Deeming Regulations have been released!!!!
- Thread starter Oliver
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I'm not sure How Old you are? And it is None of my Business. But on my Birthday, it takes 3 Boxes of these Candles to Load Up the Cake.
And there Aren't that many left in the Last Box.
Wow and here I was thinking you were 72. Until I read that last sentence.
I would think that after a sale is completed and if that transaction was completely legal, that the FDA should cease to have any interest or legal standing in the product. Ownership is passed on and any laws that the FDA deemed are/should finished. So why at that point couldn't the owner/employee help the customer with questions, changing or inserting batteries, etc? More importantly, how could the FDA enforce anything at that point? I understand the owner/employees of the vape shop would still be scared [Moderated] to do anything, but what really could the FDA do?Nope. You just can't say sorry we will not do this again nor will my employee's.
Think ISO 9000 requirements.
If your response is less than 50-100 pages with documentation backing that up
they wont even look at it. This will not be a parking ticket. The beauty of this is
even you successfully completed a PTMA your obligated yearly to go through the
process more or less to prove nothings changed. Maybe not expensive as the
original PTMA but,an ongoing cost that will dwarf the original cost over time.
There are no back doors unless or, until the courts or congress changes it.
Regards
Mike
This is so stupid........grrrrr.
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Joint Petitioners Opposition and Reply Brief - AS FILED.pdf
Page 8 refers to AA batteries that may be used in powering ecig devices? Where did they get this wrong information? Or are they testing the knowledge of the FDA or courts?
Or have I totally missed something?
Page 8 refers to AA batteries that may be used in powering ecig devices? Where did they get this wrong information? Or are they testing the knowledge of the FDA or courts?
Or have I totally missed something?
14500 is AA size and was popular at one time for smaller tube mods. AA primary batteries were used by some in the early days of DIY modding. I think they were using the same hyperbole as the our eliquid doesn't contain peanuts argument about free speach to point out the absurdity of FDA's regulation.
Thanks. I figured it was along those lines.
puck mod, and as Alexander Mundy pointed out, there are some smaller devices that use 14500 batteries.
"Congress defined “tobacco product” to mean a product “made or derived from tobacco”;
FDA does not have license to extend that definition to products not made or derived from tobacco,
regardless of the circumstances. Indeed, under FDA’s Rule, the agency could “deem” ice
cream subject to the TCA, on the theory that it is reasonably expected that some people mix ice
cream with tobacco essence to make tobacco-flavored ice cream.6 FDA could likewise “deem”
tupperware, on the ground that people may be expected to store e-liquids in the containers. Even
standard off-the-shelf AA batteries are at risk of being deemed “tobacco products” under FDA’s
boundless theory, given that consumers often use them to power vaping devices."
---
I believe what is being Argued is that the FDA can Not Extend Regulation Authority to something just because the FDA believes there is a "Reasonable Expectation".
And the referenced AA Batteries merly as an Example of what such an Extension of the FDA's Authority could Include and why.
Yes sir, I get that. Just was wondering why that particular example, that's all. Could have just as easily referred to the 'flash light' batteries. That would have been more up to date, per se.
Yes sir, I get that. Just was wondering why that particular example, that's all. Could have just as easily referred to the 'flash light' batteries. That would have been more up to date, per se.
I believe they used AA Batteries as an Example because they are so Commonly used in the USA for everyday products.
Which Supports the Idea that the "Reasonably Expected" premise of the FDA is Overreach as it could Impose Regulations to Products that are Not e-Cigarettes related in thier use.
There is enough real stuff to fuel your outrage without making it up.Nope. You just can't say sorry we will not do this again nor will my employee's.
Think ISO 9000 requirements.
If your response is less than 50-100 pages with documentation backing that up
they wont even look at it. This will not be a parking ticket. The beauty of this is
even you successfully completed a PTMA your obligated yearly to go through the
process more or less to prove nothings changed. Maybe not expensive as the
original PTMA but,an ongoing cost that will dwarf the original cost over time.
There are no back doors unless or, until the courts or congress changes it.
Regards
Mike
You missed footnote #7 at the bottom of page 8 that references a mod that uses/used AA batteries
If someone showed me this, I would be Embarrassed to say that I worked at for FDA. Even if I was just a Switchboard Operator. Or someone who Vacuumed the floors at Night.
I'm sure some of the employees of the FDA must vape. I wonder how they feel about this nonsense? Assuming they are even aware of what their fine employer is doing.
Alas they are probably the Switchboard Operators and Janitors.
I'm confident he's quite familiar with legal fee structures.
You're right that a shop operating on a shoe-string can't afford to risk that. But there are some shops out the that have done VERY well over the past few years who definitely could.
Good. This is as it should be. I might just stop by one of my local shops this weekend and see how they're handing things.
Wow! This is beautiful. The plaintiff's team was obviously ready for this.
I can't find anything in the deeming that says if retailer answers questions about the products, "demonstrates" how to do something before a sale, or explains battery safety as an example, they will become a manufacturer. None of those things are on the list of what makes a retailer a manufacturer.
I don't think that the things that are qualifiers that would change a retailer to a manufacturer BEFORE a sale would apply after a sale. At least for the most part. If a retailer sold a tank with a sign hanging in the store saying "if you buy a tank we'll build you a coil to put in it" then ya, that would be a problem because its directly related to the sale. If an elderly lady with arthritis buys a Joyetech AIO and after the purchase comes back into the store and says I can't get the top off to fill it with the liquid I don't see a problem with a store employee taking the top off and filling it with liquid for her.
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We've said all along that the deeming is trying to jam a square peg into a circle. Technology is evolving at a blistering pace around the globe. Using dated law and regulations and applying it to something that didn't or barely existed at the time they were written is pretty stupid. We all know this. Heck, the FDA probably knows this.
Now that things are unfolding we are going to see if a judge knows or agrees with this.
Congress "partially" knows it. Hr2058 and Cole Bishop are attempts to allow a new class of products to exist without harsh barriers of entry.
Once the dust settles I have a hunch that the FDA will regret not creating a flexible set of regs for ecigs. They had a chance and they blew it. If the FDA can interpret the TCA to make batteries, mods, zero nic liquid, etc to be tobacco products they could have just as easily deemed them not tobacco products. But they didn't. It could end up backfiring on them and everything goes back to the drawing board. We won't know for quite some time unfortunately.
Now that things are unfolding we are going to see if a judge knows or agrees with this.
Congress "partially" knows it. Hr2058 and Cole Bishop are attempts to allow a new class of products to exist without harsh barriers of entry.
Once the dust settles I have a hunch that the FDA will regret not creating a flexible set of regs for ecigs. They had a chance and they blew it. If the FDA can interpret the TCA to make batteries, mods, zero nic liquid, etc to be tobacco products they could have just as easily deemed them not tobacco products. But they didn't. It could end up backfiring on them and everything goes back to the drawing board. We won't know for quite some time unfortunately.
Oh good. My morning reading is settled. Interesting they got in done in 55 pages while the FDA throw the kitchen sink filing was ~120 pages. Then again, the FDA has always taken the position if something can be stated in one sentence, write at least a page.
Or more like the more words, the more that will get lost in the skimming of those words.
Double speak is always a lengthy confusing read.
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