Policy Guidance Document Regarding E-Cigarettes

[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.