FDA Synthetic nicotine not subject to FDA rules

[KODIAK (TM)]

Well, if all else fails there's this

TFN NICOTINE® Is Not A Tobacco Product

But the FDA's stance on nicotine-free liquids is still clear as mud to me.

 

[Rossum]

Remember why the FDA wasn't able to shut down vaping in 2009-2010? Because Judge Leon decided it IS a tobacco product and therefore could only be regulated as such under the (then new) tobacco Control Act.

So sure, while the FDA can't regulate tobacco-free nicotine as a tobacco product, they most certainly can regulate it as a drug; a drug that has no approval to be sold.

 

[Cool_Breeze]

Remember why the FDA wasn't able to shut down vaping in 2009-2010? Because Judge Leon decided it IS a tobacco product and therefore could only be regulated as such under the (then new) Tobacco Control Act.

So sure, while the FDA can't regulate tobacco-free nicotine as a tobacco product, they most certainly can regulate it as a drug; a drug that no approval to be sold.

I think they are out to get us...

 

[skoony]

The FDA has made no such admission.
" “Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco,"

They do not say made from tobacco. They do not say derived from tobacco. They say made or derived from tobacco. Synthetic nicotine is a conceptual derivative of tobacco.

Regards
Mike

 

[Rossum]

They do not say made from tobacco. They do not say derived from tobacco. They say made or derived from tobacco. Synthetic nicotine is a conceptual derivative of tobacco.

 

[Josh Vanderpool]

we just have to keep fighting and do our own part as an individual vapor. FAMILY! if we are together they can never tear us apart. thats the point of fellowship.

 

[skoony]

@Rossum Just saying.
I read the article. No where does the FDA say synthetic nicotine is not
a tobacco product.
Regards
Mike

 

[DaveP]

The way I read it, synthetic nicotine isn't a tobacco product, but its use as a nicotine additive in an electronic cigarette juice would make it PART of a product intended for use in ecigs, which ARE designated as tobacco products. The crazy part is that eliquids were labeled as tobacco products BECAUSE they contained nicotine derived from tobacco.

We are part of a crazy circular argument between ecig makers and the FDA (the underlined part in the quote below). Maybe if we buy the TFN product and use the TFN nic to DIY our own liquids for personal use, then there would be no violation of FDA rulings, since we are the end user, not the seller/vendor.

Maybe they'll sell the juice in two parts: a vial of nic and a bottle of no-nic juice. You mix it and shake it at home when it arrives by USPS. Legal mumbo-jumbo is irritating at best.

Vincent Schuman, CEO of Next Generation Labs, comments: “The FDA’s statements to the Court seem to confirm our long-held position: TFN Nicotine® products cannot be regulated under the Deeming Rule as they simply are not tobacco products. In order to comply with the FDA, the onus is on e-liquid manufacturers to consider how their TFN Nicotine® product is marketed, distributed and positioned to adult consumers to ensure a complete disassociation from tobacco and tobacco devices.”

 

[Cool_Breeze]

I'll not pretend I'm qualified to interpret regulations and law.

 

[snork]

deem
[dēm]
VERB
regard or consider in a specified way:
"the event was deemed a great success" ·
"the strike was deemed to be illegal"
synonyms: consider · regard as · judge · adjudge · hold to be ·
view as · see as · take for · class as · count · find · suppose · reckon · think · believe to be · feel to be · esteem
ORIGIN
Old English dēman (also in the sense ‘act as judge’), of Germanic origin; related to Dutch doeman, also to doom.

There is no part of the definition of the word "deem" that means anything other than a decision. What it actually is or what went into the decision is irrelevant. Doom. Hehe.

 

[Cool_Breeze]

deem - It is because we say so.

 

[Rossum]

@Rossum Just saying.
I read the article. No where does the FDA say synthetic nicotine is not
a tobacco product.

Just saying, any reasonable judge would react like Judy, and say, "No this clearly isn't a tobacco product!"

... At which point the FDA would say, "Cool, then it's an unapproved synthetic drug and can't be sold until it's approved via a New Drug Application.

 

[DaveP]

Right now, TFN nic is far too expensive to use in ejuice, anyway. That could change as production quantities lower unit cost.

 

[jpargana]

Maybe they'll sell the juice in two parts: a vial of nic and a bottle of no-nic juice. You mix it and shake it at home when it arrives by USPS. Legal mumbo-jumbo is irritating at best.

That's exactly what stores have been doing in my country, bacause of a tax my "robbermint" tried to put on e-liquids.
This tax is absurd: 60 cents/ml, regardless of the percentage of nicotine, for liquids with nicotine.
Is the tax on nicotine, not on e-juice? Sure. But you would get to pay the same value when buying a 3 mg/ml mix, or a 24 mg/ml - let's disregard for a moment that for the same volume, the guy purchasing the 24mg/ml bottle is bringing home eight times the nicotine as the guy purchasing the 3mg/ml mix.

So at first people were buying the stonger mixes they could find plus a boatload of non-nic liquids of the same flavour - in order to "dilute" that asinine tax, all within the law.

But stores quickly found a much better way: they are now selling mostly non-nic liquid and packs of little 1 ml ampoules of nicotine base at 90 mg/mg - just perfect to turn a standard 30ml bottle from non-nic to the usual 3mg/ml.

The reasoning? The bottle cannot be taxed. Yes, it's an e-liquid, but it contains no nicotine.
The ampoule cannot be taxed either - it has nicotine, but it is not an e-liquid. It's a flavourless and (very) concentrated base clearly meant for dilution.

(And even if it gets taxed in the future, it's way cheaper to pay 5 x 1ml x 60 cents for a pack of ampoules rated at 90 mg/mg, than it would be to pay 5 x 30ml x 60 cents for five 30ml bottles of ready-made liquid at 3 mg/ml. )

Yes... Legal mumbo-jumbo is irritating at best. Especially when the ones making the laws about vaping have no clue... about vaping.

 

[skoony]

Just saying, any reasonable judge would react like Judy, and say, "No this clearly isn't a tobacco product!"

... At which point the FDA would say, "Cool, then it's an unapproved synthetic drug and can't be sold until it's approved via a New Drug Application.

A reasonable judge would interpret the regulation as written.
The regulations are written in such a way it doesn't mater if there is nicotine
or not in the juice. It doesn't mater what combination of PG/VG,flavoring,battery
strength,wicking material or,atomizer size. Vaping in any combination is a
conceptual derivative of a cigarette.(or pipe and cigar)

I know this is the extreme interpretation. However one must consider the choice
of words used in writing the regulations and what they mean. I do not ever assume
the meaning to be what's the most favorable for vapers. I assume what is most
favorable to the FDA,BT and BP.
Regards
Mike

 

[Rossum]

A reasonable judge would interpret the regulation as written.

I disagree. A reasonable judge would interpret the regulations in the context of the legislation that gave the executive branch the power to promulgate those regulations in the first place.

 

[skoony]

I disagree. A reasonable judge would interpret the regulations in the context of the legislation that gave the executive branch the power to promulgate those regulations in the first place.

@Rossum You would absolutly be correct.
Regards
Mike

 

[Endor]

In the end, I believe that Rossum is correct in that the FDA will assert regulatory authority over synthetic nicotine as a new drug if it became a legitimate alternative to tobacco-derived nicotine, and especially if eliquid manufacturers start using it to circumvent the deeming regs.

The FDA isn't going to sit idly by on this. If it isn't derived from tobacco (and hence not under the tobacco act), then it is quite easy for them to claim it a new drug and require an NDA. If that were to happen, we're talking years before it is being sold again. And, assuming the NDA is approved and it is back on the market, the costs will reflect the need to recoup millions and millions of dollars the company spent completing the NDA.

 

[skoony]

In the end, I believe that Rossum is correct in that the FDA will assert regulatory authority over synthetic nicotine as a new drug if it became a legitimate alternative to tobacco-derived nicotine,

They won't have to declare it anything.

If it isn't derived from tobacco (and hence not under the tobacco act), then it is quite easy for them to claim it a new drug and require an NDA.

Synthetic nicotine is a conceptual derivative of tobacco.(most notably a cigarette) An e-cigarette
with out nicotine is still a conceptional derivative of a tobacco product. The FDA never said an
e-cigarette with out nicotine was safe. That is what all the language concerning anything in a
e-cigarette that can alter the vapor production in any way is a accessory to the finished product.

In the eyes of the FDA we are tobacco product users not,vapers.

Regards
Mike

 

[DC2]

I think most of us agree that Mike can not possibly be right in his extreme interpretation.
But I think it would be wise to agree that he COULD be right.

It's an interesting concept though...
And I guess it depends on what the meaning of the word "is" is.

Or in this case, what the meaning of the word "derived" is.