FDA cliff notes on fda?

[JustMeB]

they don't have to.
the word derivative covers that.
nicotine is in tobacco ergo nicotine from
any source or substitute there of can and
probably will be deemed a tobacco product.
synonyms of derivative include:copy or substitute.
regards
mike

I have to disagree as well. It says "any product that is derived from tobacco". Derived means "comes from another source". That source meaning tobacco. Nicotine is not a product, but a natural substance found in many things. (The product at this time we would be talking about is ejuice). Also, synonyms are words that are similar, but not always do they have the exact same meaning. If nicotine is coming from say, eggplant, to make ejuice, then it is no longer "derived from tobacco" but "derived by eggplant". (edited: meaning ejuice is derived from eggplant, nicotine is still it's own natural substance, and not a product)

 

[salemgold]

My freezer's full of frozen food. Please buy another 10 years worth and store it for me.

Well, you could do what I did and buy another freezer just for the nic.

 

[skoony]

I have to disagree as well. It says "any product that is derived from tobacco". Derived means "comes from another source". That source meaning tobacco. Nicotine is not a product, but a natural substance found in many things. (The product at this time we would be talking about is ejuice). Also, synonyms are words that are similar, but not always do they have the exact same meaning. If nicotine is coming from say, eggplant, to make ejuice, then it is no longer "derived from tobacco" but "derived by eggplant". (edited: meaning ejuice is derived from eggplant, nicotine is still it's own natural substance, and not a product)

your assuming that's what they mean. using the term derivative.
we use the nicotine because it was in the tobacco. it does not
matter where the nicotine comes from. we wouldn't be using it
if it wasn't in the tobacco in the first place. it is derivative because
it copies or mimics the nicotine in the tobacco.
i further believe despite what they say they will try and regulate
0 nic juice precisely because it is a derivative of tobacco.
first the cigarette. then the e-juice with nic. then e-juice with out nic.
each being a derivative of the other.
i am not saying its what the law intended or it is what they meant by it.
i do believe however they will interpret the word derivative to mean
anything and everything they want it to be. that and the chillin'.

regards
mike

 

[Alexander Mundy]

I am no lawyer so take this for what it's worth, but 21 CFR consistently uses the term "derived from" to mean that the substance was "made from". Bottled water, sweetners, food coloring, proteins, etc. can chemically be the same but have separate definitions depending on where they are "derived from" If for some reason the FDA tried to stretch "derived from" to mean the end substance, the definitions in 21CFR would fall apart in many places. Take for instance "The name of water derived from an underground formation from which water flows naturally to the surface of the earth may be "spring water."" If the intent of "derived from" was for the end substance then any water that chemically matched "spring water" could be labeled such.

 

[JustMeB]

your assuming that's what they mean. using the term derivative.
we use the nicotine because it was in the tobacco. it does not
matter where the nicotine comes from. we wouldn't be using it
if it wasn't in the tobacco in the first place. it is derivative because
it copies or mimics the nicotine in the tobacco.
i further believe despite what they say they will try and regulate
0 nic juice precisely because it is a derivative of tobacco.
first the cigarette. then the e-juice with nic. then e-juice with out nic.
each being a derivative of the other.
i am not saying its what the law intended or it is what they meant by it.
i do believe however they will interpret the word derivative to mean
anything and everything they want it to be. that and the chillin'.

regards
mike

You're probably correct as they will try and interpret it any way they want, as they do with anything that involves what they want control over. Even the 0 nic, although nothing in 0 nic is derived from tobacco. (I am guessing then it is food/pharma product?) (My guess is they never thought nicotine was the threat to them before, but that tobacco was) However, if they were challenged then....? You can't twist the English language to suit ones needs, and at the same time, it's all in how a person interprets the meaning to be when/if a challenge/judgement is decided. It is what it is, regardless of what they meant it to be/say. I personally would prefer my nicotine would come from veggies. (At least it sounds healthier that way).

 

[Jman8]

i am not saying its what the law intended or it is what they meant by it.
i do believe however they will interpret the word derivative to mean
anything and everything they want it to be. that and the chillin'.

regards
mike

Ridiculous overreach of authority.

Let's see how well they do in court with such nonsense.

I predict they get their comeuppance

Always important to understand who regulates the regulators

 

[SeniorBoy]

My apologies if this issue has already been mentioned but it appears to be germane to this thread. I've not read this entire thread.

Understanding the FDA as a regulatory authority (if and when) with respect to Vaping requires an understanding of what the FDA calls "ED"

That's FDA speak for "enforcement discretion" Please spend a few minutes in Google via:

https://www.google.com/search?q=fda...en-US:IE-Address&q=fda+enforcement+discretion

 

[skoony]

I am no lawyer so take this for what it's worth, but 21 CFR consistently uses the term "derived from" to mean that the substance was "made from". Bottled water, sweetners, food coloring, proteins, etc. can chemically be the same but have separate definitions depending on where they are "derived from" If for some reason the FDA tried to stretch "derived from" to mean the end substance, the definitions in 21CFR would fall apart in many places. Take for instance "The name of water derived from an underground formation from which water flows naturally to the surface of the earth may be "spring water."" If the intent of "derived from" was for the end substance then any water that chemically matched "spring water" could be labeled such.

derived does not mean made from.regards
mikr

 

[skoony]

Ridiculous overreach of authority.

Let's see how well they do in court with such nonsense.

I predict they get their comeuppance

Always important to understand who regulates the regulators

they will do very well in court.
that's why the term derived from is so important.
regards
mike

 

[NorthOfAtlanta]

Derive - Definition and More from the Free Merriam-Webster Dictionary

Seems to disagree with you.

transitive verb
1
a : to take, receive, or obtain especially from a specified source
b : to obtain (a chemical substance) actually or theoretically from a parent substance

And here is a high nicotine non-tobacco theoretical source.

Cultivation project: Duboisia hopwoodii

How long will it be in court again?

 

[Jman8]

they will do very well in court.
that's why the term derived from is so important.
regards
mike

Can you explain again how you view 0 nic juice is derived from tobacco? As I see it, if that is derived from tobacco, then so are pancakes and televisions.

 

[skoony]

Can you explain again how you view 0 nic juice is derived from tobacco? As I see it, if that is derived from tobacco, then so are pancakes and televisions.

first there is tobacco. then the cigarette.
then e-cigarettes with juice and nic base
at various levels of strength down to 0.
each one followed the other.
a derivative of the next.
you wouldn't have the latter products without the first.
plastic and Vaseline are derivatives of oil.
regards
mike

 

[Kent C]

first there is tobacco. then the cigarette.
then e-cigarettes with juice and nic base
at various levels of strength down to 0.
each one followed the other.
a derivative of the next.
you wouldn't have the latter products without the first.
plastic and Vaseline are derivatives of oil.
regards
mike

You are conflating two different definitions of 'derive'.

1st definition: (Oxford Dictionary):
Obtain something from (a specified source)


This is reality based.

Nicotine can be derived from tobacco. (an actual extraction of a substance from another substance)
Nicotine can be derived from eggplant.

2nd definition:
Base a concept on an extension or modification of (another concept)

This is a conceptual base, even though the concrete form of the concept is real.

The ecigarette is derived from the cigarette. (conceptually - 'drawn from' the idea of, not 'drawn from/extracted from' the actual cigarette.)


Your tobacco>cigarettes>ecigarettes is the 2nd definition - more of an evolution.
Your oil>plastics and vasoline 'analogy' is the 1st definition - "an extraction from" a substance.

Zeller, in his remarks, meant the first meaning only.

 

[skoony]

You are conflating two different definitions of 'derive'.

1st definition: (Oxford Dictionary):
Obtain something from (a specified source)


This is reality based.

Nicotine can be derived from tobacco. (an actual extraction of a substance from another substance)
Nicotine can be derived from eggplant.

2nd definition:
Base a concept on an extension or modification of (another concept)

This is a conceptual base, even though the concrete form of the concept is real.

The ecigarette is derived from the cigarette. (conceptually - 'drawn from' the idea of, not 'drawn from/extracted from' the actual cigarette.)


Your tobacco>cigarettes>ecigarettes is the 2nd definition - more of an evolution.
Your oil>plastics and vasoline 'analogy' is the 1st definition - "an extraction from" a substance.

Zeller, in his remarks, meant the first meaning only.

your right on both counts
you hit the problem right on the head.
which definition will the FDA use?
the first,the second or a little of both.
i say yes.
it doesn't matter what Zeller said its how the FDA interprets
the word derivative.
Zeller's comment was in answer to an off hand question. he seemed to be caught off
guard and i believe he responded off the cuff.
regards
mike

 

[NorthOfAtlanta]

This conversation has done much to show that it will be interesting to watch this worm its way through the courts if someone does market a non-tobacco liquid. I personally think the FDA will try and get congress to give them authority over nicotine period, as otherwise people will continue to come out with different sources and they will be playing wack-a-mole trying to control it. Much more effective than arguing semantics in front of a judge. One more thing the e-cigarette community needs to watch for as I would be willing to bet that the FDA, CDC, BP, BT, BG and their house organ alphabet groups are already looking at the possibility of someone marketing a non-tobacco nicotine.

 

[Kent C]

your right on both counts
you hit the problem right on the head.
which definition will the FDA use?
the first,the second or a little of both.
i say yes.
it doesn't matter what Zeller said its how the FDA interprets
the word derivative.
Zeller's comment was in answer to an off hand question. he seemed to be caught off
guard and i believe he responded off the cuff.
regards
mike

While the comments that Zeller made were in a Q&A, he points directly to the statutory definition. I don't think he was 'caught off guard' - in fact his preface 'this is a good and complicated question' and he seems to understand the 'complications' involved.

Zeller: "All roads lead back to the statutory definition of tobacco products. And ultimately, there has to be something there that is made or derived from tobacco...." @15:13 https://www.youtube.com/watch?v=NaWLRIjc2AU

 

[DC2]

I personally think the FDA will try and get congress to give them authority over nicotine period...

I think that Big Pharma has an end game of monopolizing the healthy use of nicotine as a drug.
And the belief that this is their end game colors my thinking on almost every issue related to vaping and smoking.

And I also think, based on my beliefs, that any nicotine derived from an alternate source will be declared a drug.
After all, the only thing that prevents nicotine from being declared a drug right now is the protection of being a tobacco product.

 

[skoony]

While the comments that Zeller made were in a Q&A, he points directly to the statutory definition. I don't think he was 'caught off guard' - in fact his preface 'this is a good and complicated question' and he seems to understand the 'complications' involved.

Zeller: "All roads lead back to the statutory definition of tobacco products. And ultimately, there has to be something there that is made or derived from tobacco...." @15:13 https://www.youtube.com/watch?v=NaWLRIjc2AU

they didn't pick the word derivative out of a hat.
it was a deliberate choice of words.
they would have said made from tobacco or tobacco product
if in fact it was what they meant.
there is no doubt e-cigs are derived from a tobacco product
namely,cigarettes.
regards
mike

 

[Kent C]

they didn't pick the word derivative out of a hat.
it was a deliberate choice of words.
they would have said made from tobacco or tobacco product
if in fact it was was they meant.
there is no doubt e-cigs are derived from a tobacco product
namely,cigarettes.
regards
mike

jeez. I thought we just cleared that up. It is you not Zeller, who is conflating the two definitions. His quoted statement was 'made or derived from tobacco'.

If you're going to stick with your original debunked argument, then I have no more to say to you on this subject.

 

[SeniorBoy]

Can you explain again how you view 0 nic juice is derived from tobacco? As I see it, if that is derived from tobacco, then so are pancakes and televisions.

I love pancakes! Does that help? /joke lol

Perhaps I can answer your question this way using part of your words:

Can you explain again how cigarette rolling papers is derived from tobacco? As I see it, if that is derived from tobacco, then so are pancakes and televisions.

See:

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf

https://www.google.com/search?q=fda...microsoft:en-US:IE-Address&ie=&oe=&gws_rd=ssl

EDIT: And of course, a vendor adapts:

http://www.rollingpaperwarehouse.com/FLAVORED-ROLLING-PAPERS-OUTLAWED_ep_59.html