Policy Guidance Document Regarding E-Cigarettes

[Vocalek]

Now available on the CASAA Web site under Resources / Documents

http://www.casaa.org/files/CASAA Position Statement.pdf


Suitable for printing and mailing or handing to legislators and others who want the facts and to know where CASAA stands on the issue. This would be especially good to give to anyone who had receiverd the Evil Empire's Policy Guidance Document.

 

[DC2]

Now available on the CASAA Web site under Resources / Documents

http://www.casaa.org/files/CASAA Position Statement.pdf


Suitable for printing and mailing or handing to legislators and others who want the facts and to know where CASAA stands on the issue. This would be especially good to give to anyone who had receiverd the Evil Empire's Policy Guidance Document.

Very nice addition to the CASAA resource library.

 

[Janetda]

I think it's great! Thanks to everyone who participated in writing it. It would be great to see something similar for snus.

 

[Kate51]

Thanks for allllll the info, once again! More letters!
I'm with Thulium, it's so maddening to see this stuff>>E‐cigarette manufacturers and retailers are making unproven health claims about their products – asserting that they are safe or safer than traditional cigarettes.Wha.........how dare Makers do that?!

What Green Planet do these people come from. And what would qualify as "scientific"? Common sense not included?
JustJulie, good point!!

 

[PhiHalcyon]

I find it kind of surprising that PhiHalcyon feels that he has a better grasp of the law than a federal district court judge.

Don't be absurd. Federal judges do not inherently possess a greater ability to understand the logic and meaning of newly written laws than anyone else. If they did, then we wouldn't need three-judge Appeals Court panels to double-check their work. Besides, three months before Judge Leon's ruling was released, I was making some of the same arguments that he did. The only difference is that I have had an extended opportunity to analyze, review, and reconsider those arguments; whereas, Judge Leon has not.

In fact, I'm working on one myself. So, yes, stock up if you can. For, this may be all that you really need to do to carry you over until there are new options on the market.

This explains a lot.

My efforts to preserve the benefits of the e-cig in a legal form do not explain anything; but my realization of the necessity of preserving the benefits of the e-cig in a legal form DOES explain my efforts to do so. Therefore, for you to believe that I make the arguments that I make because I have sought to preserve the benefits of the e-cig in a legal form is for you to turn logic on its head. Even if I had the sinister motivation you insinuated (i.e., to take down the e-cig to make room for my own product), it is not what you or I may want, but what Congress has intended, that will decide the matter.


"CASAA supports the FDA classifying and regulating the electronic cigarette as a tobacco product."

If CASSA supports vaporizers of nicotinated flavor extracts to be classified and regulated as tobacco products, then does this mean that CASSA also supports nicotinated baking powder (as a functional equivalent of snuff), and nicotinated tea pouches (as a functional equivalent of snus), to be classified and regulated as tobacco products as well?

I have never been afraid of being wrong. In fact, I would prefer that I was. But I have never understood why otherwise intelligent people are not more duly afraid of me being right about what it means to market a tobacco product in combination with an article or product that is regulated under the FDCA.

Phil: That's very interesting. Do you own a pharmaceutical or medical device company?

A pharmaceutical product is NOT necessary to preserve the benefits of the e-cig in a legal form. But, no, I do not own, nor work for, a pharmaceutical or medical device company. Nor am I in any position to turn my legal solution into a commercial product to sell. I wish that I was, because the relatively easy and fun part that remains to be done is also the part that requires more resources than what I have available. Nevertheless, since I know that preserving the benefits of the e-cig can be done in a non-pharmaceutical manner, I suspect that the solutions of others will eventually save the day. I'm just not willing to bank on it until it actually happens.

 

[kristin]

"CASAA supports the FDA classifying and regulating the electronic cigarette as a tobacco product."

If CASSA supports vaporizers of nicotinated flavor extracts to be classified and regulated as tobacco products, then does this mean that CASSA also supports nicotinated baking powder (as a functional equivalent of snuff), and nicotinated tea pouches (as a functional equivalent of snus), to be classified and regulated as tobacco products as well?

Ity depends on intended use. If a product is meant to treat a disease or addiction, it's a pharmaceutical.

If it's intended to be used as recreational nicotine, then it's currently a tobacco product.

CASAA supports further development and implimentation of the Reduced Harm catagory. Reduced harm products should not be penalized nor regulated in the same manner as the more harmful products.

The ultimate goal is not to stay "just" a tobacco product, but to get reduced harm status for smokefree alternatives.

 

[PhiHalcyon]

Ity depends on intended use. If a product is meant to treat a disease or addiction, it's a pharmaceutical.

If it's intended to be used as recreational nicotine, then it's currently a tobacco product.

No, they are prohibited forms of tobacco products under paragraph 4 of the definition of tobacco products. There are no exclusions based on intended use, or anything else. Thus, nicotinated flavor extracts and the devices used to vaporize them cannot be classified and regulated as tobacco products. This means that the only way they can be legally sold is if they are sold under a different chapter of the FDCA. Namely, the drug and device chapters. It has worked the same way with nicotine gum, nicotine lozenges, and nicotine water, before the Tobacco Act - with each of these being prohibited from being sold and regulated as foods under the food chapter.

 

[JustJulie]

PhiHalcyon--I've followed many of your posts over the course of the last year. While I occasionally agree with you, I personally feel that your legal analysis typically doesn't really reflect a broader understanding of the regulatory system.

But whatever. You are certainly entitled to your opinion.

 

[kristin]

No, they are prohibited forms of tobacco products under paragraph 4 of the definition of tobacco products.

Paragraph 4 of the Tobacco Act?

 

[PhiHalcyon]

PhiHalcyon--I've followed many of your posts over the course of the last year. While I occasionally agree with you, I personally feel that your legal analysis typically doesn't really reflect a broader understanding of the regulatory system.

But whatever. You are certainly entitled to your opinion.

Yes, I am. And unless and until it is refuted by someone who sees or understands something that I supposedly do not, then my opinion shall remain deemable as accurate. But since you have not demonstrated such a superior perception and understanding in the form of an actual argument, what shall your assessment of my understanding remain deemable as?

Paragraph 4 of the Tobacco Act?

No. Paragraph 4 of the definition of tobacco products. Section 201(rr)(4)

 

[kristin]

But who's definition? Tobacco products can be defined differently in every state. Do you have a link to where you read that?

 

[kristin]

No, they are prohibited forms of tobacco products under paragraph 4 of the definition of tobacco products. There are no exclusions based on intended use, or anything else. Thus, nicotinated flavor extracts and the devices used to vaporize them cannot be classified and regulated as tobacco products. This means that the only way they can be legally sold is if they are sold under a different chapter of the FDCA. Namely, the drug and device chapters. It has worked the same way with nicotine gum, nicotine lozenges, and nicotine water, before the Tobacco Act - with each of these being prohibited from being sold and regulated as foods under the food chapter.

If this were so cut and dry, wouldn't the FDA, with all of their high-priced attornys, already be aware of this? If so, why was that not their argument in SE vs. FDA?

 

[JustJulie]

Yes, I am. And unless and until it is refuted by someone who sees or understands something that I supposedly do not, then my opinion shall remain deemable as accurate. But since you have not demonstrated such a superior perception and understanding in the form of an actual argument, what shall your assessment of my understanding remain deemable as?

The forum is full of posts that refute your "deemable" arguments. You just choose not to agree with them.

 

[PhiHalcyon]

Section 201(rr)(4) of the FDCA states that:
"A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement)."

And since the context of this paragraph is the definition of tobacco products, it does not apply to products sold as drugs, foods, etc.; it applies to products sold as tobacco products. For, like I said, nicotinated foods like nicotine gum are prohibited from being sold as foods under the food chapter. (Namely because nicotine is not an approved food additive). Thus, any nicotinated article or product that (minus the nicotine) is regulated under the FDCA, is prohibited from being sold as a tobacco product.

If this were so cut and dry, wouldn't the FDA, with all of their high-priced attornys, already be aware of this? If so, why was that not their argument in SE vs. FDA?

I have not attempted to assess the FDA's strategies and understanding, but I will be surprised if the paragraph 4 prohibition is not brought up in next Monday's filing. For, in having been at work at understanding the logic and meaning of the Tobacco Act for many months, my take on the meaning of paragraph 4 is the only interpretation that does not open wide the door for big tobacco to essentially crush big pharm's hold on the 'safe' nicotine market. Which is simply not something that big pharm (who had the upper hand in the negotiations) would have ever signed on to.

 

[Vocalek]

Phil: You might want to read page 22 of Judge Leon's opinion. His ruling on whether electronic cigarettes should be regulated under FDCA or under the Tobacco Act hinges on the question of intended use.

http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf

Consider the consequences of throwing away "intended use" as a measure by which something is considered a drug.

Cheerios would not be able to just remove any health claims from its labels and keep selling the product as food. Given the fact that people COULD use Cheerios to lower their risk of heart disease, FDA could insist the product can't be sold as food. From henceforth it is a drug, regardless of what the manufacturer or even the end user intend its use to be. General Mills better find an IRB and start recruiting subjects for those long and expensive clinical trials.

Personally, I think the FDA already has too much power. Giving them that kind of additional power is a very frightening thought.

 

[PhiHalcyon]

Vocalek,

I understand what you are saying. And it IS alot of power. But only in the case of nicotine products. Furthermore, this would NOT be a change from the regulatory reality of the last 25 years or so.

 

[kristin]

I have not attempted to assess the FDA's strategies and understanding, but I will be surprised if the paragraph 4 prohibition is not brought up in next Monday's filing.

I don't believe they can bring enter it at this point anymore. The appeals case must be decided on current evidence already presented.

I still find it a HUGE stretch to think that they aren't already fully aware of "paragraph 4" and wouldn't have argued it already if it were applicable - especially if it was the "slam dunk" you suggest it is. The judge even gave them time to enter arguments once the Act took effect and tobacco came under FDA jusrisdiction. It woulod have bneen the perfect opportunity to make the "paragraph 4" argument. If Big Pharma had a hand in writing the text, they would most certainly have tipped off the FDA by now and would not be resorting to hiding behind the ALA and AHA.

So, no offense but I suspect you must be wrong on your interpretation.

 

[Vocalek]

The combination of battery, atomizer, and cartridge is not a medical device. It certainly is not a drug, biologic, food, cosmetic, or dietary supplement.

We have argued this until our faces are turning blue. Because something COULD be used to deliver a drug does not make it a medical device. My teaspoon can be used to deliver cough syrup to my mouth. It isn't a medical device. What makes any type of hardware into a medical device is the intended use.

Here is a statement from the manufacturer of a slightly different type of vaporizer:

"The Volcano Vaporizer , along with all other vaporization systems, are considered to be a consumer product and not a medical device."

Section 201(rr)(4) of the FDCA specifies that the tobacco product can't be marketed with another item regulated under FDCA. "Consumer product" is not one of the prohibited items.

 

[Vocalek]

The combination of battery, atomizer, and cartridge is not a medical device. It certainly is not a drug, biologic, food, cosmetic, or dietary supplement.

We have argued this until our faces are turning blue. Because something COULD be used to deliver a drug does not make it a medical device. My teaspoon can be used to deliver cough syrup to my mouth. It isn't a medical device. What makes any type of hardware into a medical device is the intended use.

Here is a statement from the manufacturer of a slightly different type of vaporizer:

"The Volcano Vaporizer, along with all other vaporization systems, are considered to be a consumer product and not a medical device."

Section 201(rr)(4) of the FDCA specifies that the tobacco product can't be marketed with another item regulated under FDCA. "Consumer product" is not one of the regulated items.

 

[PhiHalcyon]

As far I can recall, I am the first person in this forum to bring up the matter of paragraph 4. And whether I was or not, I am certainly the one who has most examined, and debated over, the meaning of it. Furthermore, I am in no way, shape, or form, against the e-cig remaining available as a legal option for all smokers. So, my prejudices are in favor of an interpretation that would benefit the cause of keeping the e-cig available. Nonetheless, despite this fact, I have examined every possible way that there is to interpret the meaning of paragraph 4, and there is only that one renders the Tobacco Act comprehensible; that does not alter the pre-existing regulatory reality (save for tobacco products now being regulated by the FDA); and that completely squares with the self-interests of both Phillip Morris and big pharm (who wrote and negotiated the Act). And that interpretation is the one that I have stated.

If anyone does, wants, or needs to believe otherwise, then that is obviously their prerogative; but, as far as I am concerned, there is no other logical interpretation. We will all find out the truth of matter soon enough. But, in the meanwhile, I will continue to do what I deem to be wise, and that is to work on making the fate of the e-cig irrelevant. For, I much prefer to put myself in a no-lose situation, than what I perceive to be a no-win one.