Comments Please on AAPHP Petitions to FDA

[Kate51]

Problem is "young people" are regulated, most states cover sales of tobacco to minors, flavored or not. FDA wants big, bright-colored warning labels!
So what about the other shoe dropping, FDA may decide to declare cigarettes as a "drug delivery device" if nicotine is designated a drug. Fortunately, Big tobacco has the hootzpa (sp?) to lobby against that. This is where it gets sticky. Perhaps Big Pharma and Big Tobacco now will have to duke it out with FDA. That shouldn't take more than a century or two to legislate.

 

[River]

I too personally don't care what they do it won't affect me but I'm thinking of all the people that it does matter to. I feel a responsibility to do what I can for the rest of the vapers in this world. Not meant as a slight. LOL

I do feel sorry for the normal population.

Nothing is a greater example of the road to hell being paved with good intentions than this kind of crap.

We are all saying, "vaping sure is great! lets help them remove all he things that make it so great! yayyy!!"

All this does it keep people from trying it, we have all seen the poll where 85% of us said we would just go underground. This affects ecf members very little.

The real harm is to the millions of smokers that will never get to find out what we got to find out.

 

[DC2]

You mention the "reduced harm" alternative. What's stopping us from trying to get that pushed through quicker?

From what I am hearing, it won't necessarily be better than being a classified as a tobacco product.

I don't remember the details, and as far as I know there isn't a specific thread on the subject, but I do recall that it is likely to require proof that there is reduced harm.

And in my opinion it is unlikely that such a classification would keep the FDA from banning flavors or regulating nicotine strengths if they wanted to do so. In fact, I doubt there is ANYTHING that can be done to keep the FDA from doing those things if they wanted to, regardless of the classification.

If I am incorrect I sincerely hope someone comes along with more knowledge, like perhaps Mr. Godshall, who can clarify some of the questions.

Couldn't the AAPHP give out info on how to help, instead of spending all their efforts on possibly classifying something in the completely WRONG category?

Good question.

 

[Vocalek]

You mention the "reduced harm" alternative. What's stopping us from trying to get that pushed through quicker? What could we, as citizens, do to help with that? Couldn't the AAPHP give out info on how to help, instead of spending all their efforts on possibly classifying something in the completely WRONG category? Part of an organization's responsibility is to educate... I personally think if we classify these things incorrectly the first time, it will be nearly impossible to try and reclassify later when a new/more relevant category is found.

Until 2009, the FDA could not regulate tobacco products.
PUBLIC LAW 111–31—JUNE 22, 2009

FAMILY SMOKING PREVENTION AND
TOBACCO CONTROL AND FEDERAL​

RETIREMENT REFORM

This law gives the FDA the power to regulate tobacco products. One of the provisions of the law is a "modified risk tobacco product" category.

So you don't get a "reduced harm" designation unless you are talking about a tobacco product. It isn't a separate thing. It is part and parcel of the FDA's ability to regulate tobacco products.

Most of us have observed that using this product does reduce our risk of disease.

But there is a catch:

http://frwebgate.access.gpo.gov/cgi...=111_cong_public_laws&docid=f:publ031.111.pdf

See
‘‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.
Pages 38 through 45 of 84

The bottom line, if you read through the law is that to go for the "modified risk tobacco product" category, there are many hoops to be jumped through and FDA still has not defined exactly what the process is to gain approval. Having e-cigarettes classified as a modified risk tobacco product would result in a delay of unknown duration before the product would be approved for sale.

So at this point, we are better off if the products are considered to be just an alternative form of tobacco.

The AAPHP has studied this situation, consulted with legal counsel, and is pursuing the avenue that seems to have the best promise of keeping the electronic cigarettes on the market.

 

[(So) Jersey Girl]

I read through the first document, and even checked several of the links. I was quite impressed with the amount of work put into the document, and also wanted to let you know the links are broken (and to request where I might find the NJ GASP report, I couldn't find it after searching the site extensively)

I think this is what you're looking for:

http://www.njgasp.org/E-Cigs White Paper.pdf

 

[DC2]

I think this is what you're looking for:

http://www.njgasp.org/E-Cigs White Paper.pdf

Wow, that Karen Blumenfeld is a real piece of work.

It hurts my head to think that anyone with any influence whatsoever would write something as completely and utterly absurd as this...

[FONT=CenturyGothic,Bold][FONT=CenturyGothic,Bold]1. Product is 'smoked', therefore not permissible under the 2006 New Jersey Smoke-Free Air Act (NJSFAA).[/FONT][/FONT]

The NJSFAA definitions section, NJSA 26:3D-57, defines smoking as "... or any other matter can be smoked": "Smoking" means the burning of, inhaling from, exhaling the smoke from, or the possession of a lighted cigar, cigarette, pipe or any other matter or substance which contains tobacco or any other matter that can be smoked.

The e-cigarette product is inhaled, and creates a smoke (as admitted by e-cigarette websites - see below) upon exhale. The heating element in the e-cigarette heats and vaporizes the nicotine/propylene glycol solution, creating the 'smoke'. Therefore, since the product is 'smoked’and creates a 'smoke', our interpretation is that the product is​

​

​

​

[FONT=CenturyGothic,Bold][FONT=CenturyGothic,Bold]not [/FONT][/FONT]permissible for use in public places and workplaces that are covered under the NJSFAA.

We surveyed some e-cigarette websites, some of which [FONT=CenturyGothic,Bold][FONT=CenturyGothic,Bold]admit [/FONT][/FONT]that their product creates a 'smoke', and that the product is 'smoked', etc. For example, Smokeless Revolution’s website admits many times, that the product creates a 'smoke':

"The EVO is an electronic, smokeless alternative that delivers true tobacco flavor through a [FONT=CenturyGothic,Bold][FONT=CenturyGothic,Bold][FONT=CenturyGothic,Bold]vapor mist smoke[/FONT][/FONT][/FONT], with your preferred level of nicotine."
​

www.smokelessrevolution.com​

Their website's “Frequently Asked Questions” section also states that a battery is used to create the smoke vapor:

...a small rechargeable battery and a unique, safe replaceable cartridge containing water, propylene glycol, nicotine, a scent that emulates a tobacco flavor and a membrane to suspend the ingredients. When using EVO, the act of inhaling or smoking it produces the tactile and craving satisfactions traditional smokers seek, and triggers a vaporizing process that releases a simulated smoke that is actually a vapor mist that harmlessly evaporates into the air within a few seconds.​

www.smokelessrevolution.com​

Other e-cigarette websites have similar language.

There is a lot more, but I just couldn't read any further after reading that.

 

[Vocalek]

For those who have asked, "where are the suppliers on this topic?" many of them have reported having product confiscated by Customs on order of the FDA. Here is just one string on the subject: http://www.e-cigarette-forum.com/forum/law-e-cigarette/70590-detained-letter-fda-4.html#post1135223

 

[kristin]

Wow, people just don't get it.

1. The FDA has already declared these a drug device, regardless of nicotine content and are stopping imports. The Judge Leon case only applies to TWO companies. Even if the ruling stands, the FDA can block every other ecig brand.

2. Getting a third category - "reduced harm" is NOT going to happen any time soon, if at all. We have to make a choice, RIGHT NOW, between "drug device" or "tobacco product." Complain all you want how it's "not fair" or "not right" but you're wasting air and time. Do nothing and it'll be a drug device. Period. Sorry, you don't have the luxury to wait until there is a third choice. While you are dreaming, wishing and hoping, they will be classified as drug devices and banned until they are proven safe. Then put into the hands of Big Pharma.

3. Being declared a drug device is BAD. It will immediately result in all devices requiring extensive testing and safety standards. Once approved, they will be in the hands of pharmaceutical companies, reduced to NRT levels of nicotine and limited flavors, not to mention EXPENSIVE.

4. Being a "tobacco product" is not the same as being a "cigarette." Snus is a tobacco product, but not a cigarette. It can be used indoors. They aren't trying to classify this as a "cigarette," they are trying to make it a "tobacco product." There is a difference.

The taxes are inevitable. Anyone who says that they'd quit e-cigs if they are more expensive can go back to smoking, for all I care. Sorry, but the health of smokers is a far greater concern than your ability to save money, IMO.

As a tobacco product, the FDA is limited on what it can regulate. We have a much better chance of maintaining the status quo. Even if pre-flavored liquid is banned under the tobacco act, flavor additives are still readily available.

5. If you do not support classification as a tobacco product, they WILL be classified as drug devices, no matter what you say. Vote in November and it won't change a thing. The new administration will bow to the FDA, unless you can vote in all vaping legislators. If ecigs become drug devices, they will be banned. Once they are banned, they will be black market, harder to get and the price WILL go up. So, if you think doing nothing will not affect you, think again.

All of this crying about how it's not fair to be put back into the "smoking" category, no flavors and increased cost is just pathetic. If you don't step up, your only choice will be the patch, gum or tobacco cigarettes. Quit your moaning and get real.

 

[(So) Jersey Girl]

Wow, that Karen Blumenfeld is a real piece of work.

It hurts my head to think that anyone with any influence whatsoever would write something as completely and utterly absurd as this...



There is a lot more, but I just couldn't read any further after reading that.[/SIZE][/FONT][/SIZE][/FONT]

Me too. I've tried several times to get thru this nonsense, but it just makes my blood boil! Saddens me that this type of person is from my beloved home state. Bet she doesn't wear flip-flops in the snow! (Jersey Girl joke! )

I found this link earlier. Read what Bill Godshall has to say:
Are electronic or e-cigarettes good or bad? Another viewpoint Missouri Group Against Smoking Pollution (it's at the end.)

 

[kristin]

My comment on #1

My husband and I had tried everything to quit smoking. He had severe emotional reactions to Chantix. We were resigned to being smokers until our early deaths. Then we found e-cigarettes. Finally, an effective and affordable way to reduce the risks of smoking!

After we bought quality devices and non-tobacco flavors, I found that I no longer craved tobacco cigarettes - they were unpalatable. I switched exclusively to e-cigs on 8/21/09. I feel, look and smell better. No more smoker's cough.

My husband struggled with "something missing" in e-cigs and because snus has been labeled in such a way as to imply they are just as bad as smoking, I was against it. After finding out snus is 98% safer than smoking, I encouraged him to try it. He has been smoke free since 12/09, using a combination of low nicotine e-cigs and 2-3 snus a day.

E-cigarettes and snus are effective because they are customizable to the user's specific needs, affordable and reduce exposure to toxic chemicals and carcinogens by up to 98%. By classifying electronic cigarettes as drug devices, it would be a defacto ban, as they would require unreasonable standards of testing, of which tobacco cigarettes currently exempt. E-cigarettes should be compared to tobacco smoking, NOT NRTS. By taking e-cigs off the market, thousands of smokers who have switched would be forced back to smoking. By classifying them as tobacco products - even better "reduced harm tobacco products" - they would remain available for smokers seeking a reduced harm alternative and automatically be banned for purchase by minors. It's a win-win for everyone.

Please protect the health of smokers - not the wealth of tobacco and pharmeceutical companies.

Thank you.

Document ID: FDA-2010-P-0095-0001: American Association of Public Health Physicians, Tobacco Control Task Force (AAPHP) - Citizen Petition

 

[Firegrl]

For those who have asked, "where are the suppliers on this topic?" many of them have reported having product confiscated by Customs on order of the FDA. Here is just one string on the subject: http://www.e-cigarette-forum.com/forum/law-e-cigarette/70590-detained-letter-fda-4.html#post1135223

Thank you for the information. I have already read through that thread but I still don't see a lot of shipments being held up. Some of those sounds like large quantities for personal use and then just some comments on the situation.

I was mainly talking about business owners that could be affected by changing the classification. Yes, we have a few affected by the FDA ban now (sorry, but I still don't see tons of suppliers affected here), but we will have almost every business owner affected if/when these things start getting taxed to death and if flavorings are banned, which COULD, not saying it definitely will, happen if these are classified as tobacco products.

I guess I was just hoping for input for the people that could lose their businesses over this. Where are their loud voices? And I'm talking affected either way, whether they are banned or reclassified, I want to hear their opinions on what should happen. We need their voices too, not just users...

 

[kristin]

Thank you for the information. I have already read through that thread but I still don't see a lot of shipments being held up. Some of those sounds like large quantities for personal use and then just some comments on the situation.

I was mainly talking about business owners that could be affected by changing the classification. Yes, we have a few affected by the FDA ban now (sorry, but I still don't see tons of suppliers affected here), but we will have almost every business owner affected if/when these things start getting taxed to death and if flavorings are banned, which COULD, not saying it definitely will, happen if these are classified as tobacco products.

I guess I was just hoping for input for the people that could lose their businesses over this. Where are their loud voices? And I'm talking affected either way, whether they are banned or reclassified, I want to hear their opinions on what should happen. We need their voices too, not just users...

If they are classified as drug devices, then they will DEFINITELY go out of business. None of these small vendors can afford the testing and clinical studies and if the larger companies are required to do the studies, the costs of ecigs will go up ENORMOUSLY to cover those expenses. Look at the costs of drugs now! They will also be forced to do whatever the FDA says and ecigs will become nothing more than NRTs - in nasty tutti-fruity, citrus and mint, with 6 mg of nicotine and no other choices. As drug devices, the ecig industry will get taken over by Big Pharma and rendered impotent. Only one or two companies will sell them and they will jack up the prices, lacking any market competition.

I'd much rather risk the additional taxes and have more freedom from FDA regulation, plus the added competition will keep the costs down.

A drug device will be much more expensive and ineffective than taxed tobacco product. Look at the difference of the cost of a box of nicotine gum and a pack of cigarettes as the perfect example.

 

[lonercom]

Vapor4Life has had more than $100,000 in juice held by customs. For any distributor this is significant.

I have visited both petitions and left my comments.

Petition 1 is asking for a retractio to the "Radiator Fluid" press release.
Petition 2 is requesting that e-cigs be regulated as tobacco. My comments are below.

The Electronic Cigarette in and of itself is simply a battery, LED and heating coil. These are common items found in almost every home. I do not believe that they fall under the purview of the FDA.

The nicotine solution used in the Electronic Cigarette is distilled from tobacco. In addition, the quantities and effects of consumption of electronic cigarettes and the fluids associated with this product are no different from products already widely available.

As such I believe that Electronic Cigarette nicotine solution, as an alternative to cigarettes, should be classified and regulated as a tobacco product. Further, since this product has been manufactured and marketed prior to 2007, it should enjoy the same consideration as conventional cigarettes.

I find it ironic that the Federal agency tasked with ensuring my health and safety would insist that I should continue to smoke cigarettes, with the myriad carcinogens and toxins, instead of E-Cigarettes that contain simply nicotine.

I am an inveterate smoker of more than 40 years. I consume approximately 3 packs of cigarettes each day and have been unable to stop. Had my once socially acceptable addiction been to illegal opiates instead, I would be eligible for subsidized Methadone Maintenance therapy. Please explain this logic?

I believe that this is a perfect example of our Government bowing to the pressure of special interest groups to the detriment of their constituency.
I Object, I Vote, and I will remember.

Thank you for your kind consideration.

This is the opportunity to let our government know how we feel. While it may not be as sexy as posting on CNN, it may made a difference.

 

[THeGAMe]

As I said before, carts with no nic are mini fog mechines. They use almost the same chems. Are fog mechines banned? Are they classified as a drug?

The answer is no to both.

In my case, after 22yrs, this year I have cut my smoking down to nothing. After my first month, I was using zero nic carts, and my dependency on nic was gone. However, I still have a strong addiction to performing the hand to mouth action. There is only one other action I have done that even comes close in my 40yrs, and its not even really close. (You can use you imagination for that one)

This product is no longer a nicotine delivery system for me, and alot of other users. Hell, I could probibly get the same results with nic gum/patch and using the vape. I can walk into a headshop and buy a hooka and assorted flavors to smoke and the FDA doesnt care about that.

My point is that if they want to ban nic juice/carts, or regulate them, fine with me. I wont use them.

However, they have no right coming after the vape. If the vaporizer system in its self is deemed a tobacco product, the price will skyrocket due to taxes, or will be banned outright.

That being said, if you want to alter your petition to specify nic carts used with the vape, then sure, you have my support. But any all encompassing request to classify vapes and a tobacco product is doing WAY more harm than good.

Now understand, my irritation isnt from you or your efforts. It is directed at the Gov. and their obvious wish to keep its cash cow going. If anything, Im dismayed at your surrender, hoping for the best in a situation that there is no good outcome for us. We are at the whims of entities that do not listen, are intent on exploiting addiction and fear, and are looking for a way to profit and tax everything the masses will allow, so long as they dont get hit with the same tax. And there wont be a ban, but a tax. Trust me.

Yup, the world needs an enema..

Anyway, your heart is in the right place.
But a little misguided..

Just a thought..
We all probibly found this site and its popular due to the phrase "ecig" or Electronic Cigarette. It might be a good idea to stop using anything that has the word cigarette in it. I can remember right around 1987 when they really started villifying cigarettes. We have 23+ YEARS of social programming in any jury.

Me?
I no longer smoke.
I do, however, enjoy my vapoizor from time to time.

 

[Mr_Phil]

As for smoking indoors? Well, out of respect I tend to go outside to vape either way. Considering a lot of people don't understand how this device works, I instead of avoiding confrontation for example at work. I just go outside and chat with co workers while vaping. Due to that a few have converted from my random small talk and them seeing me vape. Rather than trying to closet vape in the building.

Me too. I just found out one of my fellow "smokers" bought an e-cig. Now he didn't come right out and say it, but I like to think that our discussions aided his decision. And I really feel ya on the "avoid confrontation" part. My workplace has a no tobacco policy inside any building and they are draconian about it. I just would not have the energy to try and educate every employee who saw me vape....

An excellent point. Those of us who have lived with the controversy surrounding our life-line for a year or more forget that newcomers may know nothing at all about the subject. In the future, when I put in a call to action of some kind, I will try to remember to provide some background.

Awesome idea. I for one stumbled onto an adsense ad for an ecig while randomly surfing. I researched it over the Christmas holiday and waffled until about a day before the counter in my sig. I had never seen or heard of them on the news either. I thought it was a totally new product. Everyone lives a hectic life nowadays and our focus is narrow. For my part, keep putting out the calls. But, like you said, throw me some scraps. I've been checking this site out for a month and have still only scratched the surface.

Its Obvious half of the posters here have no idea how much work Bill has done for the E-Cig community I say we stand behind him 100% or you can virtually guarantee that E-cigs will be gone forever there has to be a compromise in this no matter what people think. You can't have your cake and eat it too.

I don't think anyone means any personal disrespect. I think we are all independent minded folks or else we'd still be suckin on organics y'know. And, just my opinion as an observer of politics, we've all heard so much about not "throwing away our votes" in defense of going along with partizan politics that some might just be sick of compromising even if it's the obviously realistic/pragmatic thing to do. Besides a lively discussion sometimes brings a better (workable) idea to the fore.

I'll keep this issue on my politics blog. And when I can compose a proper comment I'll do so.

 

[TheIllustratedMan]

I'll just throw in my view on the "tobacco product" vs "drug delivery device" vs "reduced harm" vs "-some new category-":

Like has been stated before (in whole or in part), a specific, (at least semi-)knowledgeable part of the government has already decided what electronic cigarettes are. They are electronic devices that contain nothing recognizable as tobacco but deliver a very addictive substance found in tobacco to the user, with the end result seeming to be that the user stops using tobacco. This makes them a drug/device combination used as a Nicotine Replacement Therapy for the purposes of quitting smoking, and should be regulated as such. The vast majority of the rest of the government knows little to nothing about the electronic cigarette, and therefore bows to the wisdom of the group who not only seems to know what they're talking about, but whose job it is to deal with such matters.
Far away from the enclave of Washington, D.C., there is a much larger, much more knowledgeable group who looks at the electronic cigarette and says "This thing looks like smoking, feels like smoking, and satisfies like smoking, but it seems to have nothing in it that's going to kill me (or at the very least, less in it that will). I like smoking, but I'd rather not get cancer or stink like an ashtray, so I think I'll go ahead and use this instead." To that group, they see something that, while not physically identical to smoking, is a complete replacement for it.
So, you have two groups looking at the same device in completely different ways, and both are really saying the same thing.

FACT - Electronic cigarettes are used in the same (or very similar) way that conventional cigarettes are used.
FACT - Electronic cigarettes can help someone quit smoking.
FACT - Electronic cigarettes (for the most part) contain nicotine, a substance that is primarily derived from tobacco.
FACT - Nicotine, on its own, is generally considered a drug, and is regulated as such.
FACT - Electronic cigarettes are consumables.

If you look at that list, you can see that most of us (FDA, e-cig user, and anyone in between) can agreed on some key principles. The difference is in interpretation. FDA says it delivers a drug, must be a drug delivery device. We say we use it like a cigarette, not as a medication, so it can't be a drug delivery device. The key is that it is a consumable product, and all consumable products are regulated in some way. This is a good thing. Without that regulation, we'd still be eating half-rotten meat painted with pig's blood.
So what do we do with that? We definitely say it's not a drug/device combo (for a multitude of reasons). It's not a food, since it has no nutritional content. We maybe could argue that it's a dietary supplement, but I highly doubt that we'd get anywhere with that. Really, the only thing that's left is to say that it's a tobacco product.
We have to keep in mind that this is a niche market. Even if there are (as some estimates claim) in excess of one million vapers in the United States today, that is less than half a percent of the total population. Ideally, we would create a new category under the FDA that is specifically for Electronic Smoking Devices (or whatever you'd like to call them). There would be a rigid set of criteria that would place a product in that category, and then it would be governed by an exclusive set of rules. Those rules would ensure quality, effectiveness of delivery, and safety.
Unfortunately, as a niche market, there will be no new category created. We will be slotted into some already-defined label and held to the rules that govern it. Down the road, when vapers encompass even 5 or 10 percent of the population, we may have a shot at becoming our own entity. Until then, we will have to play by their rules and do the best that we can.
For our own selfish purposes, for our noble goals of conversion, for the future of electronic cigarettes (and by extension their owners), we must slip quietly into the tobacco product group and meticulously chip away at the walls.

-Nate

 

[maxx]

Before attacking him I suggest you google "Bill Godshall" and do some reading. Bill is the best friend a vaper could ask for. You do yourself a disservice by not reading up on the matters being discussed in this thread before throwing accusations around.

Obviously you are the one who needs to do some reading. Specifically the location listed in my profile. I don't have to Google the man. The smokers in Western Pennsylvania know all about Mr. Godshall, believe me.

But on to more important matters. I was over at the AAPHP website. I think I hit every page, but I don't see anything about E-cig studies that they themselves have done. Are these located off-site? If so...can someone link me to them. Thanks.

EDIT: Just realized, we have been split into two threads now. One for the petition...and one for us commenting folks. Sorta like being sent outside for a cigarette. Brings back memories...

 

[Unperson]

One point of clarification, if I may...

By classifying e-cigs as "tobacco products", won't that mean that e-cigs will be subject to the astronomical taxes that tobacco products currently have in place?

The reasons that agencies have justified the incredibly large taxes placed on analog tobacco products is because of the health risks and financial burden they place on society as well as their "so called" altruistic desire to nudge individuals into cessation.

Being that personal vaporizers are not even in the same ballpark as analog tobacco, why should they be subject to these inflated taxes?

Mark my words. If we simply try to indoctrinate vaporizers in with analogs, then we'll see the government try to milk us as they do with current analog taxation.

 

[sanfordf]

After reading my way through all of the 'comments', and visiting the FDA site, and reading the potentially ineffectual (despite much hard work by many people) petitions, I am worried that the ability to smoke an e-cig is very threatened.
I am a noob, but not a fool. However, I don't know if I should buy a bunch of atomizers, USB pass throughs, batteries, etc. (I make my own juice) to prepare for the end of e-cigarettes as we know and love at this time!
Out of this concern, I will sign the petitions. I snus, so I have an alternative, but I do love the flavors and viceral experience of e-cigs. It's gonna' hurt to see it go if they don't get classified as (this annoys me like many) a 'tobacco product'.

 

[gsc4077]

Unperson. . i think the idea is that if we can get them classified as tobacco products, then they wont be completely banned (ya know, because tobacco is perfectly fine). Just trying to cut our losses at this point.