Policy Guidance Document Regarding E-Cigarettes

[DC2]

I actually agree that the new tobacco chapter of the FDCA is going to control here, but Phi simply doesn't understand it, or specifically the provision he's going on about, nor the underlying fundamental precepts of the FDCA in general, as I noted previously.

He can't understand it, because logic is getting in the way.

 

[PhiHalcyon]

He can't understand it, because logic is getting in the way.

Once again. Yeah. Which explains why the FDA is seizing e-cig shipments, and has NEVER allowed ANY nicotinated non-tobacco product to go unregulated as a drug. You would think the FDA would understand the FDCA better than anyone.

 

[yvilla]

As I said, you fail to understand the crucial concepts of "inactive" and "active" ingredients, thus you made up out of whole cloth your completely arbitrary % requirement, one that exists nowhere in either the FDCA or the FSPTCA, and that led you to your entirely mistaken belief that the ecig must needs be a "nicotinated non-tobacco product", contrary to the otherwise plain language of section one of the definition of tobacco product.

 

[5cardstud]

Whoever wrote that piece of comedy obviously has never smoked or has never tried to quit using the products they recommend. I guess all of us who have quit after decades of smoking are under a spell that makes us think we've quit. These people never cease to amaze me.

 

[D103]

Mr. PhiHalcyon, you really didn't do the I.Q. thing did you? It has been my experience that the possesion of a significant I.Q. and the the need to advertise said personal I.Q. are usually mutually exclusive.
Anyway, I do see what you are getting at when you assert that Big Pharma and Phillip Morris would not have "signed on" to the Tobacco Act leaving the "door wide open" for unfettered competition. I still think it possible that they were given assurances that any potential competition would be dealt with and that the popularity of the e-cig and the fastly growing numbers of users may, in fact have been grossly underestimated. This is a stretch, I realize, but still possible. But, if what you portray is true, that it is such a 'slam dunk' case, a foregone conclusion ( based on, in part, the now infamous 'paragraph 4') and Judge Leon's ruling is virtually meaningless, then nothing that has happened, concerning this issue, in the last several months makes any sense at all - and you are a proponent of Logic, I like it too, you just don't find it as much as one would think,) - the alphabet suits signing on to a lawsuit in the eleventh hour (I say again, these organizations are lawsuit adverse, and if this were truly a 'slam dunk' there is no way they would have exposed themselves, nor would they have needed to); they also would not be actively organizing "talking points" and "game plan" strategies, the FDA would not have wrecklessly put forth a shoddy test report on the e-cig and it's content and found itself in a corner trying desperately to defend the indefensible, the American Cancer Society would not have signed on to a lawsuit that involves the FDA fighting to classify a new technology as a "drug delivery device" which delivers a drug-nicotine-that does not, in fact, cause cancer, not to mention all the other anti-tobacco organizations involved in the same lawsuit, and the three leading Iconic Charitable Non-Profits, AHA, ALA, ACS would not have initially and publicly argued strongly against the e-cigs because they were catering to children (flavors, the mall Kiosks, etc) and then change that tactic and strongly oppose states supporting 'No Sales to Minors' legislation. In my opinion only, I feel that none of this would have happened in an atmosphere where the legal outcome is a 'done deal' - it quite simply makes no sense to me. If this were truly, 'in the bag', they would have quietly stayed out of the limelight, put forth what legal arguments you have made, squashed the whole thing and been done with it. Also, if what you are saying were accurate, I would think their collective legal teams would have put together much more effective talking points - geared towards your explanation of the legalities and regulatory realities rather than the ridiculous, inaccurate, already refuted, junk science, lame, public statements they have all been engaged in which have already gotten them into trouble publicly and will continue to do so unless they come up with a new strategy. NONE of this, sir, seems to me to be at all consistent with a "slam dunk" case, that is a foregone conclusion as you describe it to be.

 

[kristin]

A complete ..... can see that the e-cig is a drug delivery device. This is not even in dispute. The only question is whether or not it is drug delivery device that is protected from being regulated as such as a legitimate tobacco product, or whether it is a prohibited form of tobacco product that is not protected.

I say again - intended use.

It's only a drug delivery device if it is intended to treat/prevent a disease or illness.

Just the fact that they contain a drug does not make it a drug delivery device. If that were true, my can of Pepsi Max I'm sipping from is a drug delivery device, because it contains caffeine.

It's the same reason the FDA was not allowed to call tobacco cigarettes and other products a drug delivery device - and they tried to do just that. Congess made that distinction.

The fact that ecigs lack the health risks of tobacco cigarettes does not automatically make them a treatment. If that were the case, low-fat frozen yogurt would be deemed a treatment, because it reduces the risk of obesity caused by ice cream.

The thing that keeps ecigs from being drug delivery devices is the same as other tobacco products - intended use.

 

[PhiHalcyon]

My, my, my. Everyone knows so much, and I so little. Oh well. At least I know this:

If paragraph 4 was intended to prohibit marketing a tobacco product in combination with an article or product that (when sold by a tobacco product manufacturer) is sold as a drug, food, medical device, etc., then all nicotine replacement products would be prohibited from being sold as drugs and drug/device combinations! Since this is clearly not what Congress intended, paragraph 4 must prohibit marketing a tobacco product in combination with an article or product that (absent the tobacco product) is sold and regulated under the FDCA. In other words, if an article or product is regulated under the FDCA (when purchased by a tobacco product manufacturer), then combining a tobacco product with such an article or product is prohibited under the definition of tobacco products; and therefore results in a product that is prohibited from being sold as, classified as, regulated as, or even considered to be, a legitimate tobacco product.

The only thing that a prohibited illegitimate tobacco product can be sold as is an approved drug or drug/device combination.

Now, if there be anyone who does not yet understand, then they can receive their education via the ruling(s) to come. For, I am done trying to fill the cups that are full ... of something.

 

[JustJulie]

I am done trying to fill the cups that are full ... of something.

Since absolutely no one is in agreement with you, that's probably a wise move.

 

[PhiHalcyon]

Yeah. You'd think that I would have realized that six months ago, but the watchman's duties are not so easily ignored. It is the curse of one who sees what is to come. But, hey, at least I have my ark!

 

[JustJulie]

Yeah. You'd think that I would have realized that six months ago, but the watchman's duties are not so easily ignored. It is the curse of one who sees what is to come. But, hey, at least I have my ark!

Anyone who feels he KNOWS how the courts are going to rule in this case is fooling himself. Courts rule how they wish to rule, and while we can offer all the intelligent (and sometimes not so intelligent) speculation we wish, none of the analysis offered on this forum will have one bit of an effect on the case itself.

Perhaps your views would be better considered by the community if offered with just a tad less condescension. I'll be honest in saying that as of yesterday, I officially stopped paying attention to your arguments because they're dripping with sarcasm and superiority, and, to date, I've personally found enough flaws in your interpretations that it's simply not worth my time or energy to explain to you why I don't agree, especially since you dismiss any opinions contrary to your own, even when the flaws are pointed out.

But that's just my opinion, and it's worth exactly what you paid for it.

 

[PhiHalcyon]

JustJulie,

This case is not just any case. It pertains to the interpretation of a new and important law that is difficult to fully understand without a substantial amount of balanced consideration. This assures to a very high degree that this case will reach the Supreme Court if necessary to ensure that the intent of Congress is deduced in the only way that a coherent interpretation allows. And this itself assures to the same high degree, that the ultimate outcome is as deducible as the meaning of the law itself.

As for the 'flaws' in my argument above ... if you are so sure that there are some, then it should be no more difficult for you to substantiate your assertion than it is for you to make it. And, frankly, considering the stakes, it is irresponsible for you to make such an assertion if you are not willing to take the time to substantiate it for the edification and understanding of all.

Every element of every argument that I have ever made in this forum has not always been accurate. I am aware of this. But, at least I back up my assertions with an argument. You, however, just make unsubstantiated assertions that have no value nor substance as a result of your unwillingness/inability to substantiate them with an actual argument.

 

[JustJulie]

JustJulie,

This case is not just any case. It pertains to the interpretation of a new and important law that is difficult to fully understand without a substantial amount of balanced consideration. This assures to a very high degree that the Courts - even if it needs to be the Supreme Court - will ultimately deduce the intent of Congress in the only way that a coherent interpretation allows. And this itself assures to the same high degree, that the ultimate outcome is as deducible as the meaning of the law itself.

As for the 'flaws' in my argument above ... if you are so sure that there are some, then it should be no more difficult for you to substantiate your assertion as it is to make it. And, frankly, considering the stakes, it is irresponsible for you to make such an assertion if you are not willing to take the time to substantiate it for the edification and understanding of all.

Every element of every argument that I have ever made in this forum has not always been accurate. I am aware of this. But, at least I back up my assertions with an argument. You, however, just make unsubstantiated assertions that have no value nor substance as a result of your unwillingness/inability to substantiate them.

What exactly are you looking for here? Again, time and time again people have attempted to explain why they believe your interpretation is flawed. Why should I waste my breath?

Why not actually read Yolanda's posts? She is, as usual, spot on, imo.

And with that, I'm going into lurk mode on this thread unless there is something intelligent to comment on.

 

[PhiHalcyon]

Yeah. Just as I thought.

 

[Thulium]

If paragraph 4 was intended to prohibit marketing a tobacco product in combination with an article or product that (when sold by a tobacco product manufacturer) is sold as a drug, food, medical device, etc., then all nicotine replacement products would be prohibited from being sold as drugs and drug/device combinations!

Somebody is going to kick me for even asking, but... HUH???

That doesn't make any sense whatsoever. What NRT is a tobacco product that is marketed in combination with a drug, food, or medical device? I've bought a few NRT's and all I saw was the product and the packaging...Mine didn't come with any other drugs, foods, or medical devices. Did yours? One came with a CD--did you try to eat it or something?

Since this is clearly not what Congress intended, paragraph 4 must prohibit marketing a tobacco product in combination with an article or product that (absent the tobacco product) is sold and regulated under the FDCA.

So if somebody tries to market a tobacco product in combination with another FDCA regulated product... does that make the aforementioned tobacco product not a tobacco product? Does that mean a pack of cigarettes with a free lighter is medicine?

In other words, if an article or product is regulated under the FDCA when purchased (by a tobacco product manufacturer), then combining a tobacco product with such an article or product is prohibited under the definition of tobacco products; and thus, prohibited from being sold, classifed, regulated, or even considered to be, a legitimate tobacco product.

With your "165 IQ" I would have thought you would have figured out by now that 'Paragraph 4' was included to ensure that the FDA retains control over the monopoly they created for themselves by the label of "Combo Products." Pharmaceutical companies are hoping to recoup the money they shovel to the FDA to get their products pushed through before anybody figures out all the nasty side effects by puppeteering the FDA into doing their dirty work: Block or steal innovative products by declaring them a "combination" of other products. It's an insidious scam, but the government is a paid and thereby willing participant.

The only thing that a prohibited illegitimate tobacco product can be sold as is an approved drug or drug/device combination product.

Paragraph 4 says that tobacco products can't be marketed in combination with non-tobacco products. I must have missed the part where it said that certain tobacco products are illegitimate.

Now, if there be anyone who does not yet understand, then they can receive their education via the ruling(s) to come. For, I am done trying to fill the cups that are full ... of something.

I don't think the ruling from the Appellate will be 100% positive for Smoking Everywhere--Big Pharma has too much influence. However, the Appellate is obliged to defer to Judge Leon's findings of fact and after the appeal is decided the case reverts to Judge Leon so even if the Appellate determines that the FDA is entitled to continue seizing unapproved products, there is insufficient evidence in the case above for the FDA to regulate electronic cigarettes as drug devices because the FDA has not shown ANY evidence of a public health risk or that electronic cigarettes are intended to cure, diagnose, or treat any medical conditions.

 

[DC2]

If I remember correctly from all his posts in the FDA vs Smoking Everywhere thread, he believes that unless the juice we use is made up of over 50% nicotine, it is not a tobacco product because it is not made up primarily of that which is derived from tobacco. And he further believes that this fact makes it nothing more than a non-tobacco product (proplyene glycol) to which a tobacco-derived product (nicotine) has been added and is being marketed in conjunction with.

Mr. Halcyon, please correct me if I'm wrong.

 

[yvilla]

If I remember correctly from all his posts in the FDA vs Smoking Everywhere thread, he believes that unless the juice we use is made up of over 50% nicotine, it is not a tobacco product because it is not made up primarily of that which is derived from tobacco. And he further believes that this fact makes it nothing more than a non-tobacco product (proplyene glycol) to which a tobacco-derived product (nicotine) has been added and is being marketed in conjunction with.

DC, yes, that's essentially what he's going on about - and what I was referring to above when I posted about the arbitrary % figure that he, and only he, invented out of whole cloth, and that exists nowhere in the statute. And, that simply fails to comprehend the meaning of "inactive ingredients" versus "active ingredients".

Not only did I long ago rebut his arguments about the meaning of section 4 of the tobacco products definition found in the new tobacco legislation, but so did Legal One try to disabuse him of the wholly inaccurate notion that there is some arbitrary percentage of ingredients overlay to be found in the FDCA.

 

[PhiHalcyon]

"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)."

Paragraph 4 does not prohibit a product that is sold as a food, drug, etc. from containing a tobacco product. For, if it did, then no product sold as a drug could contain nicotine. Thus, in being the fourth paragraph of the definition of tobacco products, paragraph 4 pertains only to what can be sold and classified as a tobacco product. This means that paragraph 4 cannot be understood to prohibit selling a carton of cigarettes in combination with a twelve-pack of soda, either. For, the twelve-pack of soda is separately regulated as a food, and the carton of cigarettes is separately regulated as a tobacco product; and selling them together (which is not the sort of thing that is done in the real world for Congress to be addressing) does not make the carton of cigarettes any less of a legitimate tobacco product. Therefore, paragraph 4 can have only one purpose, and that is to preclude any product that would not have been considered a tobacco product before the Tobacco Act from now being sold and classified as a tobacco product.

Except in the case of a medical device (which could be argued to be an accessory of a tobacco product if marketed in combination with a tobacco product), the words "a tobacco product shall not be marketed in combination with any other article or product regulated under the FDCA" mean the opposite of the words "no article or product regulated under the FDCA shall be marketed in combination with a tobacco product". In other words, flavor extracts can be marketed in combination with a tobacco product (as non-tobacco substances used for flavoring), but a tobacco product cannot be marketed in combination with flavor extracts (as is done in flavored e-liquids). The same holds true for pg and glycerin without flavors; for flavor extracts, pg, and glycerin, are all articles or products regulated under the FDCA.

Yvilla wants to believe that the flavor extract, pg, and/or glycerin, of e-liquid are not articles or products regulated under the FDCA because, in the context of being components of a tobacco product, they are regulated as components of a tobacco product. And if she's right, then no combination product that is sold as a tobacco product could be considered to be a prohibited combination product, and paragraph 4 would serve absolutely no purpose at all!

 

[Vocalek]

Phil: Are you quoting paragraph 4 of the FDCA, or paragraph 4 of the Tobacco Act? If the former, the writers would need to have been clairvoyant. The Tobacco act did not exist yet, so how could they have been guarding against it?

Here is an alternative interpretation: The writers wanted to guard against some marketing organization giving away a free pack of ciggies with your prescription, can of Spam, lipstick, artificial knee joint, or vitamin.

Since beer isn't regulated under the FDCA, then I suppose the free pack of ciggies could come with your 6-pack.

 

[yvilla]

Yvilla wants to believe that the flavor extract, pg, and/or glycerin, of e-liquid are not articles or products regulated under the FDCA because, in the context of being components of a tobacco product, they are regulated as components of a tobacco product. And if she's right, then no combination product that is sold as a tobacco product could be considered to be a prohibited combination product, and paragraph 4 would serve absolutely no purpose at all!

What a disingenuous statement! Phi knows full well I neither want to, nor do believe, any such thing.

Flavor, PG and gycerin are of course all products regulated under the FDCA.

What he postulates about MY beliefs in the above post is a complete crock - and has nothing to do with what I'm actually saying. Which is that his argument completely misreads and misunderstands Section 201(rr)(4) of the new tobacco chapter of the FDCA (and the other subsections as well, for that matter).

I said I wasn't going to do this again, but since he keeps at it, and especially since he misrepresents my previously posted arguments, for one last time I'll explain why Phi is wrong, for those who may not have seen the extensive discussions we had about this whole argument months ago.

Section 201(rr)(1) gives us the basic defintion of a "tobacco product", which is: "The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)."

Obviously, since nicotine is derived from tobacco, and is present in quite a few pharmaceutical drug products, clarification was needed that the above expansive definition of "tobacco product" was NOT intended to change or affect in any way the classification of non-tobacco pharm products containing nicotine, already regulated under Chapter V of the FDCA.

Thus, Section 201(rr)(2) gives us the exclusion of nicotine containing drug products from the universe of tobacco products: "The term ‘tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g)."

The key thing to be aware of with respect to this is that while both tobacco products and pharm products containing nicotine deliver nicotine, it is the marketing and "intended use" (determined by a whole constellation of factors) of the product in question that makes the difference between the two.

And Section 201(rr)(3) adds just a bit more clarification: "The products described in paragraph (2) shall be subject to chapter V of this Act." (the same existing chapter governing drugs they have always been regulated under)

Okay, so in sum, subsections one, two and three of 201(rr) of the new tobacco chapter of the FDCA say that anything made or derived from tobacco intended for human consumption is a "tobacco product" to be regulated under the new chapter, EXCEPT that pharm products containing nicotine and formulated, intended and marketed for smoking cessation, or the treatment of nicotine addiction or any other disease, are of course NOT considered tobacco products, and will continue to be regulated, as always, as drug products under Chapter V.

Phi, rather than take subsection (1) at its word, which is that ANY thing made or derived from tobacco is a tobacco product (that is, including our eliquid, and even our ecigs, if viewed as an accessory part to the liquid), MADE UP HIS OWN REQUIREMENT, that there had to be a certain arbitrary percentage of nicotine in the liquid (I think he ended up with >50%) for it to be a tobacco product. And from then on he has been proclaiming that to be the truth from on high - that ecigs or ecig liquid cannot be a tobacco product, because it doesn't have the percentage of nicotine in it that HE deemed necessary. What hubris! What unmitigated arrogance - Phi knows better than those that wrote the law, oh, and he knows better than Judge Leon too, and the FDA and all its lawyers, who somehow missed raising and relying on that (fictitious) statutory requirement over the course of the entire case before Judge Leon. Bad lawyers!

I really don't understand why Phi cannot understand the concept of "active" versus "inactive ingredients" - maybe because he's so committed to his fictive percentage of nicotine requirement that he has blinded himself to reality. But seriously, I know he has seen the inactive ingredients database maintained by the FDA, and that I've also pointed to before. Does he really think, for example, that the topical ear solution that is 95% percent PG (as an inactive ingredient) is somehow automagically a PG product simply because it's way more than 50% PG, instead of what it really is - a whatever-the-active-ingredent-is product? Does Phi also think that the IV injection drug that has 82% PG, as an inactive ingredient, is a PG product, and not a whatever-the-active-ingredent-is product? Or take foods, like the McCormack flavorings found right in your grocery store, they must be sold as a PG product right, since the major ingredient by weight by far is PG? No, they are sold as a-whatever-the-flavor-is product.

Anyone who wants to look at the hugely varying percentages of PG found in numerous FDA approved drug products can do so at the FDA inactive ingredients database, just by typing "propylene glycol" in the search box found on this page:

Inactive Ingredients in FDA Approved Drugs

Bottom line for our purposes, the percentage of PG (or Glycerin, or PPG), used simply and solely as the vapor creating base for our active ingredient nicotine, is totally meaningless on the critical question whether eliquid (or the ecig itself as well) is a "tobacco product" within the meaning of 201(rr) of the new Chapter IX of the FDCA. The answer given to that by the Court will depend on the facts presented about the ecig and its marketing, on the statutory defintions of what is a "tobacco product", a "drug product" and "intended use", and on the legal precedent in this area, notably Brown & Williamson. FDA V. BROWN & WILLIAMSON TOBACCO CORP..

Now finally, as for 201(rr)(4), this subsection is actually a MARKETING provision, not truly a definitional provision at all:

"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)."

The FDA understands that it is a marketing provision, even if Phi doesn't. It has nothing to do with the proportion or make up of the various (inactive) ingredients and additives of a tobacco product, and everything to do with how tobacco products are packaged, promoted and marketed: Here is what the FDA says it means, in its draft guidance document for the industry:

A. FDA believes the following activities are included within the scope of section 201(rr)(4) of the FDCA and, therefore, are prohibited:

A tobacco product and a non-tobacco product regulated under the FDCA are physically, chemically, or otherwise combined or mixed to produce a single entity that is marketed as containing both products. For example:

• • Mouthwash (which may be a drug or a cosmetic under the FDCA) is added to the ingredients of a cigarette and the cigarette is identified as containing mouthwash.
  • Compressed or powdered tobacco is added to candy or gum (which are foods under the FDCA) and the candy or gum is identified as containing a tobacco product.
  • Nicotine that is derived from tobacco is added to water, juice, or soda (which are foods under the FDCA) and the water, juice, or soda is identified as containing a tobacco product.

A tobacco product and a non-tobacco product regulated under the FDCA are packaged together in a single package or as a unit. For example:

• • A pack of cigarettes is shrink-wrapped or sold in a box, bag, or other container with a bottle of mouthwash.
  • A pack of cigarettes is shrink-wrapped or sold in a box, bag, or other container with a skin cream.

A coupon for a discount on a specifically identified non-tobacco product regulated under the FDCA is offered contingent upon the purchase of a tobacco product. For example:

• • A coupon for a 50 cent discount on a specifically identified mouthwash is offered contingent upon the purchase of a pack of cigarettes.

Draft Guidance: The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act

 

[DC2]

Thank you for reposting your arguments.

And I even noted that you used a small bit of logic here and there.