FDA FDA deeming regulation proposals

[Roger_Lafayette]

This is one of the few unhappy scenarios that I don't envision. PG and VG are used in numerous food applications, VG especially is used by gobs of people who make their own soap. This is a bit like regulating 186xx batteries as a "component or part." The FDA may have the theoretical power to do it, but the practical ramifications are just too daunting.

I do worry a little bit that water-soluble flavorings derived from tobacco products (TFA cubano?) will get zapped or that the vendors will just drop them. RY4, and so forth. And where am I going to get VZ's amazing espresso if all this plays out in the way we fear?

But VG and PG are not at risk, methinks.

just a little note to the diy'ers.
i know a lot of you have stocked up.i believe till this all washes out
that might be a prudent thing to do.
however,if the FDA gets really heavy handed how are you going to get
your PG and VG when you have to obtain a federal license to buy it.
when you send your application along with your obscenely large check,
please include a lengthy summary of what you plan to do with it,
how you are going to do it,a detailed explanation of your mixing process and how safe it is
for you,anyone within ten miles of you and the environment.
that along with the prerequisite license from the EPA you'd be good to go.

regards
mike

 

[Stosh]

just a little note to the diy'ers.
i know a lot of you have stocked up.i believe till this all washes out
that might be a prudent thing to do.
however,if the FDA gets really heavy handed how are you going to get
your PG and VG when you have to obtain a federal license to buy it.
when you send your application along with your obscenely large check,
please include a lengthy summary of what you plan to do with it,
how you are going to do it,a detailed explanation of your mixing process and how safe it is
for you,anyone within ten miles of you and the environment.
that along with the prerequisite license from the EPA you'd be good to go.

regards
mike

As a DIY'er that has has stocked up some in the freezer, mostly from back during the last FDA scare, PG and VG aren't threatened. Most serious DIY'ers buy the PG and VG in large quantities from sites that supply the soap making, hand cream making, lotion making market. So long as it's USP quality, you're good to go, make all the soap you like, FDA don't care....

 

[Stosh]

I do worry a little bit that water-soluble flavorings derived from tobacco products (TFA cubano?) will get zapped or that the vendors will just drop them. RY4, and so forth. And where am I going to get VZ's amazing espresso if all this plays out in the way we fear? ....

Most flavorings are not a problem, I had a stock of a dozen or so years before I started vaping, used for making candy. Tobacco flavors may take a hit, depends on how the BT production and eliquid availability shakes out.

Try a few drops of that VZ espresso the next time you make chocolate cake or cookies...to die for....

 

[skoony]

This is one of the few unhappy scenarios that I don't envision. PG and VG are used in numerous food applications, VG especially is used by gobs of people who make their own soap. This is a bit like regulating 186xx batteries as a "component or part." The FDA may have the theoretical power to do it, but the practical ramifications are just too daunting.

I do worry a little bit that water-soluble flavorings derived from tobacco products (TFA cubano?) will get zapped or that the vendors will just drop them. RY4, and so forth. And where am I going to get VZ's amazing espresso if all this plays out in the way we fear?

But VG and PG are not at risk, methinks.

hi roger,
you are most certainly right.
my concern is they would make a special exemption if you use it to make juice.
i am over exaggerating,however something along the lines of how certain OTC
medications are handled.
done at the manufacturing and wholesale levels it does not seem to be out of
the realm of possibilities.of course they would bare the cost's.
like i said you are probably right.what scares me is if i can think that way,i know
they are paying someone a lot of money to think of it before i do.

regards
mike

 

[Devonmoonshire]

edited as I moved it down past the political arguments.

Sincerely;
Nate

 

[Jman8]

Thanks. I feel better now.

I've no desire to play word games with you or accept your wagers (that you seem to be so fond of). I won't waste my time debating someone who "knows" things that even Zeller, admittedly, doesn't know yet. He said he didn't know--but you do?

Trust Zeller on this matter if you wish. If Zeller says certain items would be difficult to obtain, I'd bet him.

And win.

 

[Jman8]

Here's something close:

"If electronic cigarettes are deemed to be subject to chapter IX of the FD&C Act, the cost of premarket applications would increase the cost of entering and remaining in the market......The total costs of complying with the proposed rule would create the potential for exit;"

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

This is semi-close to saying they could be priced out of compliance.

Not too close to saying they will be regulated out of existence.

Black market would easily handle the first scenario, and annihilate the 2nd consideration.

 

[Devonmoonshire]

Has anyone given any thought to the fact that these regulations as they are currently proposed may simply be a "Bartering Tool".

For example if I want 500 dollars for an item at say a flea market or some such, I will price it at 700 dollars in order to allow the buyer to talk me down.

In this case there is a possibility, (albeit a small one), that they put way more restrictions and regulatory processes into this document then they ever intend to enforce so that the Vaping Advocates can talk them down to the level that they have already decided would be adequate to satisfy their wants and needs for regulation.

Just a thought but it very well may be some sound logic to it.

Sincerely;
Nate


Reposting this for consideration since it was buried in political arguments.

 

[Kent C]

Sorry if this offends anyone..............

I got the sin bin for posting that one a while back....

 

[Kent C]

QUOTE=Jman8: This is semi-close to saying they could be priced out of compliance.

I know, that's why I said 'close'.

Not too close to saying they will be regulated out of existence.

Disagree for the 'cost of remaining in the market' part.

Black market would easily handle the first scenario, and annihilate the 2nd consideration.

Yeah, the black market is the natural progression....but that's a hedge on your part. Could happen with any product. I meant regulated out of existence in the regular market, which for some, would be 'out of existence' in their universe.

 

[DC2]

I feel quite comfortable having a wager on this "truth." I predict it doesn't happen this way. I predict it won't even get to the bolded point and willing to bet on that as well. I realize wager is entirely unlikely, but just seems to not be truth from where I'm sitting.

Are you willing to bet on whether or not flavored nicotine refill bottles will be able to be made by small businesses?

 

[neutrontech]

This is semi-close to saying they could be priced out of compliance.

Not too close to saying they will be regulated out of existence.

Black market would easily handle the first scenario, and annihilate the 2nd consideration.

I consider regulating out of existence to mean regulating out of legal existence. Black markets are not the solution and are a lose as far as I'm concerned. If the regulations cost so much that small companies go under, then we've lost. Sure a black market will develop, but that just creates criminals and many won't take that leap.

Sent from my SCH-I605 using Tapatalk

 

[Kent C]

I consider regulating out of existence to mean regulating out of legal existence. Black markets are not the solution and are a lose as far as I'm concerned. If the regulations cost so much that small companies go under, then we've lost. Sure a black market will develop, but that just creates criminals and many won't take that leap.

Sent from my SCH-I605 using Tapatalk

Just hedging the bet.

 

[StormFinch]

Nevermind... just, nevermind.

 

[Jman8]

Yeah, the black market is the natural progression....but that's a hedge on your part. Could happen with any product. I meant regulated out of existence in the regular market, which for some, would be 'out of existence' in their universe.

And "their universe" is the other hedge.

Reality will be they will be available for those that desire them, assuming FDA is both very strict on regulations (final ruling), very costly on market applications and very strong on enforcement.

Provari, based on its cost, is too costly for my (myopic) universe. Therefore, Provaris are currently "out of existence."

 

[Jman8]

Are you willing to bet on whether or not flavored nicotine refill bottles will be able to be made by small businesses?

Yes. I seek clarification on what is being said, but feeling open to this bet, for sure.

 

[Jman8]

I consider regulating out of existence to mean regulating out of legal existence. Black markets are not the solution and are a lose as far as I'm concerned. If the regulations cost so much that small companies go under, then we've lost. Sure a black market will develop, but that just creates criminals and many won't take that leap.

I believe most will take that leap. And that it'll turn the tide, as Rolygate stated elsewhere.

Black market for vaping stuff is a hedge for my position, but is not what I feel is likely to occur given current FDA proposed regulation. Depending on final rule and a few other factors (bigger than FDA) going forward, I could see black market becoming reality. For now, I see (full) black market as unlikely, though can imagine that it is occurring to some degree right now.

 

[DC2]

Yes. I seek clarification on what is being said, but feeling open to this bet, for sure.

What part do you need clarification on?

It is my opinion that small businesses will not be able to produce their own flavored e-liquids and have them approved by the FDA.
That is what I will bet you on.

 

[twgbonehead]

Has anyone given any thought to the fact that these regulations as they are currently proposed may simply be a "Bartering Tool".

For example if I want 500 dollars for an item at say a flea market or some such, I will price it at 700 dollars in order to allow the buyer to talk me down.

In this case there is a possibility, (albeit a small one), that they put way more restrictions and regulatory processes into this document then they ever intend to enforce so that the Vaping Advocates can talk them down to the level that they have already decided would be adequate to satisfy their wants and needs for regulation.

Just a thought but it very well may be some sound logic to it.

Sincerely;
Nate


Reposting this for consideration since it was buried in political arguments.

Not sure if you mean "a bartering tool for amending the proposal before it is passed", but the way you have expressed it you seem to think that after passage, the FDA would negotiate selective enforcement of its rules.

I do not in any way shape or form believe that to be the case. The FDA would have nothing to gain, since it's already got all the provisions passed into law. What kind of leverage would vaping supporters have? And the FDA would have a lot to lose from criticism by legislators for not upholding the law regarding regulating these products.

(In fact, the FDA agreeing with third parties to NOT enforce the law would probably constitute criminal misconduct on their part).

 

[Devonmoonshire]

Not sure if you mean "a bartering tool for amending the proposal before it is passed", but the way you have expressed it you seem to think that after passage, the FDA would negotiate selective enforcement of its rules.

I do not in any way shape or form believe that to be the case. The FDA would have nothing to gain, since it's already got all the provisions passed into law. What kind of leverage would vaping supporters have? And the FDA would have a lot to lose from criticism by legislators for not upholding the law regarding regulating these products.

(In fact, the FDA agreeing with third parties to NOT enforce the law would probably constitute criminal misconduct on their part).

No I mean in Fact BEFORE passage. I believe they have written this in a way that opens it up for having certain parts removed prior to passage. I think they have written this in a manor that allows us to request that certain items contained therein be removed but still leaving them regulatory control over others.

Basically a compromise that may end up making both parties happy. BEFORE it goes up for passage.