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onehandle

(51,122 posts)
Thu Apr 24, 2014, 12:38 AM Apr 2014

F.D.A. Will Propose New Regulations for E-Cigarettes

Source: New York Times

WASHINGTON — The Food and Drug Administration will propose sweeping new rules on Thursday that for the first time would extend its regulatory authority from cigarettes to electronic cigarettes, popular nicotine delivery devices that have grown into a multibillion-dollar business with virtually no federal oversight or protections for American consumers.

The regulatory blueprint, with broad implications for public health, the tobacco industry and the nation’s 42 million smokers, would also cover pipe tobacco and cigars, tobacco products that have long slid under the regulatory radar and whose use has risen sharply in recent years. The new regulations would ban the sale of e-cigarettes, cigars and pipe tobacco to Americans under 18, and would require that people buying them show photo identification to prove their age, measures already mandated in a number of states.

Once finalized, the regulations will establish oversight of what has been a market free-for-all of products, including vials of liquid nicotine of varying quality and unknown provenance. It has taken the agency four years since Congress passed a major tobacco-control law in 2009 to get to this stage, and federal officials and advocates say it will take at least another year for the rules to take effect — and possibly significantly longer if affected companies sue to block them.

“If it takes more than a year to finalize this rule, the F.D.A. isn’t doing its job,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids, an advocacy group.

Read more: http://www.nytimes.com/2014/04/24/health/fda-will-propose-new-regulations-for-e-cigarettes.html



And the gold rush for the 'next frontier' of big tobacco, who have been buying up or developing their own e-cigs, will come to an end.

Many communities, (For instance, Philadelphia is waiting for the mayor to sign the law) are simply rolling them into existing smoking restrictions. This is what makes the most sense.
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cthulu2016

(10,960 posts)
1. This will greatly assist the big tobacco companies in future control of the e-cig market
Thu Apr 24, 2014, 12:44 AM
Apr 2014

The will be far better situated to deal with any regulatory regime.

Treant

(1,968 posts)
2. True that
Thu Apr 24, 2014, 12:50 AM
Apr 2014

I expect everything but the most basic cartomizer will be banned. Which will keep smokers smoking instead of moving to the NRT of the e-cig.

Yeah, well, so what? People die, but they were smokers and hence worthless since we throw away addicts anyway.

On the up side, the FDA tripped over itself to approve the NicoMist, or whatever crap that is, with a dozen chemicals--all of which are in e-cigs, plus many others besides.

So they're busily being bribed by their pharmaceutical friends quite nicely and should have good retirements. Smokers who want to quit? You lose.

bhikkhu

(10,718 posts)
3. Perfectly reasonable regulations
Thu Apr 24, 2014, 02:07 AM
Apr 2014

While I don't think they will prevent under-age use, any more than kids can't get get drugs, alcohol or cigarettes if they are determined, its still a good rule.

And I'm glad they are requiring ingredient disclosure, the same simple rule most everyone else has to follow. For the most part, as I understand it, the main ingredients come from products made for the food industry anyway, which are labeled themselves, so it shouldn't be a great inconvenience for the e-cig producers.

 

jtuck004

(15,882 posts)
4. E-cigs have 2 deaths in 4 years attributed to them. Tobacco kills 480,000 early each year.
Thu Apr 24, 2014, 02:08 AM
Apr 2014

In the United States, tobacco use is responsible for nearly 1 in 5 deaths; this equals about 480,000 early deaths each year. (Source: Cancer Facts & Figures 2014; and US Surgeon General Report 2014)

The New England Journal of Medicine is suggesting that for those smokers who, like many, have tried the useless and wasteful gums, patches, and other tx's that don't work for the vast majority of tobacco smokers, that physicians tell them it is likely less harmful and suggest they switch, with some help.

Too bad Dr's are the only ones who take an oath to do no harm, even though I'm not really big on the power of oaths.

Perspective:
45 million tobacco smokers. <- these are now, generally, the harder core addicts, the 15% of the population that consistently smokes, even after years of work to reduce the numbers (used to be about 40%, but it dropped, then plateaued).

Between 2 and 4 million vapers, e-cig users, etc. And that's after several years of good marketing. Not much of an inroad to be all wrought up about, it seems.

Regulation. There should be a law that says they can't be sold to minors. Much better that kids get the regular tobacco cigarettes that junior high kids can be seen smoking any damn day, dying in front of our eyes. And we should make it illegal to let infants play with them, I guess. It's illegal now to endanger their welfare, but that hasn't stopped a whole bunch of people who harm them in other ways. But if a law makes someone feel better...

Some people see a potential boogey monster associated with e-cigs (which I think has much to do with their being marketed as "e-cigs" while having nothing to do with tobacco cigs) and want to wait for research that they are "safe". A half a person a year killed, vs 480,000, because they either injected the ejuice (that's not how it's done) or gave it to their baby to play with, and he or she drank the stuff. (There isn't a law that would have saved that kid from neglect, I suspect. And one should note that far more children under 5 are poisoned by getting tobacco cigs from the counter or table or purse when the adults aren't looking, and far more are poisoned or die from simple household cleaners and drugs. Gets better after age 5, btw, according to the CDC). One should note - there is not even a category for deaths from e-cigs in the poison center's reports - there are so few they are only footnotes.

Maybe if the regulations are really tough we could have a party, dance on the graves of the mothers and fathers and children who will die early from smoking tobacco cigarettes - graves that were filled much too early, graves that could have remained empty if they had substituted a relatively benign vaping pipe for their cigs - if it hadn't been for barriers placed in their way.

I know it's hard for regulators to see the harm they might impose from atop that big high horse. Or maybe some really don't care about a couple hundred thousand preventable deaths, as long as their ego gets stroked, despite their bullshit protests that "it's all about the children". (It's about themselves). The e-cigs have been around since the 60's, and gotten really popular in the past 10 years or so, now in the U.S., and people want so bad to find something terrible that they would let innocent people die, rather than acknowledge there is little or no evidence of any thing more harmful than most of the environmental stuff around us that is allowed in much greater quantities every day. Like sad little teaparty protestors, will make reality what they want it to be.

Ironically, those who want to regulate it are a great help to big pharma, a group who is now and has been harmful for us for quite a while, part of the reason we pay so much and get so little health care in this country, The big pharmaceutical companies and the people with their noses far up their asses are the largest supporters of this regulation, and their lobbyists are pushing hard for the gov to protect their profits. They stand to lose big on their snake-oil smoking cures that don't work, as well as the money they make from the cancer treatments.

Big tobacco has actually bought into this, and, frankly, regulation will help them as well. The revenue is still a small part, because they are still in the tobacco business with markets outside of here. They likely welcome some of whatever regulation anyone thinks they can get through, because they have lots of money, and are in every stinking store in the country. It very likely won't do much except help their revenue. The people making the most from this, (and it's only 2 to 4, maybe 6 million users, compared to the 45 million tobacco users out there) - are smaller companies, and it's kind of spread out, so not exactly a big goldmine. But regulation could easily make it impossible for them to do business and leave big tobacco in the driver's seat again.

Regulating e-cgs makes it easier for Walmart to sell them as well, and allows Paypal and Ebay and Amazon a chance at those profits they are missing because they won't deal in the part of the unregulated market. On the other hand this regulatory push is very likely to drive some out who need to be gone, but stands a real chance of harming the business of the many thousands of very small mom and pop stores that have opened to deal in this. Big pharma will probably send the FDA a big thank you card for this, and big tobacco will probaby sign it.

Not saying that it doesn't deserve a look at. But the harm that is happening today all around us is real, deadly, and tragic. There is a lot of data and time behind us that says the e-cig is a safer substitute, and as such can save lives, There NO data that says these are anything but relatively benign when used as they should be, by those who should be using them, and I doubt rather seriously that the law is going to do much to stop anyone, anywhere, who wants to ignore it.

Unless you can figure out how to make the main ingredient, concentrated vegetable oil, illegal. Ready to stop frying?

http://www.cancer.org/cancer/cancercauses/tobaccocancer/tobacco-related-cancer-fact-sheet

Tobacco-Related Cancers Fact Sheet <- None of which are associated with e-cigs.

Lung cancer is the leading cause of cancer death in the United States for both men and women. (Source: Cancer Facts & Figures 2014)
Lung cancer is the most preventable form of cancer death in the world. (Source: Cancer Facts & Figures 2014)
Lung cancer estimates for 2014 (Source: Cancer Facts & Figures 2014):
New cases of lung cancer: 224,210
Males: 116,000
Females: 108,210
Deaths from lung cancer: 159,260
Males: 86,930
Females: 72,330
Women smokers are 25.7 times more likely than women who never smoked to develop lung cancer. For men smokers, it’s 25 times the risk of men who never smoked. (Source: US Surgeon General Report 2014)
Besides lung cancer, tobacco use also increases the risk for cancers of the mouth, lips, nose and sinuses, larynx (voice box), pharynx (throat), esophagus (swallowing tube), stomach, pancreas, kidney, bladder, uterus, cervix, colon/rectum, ovary (mucinous), and acute myeloid leukemia. (Source: Cancer Facts & Figures 2014)
In the United States, tobacco use is responsible for nearly 1 in 5 deaths; this equals about 480,000 early deaths each year. (Source: Cancer Facts & Figures 2014; and US Surgeon General Report 2014)
Tobacco use accounts for at least 30% of all cancer deaths, causing 87% of lung cancer deaths in men, and 70% of lung cancer deaths in women. (Source: Cancer Facts & Figures 2014)

brett_jv

(1,245 posts)
6. Excellent post, thanks ...
Thu Apr 24, 2014, 04:35 AM
Apr 2014

I'm hoping all that 'comes of this' is the good stuff: Product ingredient labeling (my bottle of e-juice says what it has in it already, though the 'flavoring' ingredient is a bit vague), restriction on purchasing to people 18 and over (who can disagree with that ... though the store I buy from already enforces that), and a restriction on unprovable health claims (I took up vaping w/o EVER hearing from ANYONE that it was 'less harmful' ... but after 1 year off of tobacco and strictly vaping ... I don't need anyone to tell me it's less harmful ... that much is freaking obvious). I also hope the new regulations lead to much more expansive/thorough scientific testing of the health effects.

All that being said, my big concern is ... what you've mentioned. Which is that nobody involved actually gives a shit about what certainly appears to be significant harm reduction vs. actual smoking ... what really matters here is the cash flow of everyone potentially impacted by the current situation from Big Pharma to Big Tobacco to Big Insurance and beyond. Right now what we have in the 'e-cig' space is lots of independent, small, decentralized operations ... and ultimately, these smaller producers and distributors are likely to be put out of business if the regulations become too byzantine, oversight too strict, taxes too high, etc. Leaving only the Big Tobacco bastards who lured us in to getting hooked in the first place ... to profit from the condition of being addicted to nicotine.

I'm also very concerned that we're not too far away, with this new regulation, from seeing vapable liquid nicotine preparations taxed at a similar level as tobacco. Frankly one of the BIGGEST reasons I quit smoking cigs and moved to e-liquid was the cost. An addiction that used to cost me around $7/day ... now costs me around $1/day. Is there ANYONE OUT THERE that seriously doubts that ultimately these new regulations are aimed, first and foremost, towards preserving the REVENUE STREAM brought about by taxes on cigarettes? Millions of people switching from (taxed) cigs to (non-taxed) e-liquid has got to 'costing' government at ALL levels BILLIONS of dollars a year in 'lost' taxes ...

I mean, nevermind that many more billions will be preserved as people stop needing expensive hospital treatments under medicare/medicaid ... problem there is that nobody's done a serious study concluding that will happen yet (though I bet anything that it will prove to be true once studies ARE done), so that's not even part of the calculus involved ... all anyone sees at this moment is lost tax revenue, and no offsetting gains vis-a-vis much lower COSTS. Ultimately I think that is probably providing the biggest impetus to government to act.

 

jtuck004

(15,882 posts)
18. Imho, if we put 20% of the resources being spent on stopping smoking with the silly phone calls,
Thu Apr 24, 2014, 05:30 PM
Apr 2014

the patches, the gum, all that other snake oil toward an effort to substitute tobacco cigarettes for something demonstrably less harmful, vaping pipes, and with a little support we would come out far ahead of where we are.

Equip the former phone operators with vaping pipes and rolling carts, or shoulder bags and portable tables, or whatever. (That should be several hundred people, so we will need about 5 million cheapo pipe setups to start with, another 5 million ready soon after). Probably could get a coop to get their own vegetable glycerin, pg, nicotine syrup, perfumes flavors, etc, make the stuff for not much $. (A whole new kind of WPA). Less than $20 each, maybe 2 kinds per person). So $40-50 million for pipes, another $30 for e-liquid, parts, lab setups, etc. Say $100 million. They will need a salary and health care.

Anytime they see a smoker they offer a free pipe, assortment of flavors, and a couple of drs numbers and maybe a support group.

Put them in groups in the largest concentration of smokers - and set them in motion.

Let them be friendly evangelists every time they see a new smoker. Approach them respectfully, offer clean demo pipes like they have in the store, give them a hi-nicotine substitute for their cigs and a way to stay in contact, couple drs names, and some support. And a list of stores that meet some standard.

I mentioned the cost of this around $100 million. Some estimates put the cost of treating smoking-related disease over $200 billion a year in the U.S. If an effort to move people to substitutes was effective, that 100 million (plus something for salary and benefits, so add 5 x that) could save $10 or $20 billion of the above fairly easily, maybe a lot more. And prevent thousands of early deaths as well.

(Could hand them voting registration cards too.)

And while we still don't know that all the harmful effect of the vaping pipes (different from an e-cig) we do know that the early evidence sure looks like it is a far safer substitute for the addict, for the world around them, and far less costly to everyone. And we are dealing with addicts.

just doodling though

Treant

(1,968 posts)
9. Hear, hear, JTuck.
Thu Apr 24, 2014, 11:51 AM
Apr 2014

You know I'm a fan of e-cigs, which is obvious from the Spinner currently parked in my mouth.

The regs, however, seem to be sensitive to this argument. So far, nobody's found anything but:

1) Banning sales to under-18 year olds. I approve, most people would.

2) ID required to purchase. This may potentially impact the online sales industry, but so far those wiser than I don't see a problem and this seems to apply to Brick and Mortar.

3) No regulation of flavors.

4) Standard approval process. This is a potentially sticky wicket given the known delays, but we'll have to see how it plays out.

5) Questionable regulation of delivery devices. It's not very clear in the document as far as anybody's gotten yet, but batteries, toppers, and metal tubes aren't under the FDA's banner anyway and would leave them wide open to a lawsuit.

If there's a bomb here, we haven't found it yet.

Alan Selk

(17 posts)
19. bombs away
Tue Apr 29, 2014, 05:53 PM
Apr 2014

All liquid and the devices used to deliver the liquid would have to go through the process of applying as a new tobacco product. That means every flavor, nicotine strength, and perhaps ever PG/VG ratio is considered a new tobacco product. It would cost a minimum of $350.000, and that can run into the million+ range for each application, with no guarantee of being accepted.

This regulation will destroy all small and medium sized manufactures and most of the larger ones. In the end the only people who have the money and expertise to go through the process are large tobacco companies. This regulation is in fact handing electronic cigarettes to big tobacco.

This is nothing less then a very very big bomb.

 

phleshdef

(11,936 posts)
5. As an e-cig user, I believe this is a good thing.
Thu Apr 24, 2014, 02:53 AM
Apr 2014

My biggest fear was a ban of e-cigs, which, with this kind of action, likely will never happen. I also like being able to take comfort in being able to buy safer products. E-cigs are literally thousands of time safer than the real thing and they are the only thing that ever worked to get me away from smoking a pack of camel lights every day. I believe regulation of the E-cig industry ultimately legitimizes it and will encourage other smokers to step in and give it a try.

 

Bluenorthwest

(45,319 posts)
7. The vape shop I frequent already has an 18 year old minimum age and lists the
Thu Apr 24, 2014, 08:15 AM
Apr 2014

ingredients of their liquid. Not much of a change for most of us.

Treant

(1,968 posts)
8. Regs Out
Thu Apr 24, 2014, 11:23 AM
Apr 2014

For the zealots hoping for a total ban, this is a loss. (Yeah!)

Bans of sales to under-18 year olds is fine. The ID required bit could be an issue for online sales of liquid, but we'll have to see how it plays out.

The "component product" concept is very poorly-defined, which could theoretically impact things like clearos, tanks, batteries and, for pipe smokers, pipes. They'll get sued if they do that, as neither are medical devices nor tobacco-containing items.

The approval process isn't defined so far--but the regs are huge and I doubt anybody's read the whole thing thoroughly yet (I'm only around page 75). While a theoretical back door to banning, there are indications that the FDA intends to tread lightly here.

So far, there's nothing that concerns me overmuch.

jayfish

(10,039 posts)
10. "All in all, the deeming regulations are a disaster"
Thu Apr 24, 2014, 01:04 PM
Apr 2014
The Rest of the Story: Tobacco News Analysis and Commentary

All in all, the deeming regulations are a disaster. However, they are not as much of a disaster as they could have been. The positive side is that internet sales, marketing to adult consumers, and flavors are still allowed and that no products will immediately be taken off the market. The negative side is that new products will require pre-approval, virtually every product on the market will require a substantial equivalence determination (if not a new product approval), and that manufacturers will be forced to implicitly lie about the intended purpose and relative safety of the product by not being allowed to correctly point out that these products are much safer than tobacco cigarettes.

At the end of the day, while there are some positive aspects to these regulations, it is clear that science is not playing much of a role in the process. That does not bode well for the potential of electronic cigarettes to seriously challenge the combustible tobacco market, and thus to save hundreds of thousands of lives.


any product not on the market as of 2007 (which includes almost all electronic cigarette products) must either obtain a new product approval or a substantial equivalence determination. Given the snail's pace at which the FDA has processed cigarette substantial equivalence determinations, this could result in a literal quagmire of pending applications for the more than 250 brands of e-cigarettes currently on the market.

Treant

(1,968 posts)
11. I saw that
Thu Apr 24, 2014, 01:10 PM
Apr 2014

I love Dr. Siegel, but I think he's taking a worst-case path here.

I expect plenty of problems and lawsuits, but I don't expect a de facto ban via product refusal. That simply won't pass a court challenge.

 

Comrade Grumpy

(13,184 posts)
12. Treating two dissimilar things (smoking and vaping) the same way doesn't make "the most sense."
Thu Apr 24, 2014, 01:20 PM
Apr 2014

Except maybe in the mind of an ant-smoking zealot.

Treant

(1,968 posts)
13. Agreed, Grumpy
Thu Apr 24, 2014, 01:31 PM
Apr 2014

The law was written before vaping was a thing, so there are only two categories it can fit under: tobacco or medical.

Really? It's neither. In no other industry could I call a liquid that's (in my case) 0.5% pure nicotine extract a "tobacco" product. It's not anywhere near a high enough percentage, and it's an extract of one particular item, not the entire product.

Medical? No. No more so than my morning cup of tea is medical, even though it has neurological effects.

There really should be a third category--nicotine substitute?--but nobody can quite figure out what that should be.

onehandle

(51,122 posts)
14. Please PM me your home address.
Thu Apr 24, 2014, 01:49 PM
Apr 2014

I would like to spray unregulated gasses from an unregulated device into your personal space.

Clearly, this shouldn't be a problem.

No questions, please.

Treant

(1,968 posts)
15. Tut, tut
Thu Apr 24, 2014, 01:59 PM
Apr 2014

Propylene glycol has already been approved for indefinite exposure for fog machines. Not to mention injection directly into the bloodstream and use in the NicoMist inhaler (FDA approved).

So has vegetable glycerine.

Liquid nicotine is the exact same stuff supplied to the pharmaceutical industry for, among other things, the NicoMist inhaler--which the FDA has approved.

Flavorings? In your food. Which you breathe in while eating and smelling your food.

I am uncertain as to whether you're simply ignorant as to the situation or know about it and are intentionally lying. I don't care; in either case, you're quite incorrect.

jayfish

(10,039 posts)
16. Here we go. ...again.
Thu Apr 24, 2014, 02:04 PM
Apr 2014

Your posts become more and more nonsensical with everyone of these anti-vaping threads you post. You have every right to keep someone from vaping on your personal property. Oh, and I love how you've tweaked your angle by including the word "unregulated". You think it will insulate you from people asking you if you drive a car or use any other products with an atmospheric component. It won't.

Treant

(1,968 posts)
17. Hairspray
Thu Apr 24, 2014, 02:16 PM
Apr 2014

That stuff always made me slightly nervous. Sticky on my hair, sticky on my lungs. And the words "vinyl acetate" don't seem particularly welcoming.

Unregulated, too. Sprayed directly near my face. I'm probably dying of vinyl poisoning.

Strangely, my e-cig's contents are all regulated. Personally, I DIY, and like vendors, I only use pharmaceutical grade components. The FDA has even seen fit to approve them in combination with the nicotine inhalers (which include everything I use and 8 other things besides).

 

Comrade Grumpy

(13,184 posts)
20. No need for you to come over. I bought my own. Works great, too.
Tue Apr 29, 2014, 06:33 PM
Apr 2014

In fact, just stay as far away from me as possible.

Xithras

(16,191 posts)
21. Lol. According to this, they want to regulate bongs and hookas too.
Tue Apr 29, 2014, 08:13 PM
Apr 2014

I actually pulled down the 241 page proposal and started reading it myself, but had to stop when I hit that part because I was laughing so hard. According to this, making a bong in your garage would become a federal crime because you would be producing a "tobacco product" without government authorization or licensing.

There is no way in hell these proposed regulations would survive a court challenge. The FDA's claim is essentially that they have the right to regulate any device capable of releasing nicotine, whether you're talking about pipes, zigzags, bongs, or ecigs. That claim massively oversteps the actual authority granted to the FDA under the FD&C act. It's effectively the same as the FDA saying that they can regulate spoons, because they can be used to administer liquid medicines. I'm a bit shocked that they would even propose something so clearly illegal.

I don't have a problem with the FDA regulating ecigs, but they should restrict their regulation to the liquids that go in them. They can solve any perceived problems simply by regulating the nicotine.


https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf

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