Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Sun Vaporer]

So we wait and we stock up and we continue to vape. I don't see this delay as necessarily a bad thing.

Might be Jerry--but I would like to see a long term resolution to this--delaying getting the ball rolling has to end at some point.


Sun

[JerryRM]

Might be Jerry--but I would like to see a long term resolution to this--delaying getting the ball rolling has to end at some point.


Sun

Sun, I can appreciate your position. If I were a lawyer, I would feel the same way as you do.

[Sun Vaporer]

Well, we can at least say now that the ruling Judge Leon has already made has not been made available for publishing yet as it did not appear on the Docket Sheet. At least we know now that there is a ruling and it is just a matter of time before Judge Leon has it docketed.


Sun

[mudmanc4]

Being verbally legally challenged, my question is, does anyone know other then him, or the two parties ?

[Sun Vaporer]

Being verbally legally challenged, my question is, does anyone know other then him, or the two parties ?

The Judge and his Clerks know for sure as well as the other Clerks. Counsel for SE was not apprised as of last night--so the parties do not know yet. The ruling "not being ready for publishing" could take a while.


Sun

[mudmanc4]

The Judge and his Clerks know for sure as well as the other Clerks. Counsel for SE was not apprised as of last night--so the parties do not know yet. The ruling "not being ready for publishing" could take a while.


Sun

Thank you.

[PhiHalcyon]

I hope that this clears up a few issues of late:

There are nicotine delivery products that fit the definition of tobacco products, and there are nicotine delivery products that do not fit the definition of tobacco products. The nicotine delivery products that do not fit the definiton of tobacco products are products like Nicorette Gum; which is a combination product that contains a tobacco product (nicotine) and a food product (gum).

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."

So, is Nicorette Gum prohibited? For products regulated as tobacco products, the answer is yes. For products that are regulated under chapter V as drug products, the answer is no. The same is true of any product that is an article or product regulated under the FDCA and contains a tobacco product.

The lines are therefore clear: Cigar: tobacco product. Nicotrol Inhaler: drug product. Stonewall Dissolvables: tobacco product. Commit Lozenges: drug product. Cigarettes: tobacco product. E-liquid: drug product.

Why? Because propylene glycol and glycerin are (like gum) articles or products regulated under the FDCA. Consequently, the only way that e-liquid, like Nicorette Gum, could ever be a legal product is as an FDA approved drug product. Furthermore, since e-liquid cannot be a legal product except as a drug product, all questions regarding intended use, and/or whether nicotine is a drug, are irrelevant.

The ecig is neither marketed or "identified" as a cigarette substitute "containing" PG (as a substance one would want to consume or receive the "benefits of" separately), nor is it marketed as PG (as a substance one would want to consume independently) "identified" or marketed as also containing nicotine.

Even though at least one of the examples given by the FDA in its draft guidance leaves the impression that how a product is advertised or represented is relevant, this is simply not the case. The law says, "A tobacco product shall not be marketed in combination with any other article or product regulated under this Act." And since the word 'market' means 'to offer for sale', the phrase 'marketed in combination' is equivalent to 'sold in combination.' So, how a product is advertised or represented, or for what purpose consumers seek to buy a product, are all irrelevant. It either is a combination product, or it is not.

[yvilla]

Phooey, Phi!

Have you looked at the ingredient lists for cigarettes lately? Noticed there's propylene glycol in them? And a few hundred other things?

All the other non-tobacco ingredients are fillers; sure they serve a purpose, but their purpose is nowhere near primary.

Same goes for ecig liquid. The PG is only the carrier for the active ingredient - the nicotine.

And the word "marketed" does carry subtantially more meaning than you are giving it.

You are making the same mistake here that others did when reading the new proscription against "characterizing" flavors - thinking that meant cigarettes could contain no flavoring ingredients whatsoever. That misreading was equally phooey. The flavoring proscription is only against a cigarette "marketed" as "characterized" by a specific flavor, such as clove or fruit or candy, etc. Big tobacco can get away with adding all the flavors to cigarettes they want to, so long as they don't sell the product as, for example, a "cherry" cigarette.

Again, same goes for the ecig in this context. So long as the nic liquid is not marketed as, for example, some cool PG (anti-viral) - nicotine combination, the presence of PG as the base carrier is utterly meaningless in terms of the no combination rule.

Bottom line, if you don't read the statute (and the guidance materials) with an eye for its meaning, then you fail to grasp it.

[JerryRM]

Well, we can at least say now that the ruling Judge Leon has already made has not been made available for publishing yet as it did not appear on the Docket Sheet. At least we know now that there is a ruling and it is just a matter of time before Judge Leon has it docketed.


Sun

Now I am getting curious as to why the delay, along with everyone else on this thread !

[PhiHalcyon]

yvilla: Have you looked at the ingredient lists for cigarettes lately? Noticed there's propylene glycol in them? And a few hundred other things?

PhiHalcyon: To say that what is added to cigarettes today determines the meaning of the new law is like saying that the new speed limit must adjust itself to your speed. The FDA is still in the very early stages of the implementation and understanding of the FSPTCA. So, I certainly wouldn't hang my hat on what is. It hasn't even come to a clear resolution of the scope and responsibilities involved in ingredient reporting, let alone actually received such reports, analyze them, or begin to consider what can and cannot be added to tobbaco products.

I realize that my interpretation has broad implications, but I doubt that the FDA would balk at the prospect of additive-free tobacco products. Are you aware that one of its understandings of the combination prohibition at issue here is that tobacco products cannot be sold in the same store as a store that sells drugs, cosmetics, or food products? If the FDA has no interest in the convenience factor of purchasing tobacco products, do you really think that it will show concern for tobacco additives?


yvilla: The PG is only the carrier for the active ingredient - the nicotine.

PhiHalcyon: The law says nothing about excluding articles or products on the basis of their function in a product.


yvilla: And the word "marketed" does carry subtantially more meaning than you are giving it.

PhiHalcyon: The word marketed does not contain the meaning of "marketed as", or "marketed as being", unless the words "as", or "as being", are actually in the text of the law. If the law said, "A strawberry product shall not be marketed in combination with a dairy product.", do you really believe that there would be a legal way for you to sell strawberry yogurt with fruit at the bottom?