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

[Thulium]

I think a few people making the nicotine is tobacco claim, would also make the argument that milk should be classified as steak since they both come from a cow.

If nicotine is not a tobacco product, does that mean that lactose is not a dairy product?

[Okio]

the FDA's repeated use of the terms "marketed as containing both products" and "identified as containing ..." in explaining the meaning of the rule.

Draft Guidance: The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and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

After all this is dealing with the Marketing of the item not the production of isn't it?

[degnr8]

Why? We certainly had no trouble smoking analogs without requiring this information.

LMAO that was great

[LoneRanger]

I'd like to know the level of expertise of the posters here. I know that Legal One and yvilla are attorneys, so for me, their posts are carry more weight than others do. That's not to say that other opinions aren't valuable, but background and expertise is important when assessing a post's relevance.

Who else has a degree in law?

Sun? Are you an attorney?

PhilHalcyon? Are you an attorney?

Again, all opinions are valid, but since so much is riding on this case, I'd like to know the credentials of the people who are posting, as I'm sure others would.

Thanks much.

Some people know what they are talking about and one doesn't post after post after post after post after post after post after post after post after post ...............(Not Sun)

[tvujec]

If nicotine is not a tobacco product, does that mean that lactose is not a dairy product?

There is way more water in milk than lactose, but that doesn't make water dairy product.

Nicotine taken from tobacco can be considered a tobacco product, however nicotine in general doesn't have to come from tobacco. In practice it almost always does, since getting it from tobacco is by far the cheapest way.

[PhiHalcyon]

In order for a product to fit the definition of tobacco product, does it need to be made or derived solely from tobacco, primarily from tobacco, or, in any part made or derived from tobacco? If you say 'in any part' made or derived from tobacco, then nicotine water, candy, and gum are tobacco products - rather than prohibited combination products under Section 201(rr)(4). If you say 'primarily or solely' made or derived from tobacco, then this would correspond with a commonsense understanding of what is or is not a tobacco product; and would be both inclusive and expansive of an "as traditionally marketed" standard. Since the law does not say 'in any part' made or derived from tobacco, and an 'in any part' standard renders nicotine containing water or candy a tobacco product (rather than a combination product prohibited under Section 201(rr)(4)), it is reasonable to conclude that the proper standard in defining tobacco products is the 'primarily or solely' standard.

Therefore, since e-liquid is not 'primarily or solely' made or derived from tobacco, then the nicotine-containing liquid used in electronic cigarettes cannot be defined, nor regulated, as a tobacco product.

E-liquid is a flavored excipient solution that contains a small amount of nicotine. Because nicotine is a drug, and e-liquid is not a tobacco product, then e-liquid is a drug product. Furthermore, since the flavored exicipient solution is primarily made up of propylene glycol and/or glycerin, (and both of these are 'articles or products regulated under the FDCA'), then selling this flavored excipient solution in combination with nicotine is prohibited under Section 201(rr)(4).

Therefore, e-liquid is a prohibited combination product that cannot be legally sold unless it is approved, sold, and regulated as a drug product.

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These are the facts, and I will defend them no more until a ruling has been issued by the Court.

I understand that my words are not welcome. For a long time, I used to bristle at anything I read that seemed to threaten the continuation of my use and enjoyment of the ecig. Nonetheless, ever since I have developed my own ecig replacement product (i.e., my contingency plan), I have been blessed with the peace of mind required to view the situation openly, honestly, and without prejudice. But since I realize that this peace of mind is not shared, I have chosen to no longer torture you with my words.

Some may sing a little bunny song in celebration, but the wise will pay heed.

[mcl5000]

[danielwd]

If nicotine is not a tobacco product, does that mean that lactose is not a dairy product?

Is lactose supply soley from milk? Don't other foods, notably non-dairy foods, contain lactose?

I'm not being sarcastic, I'm really not sure of the answer and am curious. Because if the answer is "yes", then your point may not mean much because it would align with the same point made about nicotine - the fact that tobacco is not the only way to derive nicotine.

[Legal One]

In May of this year Senator Alexander was offering an amendment to the new tobacco legislation that would have carved the e-cigarette out of the new law. The result of this amendment would have been to squarely place the e-cigarette into the hands of FDA as drug/device. Working through Senator Cogburn's office we were able to kill this amendment specifically making the argument that the product is and should be regulated as a tobacco product for the intended use of cigarette smoking. There was a significant effort to get this into the correct place given that regutaion is preferred over an effective ban.

[Legal One]

regulation not "regutaion" - typing is best left to my assistant . . . .