Deeming Regulations have been released!!!!

rosesense

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    UncLeJunkLe

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    Territoo

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    I hope some nic companies manage a PTMA but I am doubtful (I know Heartlands was going for it?)

    I believe Liquid Nicotine Wholesalers is going for it too. They are also putting out a non tobacco derived line of nicotine. It still probably has to have a PTMA, but might have a better shot of getting approved. Of course the price will go up.
     

    UncLeJunkLe

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    There is a review on RY8 from early as 2012

    I actually have found the Ruyan V8 ecig mentioned here on EFC way back in 2008. Will be digging further later on tonight.

    I know this doesn't interest most people on this forum, but if the Ruyan V8 was introduced to the US market before the FDA 2007 grandfather date (is it still Feb 15, 2007 ???), that means 801 pen style ecig, which is still being made and sold from china, would be legal to import and sell within the USA, no? That's assuming that the 801 really is the same thing as the Ruyan V8.

    I know, y'all are probably thinking, but who cares!? :D But as a person who still uses pen style ecigs (but I have never used an 801 specifically), it matters to me given I can still buy them from China if I wanted to. At lest as of right now.

    Maybe we'll see a resurgence of improved 801 ecig like we saw a resurgence of improved MTL tanks. :wub:

    :pop:
     

    *RJ*

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    I actually have found the Ruyan V8 ecig mentioned here on EFC way back in 2008. Will be digging further later on tonight.

    I know this doesn't interest most people on this forum, but if the Ruyan V8 was introduced to the US market before the FDA 2007 grandfather date (is it still Feb 15, 2007 ???), that means 801 pen style ecig, which is still being made and sold from china, would be legal to import and sell within the USA, no? That's assuming that the 801 really is the same thing as the Ruyan V8.

    I know, y'all are probably thinking, but who cares!? :D But as a person who still uses pen style ecigs (but I have never used an 801 specifically), it matters to me given I can still buy them from China if I wanted to. At lest as of right now.

    Maybe we'll see a resurgence of improved 801 ecig like we saw a resurgence of improved MTL tanks. :wub:

    :pop:
    Not sure if this is what you are looking for or not.

    Dragonite International - Wikipedia
     
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    Katya

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    Thanks, I found that. But what i need is a timeline of the market release year of various models of the one specific brand, Ruyan.

    Everybody's been searching for that elusive predicate product since 2011. No luck. According to this article, Ruyan (Golden Dragon) was not being sold in the US in May 2007.

    Chinese "e-cigarette" helps you stub out the habit

    “The nicotine is delivered to the lungs within 7 to 10 seconds,” said Scott Fraser, Vice President of SBT Co. Ltd., the Beijing-based firm that first developed the electronic cigarette technology in 2003 and which is now controlled by Golden Dragon.

    This article states that e-cigarettes became available in the US in 2006.

    Electronic cigarettes attracting ‘smokers’

    First marketed worldwide in 2002 as an alternative to regular cigarettes, e-cigarettes did not become easily available in the United States until late 2006. Now, the industry has grown from the thousands in 2006 to several million worldwide, with an estimated 20,000 to 30,000 new e-smokers every week, according to Healy.

    The problem is that the FDA requires a proof of sale/purchase before Feb. 2007, and, AFAIK, no such proof has been found yet. I don't even know if the FDA knows what the predicate product is and when it it was first sold in the US.

    Unless this counts--from August 22, 2006 :

    NY M85579 - The tariff classification of a nicotine inhaler and parts from China - United States International Trade Commision Rulings

    It documents that Sottera (Njoy) was importing Ruyan products in 2006, but they were only test marketing prior to 2007, so who knows if that counts.
     
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    zoiDman

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    ...

    I know this doesn't interest most people on this forum, but if the Ruyan V8 was introduced to the US market before the FDA 2007 grandfather date (is it still Feb 15, 2007 ???), that means 801 pen style ecig, which is still being made and sold from china, would be legal to import and sell within the USA, no? That's assuming that the 801 really is the same thing as the Ruyan V8.

    ...

    It would have to be the Exact Same Product that was Sold in a US Market prior to the 2007 date.

    Although a Legal to Sell 801 from 2007 would be Interesting, what would be More Interesting is using something like a Ruyan V8 (if it is a "Predicate Product") to achieve an SE for a Modern Pen Style e-Cigarette.

    ---

    "Are there any e-cigarettes that are grandfathered and could be used as a predicate for a Substantial Equivalence application?

    It's possible that an ENDS product exists that may have been on the market in the United States as of February 15, 2007 and could be used as a valid predicate. However, the burden of identifying a predicate falls to the applicant, so a manufacturer would have to prove such a product is grandfathered.

    The FDA expects that most ENDS products that companies submit for market authorization will utilize the PMTA pathway, which does not require a comparison to a predicate product."

    FDA Center for Tobacco Products Commonly Asked Questions
     
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    Kent C

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    I actually have found the Ruyan V8 ecig mentioned here on EFC way back in 2008. Will be digging further later on tonight.

    I know this doesn't interest most people on this forum, but if the Ruyan V8 was introduced to the US market before the FDA 2007 grandfather date (is it still Feb 15, 2007 ???), that means 801 pen style ecig, which is still being made and sold from china, would be legal to import and sell within the USA, no? That's assuming that the 801 really is the same thing as the Ruyan V8.

    I know, y'all are probably thinking, but who cares!? :D But as a person who still uses pen style ecigs (but I have never used an 801 specifically), it matters to me given I can still buy them from China if I wanted to. At lest as of right now.

    Maybe we'll see a resurgence of improved 801 ecig like we saw a resurgence of improved MTL tanks. :wub:

    :pop:

    Much discussion of this early in this thread - pg60-70.

    Here's our founder chiming in:

    Deeming Regulations have been released!!!!
     

    Territoo

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    This is excerpt from tha Wikipedia page:

    Mr. Hon Lik (now Ruyan America's Chairman) patented a design (using high-frequency electronics) and is the original inventor of the first e-cigarettes sold (2003) and Ruyan has registered patents in more than 40 countries since 2003.[4] Ruyan began to form the idea for the electronic cigarette in 2000.

    In 2003, SBT was established, and the first patent was registered in the same year in China. In 2007, Ruyan's first international patent was registered.[5] The patent was later granted in the United States as well.[6]
    It looks like the Feds did their homework when they selected 2007 as the grandfather date.
     

    MacTechVpr

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    Much discussion of this early in this thread - pg60-70.

    Here's our founder chiming in:

    Deeming Regulations have been released!!!!

    But particularly poignant, what follows…

    Another thing worth pointing out.....

    This is NOT a regulation. It's a strange hybrid of regulation and prohibition. The FDA simply does not have the resources to regulate the industry as it stands, but it can regulate the remnant that will be left after the shakeout.

    Don't feed the animals. At least my opinion, if not of the of the thousands of businesses in the marketplace that've just said no to this bear trap. Wouldn't want to be one. Just sayin'.

    Good luck. :)
     
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    Myrany

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    I actually have found the Ruyan V8 ecig mentioned here on EFC way back in 2008. Will be digging further later on tonight.

    I know this doesn't interest most people on this forum, but if the Ruyan V8 was introduced to the US market before the FDA 2007 grandfather date (is it still Feb 15, 2007 ???), that means 801 pen style ecig, which is still being made and sold from china, would be legal to import and sell within the USA, no? That's assuming that the 801 really is the same thing as the Ruyan V8.

    I know, y'all are probably thinking, but who cares!? :D But as a person who still uses pen style ecigs (but I have never used an 801 specifically), it matters to me given I can still buy them from China if I wanted to. At lest as of right now.

    Maybe we'll see a resurgence of improved 801 ecig like we saw a resurgence of improved MTL tanks. :wub:

    :pop:
    I would contact CASAA for info. I know they were frantically trying to find extant ecigs from that time period as of a few years ago. Maybe you could help each other.
     
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    sofarsogood

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    I did myself a favor starting DIY 5 years ago. Flavor scares were the fashion back then so my first batches used the smallest amount of all-in-one favoring practical. So now I'm fine with 1% of one flavor full time (I mix for a brother who prefers the same.) Stronger flavor tends to cause me palatte fatigue. I never tire of 1% flavoring and it doesn't matter what flavor I use,, just enough to cover the flavor of the other ingredients.
     

    LoveVanilla

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    I just got this from Hoosier_e-cig. Haven't had a chance to check it out yet.

    Please help us help Baker White complete the FDA PMTA process
    by completing this survey (Link Below):
    Baker White Inc. PMTA Survey

    Done.

    The anti-vaping campaign was no accident. Pretty apparent if one is familiar with information warfare. This was coordinated and well-funded. My guess? $20-40M from Bloomberg, or big-Pharma to a Washington/NY media/public relations firm to execute.
     
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    MLEJ

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    I just read about synthetic nic, is that a possible alternative if nic ends up taxed or deemed out?
    Nicotine, even if synthetic, was deemed a tobacco product and subject to the Deeming.
    Was wondering if it was an attempt to skirt the "tobacco product" label ... ?
    Maybe it's just cheaper to make.

    The FDA has revised those figures, this snippet is from a FDA document:

    upload_2020-8-22_8-10-57-png.903057


    Link: https://www.fda.gov/media/130833/download
    i don't know how they sleep at night.

    Members of Congress have interns to do their research for them.

    Most legislation is written on K Street, not Capitol Hill. Safe bet the law was written by the lobbyists whose employers will benefit from it.
     

    englishmick

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    Done.

    The anti-vaping campaign was no accident. Pretty apparent if one is familiar with information warfare. This was coordinated and well-funded. My guess? $20-40M from Bloomberg, or big-Pharma to a Washington/NY media/public relations firm to execute.

    When I first joined ECF I saw a long post from one of the senior staff here on this topic. Guy said vaping needed to have a serious well funded media operation. He mentioned a staff including professionals with contacts in the media. Immediate response to negative stories in the media. A significant volume of positive stories. Ability to respond quickly to good or bad research stories. Etc.

    It was a long time ago and I can't find that post any more. My recollection is that he said it was his area of expertise and he could have organised it himself but he was too busy with his own career related stuff. Said in practice it could only come from the vaping industry and they showed no signs of being willing to cooperate and put up the large amount of money that would be needed. He suggested that without that in place we were likely to lose the battle.
     

    Bronze

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    When I first joined ECF I saw a long post from one of the senior staff here on this topic. Guy said vaping needed to have a serious well funded media operation. He mentioned a staff including professionals with contacts in the media. Immediate response to negative stories in the media. A significant volume of positive stories. Ability to respond quickly to good or bad research stories. Etc.

    It was a long time ago and I can't find that post any more. My recollection is that he said it was his area of expertise and he could have organised it himself but he was too busy with his own career related stuff. Said in practice it could only come from the vaping industry and they showed no signs of being willing to cooperate and put up the large amount of money that would be needed. He suggested that without that in place we were likely to lose the battle.
    All true.
     

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