FDA to hold listening session Feb 6 in Seattle on deeming and other tobacco regs, public invited to comment

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Bill Godshall

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FDA Center for tobacco Products will host a listening session Feb 6 in Seattle (in conjunction with the SRNT conference).
Public invited to comment, but must register by January 25.

To register, go to
Public Listening Session for the Office of Science, Center for Tobacco Products, FDA February 6, 2014 7:00 p.m. to 8:30 p.m. Sheraton Seattle Grand Ballroom B 1400 6th Avenue Seattle,.Washington.98101 Hotel Phone: (206) 621-9000 . Survey

I'll be pleased to assist any vaper or vendor who participates in drafting your comments.
Just send me an e-mail to smokefree@compuserve.com

Of feel free to use any of my previous FDA testimonies or docket submissions, or other presentations on the deeming regulations.
 

tombaker

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  • Deleted by rolygate
  • Reason: The FDA have tried to ban ecigs outright, and will now try to ban them incrementally (it's what they

Berylanna

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What are we commenting on? Will there be something TO comment on by Jan 25? Or is this like the DC one where they just want to hear our concerns?

How much have we talked about nicotine being self-titrating? What do we know about the FDA's concerns? Other than wanting to, as Zeller put it, "take this opportunity to regulate" ?

It seems to me like everything the FDA is doing wrong wrt tobacco and nicotine comes down to the ONE thing the FDA has to be VERY careful about in medicines, dosage delivery. This does not apply to cigarettes, ecigs, but it is SUCH a big deal with medicines that past generic "substantial equivalents" that looked trivial have KILLED people -- by speeding or slowing the delivery of a medicine that must be very tightly controlled in delivery.

The most-common one I've heard of is heart meds, but I have a friend who is a diabetic, and the speed of uptake for her meds might not kill her on the same day or week but everytime her blood sugar spends time out-of-whack, it does long-term damage.

So to me it looks like, nicotine prohibitionists aside, the other big problem is that the FDA has not had good advice on how smokers themselves absorb and tolerate nicotine uptake variations. The whole self-nitrating thing (like coffee.) The fact that pulling harder on a cigarette probably drastically changes delivery (not so with vaping, it's the hardest thing we have to learn!) and smokers all tolerate these changes and adjust for them without having heart attacks (*) or the kinds of damage diabetics get. Our damage has been from smoke inhalation, not dosage absorption rates.

* I am aware that the ultra-fast nic delivery with smoking DOES contribute to heart attacks but I think it would take no more than a SMALL study to show that no way does vaping EXCEED that, so only things wanting true "reduced-harm" claim status should need a big study on absorption rates.
 
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rolygate

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Berylanna, nicotine is not associated with cancer or heart disease / CVD (NICE PH45 UK; multiple professors of public health). It doesn't matter how ecigs operate, they are a consumer product with features determined by the marketplace not a regulator, since there is no inherent danger (according to Prof Hajek, they cannot cause harm even in the case of deliberate over-consumption).

Neither is nicotine anywhere near as toxic as our commercially-funded rivals promulgate: Prof Mayer has demonstrated that a new LD50 of up to 20 times greater needs to be established, and we also know that ingestion of 1,500mg of nicotine is not only survivable but causes no harm (there was a case of deliberate ingestion of this large amount of nicotine in e-liquid in order to commit suicide, but the only symptoms were abdominal pain and 'copious vomiting').

Unfortunately it is not the case that "the FDA has received poor advice" - they are very well aware that nicotine consumption is virtually harmless, it is nowhere near as toxic as claimed in public, and it is extremely unlikely that it can create dependence by itself (the brain chemistry is changed after smoking and people may become addicted to smoking and/or dependent on nicotine). There is no evidence at all, anywhere, in any form, that pure nicotine is reinforcing / can create dependence in never-smokers; there is some evidence (about 6 clinical trials for other purposes, in fact, identified so far) that it has no reinforcing effect at all.

The FDA want to ban ecigs because their mission is to protect the pharmaceutical industry. Government, in general, agrees with that policy, because ecigs represent a major economic threat: where will the billions of dollars that smoking generates come from if/when smoking is significantly reduced? How will the States manage without the enormous MSA payments?

This is an economic issue, not a health issue. 'Regulating' ecigs is not about health and never has been. Tens of millions of preventable deaths will occur if FDA policy is fully implemented. As an example, Prof Britton states that, in the UK, five million deaths would be prevented just in those alive today, if all smokers switched to ecigs. The US numbers are more than four times greater than that.

The FDA is actively trying to maintain disease rates that in a theoretical model would produce 20 million deaths. Although that can't be the practical situation since all smokers are not going to switch to ecigs tomorrow, and the FDA can't completely ban ecigs, it seems inevitable that those 20 million US deaths will eventually occur if FDA policy is fully or even partially implemented. We know exactly what their policy on ecigs is since they already told us: a total ban. We therefore know that the FDA wish to participate in 20 million preventable deaths, as they have told us this is their policy.

This is a commercial / economic issue. No public health agency would act to cause or participate actively in 20 million deaths, or even five thousand deaths which are an obvious consequence of a flawed policy. The FDA are a public health body when it suits them; when it conflicts with commercial incomes, they work for businesses that need to protect smoking, and the cost to public health is irrelevant.
 

Berylanna

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Berylanna, nicotine is not associated with cancer or heart disease / CVD (NICE PH45 UK; multiple professors of public health). It doesn't matter how ecigs operate, they are a consumer product with features determined by the marketplace not a regulator, since there is no inherent danger (according to Prof Hajek, they cannot cause harm even in the case of deliberate over-consumption).

I can't go THAT far, I had to give my kid ipecac for eating some cigarette butts, and that Israeli kid DID die. Keep the stuff away from toddlers. I vape sort-of near my grandkids, but I put my ecig on a 7' shelf if I have to set it down while I'm at their house.

The FDA want to ban ecigs because their mission is to protect the pharmaceutical industry. Government, in general, agrees with that policy, because ecigs represent a major economic threat: where will the billions of dollars that smoking generates come from if/when smoking is significantly reduced? How will the States manage without the enormous MSA payments?

I actually believe that the MSA payments are not part of the FDA's motivation. I think their #1 motivation is internal empire-building. Zeller keeps saying they "have an opportunity to regulate electronic cigarettes" and that is exactly right. A dept head in charge of 4 people can become a director in charge of hundreds of people and many millions of $$. From there you can climb anywhere, even Wall Street.

Secondarily they of course cannot conceive of not protecting BP.

However, none of those things would go over very big in a "listening session" and a lot of those folks are at least trying to pretend TO THEMSELVES that they are looking at how to do the right thing. So, unlike what we say to real human beings, when talking to the FDA directly, I was thinking that pointing out that the FDA in fact CAN and DOES regulate consumer products without requiring proof of efficacy and perfect dosage might at least let them see a way to keep the POWER even if they lose the brass (golden) ring.

If this has all come up before, then no point in looking at a vacation in Seattle.
 

AegisPrime

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I can't go THAT far, I had to give my kid ipecac for eating some cigarette butts, and that Israeli kid DID die. Keep the stuff away from toddlers. I vape sort-of near my grandkids, but I put my ecig on a 7' shelf if I have to set it down while I'm at their house.

Whilst you're quite right that nicotine (and all hazardous chemicals) need to be kept safely out of reach of children, I just want to point out that the cause of death of that Israeli child has not been sufficiently explained and no medical reports have come to light regarding what happened. No autopsy, no blood tests and all attempts to uncover what really happened (it's not even clear that e-liquid was the cause) have come up empty. Even one of ECF's Israeli posters was unable to uncover any details behind that tragic story.

A child died and the media blamed it on e-liquid - that's all we know.
 
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AegisPrime

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Unfortunately, even though adults are far safer from nicotine than the media like to portray, it is likely that children are vulnerable. However this applies to many materials. E-liquid should only be sold in child-proof bottles.

I agree completely - I am curious however about how many people have bought e-liquids that aren't in child-proof bottles because since I started vaping (which admittedly wasn't that long ago) I haven't had a single bottle delivered that wasn't child-proof.
 

rolygate

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Yes, it's good that this is normally the case now. You can still find the occasional product in a non-childproof bottle although it's rare.

There is a separate issue around glass dropper bottles: the best bottles are glass, but these sometimes come with an additional dropper. When you screw the dropper into the product bottle, it then becomes non-childproof. I don't know of a solution to this except that ideally a two-thread bottle could be produced, a bit like an eGo connector. The dropper would then be protected by a separate screw-on childproof cap on an outer thread. Needs someone to create an innovative solution.

There is a workaround: if you have toddlers then you carry two bottles, one containing the e-liquid, with a childproof cap; and one with the dropper in. It's a bit of a kludge, but then if you have toddlers then it may be the only way to safely use glass dropper bottles currently.
 

Technohydra

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*Allow me to start by apologizing for doing a copypasta of my post from the CA shipment ban thread, but with a little modification, the same points were equally valid and needed. I'm sick as hell today, so I have to limit my crusading somewhat.*

Let me put it this way; the people trying to push this legislation through have zero idea what the ecig community is trying to accomplish, or what we have already done. They don't know anything about the benefits of switching, they don't know anything about how lives have changed, they don't know anything about why we would be up in arms about it. Right now, all they know is that 'smokers' are mad because we are limiting their 'smoking' and they need to get over it.

These regulations can and will pass, unless the vaping community gets up and hits the relevant persons with so much information and testimonials that they can't ignore it. We have to convince them that vaping is not smoking, that e-juice is not tobacco, and that they can't prevent people from getting or using ecigs. And even then, they may still vote for the money.

Important things to get in this are comments from the vendors that generate sales tax, speaking as to how they may have to shut down, which could potentially outweigh the monetary gains proposed by the regulations. Also important are the users relating how they will simply go out of the states (China, etc.) to purchase instead of suffering under a overregulation. The enforceability needs to be questioned, as well as the likelihood of people doing stawman buys and a black market effect of people willing to break the law and sell anyways for a small fee. Reinforce that there is no way to ban the shipment of all components and that the legal definition of an ecig currently refers to an assembled device or kit that as a whole is an 'ecig'. Parts and arguably liquids are not in and of themselves subject to this definition, much like a gun stock is not a gun until it has all the other parts assembled onto it.

Call into question the ability of the regulations to survive intact in the Supreme Court. The last thing the FDA wants is to have their proposed regulations gutted in the courts, but still on the books, as that sets a legal precedent. State why we are doing what we are doing. Quote studies (with references) and give (verified) numerical data, where possible. Reinforce that there has never been one confirmed death or serious illness associated with vaping in almost a decade. Reinforce that minor illnesses reported from e-juice, such as nicotine overdose, have all been due to carelessness or improper use of the products, much like curling irons causing burns. Contrast keeping kids safe by limiting ecigs with kids being endangered by blackmarketeers, gang members, and 'e-juice moonshiners' doing anything they have to to make a buck, no matter who gets hurt. and reinforce that this is a technology that the consumers have developed themselves because no one else was helping us with the tobacco issue. Big tobacco is only now buying in because they are feeling the noose on their necks.

And most of all, remind them that they are beholden to we the people, and that when they choose an action, they are also selecting the consequences of it. So they had better love those consequences before they act, or they will reap them later, to their dismay.

Please, please, I beg everyone to do their part, do it well, and do it responsibly. This is the only way we stand a chance, after all is said and done (not glory hogging, just being straight with you). The government may need to be reminded that while a boot to the throat is an effective way to ensure obedience, we have a hell of a lot more throats than they have boots, and a hell of a lot boots than they do on election days. And even if they push a horrid agenda on us, we are prepared to go to the next level and tear them apart in the courts.
 
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