Comments Please on AAPHP Petitions to FDA

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Kate51

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Mar 27, 2009
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My highest regards to Vocalek, EFC, CASAA.org and to all who submit comments and those who have worked so hard in our interest. To work within the system is beyond comprehension for some, but it carries high responsibilities by those who have breached the front door. Citizen Petitions do matter. Let yourself be counted, please.
I do see the great need to keep E-cigs designated as tobacco product, however bad that sounds, the very ingredient Nicotine deems it necessary, as impractical as that may be. For FDA to name e-cigs as drug-delivery device opens too many possibilities for control, manipulation, certainly even banishment, an absolutely evil curtailment of Cigarette-Replacement-Therapy.
People, those are the only two choices. Third choice is no choice at all.
E-cigs have been 100% effective for me, check the banner below, today is a very wonderful day for me, my liberation from slow death. My promise to myself a year ago was to do no harm ~ I intend to never rescind that promise, my physical health tells me I was right. No matter what!
I have been empowered now to be able to take steps to sustain my own path. No Big Brother needed. But others coming in deserve a little help. Not a death sentence. We have up to now been relatively un-encumbered, but that will change, mark my words. It has already begun.
 
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Drummel

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Feb 11, 2010
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Seems to be a little heated, but let me try asking something(s)

1) If nothing is done will E-Cigarattes make it until the November voting before it ends up being banned and classified as a drug device permanetly? (That is for years and years to come until the masses finally get off their lazy asses and defend their rights)
(I hate complacency)

2) For those that want to do neither, or claim they are independant, I respect that, but I must ask: You are choosing to either wait for a November vote to remove evils with lesser evils (it's the way of politics, look at our history). I still applaud doing what you feel is right.
Now what are you doing for your right to Vape? You say neither. So I say what then? Are you going to create a petition? Request another avenue for E-Cigarettes? Or just say you disagree, are independant and then do ...? what? One fact seems to remain. If it's a medical device it'll be banned, no more "vendors". It'll be to the Pharmacy, IF they choose to bother marketing it, IF they choose to do whatever research to claim it's benefits according to their standards. It becomes black market for those willing to continue. And breaking the law is the greater of two evils.

The other choice is pushing it into a Tobacco classification. That does not tie it in with all things Combustable. Is SNUS banned indoors? No. Yet it's classified as a Tobacco product. Is Chew/Chaw/Spit? No. Yet it's classified as Tobacco product. The point is, just because it's classified doesn't necessarily mean a thing, it's a classification and nothing more. Can it be taxed? Sure. Will it? We can only assume whether it will be or not. Vapers don't exactly make up a super large percentile.

The point everyone is trying to make is. There are CURRENTLY two choices, as there are no other movements. Other then wishful thinkers hoping it becomes some Electro-Gadget all it's own. I know some use it at zero nicotine and enjoy the flavors, and good on them for enjoying the fine recreational hobby we call vaping!, but for the rest of the crowd that likes/wants/needs their nicotine those two choices are all they have.
1) Hope it can be kept alive and worked with.
2) Hope it gets banned and the medical field cans it, or modifies it.
3) ?? If there's a third major runner No one seems aware of it.

The flames of libery burn their brightest in their darkest hour. The problem is not enough people see the fire yet. So we have limited choices. And November is not a fix all for the vaping community. Waiting that long is just as well as sitting on your hands. Miss the bus, get another? Heh, this one doesn't run very often.

Do I know what I want to do? Sure. I want to throttle our government from front to back, but it boots nothing. We either act, or we do nothing. And doing nothing is by default voting for the greatest of two evils.

Again, to be clear, I respect EVERYONE'S opinions, this is just how I feel personally.

Don
 

natura

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Vocalek

CASAA Activist
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From My first post-
"I wasn't aware they had classified it as a drug device?

No one has answered this question. I get a host of assumptions. I do not make decisions on assumptions in signing my name to a public petition. Words can make or break petitions and what ramifications are plausible. They lumped these petitions together. That is a major no no in my book. Each should stand alone! Assumptions- LOOK we can't be wrong.. look at all these people who signed our petition.

E-Cigs could be taxed as high as cigs or cigars. QUICK TOO! How many people tried e-cigs because it was less money and ended up quitting a bad habit. These are hard cold KNOWN things here. I will not deal in assumptions, after assumption to make a decision to sign a petition that has many areas of wording that seem suspect to me.

But hey everyone has the right to do as they see fit. IMHO
My last words on subject UNLESS someone wants to reply to my words. (giving benefit of doubt that you want me to shut up and I will no problem-just do not address me or anything I have said..and I will fade away)

You aren't aware that the FDA has declared that electronic cigarettes are "drug-delivery devices"?

FDA and Public Health Experts Warn About Electronic Cigarettes

The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.

There is a huge thread here on ECF that has been following the federal court case referred to in the FDA Press Release quoted above.
http://www.e-cigarette-forum.com/fo...peals-court-stays-judge-leons-ruling-now.html

To summarize, the FDA's position is that electronic cigarettes are unapproved drug-delivery devices and has begun enforcement by seizing incoming shipments. Smoking Everywhere asked for an injunction to stop FDA from seizing product. The case was later joined by Soterra (NJOY) whose products were also ordered seized by FDA. Judge Leon granted the injunction and based his opinion on the idea that the products are tobacco products. FDA has obtained a temporary stay of the injunction (allowing them to continue seizing products) pending decision by the appeals court. FDA continues to insist these are drug-delivery devices.

You may want (as do I) to have these products just left the heck alone by everyone. But realistically, how do you picture that happening? There is a Federal Court case and ultimately the products will be legally declared to be either a product that the FDA can regulate as a combo drug-delivery devide, or as a product that the FDA can regulate as a tobacco product.

The petition asks the FDA to stop insisting on their position. That would mean that they would stop seizing products at the border, because the products would no longer be considered an "unapproved" product that CDER can regulate. Instead, they would be considered a tobacco product that does not require approval. The products could, however, be regulated to ensure safety--allowing for such things as complete accurate labeling, child-proof packaging, and testing of liquids to ensure purity.

As has been pointed out, the FDA cannot impose taxes on any product. Sure congress could impose taxes on them as a tobacco product. But let's face it, congress could impose taxes on them right now, without having to name the classification they fall into. Congress taxes the sales of furs, luxury boats, etc. Comprende?

Again, you are not being asked to SIGN the petition. People are being asked to leave comments. If you don't want to leave a favorable comment, don't. If you want to leave a comment AGAINST the AAPHP suggestion, then the FDA will take that as approval to continue their current modus operendi: Stealing the products being imported by retailers and thereby doing their best to enact a defacto ban against the product.
 
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Vocalek

CASAA Activist
Supporting Member
ECF Veteran
I smoked for 45 years. Cessation methods that failed me include the FDA-approved nicotine patch, gum, lozenges, inhaler, and Bupropion, the American Lung Association stop-smoking training course, Nicotine Anonymous, and hypnosis. On March 27, 2009 I replaced inhaling tobacco smoke with inhaling vaporized nicotine from an electronic cigarette. This invention works as an acceptable and much healthier alternative to inhaling tar, carbon monoxide, heavy metals, particulates, thousands of toxins and hundreds of carcinogens. I no longer lay awake at night listening to myself wheeze. I can laugh aloud without breaking into a coughing fit. The American Lung Association, American Cancer Society, American Heart Association, and Campaign for Tobacco-Free Kids are wrong! These are being successfully used by thousands of long-term smokers as a substitute that allows us to regain our physical health. They are a gateway AWAY from tobacco smoking. Please stop insisting on regulating them as a drug-delivery device, which would result in a defacto ban. You have the legal power to regulate these products as tobacco alternatives. You can impose reasonable regulations on electronic cigarettes such as complete and accurate information on labels, child-proof packaging, and testing of liquids to ensure purity. But do not take away our life-line! Do the right thing. Millions of lives hang in the balance.

Comment Tracking Number: 80ab950b
 

bobtow

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Dec 11, 2009
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In my opinion we should sign both petitions. It is better to lose a bit now, and be able to fight another day. Then we could start over and have the ecig classed as a vaporizer. We would be no worse off that we are now. At the moment we have lost the ability to import eliquid anyway. That could be another issue down the road. Perhaps classified as an herb. In the meanwhile, friends have gone through a lot of work on our behalf. Lets back them. I'll sign both.
 

telsie

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Jun 26, 2009
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I get that some people want e-cigs classified as tobacco products to ensure they remain legal, but I can't get on board with that. They're not tobacco products. Just because the FDA doesn't currently have a classification that fits doesn't mean c-cigs need to be forced into an existing one. Whichever one you pick, it hands control of them to the FDA anyway.

If they were classified as tobacco products, they'd probably be seen as a societal evil and inevitably be heavily taxed by states and the federal government. Also there would be no flavors allowed beyond menthol and tobacco. The only benefit is they couldn't be outright banned. I think that's unlikely anyway.

Am I completely off base on all that?
 

DirtyHarry

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Feb 2, 2010
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We need a friendly House member with status and the ability to gain co-sponsors.

Here's the deal: The FDA (and most other regulatory agencies) operate more or less without Congressional oversight, or oversight of any kind. They can do this because Congress is lazy and/or corrupt, so their founding legislation says "This agency is tasked with protecting the public safety from hazards to be determined by them" (except in many more words). This is then followed by 1,000 pages of special exemptions suggested by lobbyists.

What is needed is explicit legislation by Congress exempting PVs (specifically defined) from the assorted forms of regulation, not the least of which is the FDA but there are others that might get into the game, depending on how far BT and BP push the agenda and how popular PVs become.

This is hardly an impossible task; "special interests" do it all the time - in fact, most of the Federal codes are simply lists of interests who are exempted or have altered effects from laws the rest of us have to otherwise comply with. All we need to do is identify and cultivate enough sympathetic ears.

This, to me, is a far better way to approach the problem than to toss ourselves at the mercy of faceless corrupt bureaucrats who don't give a rip about a relative handful of people who are vaping, yet are getting marching orders from direct lobbying and Congress-critters who are being lobbied by those who see us as a threat...

-Harry Callahan
 

maxx

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Jan 23, 2010
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I'll be honest. I'm tired of compromising. As smokers we sat on our hands as we were turned into second-class citizens and and forced to pay the way of the rest of the country because we were dirty, unhealthy, uncaring, evil people. And the non-smokers cheered and said "Yeah, go get em' boys"....because the propaganda was working. Now you want me to get behind a petition that might ensure ecig availability, while perpetuating the second-class citizenship status in terms of freedom and money?

Amongst other things, that petition is an insult and why my posts are heated. All I can say is don't look at tomorrow. Look at one year from now. Go ahead...sign on for more slavery.
 

bobtow

Super Member
ECF Veteran
Dec 11, 2009
338
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I get that some people want e-cigs classified as tobacco products to ensure they remain legal, but I can't get on board with that. They're not tobacco products. Just because the FDA doesn't currently have a classification that fits doesn't mean c-cigs need to be forced into an existing one. Whichever one you pick, it hands control of them to the FDA anyway.

If they were classified as tobacco products, they'd probably be seen as a societal evil and inevitably be heavily taxed by states and the federal government. Also there would be no flavors allowed beyond menthol and tobacco. The only benefit is they couldn't be outright banned. I think that's unlikely anyway.

Am I completely off base on all that?
Where do you think the eliquid comes from? It is a tobacco product weather we like it or not.
 

bobtow

Super Member
ECF Veteran
Dec 11, 2009
338
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Wallaceburg ON. Canada
The ecigarette is merely hardware and should be seen as such. But as it stands now there are only two choices, have it classified as a tobacco product, or a drug. I should have said nicotine is a tobacco product. But if it is classified as a drug, then the hardware will be classified as a drug delivery device. then it goes to the big Pharma companies and then goodby.
 

5cardstud

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Jan 1, 2010
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You aren't aware that the FDA has declared that electronic cigarettes are "drug-delivery devices"?

FDA and Public Health Experts Warn About Electronic Cigarettes



There is a huge thread here on ECF that has been following the federal court case referred to in the FDA Press Release quoted above.
http://www.e-cigarette-forum.com/fo...peals-court-stays-judge-leons-ruling-now.html

To summarize, the FDA's position is that electronic cigarettes are unapproved drug-delivery devices and has begun enforcement by seizing incoming shipments. Smoking Everywhere asked for an injunction to stop FDA from seizing product. The case was later joined by Soterra (NJOY) whose products were also ordered seized by FDA. Judge Leon granted the injunction and based his opinion on the idea that the products are tobacco products. FDA has obtained a temporary stay of the injunction (allowing them to continue seizing products) pending decision by the appeals court. FDA continues to insist these are drug-delivery devices.

You may want (as do I) to have these products just left the heck alone by everyone. But realistically, how do you picture that happening? There is a Federal Court case and ultimately the products will be legally declared to be either a product that the FDA can regulate as a combo drug-delivery devide, or as a product that the FDA can regulate as a tobacco product.

The petition asks the FDA to stop insisting on their position. That would mean that they would stop seizing products at the border, because the products would no longer be considered an "unapproved" product that CDER can regulate. Instead, they would be considered a tobacco product that does not require approval. The products could, however, be regulated to ensure safety--allowing for such things as complete accurate labeling, child-proof packaging, and testing of liquids to ensure purity.

As has been pointed out, the FDA cannot impose taxes on any product. Sure congress could impose taxes on them as a tobacco product. But let's face it, congress could impose taxes on them right now, without having to name the classification they fall into. Congress taxes the sales of furs, luxury boats, etc. Comprende?

Again, you are not being asked to SIGN the petition. People are being asked to leave comments. If you don't want to leave a favorable comment, don't. If you want to leave a comment AGAINST the AAPHP suggestion, then the FDA will take that as approval to continue their current modus operendi: Stealing the products being imported by retailers and thereby doing their best to enact a defacto ban against the product.
Why wasn't this explained at or on the page that asks for comments instead of just telling everyone they want to regulate as tabacco product please comment? What did they think everybodies comment would be without a little explaining as you have done here?
 

Mr_Phil

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Feb 8, 2010
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I noticed that the "new members" posts measure in the hundreds. Hmm, for my money that makes up for the short time.

Someone mentioned that if you just want your opinion out there do a blog. So, I did just that. Click the link in my sig and feel free to tell me all about how I should leave serious writing to other people. :)

On the petition, we need to carefully read and comment. AS a realist I understand that battles are not won by sweeping maneuver all the time. Normally you win with each muddy bootprint continuously moving forward. So long as we remain active both as individuals (like my blog and letters to the .gov) and as a group (discussions on this forum and coordinated action) in time we'll beat this.

I still need to set a spell and think on what to write in the official comments area.

Keep it real and never, ever, surrender.
 

Kobudo

Super Member
ECF Veteran
Jan 16, 2010
399
18
Evansville, IN
My response to petition 1:

As a person who had smoked traditional cigarettes for fifteen years, I have tried multiple times to quit, using all options available to me. Two months ago, I acquired my first personal vaporizer (e-cigarette) and was able to completely break my addiction to traditional cigarettes within one week of using the new product. At the time of this writing, I have no further desire to smoke traditional cigarettes -- in fact, I now find the smell of traditional cigarettes to be extremely unpleasant. If the personal vaporizer were to become unavailable as a result of FDA actions, though, I am almost completely positive that I, along with many others who have successfully transitioned to "vaping," would be likely to return to traditional cigarettes due to the nature of the addiction to nicotine. This would be against the interest of public health.

I concur almost completely with AAPHP's recommendations to the FDA, as it provides the quickest means of ensuring the continued availability of this harm-reducing technology. I would add to the AAPHP's recommendations that the FDA should, in the interests of ethically protecting public health, undertake the appropriate steps to add a third classification for liquids containing nicotine for use in personal vaporizers rather than classify all vaporizer-related products as tobacco products, as users have already transitioned to the use of liquids that contain zero nicotine and contain no components or chemicals that were in any way derived from tobacco.
 
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