of hearing about only current vapers who have already experienced what we have and continuing to get it at any price from some source we cultivate. I'm concerned about kids but from a different angle.... the ones who are going to continue loosing parents and grandparets to smoking! Thank you very much freakin FDA! Okay... sorry for the rant but I've had it up to my eye-balls and hangin on... outa here for a while to simmer down.

 

[Sirius]

The states cannot supercede FDA regulations. They can add to sales and advertising, but they cannot create ANY of their own rules:
"The Tobacco Control Act preserves the authority of state, local, and tribal governments to regulate tobacco products in certain specific respects. It also prohibits, with certain exceptions, state and local requirements that are different from, or in addition to, requirements under the provisions of the FDCA relating to specified areas."



The other nicotine products on the market have gone through the aproval proces to market as drug therapies. E-cigarette companies are not prohibited from applying as drug therapies. But if they do ot want to go through the drug approval proces, they will have to go through the tobacco product approval process.

The pharmaceutical industry lobbied years ago for the FDA to charge them fees to be approved. They knew that would chase away smaller competitiors and - just as the government relies on tobacco taxes and MSA payment - make the FDA dependant on those fees from the drug industry. A few years ago, an FDA official was quoted by a whistleblower as saying that the American people weren't the FDA's client, the drug industry is.

So, the "payoff" was from Congress, years ago, when it authorized the FDA to collect fees from the drug industry. Then there is the neotism between the FDA and pharma - a lot of people work at one, then go to the other and then back again. Not forgetting to mention that ythe FDA puts people with pharma ties on it's committees as "advisors." Add to that the number of genuine ANTZ who work for the FDA and there is your answer.

Unfortunately, there is no "smoking gun" to point to and if you attempt to tie it all together for people, they look at you like a conspiracy theorist. Unfortunately, a great many people, like myself 5 years ago, believe that the FDA is purely altruistic in its actions.

I know we must look at the facts objectively but I believe the FDA is being paid off. I wouldn't doubt Margaret A. Hamburg,(Commissioner of the FDA) or Walter S. Harris, (Deputy Commissioner of the FDA and former CDC employee) is being paid directly by one or more of the big pharmaceutical companies. Even if someone proved that to be the case nobody would do anything about it.

 

[Anjaffm]

Black market ... blah, blah... what's the point? Has anyone bought anything from the black market? Do you know what it costs? The point is future smokers won't take the risks or pay the exorbitant prices if they can even find a dealer. They'll buy the BT products to try just as they do now and if not satisfied by them, they'll smoke. How many posts are seen by those who started that way and would have quite on vaping had there not been other alternatives? How many were able to leave smokes behind by vaping tobacco/menthol exclusively... maybe a few more... the majority of those are dualing. So the feds will be happy with that... The money will still flow into the govt from both and the medical establishment will continue its feast on smokers or dualers. Sorry to sound so snarky... the whole corrupt thing has me... well not wishing to go there... but, really, I'm sick of hearing about only current vapers who have already experienced what we have and continuing to get it at any price from some source we cultivate. I'm concerned about kids but from a different angle.... the ones who are going to continue loosing parents and grandparets to smoking! Thank you very much freakin FDA! Okay... sorry for the rant but I've had it up to my eye-balls and hangin on... outa here for a while to simmer down.

Excellent posting, thank you!

And that is precisely the intention of this whole FDA regulation (same as the EU regulation here in Europe): to keep the smoking gravy train rolling, for those who find it immensely profitable.

Current vapers will find their sources. But future - prospective - vapers will be up the creek without a paddle. They will just keep smoking. Which is precisely the intention. The intention of those who profit nicely from people smoking - buying useless NRT's - smoking - buying useless, regulated-to-death cigalikes - smoking - paying high tobacco taxes - getting sick - paying lots of money to Big Pharma - dying.

That is what those in power want.
And don't be mistaken about "protecting consumers" or "protecting chiiiildren".
Money. That is all. Human beings are expendable.

............
Excellent posting, kristin
Yes, that is the way it is.
And yes, in order to arrive at this knowledge, you have to read the sources yourself.

Reality is worse than any conspiracy theory could ever be.

 

[DC2]

So, then you'd have to conclude that FDA, along with other entities, seeks to establish this black market, otherwise you would have to conclude, they really don't have a clue how to regulate, and/or the effect their heavy handed regulations could have..

I don't think they seek to create a black market...
I think they don't care if they do.

It will probably be one of the smallest black mrkets in history.
Perhaps not even big enough to survive.

Although profitability should be quite high, so maybe...