FDA FDA deeming regulation proposals

[thanswr]

How does the online vendor verify age? Signature required shipping only? That's extra cost and a hassle because I'm at work as I'm sure many others are.

Signature required shipping is one way, but not the only way.

You can verify age online by setting up something along the lines of what the adult entertainment industry did years ago.

Not that I frequent those sites, but if memory serves, you would register on a site with a credit card. You were then given a pin number/ID number which you would use to access other sites.

It can, and has been, done.

 

[Xavier Rohrs]

I agree... it seems rather than focus on nicotine they chose to worry about "FDA APPROVED" devices which IMO can never be enforced...Talk about barking up the wrong tree...

There are so many ways vape hardware can be used and sold. They must know this so it's kind of just going through the motions because they have to. I can see the vape stores with diclaimers stating that the devices are not intended for use with nicotine.. end of problem. Who is going to enforce this crap anyway?

They are going to leave enforcement up to the states is my guess. And here in Indiana, so far, the only regulation is no sale to minors. Other than that they don't care what we do.


Also I think that all B&Ms should get together like a union, or similar, to pool their resources in the event that a show of force is necessary.

 

[Xavier Rohrs]

Signature required shipping is one way, but not the only way.

You can verify age online by setting up something along the lines of what the adult entertainment industry did years ago.

Not that I frequent those sites, but if memory serves, you would register on a site with a credit card. You were then given a pin number/ID number which you would use to access other sites.

It can, and has been, done.

One website that offers deals for the military has you scan your dd214 (discharge from active duty) to verify. The same system can be setup for state issued ID cards.

 

[Bob Chill]

There are some great points and counterpoints here. I'm definitely in the camp that it's a logistical nightmare to regulate vape gear beyond pre-filled stuff. The waters are too muddy and the sky is too grey. Consumers and manufactures are too resourceful. The workarounds are endless and policing is near impossible. Even if they try it will be a mega fail. And why bother? We've discussed at length for months. The nic is the clear and easy choke. 95% of the industry starts and ends there. Zero nic crew is awesome and I applaud them but they are tiny compared to the rest of us. If liquid nic was banned completely then the industry has been brought to its knees in an instant. That's not going to happen obviously but the target for control is clear.

Just wait 2 years. The industry is already on steroids. It's like a freight train now. 2 years could easily be triple where we are today. The language in the reg package left plenty of reasons for rational optimism regarding hardware. And if doomsday happens, there are going to be online classes on how to manufacture and wrap your own coils and build tanks from common parts. The mechanism is incredibley low tech. Anybody can do it. It's almost as easy as rolling a smoke. A battery, resistance wire, and wick is as simple as it gets.

 

[mkbilbo]

I dont understand the celebration myself. I am not a lawyer or anything of the sort. I do know that the SE process was and is a big issue. I really need to hear from the lawyers on this. Interpretation is everything! Not to mention the application/approval process.

Well, it could be more "relief" than "celebration"? As in, this is the FDA's starting position. There will be push back. And the vaping world will keep growing at it's rather startling pace, increasing it's clout while the regs are being fought over. Other countries, they've started with, "Ban it, ban it all, right now!", a much more difficult position to start from...

 

[AgentAnia]

Two comments we all need to read, from CASAA today, and Greg Conley:

CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014
Taste Your Juice | A SUGGESTION FROM CASAA’S LAWYER, GREG CONLEY…

Also, the FDA docket for comments is open, but remember, you are only allowed *one* comment, so take your time and make it count! ** Read this first: http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf

ETA: From CASAA's blog (link above, emphasis mine):

We expect to provide further analysis on Monday, April 28th, 2014. In the next week or two, we will issue a Call to Action detailing how the proposed regulations affect consumers along with suggested actions so that consumers can respond most effectively. Please remember that a comment to the FDA regulations made on Day 1 is given no more weight than a comment made on Day 75. 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.

**[MOD NOTE] Only one comment proved to be a false rumor. You may make as many as you feel necessary.

 

[2coils]

Well, it could be more "relief" than "celebration"? As in, this is the FDA's starting position. There will be push back. And the vaping world will keep growing at it's rather startling pace, increasing it's clout while the regs are being fought over. Other countries, they've started with, "Ban it, ban it all, right now!", a much more difficult position to start from...

I agree, though, some of the biggest hurdles are still on the table. There is no way smaller companies can keep making their own liquids with the current approval process. They IMO DID NOT HAVE TO regulate hardware. I don't see Innokin and the like seeking approval from the FDA. These regs are designed to kill the specialty business. If we don't change this, its GAME OVER. Bill G, Greg C, and all the others who are versed have been cautioning everyone of the approval process and the SE pathway. This has not changed. The sooner vapers realize there products are STILL in danger, troops can be set forth to rally.

There is no doubt, the FDA has bit off more than they can chew here, but that doesn't mean they wont be slapping heavy fines to those who don't comply. This needs to get fixed legally, no workarounds.

 

[CabinetGuyScott]

Watch the Dimitri & Dr. Gilbert Ross video above.. We have more than 2 years.. Probably more like 3-4, minimum...


But yeah, that's been my thought, too.. that they're setting up for "bigger & better" things down the road..

Gotta boil us froggies slowly so we don't jump out...


Hey, we've known it was on the horizon for a while now..

At the very least, fight for the future vapers.. They deserve the same opportunity that we've enjoyed so far...

This is something I too think about... our fight now is also to the benefit of those who have yet to 'discover' the fantastical options of vape!

A form of pay it forward

 

[Kent C]

Two comments we all need to read, from CASAA today, and Greg Conley:

CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014
Taste Your Juice | A SUGGESTION FROM CASAA’S LAWYER, GREG CONLEY…

Also, the FDA docket for comments is open, but remember, you are only allowed *one* comment, so take your time and make it count! Read this first: http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf

ETA: From CASAA's blog (link above, emphasis mine):

He offers 'consulting services' for vendors? Hmm.... thought this was a consumer group not an industry group.

 

[Cool_Breeze]

He offers 'consulting services' for vendors? Hmm.... thought this was a consumer group not an industry group.

Hey, Kent...

It's hard to tell what interests anyone or any group represents in the vaping world. I suspect most are compromise outlooks...attempts to balance interests from various groups of constituents...when in doubt, gravity goes toward the money. End users may sometimes be included as just a convenience to further ends which may not be apparent to them.

There's lots of speculation on just what the proposed FDA rules mean to the vaping community. I suspect most of the speculation comes from people not really qualified to attempt to interpret.

The greatest unknown in this whole scenario is what the traditional tobacco industry has developed or has under development. These to us unknowns may have more impact on the actual outcome than what we, who see our ourselves as the center of the vaping realm, might have to offer.

 

[AgentAnia]

He offers 'consulting services' for vendors? Hmm.... thought this was a consumer group not an industry group.

As I understand it, Conley has resigned from the CASAA board. Phil Busardo's headline is unfortunate, therefore.

Conley is currently president of the American Vaping Assn.: The American Vaping Association

 

[JohnD0406]

The ANTZ must be jumping for joy and hope your views become mainstream. It is exactly what they want. Just roll over and make believe the black market will solve everything. Sounds like a great plan.

Well, it certainly has solved everything for numerous other markets. Let's take one for example - lasers. Anything over 5mW is illegal to buy/own/sell without a license. Customs seizes any it finds - that's a fraction of what's being shipped. Everyone who wants one, has one. People see others using them and ask "where can I get one". It's really not that hard.

Let's take another industry for example - drugs. Doesn't everyone who wants something, have it? The 'community' helps itself. Despite the strong efforts by government, it's a booming industry and they've failed to squash it over many, many years. I go to clubs and see it first hand. How many times do I get approached by people just standing in line outside, and get just about the whole menu offered before I even get into the dark, safer environment inside? Yeah, it's that 'available'. Our industry isn't nearly as difficult a fight.

In the meantime the vast majority of products now freely available to us disappear, B&M stores will be gone (nothing to sell), along with every medium the small producer and most larger ones. If this regulation passes as is, nearly everything now on the market will be gone, and that is not fear-mongering, thats reality.

No, you had it right the first time - it's fear-mongering. "Gone"? Where exactly do you think they'll go? Will they all turn into pumpkins at midnight? No - they're all over the world, and will continue to be all over the world. Sure, some companies won't ship to the US (some already don't), but that's what proxies are for - I use 'em all the time, for legal items not available for purchase in the US. No, worst case still wouldn't be all that bad, really. Bad for businesses that go out of business, but that's any business risk, especially when you KNOW what the future holds in store for your business - regulation.

The black market may help those that already know there way around, but for the vast majority of current and future smokers who want to make the switch the black market is not going to help. The ignorant lazy attitude of black market solutions is in fact a death knoll for millions of smokers.

No, no, it's not. There are far too many ex-smokers turned vapers out there to encourage others to quit. "So, where can I get one of those?" "Here, let me help you". Done. We're already doing that today. People at work ask me about it every day (I work in a large company), and I take them to the vape shop, explain their options, and help them out. OK, so worst case I take them online and help them out instead of going to the B&M. Not really a big difference there. Ever introduce someone to FastTech?

I hope none of this fear-mongering comes to fruition, and will fight the good fight along with everyone else, but in the end, I know everything will be just fine, either way. I'd rather see the B&M's stay in business. Some of them have become friends, and it's nice to be able to sit down at the juice bar. All we can do is follow the guidance of the experts, such as CASAA, and hope for the best - but the worst really isn't all that bad.

IMHO, it'll end up somewhere in the middle. B&M's will still be open, selling less variety of products and juices, and that'll be just fine for those wanting to quit smoking. The rest of us - those with more than a single mod - are hobbyists, and will get the new products that get announced from our favorite manufacturers, by whatever means necessary.

Okay, I may have been a bit harsh on that last one..... so it goes.....

Yes, yes you were. I don't know where you're getting your opinion from, but I get mine from experience with other industries. All this fear-mongering about how everything will magically disappear is just... plain... wrong.

 

[mkbilbo]

I agree, though, some of the biggest hurdles are still on the table. There is no way smaller companies can keep making their own liquids with the current approval process. They IMO DID NOT HAVE TO regulate hardware. I don't see Innokin and the like seeking approval from the FDA. These regs are designed to kill the specialty business. If we don't change this, its GAME OVER. Bill G, Greg C, and all the others who are versed have been cautioning everyone of the approval process and the SE pathway. This has not changed. The sooner vapers realize there products are STILL in danger, troops can be set forth to rally.

There is no doubt, the FDA has bit off more than they can chew here, but that doesn't mean they wont be slapping heavy fines to those who don't comply. This needs to get fixed legally, no workarounds.

Oh there are trap doors in there for sure but I refuse to panic. They clearly are accepting that vaping is going to be around in some form or other, they didn't start at: "KILL IT!" as some nations did and do. And as they, themselves, attempted with the classification as medical devices (which blew up in their faces).

And some of the regs are rather reasonable. Sure, the vast, vast bulk of the vaping business now are vapers who aren't solely out to make a profit--as in profit at all costs and screw the customers--but the more this thing grows, the more it'll attract the dishonest out to make a quick buck. Imagine what it would do to the vaping world if a significant contamination event ripped through, putting people in hospitals or some such. Somebody will try sell bad juices. It's going to happen. Not everybody is a good person. Some are going to see dollar signs and not give a flip about quality and safety. Somebody needs to police them. Some degree of disclosure, testing and inspections isn't necessarily a bad idea.

While it is certain the ANTZ and pharma will be working to bend this to suit their agenda and people can't sit back and "relax", it's still not as bad as it could have been. They're not going to get their first proposal. People are going to push back. A lot. Starting at this point rather than, say, a total ban, is better. Not that it's puppies and kittens and ice cream for all but look at what folks in, oh, doesn't Australia have a pretty much blanket ban? And folks in the EU are fighting heavy regulation if not outright banning.

I mean, the FDA could have started with, "off the market until proven safe". They actually have the legal authority to do so. But they're not starting there. I, for one, would rather start from this position than where a lot of folks are being forced to start.

 

[Kent C]

As I understand it, Conley has resigned from the CASAA board. Phil Busardo's headline is unfortunate, therefore.

Conley is currently president of the American Vaping Assn.: The American Vaping Association

Ah... our first lobbying group. I'm sorry but my long ago 'rent-seeking' posts were rejected out of hand by some here. I'm just highlighting some things. As I told someone - when the hammer comes down, clarity occurs.

 

[krawhitham]

Just finished reading through the whole thing, and I think it's completely bad. Here's what struck me that I can remember off the top of my head after a first reading:

1) All e-cig, e-liquid and DIY nicotine mfg's will have 2 years to submit a new tobacco product application. Note that NO new tobacco products have EVER been approved by FDA

They approved new Newport non-menthol cigarettes last June

 

[mkbilbo]

(2) The petition contains false statements. The very first sentence is FALSE. The FDA has only PROPOSED regulations.

Even the title I saw is badly flawed. There's no "veto" available. The FDA has authority granted by Congress from the 2009 bill. Not that the executive has no power with regulatory bodies but they were designed to be somewhat independent and it's not simple as a veto stamp.

 

[Kent C]

Hey, Kent...

It's hard to tell what interests anyone or any group represents in the vaping world.

History if similar situations and similar behavior gives a good guide. See my reply above.....

 

[KODIAK (TM)]

My take on all of this is simple: If the FDA was able to recognize vaporizors as a health risk, they would have done so. In that case, today's report would have been vastly different.

The FDA has taken a "please present us with your evidence" approach that vaping is safe. No one has been sitting on their hands. There have been umpteenth studies that are already completed or will be completed soon.

Vaping will not be banned. Will it be regulated? Of course, and it should be.

If you're going to present a product as being safe, prove it.

If you're going to present a product as being a successful stop-smoking device, prove it.

In other words, prove your claims. Others have done and will be doing the studies. There's the evidence to present to the FDA.

Will it cost money to do so? Of course, but that will be the cost of doing business.

The fact is the "wild west" days of anything goes was never going to be forever. No more titanium dioxide travesties in vape juice.

It looks to me like the FDA is taking a look at an industry in its infancy and is letting it develop.

As for BT taking over: Maybe. They're a big business. Their business model is changing and they're going to change with it.

Did vapers get everything we wanted? Of course not. But neither did the hysterics that have sweeped the country. They're the big losers in this. The FDA turned their backs on hysteria.

IMO, The FDA has all but said "vaping is here to stay".

This post is so naive and contains so many fallacies I can only shake my head.

 

[2coils]

EVERYONE, check your email! The White House just responded to the petition from a year ago!!

 

[mkbilbo]

Interesting, this just dropped into my email...

https://petitions.whitehouse.gov/response/regulation-electronic-cigarettes-fda?utm_source=wethepeople&utm_medium=email&utm_content=ecigarette-response

It's the response to an older, previous petition. And has some interesting comments. Such as:

We know that those applications may require time and resources to develop. That's why the FDA does not intend to take legal action against manufacturers for marketing their products without prior authorization until the FDA issues its decision on the application -- so long as the manufacturer gets its application in within two years and thirty days after the final rule is published. Our hope is to provide manufacturers flexibility as the FDA completes its review.

Nothing is going to happen overnight. The application deadline alone is two years. And the regs can't go into effect immediately.

It's not so much a "doomsday" as a protracted trench war...