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FDA's August 2022 Deadline Moved Ahead

It appears that we don’t have quite as much time to stock up, as we thought.

https://www.bloomberg.com/news/articles/2019-07-12/judge-gives-e-cigarette-makers-10-months-to-seek-fda-approval

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the FDA issued a guideline last month to help e-cigarette makers craft their applications.

I read recently that the FDA’s requirements surrounding applications are so onerous in their complexity that (reportedly) not a single company had submitted applications - a massive undertaking for smaller companies

.

(June 13, 2019): “The FDA also said in the brief that it would aim to finish a draft guideline it put out in March that would ban most flavored e-cigarettes from retail stores within four months.”

March 2019 FDA Draft Guideline referenced:
https://www.fda.gov/media/121384/download

The above draft FDA rule appears to set forth wide ongoing leeway for the FDA to, at their discretion on an ongoing basis, interfere with and/or terminate commercial sales of:

“All ENDS products that are targeted to minors or likely to promote use of ENDS by minors”
(Pages 12-15)

Definitions (Pages 6-7):

ENDS refers to electronic nicotine delivery systems and includes devices, components, and/or parts that deliver aerosolized e-liquid when inhaled.”

Component or Part means any software or assembly of materials intended or reasonably expected: … (2) to be used with or for the human consumption of a tobacco product. … The following is a non-exhaustive list of examples of components or parts of ENDS (including e-cigarettes): e-liquids; atomizers; cartomizers (atomizer plus replaceable e-liquid-filled cartridge or pod); clearomizers; tank systems; flavors; and bottles that contain e-liquids.”

It appears (in this March 2019 draft FDA rule) that any e-liquids, atomizers, tank systems, flavors, and bottles that contain e-liquids which the FDA may deem and thus declare as being “targeted to minors or likely to promote use of ENDS by minors” are listed within “Priorities for Use of Enforcement Resources” (Page 13).

“Many ENDS products are being marketed to minors through a wide variety of media and technology and their labels and labeling, print advertising, and/or online advertising are appealing to minors. … Many companies are also utilizing social media to market their tobacco products to minors. … Any efforts to entice minors to use tobacco products is of concern to FDA. At this time, FDA is prioritizing its enforcement to focus on products that are targeted to minors or likely to promote use of ENDS by minors. FDA requests comments on examples of products that are targeted to minors or likely to promote use of ENDS by minors.” (Pages 14-15)

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The anti tobacco & save the children (since we can’t cook them) groups wanted a 4 month deadline, but the Feds weren’t ready to move that quickly, it appears.

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At least this doesn’t appear to apply to DIY. Just commercially marketed products.

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I’m not sure how it will affect mods, tanks, coils (if one uses drop in / disposable coils), etc.
It wouldn’t shock me at all, to see them target nicotine, at some point.

What was the initial date Aug 2018? Or something along those lines. No, let’s make it 2022, we’ll give you 4 years. No wait, let’s make it 2020. They can do what they want, when they want to. That makes me very wary.

If they make it too difficult for the commercial juice makers to stay in business, AND target nicotine, that will most likely stick a fork in DIY as well. Those making 0 nic will probably be ok, but I think they are in the minority.

Considering the unpredictable nature of the FDA, who knows what they’ll come up with between now and the 2020 deadline.

Stay tuned I guess!

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Why not teach our youthful academics that “Big Brother” is always watching and listening to them (you know, “homeland security”, of course). Check out the effusive raving over the “FlySense”. Bully those little bullies more gooder with the Soter Tech so-called “Vaping and Bullying Detector”. Remotely detect and prosecute Nicotine infused glycols like a pro. Vanquish hormonally-driven sins like a true authoritarian badass … :stuck_out_tongue:

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The document is here
https://www.fda.gov/media/127853/download

Some believe it will not have any effect on liquid Nic as it requires further processing to be e-liquid.

Therefore, those establishments engaged
in mixing and/or preparing combinations of liquid nicotine, flavors, and/or other e-liquids or
creating or modifying e-cigarettes for direct sale to consumers for use in ENDS are both tobacco
product manufacturers and retailers, and consequently are subject to all the requirements
applicable to manufacturers and retailers including the PMTA requirements.

I am not so sure about that. While it says combinations of nic/flavours/other liquids they could easily stretch it to preparing the liquid nicotine (or nicotine salts). I guess time will tell.

For the purposes of this guidance document, e-liquids include liquid nicotine, nicotine containing liquids (i.e., liquid nicotine combined with colorings, flavorings, and/or other
ingredients), and liquids that do not contain nicotine or other material made or derived from
tobacco, but that are intended or reasonably expected to be used with or for the human
consumption of a tobacco product.

Nicotine containing liquids with the “or other ingredients”: is pretty broad and could mean Nicotine with pg or vg.

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I think it’s likely we may have to pay a yearly fee to secure an id#/permit to buy nis/salts at the higher concentrations.

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Ya similar to what they do in the EU you can buy higher concentrations if you are a business manufacturing (I don’t know if there is a fee attached or not)

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Nope they covered that with the statement

or reasonably expected to be used with or for the human consumption of a tobacco product.

So a 0mg juice is still a tobacco because you can add nic to it.

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I don’t think here in the US we will have to get a buisness id, just a personal use permit that all vendors will have to ask for before allowing the sale.

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It really depends on how/if they want to apply their force. They will most likely focus on pods/closed systems first how far they take it after that will be entirely at their whim.

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It’s actually a pretty common government practice to require personal use permits for products here at both state an federal level. Good business really collecting fees for legal but controlled substances. Doubt that they’ll go as far as needing a prescription but that is a real possibility as well.

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That is where we are in Australia right now and it could get much worse. Australia likes to follow the USA so I am not expecting things to get better here anytime soon.

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Good old FDA BS logic to suit authoritarian ends. It’s not (reasonably) an “anything else” simply because “anything else” could possibly be added to it. One can think of various other substances/alkaloids that might alternatively be added. Effectively, “thought crimes”.

Good luck finding a physician willing to prescribe Nicotine - that is, for personal recreational enjoyment, as opposed to medicalized/monetized “detox regimens”. If one is young, they don’t want to “corrupt”. If old, they worry about cardiovascular effects.

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Can you still have nic shipped in legally?

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You are assuming that the doctors give a shit. Believe me they don’t, easy money writing scripts for nic.

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Well there are a few here in Australia that will prescribe for smoking cessation so it is not beyond the realms of possibility given that there are some doctors that understand risk minimisation.

@Letitia
I have a prescription so I can ship nic legally. That said Australian customs are not currently halting Liquid Nic - until the TGA (Theraputic Goods Administration) makes a decision one way or the other. Currently we can import a 3 month supply for personal use (with a script, I have never been asked to produce it) this is done under the personal import scheme that the TGA allows.

As a reference we used to be able to bring CBD (without a script) in under the same scheme but the TGA said it has a therapeutic benefit and made it legal. In making it ‘legal’ you have to now have a script to import it - a script for cbd can only be obtained from an authorised doctor of which they are currently less than 20 in the whole country. So they pretty much fixed it until it was broken.

I am happy for them to leave it as because when/if they “fix” it it is likely to be fixed in a shitty way.

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In the U.S, prescribers demonstrably readily “jump when the PTB say jump”. It would be an egredious shame if one had to grovel and to pay a prescriber for Nicotine. I would not underestimate socio-political inquisitory powers that the FDA/CDC/CPSC agitprop machines wield. They have made quite an ugly mess of medicine.

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Apathy and frustration here runs rampant. Thanks largely due to the FDA and the government payments always falling behind medical professionals are fed up, especially in the poor states like mine. They will provide the scripts just like they did for medical thc.

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