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

[derfvapor]

Hopefully it will be in our favor

[PhiHalcyon]

It might indeed be wiser to conform the ecig to the tobacco product classification, however in ideal world that is not what ecig really is. Tobacco regulations exist because cigarettes are dangerous, and tobacco is a good source of tax income. In real world that'll mean ridiculous taxes, strong control of commerce and a lot of punitive elements on a product that might not be dangerous at all.

This is why the ecig is being reinvented as something other than what it is today. And even though I cannot really comment any further on the matter at this time, I will say that the tax issue has been factored into its design. I want the freedom to vape AND not pay outrageous taxes.

[PhiHalcyon]

And you know darn well I have already presented very strong arguments earlier in this thread that your reading of this provision is simply incorrect as well.

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."

According to the FDA's draft guidance of this prohibition, this includes a situation where:
"A tobacco product and a non-tobacco product regulated under the FDCA are physically, chemically, or otherwise combined or mixed to product a single entity that is marketed as containing both products."

An example given is: Nicotine that is derived from tobacco is added to water, juice, or soda (which are regulated under the FDCA) and the water, juice, or soda is identified as containing a tobacco product.

What you want to take from this is that as long as you don't tell consumers that your product is a combination product, then it is okay to sell it. Which is ludicrous; and not an argument at all.

[yvilla]

What you want to take from this is that as long as you don't tell consumers that your product is a combination product, then it is okay to sell it. Which is ludicrous; and not an argument at all.

I certainly wasn't going repeat my argument on this, but since you apparently want to repeat yours, I will simply point to mine:

http://www.e-cigarette-forum.com/for...tml#post743948

(and several posts both above and below that particular post).

[PhiHalcyon]

I don't wish to rehash the argument either, but I felt the following post I made to Jacob sealed the deal.

Propylene glycol and glycerin are sold and regulated as many things. One of these things is as excipients (substances used as a diluent or vehicle for a drug); which is precisely what they are used for in e-liquid. Furthermore, not only are excipients, like candy, regulated under the FDCA, but once you add nicotine to candy, the candy itself has become an excipient. Thus, it is fair to say that the fundamental purpose of the combination prohibition is to prohibit non-tobacco excipients from being used for the delivery of nicotine in a commercially marketed product that is not sold and regulated as a drug product.

[bogiediver]

Section 201(rr)(4) of the FDCA (added via the FSPTCA) 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."

I think you need to read the full text, as well as:

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

And not take things out of context...

JMHO

-bogie

[PhiHalcyon]

I have read the full text the FDA's first attempt to fully understand the combination prohibition. And it doesn't change the conclusion I quoted to yvilla one iota.

Added:
Nonetheless, this does not necessarily mean that there is not room for the FDA to choose to treat e-liquid as a modified risk tobacco product. But the drug companies that have spent millions of dollars in getting their nicotine products approved will probably have much to say about it. Only time will tell.

[JacobT26]

I have read the full text the FDA's first attempt to fully understand the combination prohibition. And it doesn't change the conclusion I quoted to yvilla one iota.

I have to agree with him, even though I don't want to. Propylene Glycol is regulated as a food additive, and nicotine as a tobacco product combined with a food product is against the regulation. Of course the use of it in cigarettes is also illegal by this reading, I see it more likely that the FDA will come down on cigarettes for this rather then give us an out because of it. Even if the nicotine is decided to be a tobacco product by the judge the liquid still violates the combination, so... **** sucks, order from China.

[deewal]

More Bollocks. It's actually an Alien Artifact.

[mirinuh]

PG has long been used as a tobacco humectant. Guidance has suggested that the combo of tobacco and PG is grandfathered.