Deeming Regulations have been released!!!!

DaveP

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From the VTA--just in.

"This is a BIG DAY for the vapor technology industry. The day that so many said could not come has arrived. And, just like with every other deadline imposed by the FDA, the vapor industry has stepped up to the task.

Once thought impossible, already reports are coming in of many manufacturers filing their Pre-Market tobacco Applications (PMTAs) covering what is sure to be thousands of products. Congratulations to all those companies who dug in, did the hard work, gathered the science and submitted their PMTAs by the deadline. Yes, companies had to make some tough decisions along the way, but that was always expected as we headed into the final phase of the Deeming Regulation.

Last week, the FDA confirmed it will take each applicant's individual circumstances into account during the review process. To be sure, FDA already has been quickly replying to early applicants and issuing initial acceptance letters accepting applications for a variety of products.

While this may feel like a finish line, it is really only the beginning of an ongoing process with FDA as CTP reviews each application submitted and engages with further questions of the applicants.

VTA will continue our existing dialogue with FDA to strongly advocate for our members participating in the process. To that end, the process rolls out as follows:

Phase 1: Administrative Review. FDA initially reviews the application to make sure that basic requirements are in the application, it is in English, it includes required contact information and that it contains product identifying information. If these basic elements are included, a company should receive a letter from FDA accepting their application for further action. If not, FDA will send a “refuse to accept” letter.

Phase 2: Filing. FDA engages in a preliminary scientific review to make sure that everything required by the statute is included, such as health risk data, HPHC studies, descriptions of components, ingredients, additives, and principles of operation, description of facility controls, manufacturing, etc. If FDA finds these elements, a company will receive a letter accepting the application for filing. If not, FDA will send a “refuse to file” letter.

Phase 3: Substantive Review: This is FDA’s full-blown evaluation of all the science and data presented in each application. FDA will take recommendations from TPSAC and will engage with the applicant with questions. This process could take up to 12 months and during this time FDA may send the applicant a deficiency letter, giving them 90 days to provide missing or deficient information. If FDA has made a scientific decision to issue a marketing order, FDA will send an environmental information request letter before it can issue a final marketing order. Otherwise, FDA will send a “no marketing order” letter.

Phase 4: Post Marketing Reporting. As part of its approval process, FDA may require that the sale and distribution of your product is restricted (i.e., to protect kids). Or FDA may require the applicant to establish and maintain certain records and make certain reports available to FDA. Post market reports will vary based on submission and may include a requirement that the applicant engages in serious or unexpected adverse experience reporting or any manufacturing deviations.

VTA’s full, in-depth analysis summarizing the important developments for those impacted by the PMTA deadline, particularly as it relates to FDA’s enforcement now that the PMTA deadline has been reached, can be found here."

All that testing and information gathering will take many years. We've already done the testing for them and we are much healthier than we would be if we all had continued to smoke burning tobacco cigarettes. The proof is already in on vaping, IMO. My fingertip O2 tester shows my blood oxygen levels to be at 98 and 99 regularly, even if I've just vaped like a fiend.
 
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stols001

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Synthetic Nic Disposable Skirts

It was an interesting article but I too was disappointed it was not, say, a hula skirt I could melt down in a pot on my stove (with several in my suitcase) but no. Although synthetic nic is both interesting and expensive.

IDK I have the feeling once they get themselves together, the more innovative the new (not yet deemed) product is, the more aggressive they are going to get. I mean...

Long Live Vaping for However long IT (and the world//universe) lives.

Anna
 

DaveP

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For those who haven't thought far enough ahead, you can calculate the amount of nic base you need to project usage forward. Most have done that and stocked up. For those who haven't, it's imperative that you do it now if you plan to mix your own juice. At some point it's likely that government will tax nic base at a high rate to discourage DIY and price juice vendors out of the market. Just my thoughts, thinking ahead. Better to do it now. The price won't drop and may rise due to government intervention.

How much Nic base to last a year if vaping
 
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440BB

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For a number of weeks we've been looking at how things will get through customs, labeling and enforcement. Perhaps some have become complacent, thinking they could likely continue getting chinese shipments with the occasional seizure.

Cutting off Paypal for international vendors was the actual immediate threat. Now we know.
 
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stols001

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Yup. As far as I can tell,. Buybest is just gone. I mean it was a small site, but looks like they just took it down. USA vendors could actually UP their prices until they run out of stock.

Kind of effective. I believe I have mentioned everywhere I thought this might happen but I was not going to GIVE THE GOVERNMENT any good ideas.

Course, FDA has been dealing with this for a WHILE, so they are used to offshore pharmacies and etc. The amount of China sites in comparison are very small.

Anna

Suck it FDA. Ah,. sorry.
 

Myrany

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For a number of weeks we've been looking at how things will get through customs, labeling and enforcement. Perhaps some have become complacent, thinking they could likely continue getting chinese shipments with the occasional seizure.

Cutting off Paypal for international vendors was the actual immediate threat. Now we know.
So I mentioned the week before the 9th. I was also promptly ROFLstomped for daring to say it. Yeah many of us saw this coming.
 

MLEJ

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USA vendors could actually UP their prices until they run out of stock.
ElementVape has had more stuff in stock than most or all of the US online vendors and, far as i know, hasn't had any big sales or discount offers lately. Their regular prices are hardly the lowest, either. I wondered if it was denial, obliviousness, or a business strategy. Strategy seems the most likely now.
 

stols001

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I think some vendors want out quickly and are salesing it up whereas others don't have said desire and are just selling as they would.

This is the FDA and yeah, they will get the warning shut down letters to the USA vendors soon enough. Really.

It's kinda weird how like China is going. Maybe the FDA has not located ALL the China sites yet IDK. Or some are like, "You can just come and GET US, FDA."

I really don't know how this works I mean can the FDA set up a trade embargo on these sites? How do they get "punished" for selling? Let me be clear I have ZERO clue how international trade actually works in any kind of fashion. I have taken it for granted all my life and etc.

Anna
 

Territoo

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    I think some vendors want out quickly and are salesing it up whereas others don't have said desire and are just selling as they would.

    This is the FDA and yeah, they will get the warning shut down letters to the USA vendors soon enough. Really.

    It's kinda weird how like China is going. Maybe the FDA has not located ALL the China sites yet IDK. Or some are like, "You can just come and GET US, FDA."

    I really don't know how this works I mean can the FDA set up a trade embargo on these sites? How do they get "punished" for selling? Let me be clear I have ZERO clue how international trade actually works in any kind of fashion. I have taken it for granted all my life and etc.

    Anna

    There's nothing they can do to China. They can and will stop a few packages, but far too much of our stuff comes from China. There's no way they can just shut down vaping without the cooperation of the Chinese vendors. Millions of individual packages come each week from China--ebay, Amazon, Wish, Alibaba, et cetera. They would have to try and stop them all and it ain't happening. We are to reliant on the Chinese. Using financial payment systems is a better way, but it only works on vaping only sites, or again with cooperation of the Chinese. I'm not sure what happened that Heaven's Gifts dropped PayPal so quickly and others haven't.
     

    UncLeJunkLe

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    So I mentioned the week before the 9th. I was also promptly ROFLstomped for daring to say it. Yeah many of us saw this coming.


    But paypal and merchant processors are 2 different animals.

    Paypal is 3rd party.

    Long time ago, vape was deemed "high risk" by USA merchant banks, so paypal, as a 3rd party processor, had to stop collecting payment for vape in the USA, just like tobacco and other "high risk" products.

    So USA vendors moved to merchant processors, but that was fairly short lived since vape was deemed "high risk". They were using regular old merchant processors, who had to drop them - so they dropped them and the vendors moved to high risk merchant processors (and got gouged with fees at first because only very few slimy companies were taking these accounts - and prices went up as a result). Then the market started opening up to vape shops and the more reputable companies came in and offered much better fees for high risk merchants.

    And here we are today. Vape is "high risk", severely being regulated, but not "forbidden" or illegal. And therefore merchant processors can still take payment for vape, just not 3rd party processors. But the account has to be underwritten for "high risk transactions" and therefore the fees are higher than a regular merchant processing account. Those with better histories and higher processing volumes get the best prices.

    You can't lump merchant processors and 3rd party processors in the same lot. They aren't the same and do not and cannot operate in the same manner.

    HeavenGifts will figure it out. Unless this is a Chinese government issue, they will start taking credit cards again, only this time directly through their own merchant processor and internet gateway.

    On the other hand, if it is a Chinese government thing, then they may not be able to collect payment through a merchant processor either, or even Ali Pay, the Chinese 3rd part processor.

    In that case, crypto currency will be the only way. But if this is a chinese government thing, staying in business is not gonna be likely anyhow.
     

    Myrany

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    But paypal and merchant processors are 2 different animals.

    Paypal is 3rd party.

    Long time ago, vape was deemed "high risk" by USA merchant banks, so paypal, as a 3rd party processor, had to stop collecting payment for vape in the USA, just like tobacco and other "high risk" products.

    So USA vendors moved to merchant processors, but that was fairly short lived since vape was deemed "high risk". They were using regular old merchant processors, who had to drop them - so they dropped them and the vendors moved to high risk merchant processors (and got gouged with fees at first because only very few slimy companies were taking these accounts - and prices went up as a result). Then the market started opening up to vape shops and the more reputable companies came in and offered much better fees for high risk merchants.

    And here we are today. Vape is "high risk", severely being regulated, but not "forbidden" or illegal. And therefore merchant processors can still take payment for vape, just not 3rd party processors. But the account has to be underwritten for "high risk transactions" and therefore the fees are higher than a regular merchant processing account. Those with better histories and higher processing volumes get the best prices.

    You can't lump merchant processors and 3rd party processors in the same lot. They aren't the same and do not and cannot operate in the same manner.

    HeavenGifts will figure it out. Unless this is a Chinese government issue, they will start taking credit cards again, only this time directly through their own merchant processor and internet gateway.

    On the other hand, if it is a Chinese government thing, then they may not be able to collect payment through a merchant processor either, or even Ali Pay, the Chinese 3rd part processor.

    In that case, crypto currency will be the only way. But if this is a chinese government thing, staying in business is not gonna be likely anyhow.
    I did not distinguish (or mean to if it was taken that way) between one type of processor and another. To my way of thinking all they need to do is shut down our ability to pay for goods and internet sales are effectively dead. Be it through pay pal or credit cards.

    Many of us are not comfortable with cryptocurrency and will not go that way.

    Honestly outside of HG this shut down of Paypal seems to be mostly on Aspire products which were shut down quite awhile ago. I could be wrong but that is what I am seeing in peoples reports of problems.
     

    UncLeJunkLe

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    I did not distinguish (or mean to if it was taken that way) between one type of processor and another. To my way of thinking all they need to do is shut down our ability to pay for goods and internet sales are effectively dead. Be it through pay pal or credit cards.

    Many of us are not comfortable with cryptocurrency and will not go that way.

    Honestly outside of HG this shut down of Paypal seems to be mostly on Aspire products which were shut down quite awhile ago. I could be wrong but that is what I am seeing in peoples reports of problems.

    I agree.

    We just have to wait and see. Heck, this could be a mistake and HG is reporting it as Paypal banning international (or at least chinese) vape transactions, when in fact something triggered paypal to erroneously shut their account down (it does happen to merchants all the time but the more money you bring in the easier it is to fix). Maybe their PP account will get reinstated and this whole thing will be about nothing lol.

    Only time will tell. But the fact that BuyBest took all their vape products down does make me wonder.
     

    MLEJ

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    but far too much of our stuff comes from China
    There are UK vendors, too. With the positive attitude toward vaping there, they could remain a source for our needs, no?

    To my way of thinking all they need to do is shut down our ability to pay for goods and internet sales are effectively dead.
    Anyone else remember paper checks & money orders?
     

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