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

[PhiHalcyon]

I said that because i read on the FDA site that 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. This includes, among other products, cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.thats why,didnt know about the 50% I thought that the pg/vg could be considered as a component/part or accessory when combined with natural pesticide free tobacco

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.

[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.