White House OMB rejects FDA's draft regs for e-cigs as too restrictive, tells agency to draft/submit a new proposal

[Bill Godshall]

Smokey Joe wrote:

If it helps, ECF traffic has doubled year on year for the past 5 years, and the latest December to February period has seen by far the biggest increase - if it continues at this rate we may see a trebling of traffic this year (hence a massive server migration happening soon!). Clicks out to suppliers have remained proportionally the same (Ie in line with overall traffic), so my assessment is that B&M visibility is driving the whole thing forward, and that a segment of the new market is also looking online.


Wow

That's refreshing, and may be the best (and perhaps most important) news I've read in months.

Unless and until FDA bans online sales of e-cig products, the Internet will ensure vapers' and smokers' access to the vast majority of e-cig products. Even if FDA imposes a ban or restrictions on online sales (which likely won't occur for at least two more years), it remains to be seen if FDA could enforce any ban or restrictions on Internet marketers located in other countries (outside the reach of the US Justice Department), where many e-cig companies are likely to relocate if/when FDA imposes an Internet sales ban.

There's been negligible, if any enforcement of e-cig sales bans over the Internet to consumers in nations that have banned e-cig sales, which is why most Canadian and Australian vapers buy on the Internet from companies in other countries.

Here in the US, excessive state taxation and/or unwarranted state regulation of e-cig manufacturing, packaging, labeling and/or retailing of e-cig products will just encourage vapers and smokers in those states to purchase vaping products from the Internet.

Its also doubtful that any future state laws that ban or restrict e-cig sales on the Internet can be enforced, at least against companies located in other states (as states have no legal authority to regulate the Internet, and it would cost states lots of money they don't have to try enforcing).

So it appears that Internet sales of e-cigs has been, and will continue to be the chief beneficiary of national and state laws that ban, unfairly tax, and/or excessively regulate e-cigs and their marketing, while the chief losers are e-cig businesses located in jurisdictions where those laws are enacted.

 

[Uma]

You're kidding, Uma? Please tell me you're kidding. They're only going to keep the dangerous part of burning tobacco? I bet you could roll and smoke spinach leaves and find more dangerous tars than anything in our liquids.

Wish I could say I were.
smoke & tar kills living cells dead. Nicotine multiplies living cells. (Opposes the smoke, balances out the smoke). Ever hear of "smokers paradox"?. IMO, Without the nicotine, smokers will be zombified or dead. End game. ANTZ win.

Bill, sorry I didn't make myself clear.


I'm quite aware of the FCTC non-ratification. That wasn't really my point - it's much more about having an organisation with international clout pronouncing on the issue. In other words, this is a battle of ideas not science or law.


Zeller's appointment is a political one. He needs to be seen to be on the right side of history, or that he had his hand forced. Sure, the FCTC can't force it through legal mechanisms, but it will certainly influence public opinion, media reporting and politicians. We already know that Stanton Glantz (and Neal Benowitz, sadly) are writing the e-cig book for the WHO (http://dropproxy.com/f/661 - PDF), and if the FCTC COP sides with their assessment they will have a huge lever.

Change lab solutions has been outlining how to ban eCigs and tobacco, using innuendos over and over again until the "aha!" Clicks in. The innuendos consist of licensing, sting operations, revoking licensing, bans, banning town by town, etc. (Creating blackmarketing)
How to Regulate E-Cigarettes and Other Electronic Smoking Devices in Your Community | ChangeLab Solutions
(Trust me, there are a lot more of these "guidance" pamphlets there).

The WHO follows it up with their Deadline goals, of licensing, revoking, tracking, fees, fines, imprisonment, ... (For black marketers)
All 3 go hand in hand, all supported with big Pharma money.
http://www.who.int/fctc/protocol/about/Protocol_overview_Oct2013_EN.pdf?ua=1

 

[DrMA]

snip...
We already know that Stanton Glantz (and Neal Benowitz, sadly) are writing the e-cig book for the WHO (http://dropproxy.com/f/661 - PDF), and if the FCTC COP sides with their assessment they will have a huge lever.

I think the e-cig industry and/or consumers themselves need to hire their own experts to refute the Slantz "Background paper" ASAP. This has been done before in response to the FDA summary of electronic cigarettes during the 2009 trials.
http://casaa.org/uploads/Exponent_Response-to-the-FDA-Summary.pdf

I just so happen to be currently employed by Exponent as a Managing Scientist and our Health Practice could easily take on this task and present the real science. Unfortunately, I cannot convince the upper management to take on such a task pro bono...

I'm thinking we should be setting up a crowd-funded initiative like the latest Farsalinos study... Thoughts?

 

[Uncle Willie]

I think the e-cig industry and/or consumers themselves need to hire their own experts to refute the Slantz "Background paper" ASAP. This has been done before in response to the FDA summary of electronic cigarettes during the 2009 trials.
http://casaa.org/uploads/Exponent_Response-to-the-FDA-Summary.pdf

I just so happen to be currently employed by Exponent as a Managing Scientist and our Health Practice could easily take on this task and present the real science. Unfortunately, I cannot convince the upper management to take on such a task pro bono...

I'm thinking we should be setting up a crowd-funded initiative like the latest Farsalinos study... Thoughts?

Start a thread and ask the Industry, i.e. those that are making the money and see if they would be willing to pony up .. it's high time the "industry" put some meat on the bones, IMO ..

 

[Roger_Lafayette]

I'm a little confused about why states can't impose their own taxes, labelling, and manufacturing/registration requirements on vendors Or a F2F sale requirement for that matter. Let me split this up into two types of Qs.

1) Will the courts support it? Yes, there's pre-emption (which congress can deal with, if the folks back home want them to). And there's the commerce clause (would that stop congress from mandating F2F sales? or allowing the states to do so?). Equal protection (states would have to treat all vendors equally). Rational basis? Naah. If the case against court enforcement is so strong, why are all these jurisdictions even bothering? (Surely there must be someone in the state of MN who knows this area of the law well enough.)

2) If the courts do support it, what about the enforcement practicalities? We've already seen this with analogs. A state can sue a vendor in another state for violating its laws. If I (knowingly) mail a bottle of booze to a minor in another state, am I safe? It's a criminal violation, so I could be extradited. But if there's a civil penalty, the state-in-Q could easily enough file suit against me in my home state.

Lots of people think that they don't have to pay the $250 of parking tix that they ran up in their previous state. True enough. But only because it's not worth it for the state to try to collect them. But if you're a big enough vendor, it most certainly is (imagine if you owed $50,000 in parking tickets.)

And once a state gets the sales data from a large vendor (as part of a settlement), then of course it can generate bills for all the customers. (Also done with analogs, quite successfully.) Remember there are plenty of enforcement fines that states can levy to get their costs back. It's messy, but not impractical. The states could even sell their rights to private parties, who would go about handling the mechanics of collection (it's like any other form of debt ... damage awards and other monetary legal judgements are bought and sold all the time. Or they could outsource the collection process. Really, it's not a huge problem - as long as there's an expected return which would justify the investment, as a result of fines and penalties. Typically these statues penalize violaters per infraction. Adds up fast.

Foriegn vendors? Well, actually US customers used to sieze analogs all the time. But beyond that, there's the Q of economies of scale. No one is going to ship (or buy) 10 ml. of e-juice from China, it's not worth it. A few liters of high-concetration nic. juice? Maybe, but would the customer really want to do that for their own use from an unknown faraway vendor? (Maybe Europe or Canda. But then the states could go after the larger vendors, just as they would if these vendors were located in another US state.) And usually the stuff from overseas gets funneled through a US retailer or distributor before it reaches a retail customer.

I hear folks talk about Canadian vapers who buy from US vendors. But the issue w/ Canada is that they don't have anything on the books that would entitle them to levy heavy taxes or fines/penalties/etc. All they have is that HC directive, which doesn't (as far as I know) connect to specific statues with particular penalties. If they did, it would definitely be worth it for Canada to go after US vendors. They'd start with the big ones. Eventually smaller US vendors would decide that it wasn't worth it.

Maybe I'm missing something here?

 

[DrMA]

Start a thread and ask the Industry, i.e. those that are making the money and see if they would be willing to pony up .. it's high time the "industry" put some meat on the bones, IMO ..

Good idea.
http://www.e-cigarette-forum.com/forum/showthread.php?t=532905

Not much interest so far...

 

[Oliver]

So it appears that Internet sales of e-cigs has been, and will continue to be the chief beneficiary of national and state laws that ban, unfairly tax, and/or excessively regulate e-cigs and their marketing, while the chief losers are e-cig businesses located in jurisdictions where those laws are enacted.

Possibly, or another way of looking at it is within the context of the growth of both the e-cig sector specifically and online sales generally. Vape stores are, in a sense, a bit of an odd occurrence in an era in which traditional retail is seeing an overall decline. There are obvious reasons for their success, however - principally the emergence of the vaping subculture, and the need for consumers to experiment with different products; best done in a high street location (try before you buy, in other words).

Not doubting the impact of state and national laws, by the way. They are either having an impact currently, or will have an impact going forward - but there are multiple influences at play here.

 

[sonicdsl]

I wonder how this development will affect what the FDA puts together?

The EU today has voted to effectively kill ecigs today (not a straight ban, but nearly).

For example: Nicotine capped at 2.0% (20 mg/ml)!!

See this thread:

http://www.e-cigarette-forum.com/fo...urope-has-fallen-big-money-has-triumphed.html

Just shameful.

 

[Uncle Willie]

Good idea.
It's time for the ecig industry and consumers to get involved

Not much interest so far...

I checked your new thread .. only suggestion I would have is to give at least a rough idea of the cost and what amount of time it would take .. get some endorsement if possible from SmokeyJoe or other ECF honchos .. PM the registered vendors and gauge interest ..

 

[sonicdsl]

SJ posted in the thread earlier... consider ECF honchos involved, well, at least interested.

 

[aikanae1]

The internet is not secure. If a foreign country markets to US citizens, the DOJ considers them within their jurisdiction. There's extradiction treaties everywhere. All credit cards report sales to states already. Most vendors are being forced to charge state taxes. The reason ppl can't buy cigs online is due to a boycott from credit cards. The end. Even if you are able to find someone to ship, you can get a bill or fine 6 months later and the debt can be sold which will triple, may include criminal charges for non payment. It's amazing how efficent they can be on this stuff.

One of the things I spotted in the summary of the EU legislation this morning;
"The new Directive includes strong measures against illicit trade of tobacco products to ensure that only products complying with the Directive are sold in the EU. It introduces an EU-wide tracking and tracing system for the legal supply chain and visible and invisible security features (e.g. holograms) which should facilitate law enforcement and help authorities and consumers detect illicit products. The measures foreseen in the new Directive will help to redirect tobacco trade to legal channels, and may also help Member States restore lost revenue."
EUROPA - PRESS RELEASES - Press release - Questions & Answers: New rules for tobacco products

Yup. It's about the revenue. Most states (and I think Calif was one) sold their tobacco settlement for a one time cash payment of about $0.30 on the dollar. They also banked on the fact that sales would continue to grow. So now they still owe that money due to selling bonds. They have an investment to see ppl continue smoking. I'm sure there's more indepth articles than this, but essentially the tobacco market may also be considered to big to fail.
http://www.economist.com/news/finan...ette-sales-may-be-harmful-your-wealth-unlucky

 

[sqirl1]

awesome news. the longer it takes the less likely they are to do much as our industry just keeps getting more and more solid. pretty soon we'll have almost as much lobbying power as John$on and John$on

 

[CabinetGuyScott]

...

Yup. It's about the revenue. Most states (and I think Calif was one) sold their tobacco settlement for a one time cash payment of about $0.30 on the dollar. They also banked on the fact that sales would continue to grow. So now they still owe that money due to selling bonds. They have an investment to see ppl continue smoking. I'm sure there's more in-depth articles than this, but essentially the tobacco market may also be considered to big to fail.
http://www.economist.com/news/finan...ette-sales-may-be-harmful-your-wealth-unlucky

Here's a really really happy thought / fantasy...

According to this article in the Economist, California & New York were early adopters to selling their tobacco settlement monies in bonds.

If cigarette sales continue the downward trend, highly fueled by our vapors, and the tobacco companies further reduce their payments to the states, could it be possible that we could tip CA & NY over the financial cliff?

Oh the sweet irony if it were to be so

 

[Katya]

Here's a really really happy thought / fantasy...

According to this article in the Economist, California & New York were early adopters to selling their tobacco settlement monies in bonds.

If cigarette sales continue the downward trend, highly fueled by our vapors, and the tobacco companies further reduce their payments to the states, could it be possible that we could tip CA & NY over the financial cliff?

Oh the sweet irony if it were to be so

Have mercy...

 

[pamdis]

Here's a really really happy thought / fantasy...

According to this article in the Economist, California & New York were early adopters to selling their tobacco settlement monies in bonds.

If cigarette sales continue the downward trend, highly fueled by our vapors, and the tobacco companies further reduce their payments to the states, could it be possible that we could tip CA & NY over the financial cliff?

Oh the sweet irony if it were to be so

They will never let this happen -that's one of the reasons why they are trying so hard to keep us smoking, and why if we don't, they will tax the heck out of e-cigs instead.

 

[Jman8]

I'm not feeling like this is good news, anymore than I felt when April 2013 came and no de facto ban was in place. As that was 10 months ago, then we are really in awesome news category from that period. I recall being one of the naysayers (claiming nothing significant would happen then) and most everyone else online saying, "but it will someday!"

Well from what I gather, that is still in effect and I think the potential de facto ban is alive and well, not to mention usage bans have gone from potential to historical.

Thing is, a vaper can get around usage bans, and flavor bans and even nicotine restrictions. But the online one would be very tough to get around. I still think flavors is the biggest deal of them all as I don't have the resources, nor time to make the million combinations currently available to me and what clearly makes vaping the better experience to all other ways of getting nicotine, or even enjoying a habit that doesn't include nicotine. This thread has suddenly made me a little more concerned about online sales ban even while I don't think that will ever go away entirely for as long as the world wide web is in existence.

 

[Roger_Lafayette]

<snip>But the online one would be very tough to get around. I still think flavors is the biggest deal of them all as I don't have the resources, nor time to make the million combinations currently available to me and what clearly makes vaping the better experience to all other ways of getting nicotine, or even enjoying a habit that doesn't include nicotine. This thread has suddenly made me a little more concerned about online sales ban even while I don't think that will ever go away entirely for as long as the world wide web is in existence.

You can "pay your money and take your choice" when it comes to the effect of internet sales restrictions. I'm one of the folks who think that they can and will be effectively enforced, although it may be some years before all the sellers are brought into line by the states that want to take their cut in taxes (or protect minors, allegedly). But the financial incentives for the states to do this are clearly there, and the pragmatic realities are hardly daunting. They successfully did it with analogs, after all. Why should vaping be different?

Most of us are beginning to stock up on DIY supplies, because that's where one critical choke point exists: water-soluable nicotine. There's a good thread out there on storing it: http://www.e-cigarette-forum.com/fo...ttle-help-freezing-nic-juice.html#post2126610

***

Equipment is the other crucial issue ... personally, I'm not all that handy with hardware, so I'm going to have to try to figure out what sort of rebuildable is easiest to make and maintain. Batteries are going to be a real bear. If the US takes the same stance towards batteries as the EU has, then the ideal homemade rebuidable is going to have to use rechargeable batteries that have other common applications (e.g. cell phones, etc.). I bet there's already a thread out there somewhere on this.

***

Flavors may not as much of an issue, depending on how picky you are. Water-soluable flavorings have too many other uses, it's simply not going to be practical for the gov't to ban them or require a license to purchase them. Ditto PV and VG.

Lots of places sell those little plastic or glass bottles. The plastic ones come with drippers, and places like The Flavor Apprentice or My Freedom Smokes will sell you glass bottles with eyedroppers. It's taken me about a month to get a menthol and a tobacco flavor that I like. They're still nowhere near as sophisticated as Johnson Creek, but just as satisfying in a different way. You can get a lot of great advice on the DIY forum, many posters put recipies up on their blogs.

What I personally do is to "fiddle" by dripping in small amounts of flavoring until I think I'm ready to make a test batch. And then I just keep on "fiddling" until I think I'm ready to start putting it into "production" - i.e. make 15 or 30ml at a time. Really, it's a lot like cooking ... you might not be able to make a lasagne that's as good as a great Italian restaurant in your own kitchen (well, I can't) but beating Fazolli's is definitely a goal within reach.

***

All in all, I'm much more concerned about the equipment problem than I am about flavors. I don't mind vaping a flavor that might be less than ideal. But if I have to deal with a leaking PV or my batteries fail, then that's a completely different story. And that's not to mention the safety issues that can arise with failing homemade equipment. It's also much more expensive to have all the electronic gear that you need to test things like voltage levels, etc. Messing around with flavors is pretty cheap, easy, and foolproof by comparison.

The one good thing I have to say about equipment is that I don't think US authorities are going to be moving as aggressively on the equipment front as the EU. They appear to be more concerned with the all-in-ones (what some folks call "cigalikes"), and e-juice. But when the time comes, don't underestimate their abilities. I remember when they cracked down on "paraphernalia" back in the 70s and 80s. That will be the justification this time, too - it won't be about vaping, it will be about enforcing drug laws. And it will be just as illegal to sell it to vapers as it was some decades ago. (Although I'm not worried that juries are going to convict ordinary vapers for having homemade vaping equipment ... therefore I'm not worried that prosecutors are going to bring these cases to trial.)

***

But realistically: we might want to plan for the day when our only commercially-available option will be non-refillable all-in-ones (or "cigalikes" if you will) from B&Ms. Perhaps these will come in tobacco flavors, or they may simply be unflavored. People will try to tear them apart to make them refillable, but the FDA will react by issuing regulations to make this more and more difficult. Of course those reg.s and the taxes will push the price up to stratospheric levels. It's certainly possible that it will become cheaper to smoke tobacco cigarettes at some point. I'm not ready to get rid of my RYO (injector) machine just yet.

I hope that these scenarios will never come to fruition, but I think it would be wise to plan for the possibility. Right now our only "friends" with deep pockets are the BT companies, and they're going to make a killing if we all have to buy non-refillable cigalikes at B&Ms, and/or it's actually cheaper to smoke tobacco cigarettes.

BT, the regulators, most politicians, and the lion's share of the public health community all regard that as an ideal outcome. It serves their pocketbooks and/or jibes with their world view. The public at large couldn't care less. So our only choice will be to learn how to fend for ourselves.

***

Over the very long term, I anticipate that TNSAs (tobacco-specific nitrosamines) could theoretically become a Schedule I controlled substance. (Although nicotine has medical uses, it can be derived from other substances). But I think that's at least a couple decades away, if it ever happens.

For the forseeable future, it's going to be too expensive to put tens of millions of vapers and/or smokers in prison. The public at large just won't stand for the tax increases needed to do that, even in the event that a PR campaign could be successfully mounted on behalf of criminalizing nicotine use. And anyway ... gov'ts, BP, and BT all need the revenues from keeping it legal

 

[Sundodger]

Roger....I don't think you will see any B&M's left if all there is is cig-a-likes only left to sell and buy. They already have them stacked near cigs in drug/convenience stores, there will be no need for the B&M's. The only way they may survive would be that sampling would still be allowed, flavors remain legal, and no vaping/sampling in any store that isn't vape equipment only.

 

[Roger_Lafayette]

Roger....I don't think you will see any B&M's left if all there is is cig-a-likes only left to sell and buy. They already have them stacked near cigs in drug/convenience stores, there will be no need for the B&M's. The only way they may survive would be that sampling would still be allowed, flavors remain legal, and no vaping/sampling in any store that isn't vape equipment only.

I wasn't referring to vape stores. Just B&Ms as opposed to over the 'net.

 

[rothenbj]

"Equipment is the other crucial issue ... personally, I'm not all that handy with hardware, so I'm going to have to try to figure out what sort of rebuildable is easiest to make and maintain. Batteries are going to be a real bear. If the US takes the same stance towards batteries as the EU has, then the ideal homemade rebuidable is going to have to use rechargeable batteries that have other common applications (e.g. cell phones, etc.). I bet there's already a thread out there somewhere on this."

I have flashlights that use the same rechargeables that are used in my e cigs. In fact, I bought an LED light that uses 18650's that just amazes me with the light it produces and how long I go between recharges. It wide angles 30-40 yards or telephotos out to over 100 yards. Batteries are not an issue.

Actually, I'm not really worried about any bans on hardware whatsoever or flavors for that matter. The biggest issue would be control over nicotine, if the FDA decides to go that way.