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

[tvujec]

Pg/vg, and any other non-tobacco substance added to a tobacco product, are indeed components of the final product. But, the final product is not regulable as a tobacco product unless the ratio of tobacco (or tobacco derivatives) to the sum of non-tobacco components is greater than 50%. Pure nicotine is obviously a tobacco product, and non-tobacco substances used for flavoring, coloring, and sweetening could all be added to it as non-tobacco components. But, once the sum of those three non-tobacco components exceeds the amount of nicotine in the product, it has become a nicotine candy product -which is the type of product that is explicitly prohibited from being regulated as a tobacco product.

Is this 50% something that was written in the law, or just your assumption? Either way, although it might seem intuitive, there are numerous examples where it just doesn't stand.

Let's start with the fact that much of the milk used world wide is first condensed and then mixed with water from independent source. The result is still a dairy product and regulated as such, although less than 5% came from the cow.

You might want to assume that water is the special case, but it is just a solvent, for which only purity is regulated, and exactly the same treatment applies for pg/vg.

Even if you establish water as a special case, and remove the possibility for free usage of pg/vg as solvents, you would still be able to mix the water based e-liquid. A lot less vapor and a lot more danger of spontaneous evaporation but e-liquid nonetheless. However, how do you propose that government starts regulating pg/vg without cake industry going crazy?

 

[PhiHalcyon]

tvujec,

E-liqiud (as currently formulated) is, like nicotine candy, a drug product with a tobacco product component - which is prohibited from being regulated as a tobacco product under paragraph four of the definition of tobacco products. Whatever the definition of dairy products is is irrelevant.

 

[eric]

So is chocolate milk, of which 5% of its milk is actually derived from cow, like vitamin D candy?

I'm not sure I understand how tobacco products have to be composed of 50% tobacco. Where is this referenced?

 

[PhiHalcyon]

SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) DEFINITION OF TOBACCO PRODUCTS.—Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:
(rr)(1) 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).
(2) 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).
(3) The products described in paragraph (2) shall be subject to chapter V of this Act.
(4) 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).


900(1) ADDITIVE.—The term ‘additive’ means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical.


As 900(1) above shows, Congress understood that non-tobacco substances are sometimes used as additives in tobacco products; and that these additive substances would generally tend to become a component of those tobacco products. Congress even extended the definition of 'tobacco product' to include these 'components'. Therefore, some products that are regulable as tobacco products will partially consist of one or more non-tobacco components.

As 900(1) further shows, Congress understood that some of the non-tobacco substances used as additives in tobacco products would be "substances intended for use as a flavoring or coloring." Add to this to the well-known fact that many smokeless chewing tobacco products contain added sweeteners, and what results is the prospect of a tobacco product that contains the three primary ingredients of a hard candy product (i.e., substances used for flavoring, coloring, and sweetening).

In contrast, Congress precluded products such as nicotine candy from being regulated as tobacco products by stating in the fourth paragraph of the definition of tobacco products, "A tobacco product shall not be marketed in combination with an article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement)." 201(rr)(4)

So, on one hand, a tobacco product can partially consist of the non-tobacco food additives used to make hard candy, and yet, still be regulable as a tobacco product; and, on the other hand, a hard candy product can partially consist of tobacco/nicotine, but not be regulable as a tobacco product. The difference between these two is obviously one of proportions. Such that, a product that is primarily made or derived from tobacco is a product that is regulable as a tobacco product; and a product that is not primarily made or derived from tobacco is not regulable as a tobacco product.

 

[LoneRanger]

Oh gee here we go again! time for a vacation!! Useless chit chat!!!!!

 

[LoneRanger]

Oh gee here we go again! time for a vacation!! Useless chit chat!!!!!

Silence is golden

 

[tvujec]

So, on one hand, a tobacco product can partially consist of the non-tobacco food additives used to make hard candy, and yet, still be regulable as a tobacco product; and, on the other hand, a hard candy product can partially consist of tobacco/nicotine, but not be regulable as a tobacco product. The difference between these two is obviously one of proportions. Such that, a product that is primarily made or derived from tobacco is a product that is regulable as a tobacco product; and a product that is not primarily made or derived from tobacco is not regulable as a tobacco product.

Where do you get the obviousness of the proportion from the above?!?!? Proportions in relation to what exactly? Mass, volume, taste, smell, ...? Just for fun, if it is mass, I'd say that more than 50% of those Virginia Slims are non-tobacco (paper and filter). My example with milk has a lot to do with this here. It shows that the law doesn't just assume that X is a product of Y if it contains more than 50% of Y. It has to explicitly state that, and the above doesn't even come close.

You're trying to devise something very far fetched from the letter of the law that has nothing to do with its spirit. The purpose of the law as stated is to allow additives already used, but to avoid making them more appealing to kids. If the purpose was to stop any invention in less harmful tobacco consumption, one could possibly show that lawmakers didn't want ecigs, but even then, judge would have to defer to the lawmakers and ask them to fix it.

 

[PhiHalcyon]

tvujec,

Okay genius. You tell me. At what point does a tobacco product with the non-tobacco components used to make candy become a prohibited product under paragraph four?

 

[eric]

tvujec,

Okay genius. You tell me. At what point does a tobacco product with the non-tobacco components used to make candy become a prohibited product under paragraph four?

When a Judge makes the distinction.

 

[PhiHalcyon]

When a Judge makes the distinction.

Okay. Now that you have confessed that your capacity to deduce the answer for yourself is non-existent, you may as well not say another word.

 

[eric]

Okay. Now that you have confessed that your capacity to deduce the answer for yourself is non-existent, you may as well not say another word.

I haven't confessed any such thing, my friend.

 

[tvujec]

tvujec,

Okay genius. You tell me. At what point does a tobacco product with the non-tobacco components used to make candy become a prohibited product under paragraph four?

Simple. Candy is food. 201(rr)(4) prohibits mixing tobacco with food.

PG/VG is indeed used to make candy as well as other foods or even drugs, cosmetics and dietary supplements but that doesn't make it food, drug, cosmetic or dietary supplement in our case. It is indeed sold as a skin product. But in case of ecig it is just a *solvent*, like water, but better since it protects from spontaneous evaporation. Water is also often sold as a dietary supplement, and if we would apply this logic, much of smokeless tobacco would become illegal since the water is often added from the independent source.

Lawmakers were indeed very careful when writing the law, to not allow FDA to ban tobacco altogether. Making a law that would keep e-cigarette off the market without banning any common tobacco products as a side effect seems to be impossible without explicitly writing e-cigarette into law.

Just to expand a little bit on why the 50% is arbitrary and can't be used as a differentiating factor if something is additive or combination. Let's say that you make a candy from 10% sugar and 90% tobacco. If it tastes like a candy and it is consumed like a candy, it'll still be a candy, and therefore prohibited by 201(rr)(4). Solvents and vehicles on the other hand do not change the nature of a product. E.g. mixing a dietary supplement in 99% solvent, doesn't make it food, or even food-dietary supplement even though said solvent might be used in food. Same applies to tobacco product. Adding paper (not exactly solvent, but definitely vehicle) to a cigarette doesn't make it a combination product, even though cellulose is also a major component of all edible greens.

 

[PhiHalcyon]

tvujec,

The differentiating standard of greater than 50%, or primarily, is the only NON-arbitrary ratio that can be chosen. It is all other potential ratios that would be arbitrary. According to your logic, Stonewalls would be a candy product, which is absurd.

Nevertheless, since you love to fancy yourself as knowing better than I, then I will stop making my suggestions in this forum on how to save the ecig, and leave that task to you. Good luck.

 

[webtaxman]

Promise? Your credibility was lost in your own bias formed by somehow presuming one even cares that you may have something up your sleeve. If you cared about the e-cig, you'd share this special information at a "sensitive time."

Eric had the correct answer - a judge will determine it. In fact, a judge has already made the determination. We await to see how other judges will decide. One way or another, it is ultimately going to be decided by judges, and not you or me.

 

[curiousJan]

At what point does a tobacco product with the non-tobacco components used to make candy become a prohibited product under paragraph four?

The PG/VG component is present for it's ability to carry the nicotine, not for flavoring properties. I believe, and IANAL, that this will cause it to be defined by the Court a bit differently than you have. Just MHO.

Jan

 

[PhiHalcyon]

The PG/VG component is present for it's ability to carry the nicotine, not for flavoring properties. I believe, and IANAL, that this will cause it to be defined by the Court a bit differently than you have. Just MHO.

Jan

What you are saying is that the pg/vg in e-liquid is an excipient; and, indeed it is. So is the candy in a nicotine candy product. Or the water in nicotine water. Or the gum in nicotine gum. The only sort of product that can deliver nicotine without being regulated as a drug product is a tobacco product. But, as the FDA said in its reply to the Appeals Court, "... Congress recognized that its new definition of "tobacco product" — which includes products "derived from tobacco" as well as products that contain tobacco, id. § 321(rr)(1) — would potentially reach nicotine drugs and devices already subject to regulation under the FDCA, and made clear that it was not altering the FDA’s authority to regulate such drugs and devices under the preexisting provisions. Congress thus excluded from the definition of "tobacco product" any article that is a drug, device or combination product under the FDCA, id. § 321(rr)(2)); provided that such articles shall continue to be regulated under the FDCA provisions that govern drugs, devices, and Combination products, id. § 321(rr)(3));" And it was right. Non-tobacco products that contain a tobacco product, (rather than being a tobacco product that contains non-tobacco components), are to be regulated as drug products. And since e-liquid (as currently formulated) is not a tobacco product that contains non-tobacco components, but a non-tobacco product that contains a tobacco product, e-liquid shall be regulated as a drug product. No other outcome is possible ... unless, as I have been saying, e-liquid is reformulated to be a tobacco product that contains non-tobacco components (i.e., is primarily made or derived from tobacco).

 

[TropicalBob]

unless e-liquid is reformulated to be a tobacco product that contains non-tobacco components (i.e., is primarily made or derived from tobacco).

And that virtually defines the Ploom, supposedly almost ready for sales. It uses a soaked tobacco plug for vapor production, is not lit, and functions like an e-cig. BUT IT USES TOBACCO, a critical difference to regulators. The Ploom should not face "drug delivery device" and "drug" accusations.

On the other hand, a determined FDA could shoot it down as a new cigarette product needing umpteen-gazillion studies to determine its impact on public health, etc.

 

[deewal]

On the other hand, a determined FDA could shoot it down as a new cigarette product needing umpteen-gazillion studies to determine its impact on public health, etc.

This is great fun.The Battle for Control. (Now in HI-Def and 3d.)

Iv'e got it TBob. Clarke Gable would have been ideal.

 

[tvujec]

tvujec,

The differentiating standard of greater than 50%, or primarily, is the only NON-arbitrary ratio that can be chosen. It is all other potential ratios that would be arbitrary. According to your logic, Stonewalls would be a candy product, which is absurd.

Again, it is arbitrary unless you define what you use for measurement. Is it mass, volume or something else? Where in the law is that stated? Once again, solvents, vehicles and excipients, do not change the nature of a product. Intent does. Stonewalls are actually good example. The fact that they contain splenda, doesn't make them a combination product, independent of the percentage of mass, volume or something else.

Also, your arbitrary rule would make nicotine inhaler a tobacco product, since it contains more than 50% nicotine extracted from tobacco. That is clearly not in either the letter or the spirit of it.

Nevertheless, since you love to fancy yourself as knowing better than I, then I will stop making my suggestions in this forum on how to save the ecig, and leave that task to you. Good luck.

You're not saving ecig, you're preparing grounds for your future money making enterprise.

 

[JustMeAgain]

And that virtually defines the Ploom, supposedly almost ready for sales. It uses a soaked tobacco plug for vapor production, is not lit, and functions like an e-cig. BUT IT USES TOBACCO, a critical difference to regulators. The Ploom should not face "drug delivery device" and "drug" accusations.

On the other hand, a determined FDA could shoot it down as a new cigarette product needing umpteen-gazillion studies to determine its impact on public health, etc.

What legally defines 'a new cigarette product'? Would, say, a different filter or paper constitute a tobacco cigarette as a new product?