Class Action Exploding Devices

[Verb]

...

We already know what the FDA has deemed to be a "tobacco product" ...

Actually, we don't. The FDA has issued public statements that are very inclusive and then back-pedaled in court to a case-by-case basis stance. Zero nicotine eliquid and hardware sold without nicotine containing eliquid are very much a gray area. It was interesting to notice, in the one federal underage sting since the deeming, not a single bust was for zero nic liquid or hardware alone. They only went for sales that included nicotine containing eliquid or disposables that contain nicotine. Their actions tell of their confidence in their over-reach.


In the past, when consumers and vendors have sent direct questions to the FDA, such as yours, the response did little to clear things up.

 

[Shekinahsgroom]

In the past, when consumers and vendors have sent direct questions to the FDA, such as yours, the response did little to clear things up.

Not asking and just assuming is much worse, but to each his own.
Any response from the FDA would be better than no response.
However, I have also contacted (just last night) a law firm that specializes in representing interests in manufacturer registration and PMTA applications. I'm waiting for their response....as well as the FDA's.

 

[Verb]

Not asking and just assuming is much worse, but to each his own.
Any response from the FDA would be better than no response.
However, I have also contacted (just last night) a law firm that specializes in representing interests in manufacturer registration and PMTA applications. I'm waiting for their response....as well as the FDA's.

I'm not saying, don't bother asking. I appreciate you taking the time.

 

[Shekinahsgroom]

Hmm...this thread looks slightly familiar, doesn't it?

https://www.e-cigarette-forum.com/forum/threads/president-trump-just-saved-vaping.785209/

 

[Lessifer]

Hmm...this thread looks slightly familiar, doesn't it?

President Trump just saved vaping

Yes, and if you read through it, it's one person who doesn't understand what he's reading, trying to be informed by many others. Very familiar...

 

[Shekinahsgroom]

Yes, and if you read through it, it's one person who doesn't understand what he's reading, trying to be informed by many others. Very familiar...

Thanks for clarifying your point of view in that thread, Less...but not everyone in there is on your side.

I didn't read the whole thread and kinda skipped to the end looking for the results...only to find that Classy had to lock the thread because peeps couldn't stay on topic; sin taxes and colonoscopies, really?

Geeez, what went on in there?

I feel sorry for the OP, seems to be a common occurrence where people try to help. Looks like you got the blame for derailing it Less?

You seemed to like Train2's post?

"It'd be nice. Maybe call and ask the lovely folks at the FDA to confirm."

 

[Lessifer]

Thanks for clarifying your point of view in that thread, Less...but not everyone in there is on your side.

I didn't read the whole thread and kinda skipped to the end looking for the results...only to find that Classy had to lock the thread because peeps couldn't stay on topic; sin taxes and colonoscopies, really?

Geeez, what went on in there?

I feel sorry for the OP, seems to be a common occurrence where people try to help. Looks like you got the blame for derailing it Less?

But I have an appreciation for your unique way of putting up an argument.

Ya know what they say about opinions...

You seemed to like Train2's post, Less?

"It'd be nice. Maybe call and ask the lovely folks at the FDA to confirm."

That other thread was about the administration freeze of pending regulations. The OP mistakenly considered the deeming regs to be pending, even though I and a few others repeatedly pointed out that the deeming regs are not pending, they were published to the federal register and have been effective since 8/8/2016.

Similar to the way you believe the deeming regs consider mixing e-liquid for personal use, without intentions to distribute that liquid to others, makes you a manufacturer.

By all means though, if you get a response from the FDA, please post it. What, specifically, did you ask them by the way?

I've asked them questions myself, but they've never given an actual clarification of anything, they simply quote sections of the regulations without actually answering the questions.

 

[Shekinahsgroom]

I've asked them questions myself, but they've never given an actual clarification of anything, they simply quote sections of the regulations without actually answering the questions.

Soooo...am I reading your statement as an admission that you point of view of the law may not actually be correct since the FDA hasn't answered your own questions?

 

[KODIAK (TM)]

I'm waiting for their response....as well as the FDA's.

Tired of waiting on your slow azz. I called for you. (yes, one can actually still dial phone numbers and speak to real people in this day and age):

AK, ID, MT, OR, WA
Seattle District
Vacant - Please contact Mary Ellen Taylor in the San Francisco District
(510) 337-6888
FAX (510) 337-6708
maryellen.taylor@fda.hhs.gov

I'm paraphrasing but Mary Ellen sez you're basically full of crap.

"You are fine as long as you don't sell it. We have no jurisdiction over what you do in your own home".

The above is a direct quote. How embarrassing it was to even ask. I left the contact information above should anyone else wish to follow up on me. She answered me on the 2nd ring.

 

[classwife]

...knock off the attitude in here - SHEESH !

 

[Lessifer]

Soooo...am I reading your statement as an admission that you point of view of the law may not actually be correct since the FDA hasn't answered your own questions?

My questions were on a different subject. Trying to get clarification from the FDA about a difference between free samples and taste testing.

I don't know anyone but you who believes the regulations apply to DIY for personal use, but if you get confirmation from the FDA, I'll admit I'm mistaken.

ETA:
Even more to the point, all this started with a statement by Bill that the FDA regs would lead to increased DIY. You didn't dispute that, just asserted that the FDA regs also cover DIY. The FDA, with the impossible standards they are setting, is making vaping less safe, not more.

 

[Shekinahsgroom]

"You are fine as long as you don't sell it. We have no jurisdiction over what you do in your own home".

The above is a direct quote.

Thanks for calling Kod, but I sent an e-mail for good reason. I need something in writing and direct clarification of the TCA's regulations so that it can be proven and used as evidence.

Simply quoting what someone said on a phone conversation isn't clarification or evidence that can be shared.

There are a lot of unanswered questions that cannot be summed up as "You're full of crap...", but thanks for trying anyways.

 

[KODIAK (TM)]

Simply quoting what someone said on a phone conversation isn't clarification or evidence that can be shared.

Yes indeedy... audit trails are nice. But now that I have greased the wheels for you why don't you give ol' Mary Ellen a call and ask for a written confirmation? Personally, I was so humiliated for asking such a stupid question I didn't stick around long enough to ask for one myself. I'm sure she's in the break room right now having a good laugh with her FDA cohorts:

"Some semi-old-fart-geezer just asked me if he was a manufacturer!"

 

[classwife]

Simply quoting what someone said on a phone conversation isn't clarification or evidence that can be shared.

Yes indeedy... audit trails are nice. But now that I have greased the wheels for you why don't you give ol' Mary Ellen a call and ask for a written confirmation? Personally, I was so humiliated for asking such a stupid question I didn't stick around long enough to ask for one myself. I'm sure she's in the break room right now having a good laugh with her FDA cohorts:

"Some semi-old-fart-geezer just asked me if he was a manufacturer!"

I did not say what you quoted above - knock it off

 

[B2L]

I'm sure she's in the break room right now having a good laugh with her FDA cohorts:

Absolutely, cackling about their evil plan working

 

[Lessifer]

Let's hit this from another angle. What enforcement action would be taken against an unregistered manufacturer who does not distribute their product?
Compliance & Enforcement

 

[Shekinahsgroom]

Does anyone want to add to the list of questions that need to be clarified?

1. Clarification of what the definition of a manufacturer means and how it pertains to registration.
2. Clarification of DIY importing.
3. Clarification of DIY manufacturing; both juice and devices.
4. Clarification of DIY labeling.
5. Clarification of DIY distribution.
6. Clarification of DIY underage.
7. Clarification of DIY exporting.

I'm very interested in what the FDA has to say (in writing) in particular about DIY underage usage and how they intend to handle/control it? If in fact they are not regulating DIY, then having something in writing that can be widely shared would mean that retail sales of anything would be in jeopardy of collapsing altogether.

I mean really, who in their right mind would buy anything retail if you could just DIY everything?
I myself have never bought a retail mixed/flavored juice....ever.
Ya know that all of these new regs and PMTA's are gonna raise prices dramatically, so if DIY cannot be controlled, then theoretically....retail sales should collapse.

This forum is a pretty solid foundation for distributing information, so just imagine what a written statement directly from the FDA could do for everyone that wants to DIY and not be regulated in any way whatsoever?
That includes underage usage....

What would happen to the regulations as a whole if the media got a hold of such a confirmation?

**BREAKING NEWS** FDA cannot regulate or control underage usage of vaping products!

Instead of the media working for BT, they could be working for us! But we need proof in writing first...

 

[Shekinahsgroom]

Let's hit this from another angle. What enforcement action would be taken against an unregistered manufacturer who does not distribute their product?
Compliance & Enforcement

Note: Absence of a retail establishment from this database does not imply compliance with all applicable statutory and regulatory requirements.

 

[Lessifer]

Does anyone want to add to the list of questions that need to be clarified?

1. Clarification of what the definition of a manufacturer means and how it pertains to registration.
2. Clarification of DIY importing.
3. Clarification of DIY manufacturing; both juice and devices.
4. Clarification of DIY labeling.
5. Clarification of DIY distribution.
6. Clarification of DIY underage.
7. Clarification of DIY exporting.

I'm very interested in what the FDA has to say (in writing) in particular about DIY underage usage and how they intend to handle/control it? If in fact they are not regulating DIY, then having something in writing that can be widely shared would mean that retail sales of anything would be in jeopardy of collapsing altogether.

I mean really, who in their right mind would buy anything retail if you could just DIY everything?
I myself have never bought a retail mixed/flavored juice....ever.
Ya know that all of these new regs and PMTA's are gonna raise prices dramatically, so if DIY cannot be controlled, then theoretically....retail sales should collapse.

This forum is a pretty solid foundation for distributing information, so just imagine what a written statement directly from the FDA could do for everyone that wants to DIY and not be regulated in any way whatsoever?
That includes underage usage....

What would happen to the regulations as a whole if the media got a hold of such a confirmation?

**BREAKING NEWS** FDA cannot regulate or control underage usage of vaping products!

Instead of the media working for BT, they could be working for us! But we need proof in writing first...

1. Clarification of what the definition of a manufacturer means and how it pertains to registration.
This really is the only "question" though most of us know the answer.
2. Clarification of DIY importing.
Whoever you purchased it from is the manufacturer/retailer.
3. Clarification of DIY manufacturing; both juice and devices.
Same as #1
4. Clarification of DIY labeling.
If the bottle is only used by you, no one else cares what is on it.
5. Clarification of DIY distribution.
Distribution is distribution, if you distribute it, it's no longer personal use.
6. Clarification of DIY underage.
If you are old enough to buy the individual supplies, you are old enough to mix and use them. The "regulation" aspect of this would come from the nicotine. Whoever you buy nicotine from is the manufacturer/retailer.
7. Clarification of DIY exporting.
Same as distribution, if you give/sell it to anyone else, it is no longer personal use.

Also, the fda cannot control underage usage of vaping products, just as they cannot control underage usage of cigarettes. The only thing they can attempt to control is the sale, marketing and distribution of products. i.e. the FDA can say it is illegal to sell cigarettes to minors, but they have no jurisdiction over minors smoking.

 

[Lessifer]

Note: Absence of a retail establishment from this database does not imply compliance with all applicable statutory and regulatory requirements.

Do you know what retail means?