FDA FDA deeming regulation proposals

[Gato del Jugo]

I may adopt some of this in response to the fear mongering which cites nothing from FDA proposal but suggests, yet again, that we're doomed.

Part of the issue of the proposal is that it's so vague at times, and even conflicting within itself, that there's a lot of confusion in trying to interpret that jumbled mess (and yes, I've read the entire thing, too)..

Whether that's intentional on the FDA's part, who knows...


To be honest, one could argue that the FDA has done quite a few sketchy things over its lifetime, and many people don't exactly trust them for various reasons...

 

[MorpheusPA]

We urge the vaping community and others interested in opposing regulation that discourages tobacco harm reduction to await further analysis before acting. There is no benefit in acting or opining precipitously.

But it's so much more fun to fly off the handle, threaten Second Amendment solutions, and complain bitterly on a Web forum!

/snark

For now, standing on the street corner and screaming, "The End Is Nigh!" really isn't helping anybody.

I am content to wait to see what shakes out as, at this point, we don't know what the final form will be nor what the heaviness of the hand enforcing this will be. We don't know what all the implications are at this point as I cannot imagine that anybody with direct FDA knowledge has fully analyzed the document yet.

At such a time as we do and some manner of united voice arises, count me in (if I agree with your methods).

 

[Gato del Jugo]

Let's say 10,000 individual vapers respond to the FDA proposal, and all cite evidence on something the proposal says, "there currently is no evidence on this point." Well, I'm thinking, and being entirely reasonable, to say that would influence the resulting regulation.

I'd say that CASAA's probable lawsuit against the FDA will have much more influence...

 

[Worzel]

The FDA has already been presented with alot of evidence in regards to ecigs by the likes of folks like Bill Godshall. Yet, even now they deny that the evidence even exists.

They are not truly looking for evidence against their agenda, only the evidence that backs their agenda.

I agree that we need to tread lightly. I did the comment on the Regulations site, because I was emailed that link from WhiteHouse (I still get emails for a petition I signed with them years ago) But I worded myself verrrrrryyy carefully. I didn't spout off about DIY juice, or RBA's, or mods. I don't want all that to show up on their radar. I don't want to remind them how vast the vape market is. I just stuck with their proposal and only gave my opinion on those topics. Nothing cruel, just pretty much pointing out the gray areas in their proposal.

-Another thing, I didn't post anything on the comment about being a vaper, what it did for me, yadda yadda. I didn't even let onto them that I vape. I referred to them as e cigarettes (the only jargon they understand).

Sent from my bird in a moist little package

 

[Jman8]

To be honest, one could argue that the FDA has done quite a few sketchy things over its lifetime, and many people don't exactly trust them for various reasons...

If anyone reading this thinks that I implicitly trust the FDA, especially as it relates to regulation of eCigs, then IMO, you lack comprehension on what I've been purporting and/or don't really care to 'know' my position.

At same time, the writing was on the wall long before 4/24/14 regarding 'deeming regulation.' We all knew it was coming, and now that day has come. Now it is 'game on.' Now is the time to step up your political game, and put away child's toys of whining and fear mongering.

So many comments read like Glantz's take on the proposal, and essentially amount to throwing in the towel, giving up, self defeat, whoa is me. Which I take as ENTIRELY based on FDA track record, and which I can very much understand. Yet, FDA is not being heavy handed right now, and we (many of us) fully expected them to be just that. If they are going to be heavy handed, it'll continue to be at a snail's pace, and so the golden era is still alive for awhile. Enjoy it. Vape on. Yet, realize you truly have golden opportunity to shape things. Both with your words and actions. I have faith in the vaping community to step up to the plate and give it our all and make for a viable outcome that continues to deliver a thriving industry.

Weeks and months before FDA did what they just done, state and local municipalities were throwing punches at us left and right. I'm pretty sure that isn't going to stop. Thus, we will continue to fight there or face a world where despite anything FDA might do, you may be faced with actual law that says you cannot vape outside, in front of your own house, 1 step off your own property. I'm still going to advocate for 'vaping everywhere' cause I still think that is the most reasonable position to have. It helps, admittedly, that I live in a state that while this issue has come up, it was 'our side' that sought to ensure it was able to continue in a way that wasn't restrictive. And so, in last few public indoor places I've been, it has been explicitly allowed. That bodes well for me and others where I live. But I'm still interested in the fight in places where it is going the other way, and still hope to exercise influence that changes the narrative of how that fight appears, even while defeat on some of those fronts has already been sealed.

FDA is one, rather key, piece of larger picture. But isn't end all and be all. Like most institutions on this planet, I see little to no reason to implicitly trust in what they are delivering daily for public consumption and interaction. Yet, I see reason to address regulations that are proposed and that currently seem wide open to interpretation and influence.

It could go the pessimistic, sky done fell, we are doomed way.
But what if it goes the other way?
And what if your thoughts, words and actions help bring about a world in which it does go the other way?

 

[Worzel]

It could go the pessimistic, sky done fell, we are doomed way.
But what if it goes the other way?
And what if your thoughts, words and actions help bring about a world in which it does go the other way?

I think, if the sky were to fall, it would have fallen with THIS proposal. What I got out of it was that they pretty much have no proof vaping is bad, and no proof vaping is good. That they are the FDA, and they have to do something, because they are the FDA, and that's what they do. This proposal looks to me like a slap on the wrist compared to what we were fearing. I get the feeling the FDA was nagged into half-hearted motion by the ANTZ. The FDA have bigger fish to fry. Now if more children are allowed to drink e liquid and get sent to the hospital, people keep their pass-thru batteries plugged where they shouldn't be plugged in and they catch fire, or someone blows their face apart doing something dumb with a mod, then we have reason to worry.



Sent from my bird in a moist little package

 

[Myk]

But it's so much more fun to fly off the handle, threaten Second Amendment solutions, and complain bitterly on a Web forum!

I know I for one will be revolting if the FDA forces me back to smoking.

By that I mean I won't go back to smoking, I won't take the BP drugs that cause cancer. I will get an ostomy and I will empty my bag wherever I please. They thought smoking inside was bad? Just wait until they get a whiff of that stuff.

 

[aikanae1]

I think some are assuming that vapers are speaking to an agency based in logic and desire to do the best they can, etc. and that is not the case. The FDA is crazy and it's impossible to talk logic to crazy. It's like their Facebook page where they have several posts pulling out draconian arguments and examples that were debunked 5 years ago. The FDA is more like an irritant teen with their fingers in their ears saying "la, la, la, la. I can't hear you". Its crazy-making and there is no real two way conversation.

I thought this was well said:

The FDA has already been presented with alot of evidence in regards to ecigs by the likes of folks like Bill Godshall. Yet, even now they deny that the evidence even exists. They are not truly looking for evidence against their agenda, only the evidence that backs their agenda.

And that's the truth. Much of this "sky is falling" attitude is in direct relationship to the FDA putting their fingers in their ears and singing over anything we have to say.

 

[DC2]

Just to be clear, and not concerned with bet at all in this moment, what would it take for you to see this differently? Is it simply a matter of time, and 'we shall see?'

I would most definitely have to see it to believe it.

The track record of the FDA with respect to these issues is a matter of public record.
And that track record shows nothing encouraging as far as I can see.

IMO, vaping community needs leadership right about now that has attitude of, 'we got this covered' and/or 'we can do this.' I'm in that camp cause science is on our side, FDA proposal indicates (to me) that we have political momentum on our side, and because business is booming.

I would imagine that when CASAA issues their guidance, they will be asking us to do the same thing that you think we should do.

 

[thanswr]

The biggest hurdle I see for the FDA is regulating a product as "tobacco" when it doesn't contain tobacco. Yes, I do see the dipsy doodle logic that says, since nicotine is extracted from tobacco, it can therefore be classified as a tobacco product. That's a stretch that would make Gumby envious. It would be like regulating corn because you can make an alcoholic product from it. Corn is not alcohol and nicotine is not tobacco. Saying so doesn't make it so. The facts are the facts.

IMO, that is the real flaw in the FDA's proposal. That's where the FDA will lose in court. The FDA proposal is heavy on "we believe" and woefully light on "we know".

On another note, I've read the proposal again and none of this makes sense. It's like the FDA had a brain storming session and decided to write all the random thoughts on paper.

So, I sent the proposal to a friend of mine who happens to be a government auditor. Maybe I was reading something wrong. Maybe my personal feelings were coloring my perspective. No, he had the same "what the hell" reaction. It made no sense.

 

[pamdis]

The biggest hurdle I see for the FDA is regulating a product as "tobacco" when it doesn't contain tobacco. Yes, I do see the dipsy doodle logic that says, since nicotine is extracted from tobacco, it can therefore be classified as a tobacco product. That's a stretch that would make Gumby envious. It would be like regulating corn because you can make an alcoholic product from it. Corn is not alcohol and nicotine is not tobacco. Saying so doesn't make it so. The facts are the facts.

IMO, that is the real flaw in the FDA's proposal. That's where the FDA will lose in court. The FDA proposal is heavy on "we believe" and woefully light on "we know".

On another note, I've read the proposal again and none of this makes sense. It's like the FDA had a brain storming session and decided to write all the random thoughts on paper.

So, I sent the proposal to a friend of mine who happens to be a government auditor. Maybe I was reading something wrong. Maybe my personal feelings were coloring my perspective. No, he had the same "what the hell" reaction. It made no sense.

In essence they could have taken it down to around a dozen pages, by saying these products will be subject to all the current regulations, here's the new compliance dates, here's the questions we are requesting comments for, and they're done.

All the rest is justification in my opinion, and fluff to add heft, since they are calling it 'an historic step'.

 

[mkbilbo]

For now, standing on the street corner and screaming, "The End Is Nigh!" really isn't helping anybody.

But I stocked up on sack cloth and ashes! Whadum I gonna do with all this????

 

[Talyon]

I like the sarcasm.

Even while you missed the mark on what I said, it's still a good show.

I may adopt some of this in response to the fear mongering which cites nothing from FDA proposal but suggests, yet again, that we're doomed.

TY, Im sure and do hope that NO one missed my sarcasm.

I missed nothing of your message or points in any of your posts, u see it your way most see it our way it's all good, so long as we continue to fight nonsense regulations against Vapeing.

The END Game can be seen many ways I suppose, but the NOW is NOW and it's vitally important for all to wait for CASAA's cue to move in the proper manor on these proposed ridiculous regulations against Vapeing.

My choice to fight the FDA however I can on these deeming regulations is NOT fear mongering, so please stop labeling those who oppose these regulations as fear mongering. TY.

 

[mkbilbo]

The biggest hurdle I see for the FDA is regulating a product as "tobacco" when it doesn't contain tobacco. Yes, I do see the dipsy doodle logic that says, since nicotine is extracted from tobacco, it can therefore be classified as a tobacco product. That's a stretch that would make Gumby envious. It would be like regulating corn because you can make an alcoholic product from it. Corn is not alcohol and nicotine is not tobacco. Saying so doesn't make it so. The facts are the facts.

IMO, that is the real flaw in the FDA's proposal. That's where the FDA will lose in court. The FDA proposal is heavy on "we believe" and woefully light on "we know".

On another note, I've read the proposal again and none of this makes sense. It's like the FDA had a brain storming session and decided to write all the random thoughts on paper.

So, I sent the proposal to a friend of mine who happens to be a government auditor. Maybe I was reading something wrong. Maybe my personal feelings were coloring my perspective. No, he had the same "what the hell" reaction. It made no sense.

Yeah there are some serious problems in this whole endeavor. They would, I suspect, been on more solid ground claiming jurisdiction over extraction and sale of nicotine. The "e-cig" is too slippery a concept, too vague. I use an Innokin VTR which isn't even remotely "cig" like. And, basically, it's composed of common electronics. It's derived from tobacco how exactly?

They could easily trip themselves over their own clown shoes. Take batteries for example. Lithium-ion is the dominant rechargeable. They're in everything. And APVs such a as my VTR were designed to use common, "off the shelf" 18650s. The FDA can't do squat about batteries without getting slapped down hard by the entire electronics industry.

Or the obsession with flavors. Okay so maybe they force, oh, Mount Baker to sell 0 nic only. That stops me mixing nic in how? Well, it don't. So they push MBV off a cliff. So I buy LorAnn. Who sells baking supplies. So... go after bakers too maybe? What?

One thing that bothers me a great deal is they don't actually seem to have a clue what they're doing. They didn't do their homework. The "e-cig" is barely a thing. It's a form factor more than a product. And cases in law can often turn on seemingly trivial technicalities. There's a weird possibile opening for the vape world to respond, "What's an e-cig?", and keep going.

They could make a real mess of things then get smacked down in court. But after the damage. Ultimately, nicotine is a legal drug. Like caffeine. How do you ban it without, oh, outlawing tobacco? Creating giant black markets in the process? Um... dunno?

It's going to be a bumpy ride...

 

[Rossum]

It's going to be a bumpy ride...

Indeed -- particularly for small businesses currently making their own juice. Have a look at the Deeming Reg, Section IX. Paperwork Reduction Act of 1995. There's a table that starts on page 158 and extends to page 159.

It seems the FDA only expects between 140 and 188 companies to respond and report ingredients in the category "Other Tobacco, E-Cigarettes, and Nicotine Product Manufacturers" (the only category which e-cig or e-juice manufacturers could fit in).

That would leave most of the small B&Ms that currently mix and sell their own juice either not doing that anymore, or out of compliance with the FDA regs (and thus subject to raids by armed government agents -- just like people who have the audacity to sell raw milk and certain dietary supplements without FDA approval). That further raises the question: How many B&Ms will be able to survive at all without being able to mix their own juice (which is the only part of a typical B&M business that has decent margins)?

 

[Bobbilly]

The only historic moment is they are ignoring a chance to eradicate tobacco use for future generations by serious looking at this as a alternative. They are blindly moving ahead on a anti tobacco agenda

 

[MorpheusPA]

But I stocked up on sack cloth and ashes! Whadum I gonna do with all this????

Ashes can be used to make lye for soap making, and sack cloth is an excellent filter to keep the waste ash from the final product!

Additionally, small amounts of ash can be used to help neutralize an acidic pH in your lawn and gardens.

(See? We can make something positive out of almost anything!)

 

[thanswr]

Yeah there are some serious problems in this whole endeavor. They would, I suspect, been on more solid ground claiming jurisdiction over extraction and sale of nicotine. The "e-cig" is too slippery a concept, too vague. I use an Innokin VTR which isn't even remotely "cig" like. And, basically, it's composed of common electronics. It's derived from tobacco how exactly?

They could easily trip themselves over their own clown shoes. Take batteries for example. Lithium-ion is the dominant rechargeable. They're in everything. And APVs such a as my VTR were designed to use common, "off the shelf" 18650s. The FDA can't do squat about batteries without getting slapped down hard by the entire electronics industry.

Or the obsession with flavors. Okay so maybe they force, oh, Mount Baker to sell 0 nic only. That stops me mixing nic in how? Well, it don't. So they push MBV off a cliff. So I buy LorAnn. Who sells baking supplies. So... go after bakers too maybe? What?

One thing that bothers me a great deal is they don't actually seem to have a clue what they're doing. They didn't do their homework. The "e-cig" is barely a thing. It's a form factor more than a product. And cases in law can often turn on seemingly trivial technicalities. There's a weird possibile opening for the vape world to respond, "What's an e-cig?", and keep going.

They could make a real mess of things then get smacked down in court. But after the damage. Ultimately, nicotine is a legal drug. Like caffeine. How do you ban it without, oh, outlawing tobacco? Creating giant black markets in the process? Um... dunno?

It's going to be a bumpy ride...

My APV of choice is a Maraxus. Is that an "e-cigarette"? It certainly doesn't look like a cigarette. Although my personal favorite are those government types who want to ban "e-cigarettes" because a cop may mistake an "e-cigarette" for a real cigarette. My feeling is, if a cop can't tell the difference between a Maraxus and an "e-cigarette", they need to surrender their weapon because they're blind.

It really looks to me like the FDA based much of their proposal on regulating analogs. You called it correctly: What is an "e-cigarette"?

As for vendors like MBV or Copper Creek, can you regulate their sales for 0 nic products? A workaround would be to sell the 0 nic liquid as a food additive. Basically, that's the components in vape liquid less the nicotine. Then get an okay to sell vials of "liquid nicotine" as another additive.

Upstream, I had commented that other than nicotine, there's nothing in vape liquid that isn't readily available.

You can buy food grade VG in a drug store, supermarket, big box store or online. VG is an additive for many commercial cake makers as it gives moistness to the product.

Food grade PG can be bought through any fog juice vendor. (Insert my plug for Froggy's Fog). Is the FDA going to regulate fog juice now as a component of "e-cigarettes"? Oddly enough, the FDA has already approved vaporized PG in such products as Nicorette Quickmist. PG is used an an antibacterial in hospital ventilation systems.

As for flavorings, the FDA is not going to shut down Wilton's or McCormick's or Spice Island or the Perfumers Apprentice or any other group that caters to the cook or baker.

Is the FDA going to regulate the sale of batteries as "e-cigarette" components? I doubt it since this entire society either runs on electricity or batteries. Do Rayovac or Duracell have something to worry about? My best guess tells me they've already been through the regulatory process.

Should there be a ban on "e-cigarettes" and vape liquid for sale to minors? For most B&M's and online liquid vendors, that's old news. Should there be a "warning label" on vape liquid bottles? Every bottle of vape juice I have already has a warning label.

The FDA wrote up a very badly written proposal that's chock full of holes. It makes no sense. It is the perfect example of a government entity entering an area they know nothing about and felt the need to do "something". Which, I suspect, will be the downfall of this proposal.

 

[Bobbilly]

They just want it deemed under their authority then it starts. That's why there is nothing too controversial.

 

[KreeL]

Who and What ever wins against the FDA? Big Pharma wins. Big Tobacco wins. Harmful abused products abound with the FDA stamp of approval. In a nutshell, the FDA is a bribable organization. You can push them around if you have the money. Pure and simple. Right now we're a mosquito on the rump of the first two winners. You want to quit smoking? Here's the Patch! You want to kill yourself? Here are some cigarettes! Watching this unfold as a vaper for several years, I knew it was inevitable that what we are seeing now was in our future. In a way I blame ourselves. Rather than compete with China ejuice by making facilities that included sterile and exacting ejuice manufacturing practices, we let ourselves fall into the trap of the local highschool dropout mixing ejuice behind the counter at the local vape shop. We have to be smart AND be rich. We're not both as of yet.