Deeming Regulations have been released!!!!

mattiem

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slm said:
This may be a little OT but I've got more emails for juice sales today then ever! What's going on there? Did I miss that I won't be able to mail order juice anymore after midnight Sunday?!
If I am understanding correctly then If an e-juice mixer can't confirm and prove that the e-liquid he makes 8/9 is exactly the same e-liquid he made 8/8 then he is breaking one of the numerous edicts of the deeming regs so I am thinking that is why you are seeing all the sales. If something doesn't change and change quickly I am afraid a lot of the e-liquid makers will have to close up shop. :(
 

Eskie

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If I am understanding correctly then If an e-juice mixer can't confirm and prove that the e-liquid he makes 8/9 is exactly the same e-liquid he made 8/8 then he is breaking one of the numerous edicts of the deeming regs so I am thinking that is why you are seeing all the sales. If something doesn't change and change quickly I am afraid a lot of the e-liquid makers will have to close up shop. :(

Many small vendors will eventually close. For all vendors, so long as they have records which can be produced indicating the e-liquid made on 8/9 was prepared in the same manner as an e-liquid they sold before 8/8, and assuming they have proper labeling, child resistant cap, and evidence they have confirmed the purchase was made by an individual over the age of 18, they may continue to sell that e-liquid.

There will be no new flavors released after 8/8 without an approval from the FDA, either by PMTA (good luck) or SE (like that will ever happen).
 
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BrentMydland

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In response to numerous recent comments. I have a degree in biology and chemistry, am currently in med school, and have done my fair share if research products and scientific writing and I can tell you that unfortunately in this area its actually encouraged to write superfluously and be as wordy as possible and in a lit of cases ambiguous as well. You've probably seen pub med articles and the like and the FDA deeming is no different. Even after reading things Luke this for years it was hard for me to decipher it all and I can only imagine how difficult it is for those who aren't accustomed to that style. IMO its 100% done on purpose mostly so many won't be able to understand it or make it so hard to read than many interpret it wrong or give up entirely but also to keep in ambiguous enough to interpret it as they wish down the road . it one thing to release a document like that to your peers but something of this magnitude that so many need to be able to understand should have been published with a more general public friendly style.
 

rothenbj

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If I am understanding correctly then If an e-juice mixer can't confirm and prove that the e-liquid he makes 8/9 is exactly the same e-liquid he made 8/8 then he is breaking one of the numerous edicts of the deeming regs so I am thinking that is why you are seeing all the sales. If something doesn't change and change quickly I am afraid a lot of the e-liquid makers will have to close up shop. :(

Could you imagine if that type regulation was made for any other product? I don't believe even the Pharma products are being held to the standards they set for e cigs. Hopefully the industry is comparing the two.

http://www.fda.gov/downloads/Drugs/.../Guidances/UCM217043.pdf
 

kbeam418

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Another thread was posted just this morning about no more colds since vaping came into their lives. I am pretty sure the FDA doesn't want to hear reports like that but it seems to be one of the numerous benefits of vaping. One person did come in and point out that it was just because we are no longer smoking but I don't believe that is all it is. Non-smokers still get a cold or the flu just like so many of us smokers did. I truly believe the lack of respiratory ills has a direct link to the pg/vg in our e-liquid.

If it weren't for the fact that too much money is being lost, the FDA and health agencies would be all over this fact. I really hope that someday they will get their heads out of the money bag (as opposed to sand) and see what a miracle this truly is. Sadly, I don't see this happening in my lifetime :(

I got a cold in the beginning of summer (I've always got one since a kid) vaping menthol e-liguid helped with my sore throat, made breathing much better, ad reduced my coughing. Instead of reaching for a cough drop, I reached for my vape because it was MORE effective!
 

Alexander Mundy

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In response to numerous recent comments. I have a degree in biology and chemistry, am currently in med school, and have done my fair share if research products and scientific writing and I can tell you that unfortunately in this area its actually encouraged to write superfluously and be as wordy as possible and in a lit of cases ambiguous as well. You've probably seen pub med articles and the like and the FDA deeming is no different. Even after reading things Luke this for years it was hard for me to decipher it all and I can only imagine how difficult it is for those who aren't accustomed to that style. IMO its 100% done on purpose mostly so many won't be able to understand it or make it so hard to read than many interpret it wrong or give up entirely but also to keep in ambiguous enough to interpret it as they wish down the road . it one thing to release a document like that to your peers but something of this magnitude that so many need to be able to understand should have been published with a more general public friendly style.
There was a paper written a long time ago by an engineer that was a satire on the lengthy and obscure words that fellow engineers use in published papers. Amazingly it was published in an esteemed engineering journal and years later several short videos were made using his paper. Here is the original one.

 

Alexander Mundy

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One consequence of the Deeming I hadn't thought of is whether posting test results or even saying your eliquid doesn't contain diketones would be considered a modified risk claim. Picked this up from the diketone free tested vendor thread.

mel-png.586197

https://cdn2.bigcommerce.com/server...loaded_images/testresults-1-.png?t=1468341322

Now how about that for irony, FDA just took away consumers ability to make what they feel are safer choices unless someone besides a vendor does independent lab testing and publishes the results. The voluntary testing and publishing by vendors was driven by a free market and consumers and (at least in this vendors eyes) the FDA has just created what might well be a less safe market by regulating it.
 

Alexander Mundy

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Jeremy Dollar of Goodlife Vapor meets with U.S. representative Sanford Bishop

http://www.tasteyourjuice.com/wordpress/archives/13581

I agree with the premise of the article that you have to play ball with the big boys, but the root of the wider problem is exactly that you have to play ball with the big boys. Term limits would go a long way but even then it might be hard to crush the power aspect since it is so ingrained in politics now.
 

DC2

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One consequence of the Deeming I hadn't thought of is whether posting test results or even saying your eliquid doesn't contain diketones would be considered a modified risk claim. Picked this up from the diketone free tested vendor thread.
I don't know if you DIY or not...
And if you do, I don't know if you use diketone-free flavors...

But it is well within the realm of possibility that flavor manufacturers will not be able to tell you which flavors do or do not have diketones, because by intended use that would clearly indicate the product is intended for use with a tobacco product.

Would the FDA push it that far?
 

Alexander Mundy

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I do DIY and I do avoid diketones. Not because I am for certain they are a hazard, but because that is what I choose to do. For any flavors I do not know the results already (and assuming the ones I do know about don't change) my choice was just taken away.
 

Mazinny

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Flavourart is an Italian company. Their vape line is all diketone free. They aren't allowed to publish their test results !? How would that work ? Keep test results up for their European customers and stop selling to U.S. vendors, or remove test results, so Europeans don't have access to them either ?
 

Eskie

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Flavourart is an Italian company. Their vape line is all diketone free. They aren't allowed to publish their test results !? How would that work ? Keep test results up for their European customers and stop selling to U.S. vendors, or remove test results, so Europeans don't have access to them either ?

Post them on their European site if not otherwise restricted by the TPD. Just because a US user chooses to visit a site hosted in Italy does not imply the FDA has jurisdictional reach regarding that site or those claims. If any vendor in the US chooses to publish those results in connection with FA products, that could trigger a response. Still, there's nothing I can recall in the deeming regs (like I could possibly remember all that :censored:), but posting a test result WITHOUT any additional statements like "See? It's really safe!" might very well be allowed as it is simply an objective third party certificate of analysis up to the end user to interpret. It might very well not run afoul of the regs. however, not sure I'd want to be the test case for that.
 

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