Deeming Regulations have been released!!!!

Robino1

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E-cig FDA deeming regulations explained by Dr. Michael Siegel. On YouTube.
Ok, I listened to it. He did say the Amendment was approved out of committee. Which is what we are saying also. The HR2058 is still sitting waiting to see what happens with the Amendment that is working its way through the system. You can get to that part starting at about 9:40 into the video. (I would start a little before the 9:40 marker)



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Robino1

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It's the Agricultural Appropriations bill. There are 12 different appropriation bills that fund our government. They make up the budget. HR2058 provisions were amended to the Ag appropriations bill as another avenue to get them passed. The 12 appropriation bills are written and voted on each year...at least they are supposed to be and that used to be the way but since no one in government gets along anymore we often operate on the previous year's budgets (called continuing resolutions).
That's what I said :rolleyes: :p
 

zoiDman

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Ok, I listened to it. He did say the Amendment was approved out of committee. Which is what we are saying also. The HR2058 is still sitting waiting to see what happens with the Amendment that is working its way through the system. You can get to that part starting at about 9:40 into the video. (I would start a little before the 9:40 marker)



Edit to tag @zoiDman


This is the Current Status of these items as I understood them.
 

hittman

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    I don't know if this has been brought up before on this thread but there's one thing I was thinking about. If this thing does go thru then we can forget free/$3-$5 shipping charges. I started using snus before the PACT act and was paying around $5 to have snus shipped via usps. When PACT was approved, usps stopped carrying tobacco products and they could only ship UPS with adult signature required. Shipping charges went from around $15 for shipping in the US and $30-$40 for overseas shipping. I have to think that we are looking at the same type of thing.
     

    sparkky1

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    zoiDman

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    Icemanxxxv

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    LOL! So I called the FDA as a "consumer" option and was transferred to voice mail for a given employee whose name escape me. Leave a message!

    So I called the FDA as a member of the press/media option which believe it or not is legit /lol Recording to call another number. OK I did and ran into another employees voice mail.

    So.... "Operators are standing by...." not so much.

    Stay Strong! Continue to fight!

    :)
    My same results[emoji35]

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    Icemanxxxv

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    So, surely the FDA will grant one or two uninspiring vaping devices, built from the ground up, that are likely highly "medicalized," have tiny liquid capacities and most certainly will be lacking in ascetics, and overall desirability. A sort of "there, you got something." If so, the irony being that they will probably be less sophisticated, capable and "safe" as, say, a DNA 200 (let's say the DNA chip on their review table would hypothetically be limited to 30 watts to leave high power out of the equation). My prediction of the FDA's offering likely not being as "safe," is in the sense of temperature control not overheating and releasing undesired components in the e-liquid. I somehow suspect a mature chip like the DNA, or similar, would outperform whatever the FDA oversees, approves, funds or nurtures.

    My question is, does anyone expect even one license will be granted for, and let's get specific, a DNA 200 device (say in a lower wattage form factor)? Let's also assume a paired tank with this device is under 2ml and not a cloud chucker, reasonable and modest in all respects and is of high material and manufacturing quality.

    I keep having this negative, cynical, defeatist attitude that the approval process may not even allow one current, best-of-class device on the market (not even if simply wattage limited).

    Because if one such device gets the green light, it opens the door to "substantial equivalency" claims and potentially unravels all the hard work the FDA has done to (presumably, and in my opinion) kill the industry.

    I seem to recall reading a quote from the FDA front guy, when asked a similar question, saying something along the lines of "we can't predict and will have to see the testing results on a case-by-case basis." (paraphrasing)

    Yeah, right.
    If I had a chip company that got put out of business by the deeming rules I would release all drawings and part numbers and schematics on open source so we could just make our own chips. The software is already out there. Open source so all us DIY'RS can just press on with pride. Can they really stop China from selling to us on the internet? Just asking if anyone knows.

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    Robert Cromwell

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    If I had a chip company that got put out of business by the deeming rules I would release all drawings and part numbers and schematics on open source so we could just make our own chips. The software is already out there. Open source so all us DIY'RS can just press on with pride. Can they really stop China from selling to us on the internet? Just asking if anyone knows.

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    It would appear so.
    From their website.
    Manufacturer, Distributor, and Importer Compliance
    To legally sell a new FDA-regulated tobacco product in the United States, you must receive a written order from FDA permitting the sale of a new tobacco product under one of three pathways to market.

    In addition, any products marketed with modified risk claims must have an FDA order in effect that permits such sale or distribution.

    If your product is found to be Not Substantially Equivalent (NSE), it is illegal to sell or distribute the product in interstate commerce and to import the product into the United States.

    Manufacturers may not distribute any smokeless tobacco product without a required warning statement for every smokeless tobacco package and advertisement.

    If you are found in violation of FDA rules and regulations, your product will be considered "misbranded" and/or "adulterated," making it illegal to sell or distribute the product in interstate commerce and to import the product into the United States. Doing so may result in FDA initiating regulatory action (e.g., seizures, injunctions).

    FDA restricts the way tobacco manufacturers, retailers, and distributers can advertise and regulated tobacco products, especially marketing efforts designed to appeal to youth.
     

    Icemanxxxv

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    It would appear so.
    From their website.
    Manufacturer, Distributor, and Importer Compliance
    To legally sell a new FDA-regulated tobacco product in the United States, you must receive a written order from FDA permitting the sale of a new tobacco product under one of three pathways to market.

    In addition, any products marketed with modified risk claims must have an FDA order in effect that permits such sale or distribution.

    If your product is found to be Not Substantially Equivalent (NSE), it is illegal to sell or distribute the product in interstate commerce and to import the product into the United States.

    Manufacturers may not distribute any smokeless tobacco product without a required warning statement for every smokeless tobacco package and advertisement.

    If you are found in violation of FDA rules and regulations, your product will be considered "misbranded" and/or "adulterated," making it illegal to sell or distribute the product in interstate commerce and to import the product into the United States. Doing so may result in FDA initiating regulatory action (e.g., seizures, injunctions).

    FDA restricts the way tobacco manufacturers, retailers, and distributers can advertise and regulated tobacco products, especially marketing efforts designed to appeal to youth.
    We are talking China selling to individuals.

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    mikepetro

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    If I had a chip company that got put out of business by the deeming rules I would release all drawings and part numbers and schematics on open source so we could just make our own chips. The software is already out there. Open source so all us DIY'RS can just press on with pride. Can they really stop China from selling to us on the internet? Just asking if anyone knows.

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    Customs!!!! Just like they did back in 2009 with nJoy.

    From the FDA
    "Office of compliance and enforcement has been preparing for day 91."
    "If needed- we work with law enforcement to stop ilicit trade- but we can't talk about it openly."
     

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