Comments Please on AAPHP Petitions to FDA

[kristin]

Kristin, don't think by my post here that I'm trying to debate with you. I'm just trying to understand everything and make the best decision.

No problem! I'm really not trying to debate anything, but trying to get people past the idea that there is in any way a "third option." Wishful thinking will get us nowhere and people also need to know that stockpiling will only get them so far - ecig liquid is only good for a few months. Eventually, it'll go bad or run out - we need to look beyond that.

Valid point. However, with FDA regulating ecigs as a tobacco product, and with the impending advent of the PACT act (barring a miracle of sorts), I don't see how the millions of smokers will have a cost-effective and local way to get access to ecigs.

The PACT Act was addressed earlier by Yolanda (Yvilla). The Act does not cover all tobacco products - it distinctly defines the covered items as containing tobacco leaf. Ecigs may be considered a tobacco product, but they fail to fall under the definitions of the PACT act. It would take an act of congress to add them to the PACT act, which gives us time to lobby for it NOT to be covered. As a tobacco product, they remain on the market and the FDA has limited regulation over them and cannot ban them. They have a better chance of staying on the market because of that.


And we are still able to get them anyway. I realize, of course, that the final outcome of the court case has yet to be decided, but the FDA has been stopping shipments for quite some time. We the consumers are not, as yet, having much difficulty obtaining needed supplies --even though the FDA has declared them a drug-delivery device.


Current vapers are able to get supplies, but because of the FDA statements, you can see the importance of the second petition. People need to hear the truth and know that these are available to them and proven safer - even by the FDA's own report. Smoking Everywhere is nearly bankrupt fighting this in court. Soon their customers will have to find new sources and as the vendors start being targeted by the FDA and local governments, there will be less and less sources to purchase supplies. Not to mention the fear in the U.S. of Chinese imports.

The status quo will not remain once the FDA is done in court and can devote full time to fighting ecigs. Not only that, we'll have to start worrying about how the local governments will treat "unapproved drug products," not just the FDA. If the proposed law goes through in New York, you'll start seeing local kiosks closed down and people who currently own ecigs will be doing so illegally and can be prosecuted. It will snowball. As a tobacco product, they will be perfectly legal like cigarettes.

Because of the PACT act, I'm not, as yet, seeing a serious benefit to going down the tobacco products road. As YET.

See my above comments (and Yvilla's earlier in the thread) about PACT.

Valid point. However, I imagine that if the ecigs become heavily regulated, many of these vendors will go out of business anyway --at least the ones who don't have much capital. Government regulation always costs the little guys more money than they can afford.

Again, the FDA cannot regulate tobacco in the the same strict way as they can drugs. They will be LESS regulated as tobacco products. For example, the new tobacco act that gave the FDA jurisdiction over tobacco specifically forbids them to force tobacco companies to eliminate nicotine. They have no such restrictions if it's a drug.

We will never have the "save the kids antis" off our backs until recreational nicotine is made 100% illegal and wiped off the face of the earth. The more they get, the more they take. This is the same road we have all already been down with smoking. And where has it gotten us?

True. But if they are treated as "drugs" they will be removed from the market altogether for YEARS. If they are tobacco pruducts, we will have time to start introducing the reduced harm concept - to which many doctors are coming around. This petition is proof of that fact - this was written by health professionals who would have fought ecigs tooth-and-nail only a few months ago (and they were.) Health professionals are seeing the light and see the need to keep these on the market. As a "reduced harm tobacco product" we'll have a chance to bring even more of them around.

As far as kids are concerned, one thing that the antis have been spouting (next to flavors) is that they are legal for minors. As tobacco products, they will automatically be illegal to sell to minors and we will no longer see shady legislation like that in New York that starts out saying it's to keep them from kids yet bans them from everyone. There will be no need for these additional laws on local levels in the guise of protecting kids.

That is a good goal to have, and one I am fully behind, but I'm sceptical that it could ever be pulled off --or not in the forseeable future, anyway. Tobacco taxes make up a tremendous amount of states revenue. Every time the smoking rate drops, some politician wants to raise the tobacco taxes. If massive amounts of smokers turn to ecigs, the states will lose millions, if not billions, in revenue. That won't work for them, of course, so they will try to recoup their losses by turning to heavy taxes on ecigs. Nicotine addicts are the favorites for excess taxation.

Again, cigarettes are currently heavily taxed and cost about 35 cents a cigarette. A Nicotrol cartridge is over $1 (equals one cigarette.) It'll be much more affordable as a tobacco product than it will be as a drug!

 

[kristin]

Just as an aside - it completely turns my stomach that these need to be lumped in with tobacco. It goes against everything I stand for or ever wanted to see happen with ecigs. I used to insist on calling them PVs and hated slang like "juice" and argued for them being classified in their own category. If we had the luxury of time, I'd be right in there with everyone else insisting on fighting the "good fight." But the FDA has forced our hand. We haven't had a chance to get a third category set up and we need to convince the FDA to call these tobacco products until we can get that third category accepted and established. It's not going to happen overnight, so we need to take the best course of action to keep ecigs legally available and on the market until that happens. That is the ONLY reason I am supporting this move.

 

[Sun Vaporer]

It is not even "our" option, rather it is what is being advanced and litigated right now in Federal Court with Plaintiff's, SE and NJOY arguing that it is a "tobacco product"---as it is the only plausable argument to make based on the law. Down the road hopefully there will be further options, but if you what to keep the e-cig on the market, then you have to follow the logic SE and NJOY are arguing. Hopefully the Appeals Court will uphold the District Court's ruling that the e-cig is a "tobacco product".


Sun

 

[ChipCurtis]

They are NOT in limbo. The FDA has declared them drug delivery devices and are requiring appropriate clinical trials and standards. Smoking Everywhere and Njoy are contesting that in court, but they have not won yet.

I do consider e-cigs to be in legal limbo, for the simple fact that they are not classifed legally (yet) as drug-delivery devices. In fact, they're not classified at all yet.

The position that the FDA has taken, combined with the current standing in the courts, means that for now they are de-facto banned on the basis that FDA can continue to have customs seize packages. That's all. They are not de-jure banned (which means by actual legal statute) at this stage.

If e-cigs were de-jure banned, the FDA would actually start having people arrested for attempting to import them, instead of just having customs hold the packages.

I just wanted that to be clear, as it seems a lot of people think that the FDA's position has actually made e-cigs illegal at this point.

 

[taz3cat]

Kristen, we don't have ta third options, Judge Leon ruled they were tobacco products, because that is what they are. Nicotine is by-product of tobacco. If Judge Leon had not ruled that they were tobacco products the FDA would have banned and started fining people for having them. Just as Maryland is planning on making it a misdemeanor $1000.00 (no I did not put in too many zeros) for having a e-cigarettes in your possession. It is time for vapers to unite and make comments on what the FDA is doing.

The FDA needs to retract its lies (say it nice) and except that they are tobacco products and the are alternative to smoking cigarettes, nothing more and nothing less. Get with the comments we need all of you.

 

[telsie]

...Just as Maryland is planning on making it a misdemeanor $1000.00 (no I did not put in too many zeros) for having a e-cigarettes in your possession.

Actually, that's incorrect. The $1000 fine would be for sale or distribution. Possession and use of e-cigs would still be legal in Maryland even if the bill passes.

Sorry for the OT post, but I wanted to clarify that.
Carry on.

 

[taz3cat]

Actually, that's incorrect. The $1000 fine would be for sale or distribution. Possession and use of e-cigs would still be legal in Maryland even if the bill passes.

Sorry for the OT post, but I wanted to clarify that.
Carry on.

Thanks Telsie for the correction, I am glad to know that I can still vape in Maryland after they pass this law, if I only carry one PV with me at a time (usually have 3 or 4 in my purse) any more and they could charge me with trying to sale them. I don't know where I will be able to buy one and I believe that a police officer may view things differently, but what do I know, I have only been vaping about 2 years and have seen just about everything happen that people said could not happen.

By the way have you signed the petition to the FDA yet?

 

[OutWest]

What with some of the states now moving to ban the sale of all non-FDA approved products that contain nicotine, I cannot help but change my mind regarding having ecigs classified as tobacco products. Ideally, they were fall under the same classification as caffeine tabs and such, but time is of the essence, so....

On the positive side, should the appellant court rule in favor of NJoy and SE and uphold Hudge Leon's ruling that ecigs are tobacco products, there is hope. Not only for those two companies, but for everyone. There as two govt grants available regarding safer nicotine products.

If anyone has the resources/contacts for having studies done, there are two grants available. Go to grants.gov and click on basic search. Then, in second box put in grant numbers:
PA-09-047
and
PA-09-046

One has a funding limit, the other has no funding limit.

I'd apply myself (as a small business, for they too can apply), but I dont have the contacts, etc to put it all together and get the ball rolling.

So, as much as we may dislike it, I think we all need to support the idea of it being classified as a tobacco product and then through the grants and research, have it re-classified as one of the safer tobacco products.

 

[taz3cat]

I hope everyone is signing the petition and asking the FDA to take back their misinformation and classify the PV's as tobacco products, that is the only way we can win right now, other wise we lose everything. If the FDA was logical/reasonable we would not have this discussion they would just make them a harm reduction alternative to tobacco cigarettes. In other words just another consumer product that need oversite for quality control. Right now they are not even giving us that, we have great suppliers, but we still all want quality control of the e-liquids. The FDA is not protecting us, or doing anything for us, they want to ban the PV by calling it a drug delivery device.

Some of us have been trying for a very long time to get people to understand that if people keep make health claims we lose, our PV. Those of us who switch from tobacco cigarettes to PV just got a wonderful bonus.

 

[ChipCurtis]

Those of us who switch from tobacco cigarettes to PV just got a wonderful bonus.

I love this idea.

Goldman Sachs and AIG got their bonuses on the backs of taxpayers, now this is the way for smokers to get their bonuses and take their money back.

 

[rj48203]

These comments are in support of petitions FDA-2010-P-0095-0001 and FDA-2010-P-0093-0001, submitted to the FDA on February 7, 2009.

I represent no one other than myself. I have not received, nor do I anticipate receiving, any financial or other consideration from any electronic cigarette enterprise, tobacco-related enterprise or pharmaceutical enterprise.

The Food and Drug Administration (FDA), according to its own statements, is responsible for:
· Protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation
· Regulating tobacco products
· Advancing the public health by helping to speed product innovations
· Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health

The FDA, in its actions to date concerning electronic cigarettes, and more specifically in its July 22, 2009 press conference on e-cigarettes, has demonstrated significant failure to carry out every one of these four responsibilities. Specifically:

1. The FDA has failed to protect the public health as a result of its actions clearly intended to keep electronic cigarettes off the market in what can only be seen as an attempt to expand its own powers while, at the same time, serving to protect, rather than regulate, the interests of the pharmaceutical and tobacco industries.
2. Rather than properly regulate, and that only within the bounds of regulations co-authored by the tobacco industry itself, the FDA is protecting the interests of that industry by attempting to prevent other, less expensive and less harmful, products from competing with it.
3. The FDA is stifling, rather than speeding, product innovations that have the clear potential to save millions of lives.
4. The FDA has attempted to inflame the public, rather than educate it, with inaccurate, incomplete, irrational information based not on science, but on some unstated FDA organizational objective that clearly has no relationship to science. This is manifestly evident in the July 22, 2009 FDA press conference and press release concerning e-cigarettes.

For these reasons, I am submitting these comments in support of the two AAPHP petitions to the FDA, namely FDA-2010-P-0095-0001 and FDA-2010-P-0093-0001. Electronic cigarettes should be properly classified by the FDA as “Tobacco Products” rather than as “drug-device combinations. The FDA also needs to correct the incomplete, false and misleading information it provided to the public on July 22, 2009. If the FDA is concerned about embarrassment for changing its position, I can assure the FDA that such a change would be considerably less embarrassing than clinging to the untenable position it has thus far embraced. Finally, the FDA has a clear organizational and ethical responsibility to actively pursue and support tobacco harm reduction strategies.

The FDA is rightly expected to be a paragon of rational scientific thought and behavior, and, given its charter to protect the public, of ethical conduct. In most instances, this has been the case. However, the FDA press conference and press release of July 22, 2009 demonstrated abject failure to live up to these perfectly reasonable expectations. The announced conclusions were illogical, irrational and appalling for the transparent pretense they attempted to pass off as scientific rigor. Surely, every FDA scientist worthy of the name must have been deeply embarrassed by this spectacle.

In its descent into some unstated political or other misguided agenda, the FDA revealed an utter, and manifestly intentional, failure to find and consider information on the subject, information readily available in the scientific literature, the vast majority of which contains findings contrary to the FDA’s unfounded conclusions and bizarre prejudice against e-cigarettes. I say intentional because I saw many letters to the FDA that directed the organization’s attention to this literature prior to the press conference.

To exacerbate this woefully incomplete and groundless analysis, the FDA made the patently absurd choice not to make the obvious comparison with Nicotine Replacement Therapy (NRT) products, which are regulated at the much more stringent level of drugs. Even worse was the stunningly obtuse decision to evade comparison with tobacco cigarettes, whose delivery of harmful content exceeds that of e-cigarettes by several orders of magnitude.

The FDA’s conduct in this matter is inexplicable in any rational or scientific context. Absent a reasonable explanation from the FDA, we are forced to the conclusion that the reasons for this conduct must lie elsewhere. Some of the most glaringly obvious candidates include the following:

1. As any, even casual, student of organizational behavior recognizes, organizations seek out and protect that which nourishes them and work to expand their scope to the maximum extent possible within the limits of their charters and outside controlling forces. In the case of the FDA, the primary source of such nourishment has been the pharmaceutical and medical device industries, and, subsequent to the FDA/Tobacco law, the tobacco industry, which co-authored the act. The maximum extent is determined empirically by exceeding perceived limits and then gauging the reaction.
2. It is not at all unusual for a regulatory agency, having worked closely with a regulated industry, to gradually, and by imperceptible steps, come to perceive that industry as a constituency rather than as merely a subject of regulation. The Federal Aviation Administration is a well-known example of this phenomenon. It would be easy to conclude, correctly or not, that the financial threat posed by electronic cigarettes to both the pharmaceutical and tobacco industries has had some bearing on the FDA’s behavior.
3. There is some other intentionally unstated agenda driving the FDA’s behavior in this matter, an agenda obviously more important to the FDA than its clear responsibilities for public health.

Regardless of the real reasons, the FDA’s conduct is simply wrong.

Judge Leon’s ruling, in my opinion, clearly and correctly deals with the FDA’s strange attempt to regulate e-cigarettes as medical devices, an attempt that would effectively result in keeping e-cigarettes off the market for years, if not forever. Given the complete lack of evidence of any harm and positive evidence that e-cigarettes are as safe as, and more effective than, current approved NRT products, this is unethical. The studies desired by the FDA on the basis of e-cigarettes being classed as medical devices are impracticable, given the size and time required to produce the demanded results. Worse, such studies would be unethical, given the necessary exposure of thousands of people to known harmful substances that are avoided in other arms of any such study.

In summary, the actions of the FDA regarding e-cigarettes are clearly in conflict with its own stated responsibilities and obviously harmful to the public health. Its justification for these actions is based on an analysis that even an 8th grade student would be embarrassed to call science. While I am surprised it has taken so long for some scientific organization to bring the FDA to task for these actions, I am very pleased that the subject petitions address the matter in a thorough and rigorous manner and provide clear, practical and science-based recommendations to redirect the FDA toward meeting its responsibilities.

Additionally, I wish to go on record with anecdotal evidence supporting the AAPHP petitions. I was a cigarette smoker for 45 years, at one point smoking 2 packs of unfiltered cigarettes per day. Numerous attempts over the years to quit all ended in failure. In later years, I tried NRT products, including patches, gum and lozenges. Those attempts, driven, I believe, more by faith in the products than by actual effectiveness, met with similar failure. Even a heart attack did not deter the habit for more than 2 weeks.

In early 2009, an Internet advertisement for “electronic cigarettes” caught my attention. Curious, I went to one of many Internet forums on the topic and reviewed the experiences of many who had tried the products. I was struck by the almost universal stories of how easily they had given up tobacco cigarettes with e-cigarettes as a substitute.

Concerned that this might be either a fad or a case of exchanging one serious problem for another (Fen-Phen came to mind), I researched the scientific and medical literature, something that the FDA, with all of its resources and sophistication, apparently failed to do. Finding that the e-cigarettes did, indeed, deliver nicotine in useful quantities, while delivering no, or in a few cases barely detectable, amounts of the hundreds of harmful substances delivered by smoked tobacco, I purchased an electronic cigarette kit.

On March 19, 2009, I smoked my last tobacco cigarette. On March 20, 2009, I was smoke-free and remain so to this date. The only two difficulties involved were, first, that there was some anticipatory anxiety over whether it would actually work and second, that I missed the taste for tobacco flavor to which I was habituated. Electronic cigarettes were somewhat fussy in use, but this was more than offset by the fact that they could be used practically anywhere without exposing others to smoke and without producing an unpleasant residual smell in the surroundings. My breathing improved noticeably within days.

After six weeks, I began using e-cigarette liquids containing progressively lower levels of nicotine. This caused some minor, but not insurmountable, discomfort. After three weeks of this weaning process, I was using a liquid containing no nicotine. On June 20, 2009 I stopped using the e-cigarette entirely.

Financially, the cost of using e-cigarettes was about half the cost of the tobacco cigarettes I would otherwise have purchased. Interestingly, it was also significantly less expensive than FDA approved NRT products.

I strongly urge the FDA to reclassify electronic cigarettes from a “drug-device combination” to a “tobacco product” and to follow the Harm Reduction recommendations provided in the petitions. I also strongly urge the FDA to publicly correct the strident and unsupportable stance against reclassification and harm reduction strategies it enunciated in its July 22, 2009 press conference and press release.

 

[CES]

they have 51 comments posted for FDA-2010-P-0095-0001, and 22 for FDA-2010-P-0093-0001. Those numbers don't include my posts. How do we go about using the comment tracking numbers to find out what's up?

 

[Bill Godshall]

I haven't posted on this thread in two weeks, as I've been spending much of my time correcting and refuting false claims and fear mongering statements made by e-cigarette prohibitionists (who most defininately don't want the FDA to reclassify and regulate e-cigarettes as tobacco products) and by those who want to ban the use of e-cigarettes in all locations where smoking is banned.

To address several issues:

Per inquiry by CES above, by using the tracking number on the FDA petition dockets, you can monitor and access all of the comments that have been submitted, and you can also submit comments to other people's comments (e.g. to correct inaccurate claims made by other commenters).

Per comments about e-cigarette taxation, although Congress and State legislatures can tax anything they can get a majority of votes to enact, at least several years will pass (after the FDA reclassifies e-cigarettes as tobacco products) before State legislatures would be able to get enough votes to tax e-cigarettes (and it may be more than a decade before Congress could do so) simply because e-cigarettes cannot generate the massive revenues needed by state and/or the federal government.

Unless a tax proposal can generate about $25 million/year in state government revenue (or about $500 million in federal revenue), its not worth the political capital or the costs of tax collection/administration for politicians to enact it into law.

So until e-cigarette sales exceed $2 billion annually in the US, it is unlikely that any state would tax the products, and Congress is unlikely to consider taxing them unless sales exceed $3-$4 billiion. For comparison, an estimated $100-$200 million of e-cigarettes were sold in the US in 2009.

If/when e-cigarette sales increase by that much (ten to twenty fold), their price will have dropped significantly (e.g. by 25%-50% or more) as that's what has happened economically with virtually every successful product after it was introduced.

The highest tax rate that e-cigarette opponents are likely to be able to enact would be about 30% (and that would occur only if no e-cigarette users opposed it). So any tax on e-cigarettes would be offset (or more than offset) by the price decline due to increased sales.

For disclosure, I've been the most aggressive campaigner during the last 20 years to increase cigarette taxes (with very little success from 1990 to 1999). In 1991, I was the first person to organize a successful campaign (in the US) to increase cigarette taxes for the purpose of reducing cigarette consumption and reimbursing government healthcare expenditures due to smoking diseases (when I collaborated with then PA Governor Bob Casey). That was also the first time a Childrens Health Insurance Program was created (in PA) using cigarette tax revenue.

I also campaigned for the past five years to increase the federal cigarette tax from $39/pack to $1/pack to fund the State Childrens Health Insurance Program (SCHIP), which Congress enacted last year.

 

[Bill Godshall]

Per comments about the whopping increase in federal tax rates for Roll-Your-Own tobacco and for Little Cigars last year, that occurred because the large cigarette companies wanted those products (RYO and Little Cigars) to have the same tax rate as cigarettes (i.e. $1/pack).

Cigarette companies didn't want more smokers switching to RYO or Little Cigars (to save money), so they basically told Congress to tax RYO and Little Cigars at the same rate of cigarettes.

 

[Oliver]

Hey, rj, fantastic post! Good man for taking the time to write such a considered and eloquent submission.

SJ

 

[lizziebith]

I appreciate your efforts Mr. Godshall. It is ironic that due to my use of e-cigarettes I am no longer buying normal cigarettes (and am thereby NOT contributing my sin tax dollars to the SCHIP), and I can now, finally, afford to purchase health insurance for myself.

I do have two questions though: what happens to the SCHIP if all smokers quit? Also, political rhetoric several years ago got early sin taxes on cigarettes approved "to cover the higher cost of health care for smokers." How can I apply for this health care coverage I paid for?

I'm sorry if I am interpreting the issues wrong. I did sign and comment both of the petitions, and did not include anything inflammatory such as the above.

 

[miss MiA]

I haven't looked for existing discussion of the following hypothesis but seems it would be there: One of my worries is that one way or another, either way things go, insurance companies may start inquiring about clients' ecig usage, and jacking rates and/or denying claims based on throwing darts at whatever they can think of that could possibly be related. Or just categorizing as smokers straight out. Don't know if that's realistic or not (tho I imagine it's realistic that they would/will if they can).

Edit: wanted to clarify that I raised this only as a general digression into insurance matters after lizziebith brought up insurance above; not as an objection to the petition!

 

[basic_atheist]

I haven't looked for existing discussion of the following hypothesis but seems it would be there: One of my worries is that one way or another, either way things go, insurance companies may start inquiring about clients' ecig usage, and jacking rates and/or denying claims based on throwing darts at whatever they can think of that could possibly be related. Or just categorizing as smokers straight out. Don't know if that's realistic or not (tho I imagine it's realistic that they would/will if they can).

Don't worry about it. They can't prove whether you do or not. It's your word against theirs. If they do ask, then you can always say, "NO".

If you puffed on a real fog machine on a regular basis, would you tell them that too?... Probably not, right?... so what difference does it make?

Even if you do use Nicotine, they don't have to know what your source is. You can always say you use OTC NRT's.

Nicotine is Nicotine. No matter what the source is, it's still Nicotine.

 

[miss MiA]

Don't worry about it. They can't prove whether you do or not. It's your word against theirs. If they do ask, then you can always say, "NO".

If you puffed on a real fog machine on a regular basis, would you tell them that too?... Probably not, right?... so what difference does it make?

Even if you do use Nicotine, they don't have to know what your source is. You can always say you use OTC NRT's.

Nicotine is Nicotine. No matter what the source is, it's still Nicotine.

Yeah I hope so... My imagination was running to a scenario like, for example, you so happen to have some kind of respiratory ailment -- one that anyone can have, whether smoker or nonsmoker or vaper or nonvaper -- and they did some tests... Might PG or VG show up in the results, and lead to the insurer denying claims related to that or future instances of respiratory ailments, if an e-smoking question had been in their forms and you'd answered no...

 

[basic_atheist]

Yeah I hope so... My imagination was running to a scenario like, for example, you so happen to have some kind of respiratory ailment -- one that anyone can have, whether smoker or nonsmoker or vaper or nonvaper -- and they did some tests... Might PG or VG show up in the results, and lead to the insurer denying claims related to that or future instances of respiratory ailments, if an e-smoking question had been in their forms and you'd answered no...

So, you do alot of cooking (VG), or you spend alot of time at dance clubs around fog machines (PG), or both.

No crime in that. Sounds like you're a very active person... LOL.

I mean, seriously, what are they going to do? Get a search warrant and go through your house looking for e-cig hardware and juice?

I can see it now... you have your batteries stashed in remote controlled cars, cartridges and atomizers hidden the table lamp bases, e-liquid sitting in an olive oil bottle beside the stove, flavorings in the vanilla extract bottles in the cabinet... uhhh... dammit, where do we put the chargers?