FDA URGENT FDA Call to Action: Submit Comments on FDA's Proposed Intended Use Regulation

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JustJulie

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URGENT Call to Action re FDA regulation - Comments due TUESDAY, November 24, 2015.

This isn't a complicated or time-consuming Call to Action, but it's an important one. FDA is seeking to prohibit manufacturers (which would include most vape specialty shops) from providing honest and helpful information to consumers.

Please set aside 15 minutes to let FDA know why this kind of rule is bad for consumers and represents suppression of information that you believe you are entitled to receive.

See the Call to Action for full details on how you can make your voice be heard.

CASAA: FDA Call to Action: Submit Comments on FDA's Proposed Intended Use Regulation
 

Kent C

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A: "Which nicotine level should I start with?"

B: "How much do you smoke?"

A: "About a pack a day."

B: "Well then, I suggest you start with 16mg/ml."

A: "Intended use violation!" (Flashes badge and initiates the forced closing of the vape shop...)

Exactly! Grrrrreat example nicnik :thumb:
 

sofarsogood

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I went to the actual proposed rule and tried to read it. Who ever wrote it should be fired and the person he works for should be fired and the person he works for, etc. All of this is designed to be exclusionary. They should hope they never need my respect or support on anything.

But then I calmed down and thought of something i wanted to say. (If you are inspired to do the same be sure to copy and paste the first paragraph. Apparently it's required.) So I completed the process as follows:
-------------------------------------------------
I am commenting on the Proposed Rule “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses’”(Docket No. FDA-2015-N-2002)

Your intended-use rule reminds me of hate speech laws. I oppose it.

I am an American. I started vaping 13 months ago and stopped smoking 6 weeks later. Vaping protects me from relapse. Besides feeling better I will save $3,000 a year. Those two benefits are equally important.

Harsh regulation of ecigs is a threat to my health and an insult to my dignity.

Thank you
 
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pennysmalls

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So if vaping products can be sold as tobacco products only, not as cessation products, and a smoker asks a vape shop to help them figure out what device and liquid they should purchase that meets with the level of their current intake of tobacco how is that different than cessation? One can switch as long as it's considered not switching/ceasing smoking? There are no words for this level of stupidity.
 

Mike Abrams

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How is this any different than going to Walgreens and looking at the Nicoderm and saying which strength should I start with?!?


Sent from my Commodore 64 using Tapatalk

Difference is that Nicoderm is just a medication, whereas vaping is actually pleasurable due to taste, the process of hand and oral satisfaction, and yes- nicotine when included. The fun police, people with too much time on their hands, don't like something that resembles smoking, and has potential to be dangerous in the wrong hands..... e.g. people who don't know how to build safely, or use unregulated mods without referring to an ohm's law calculator.

Then there's the aspect of people going from analog smoking to an actual hobby with a degree of intentional complication, if you will. Even with more restrictive policies as to where one can smoke, cigarettes are still the most convenient guilty pleasure. All one needs to do is step outside and flick their bic. That's probably all the majority of Americans (smokers and non) need to understand. Not so easy to do that with a beer, gambling, or other common vices...... not to mention that there's a little maintenance on vaping equipment, as at a minimum, we need to add juice, change and prime prebuilt coils, charge and change batteries, and sometimes even disassemble and clean out our tanks. Imagine that..... could be too much for the common person. Can't stick your PV in the microwave...... it's more like real cooking. I bet most of us have several tanks, a variety of coils, more than one mod, several juices, and if they are serious enthusiasts, a good deal more.

Finally, many people don't want to see junior blowing clouds. My parents both smoked Reds before they finally reformed, and plenty of them. Let's say I was born 20 years later, and came home from college with a TFV4. Not sure what they would have done, but safe to say it would not have been pretty if I were blowing massive clouds in their house. I did not smoke in front of my folks, but being it was a smoking house, it was easy to do so in the basement late at night, or elsewhere when they were not home. Somehow the dog was very amused when he saw me smoke...... running around, wagging his tail. Not used to seeing me do this, he was a rebellious hound himself, and I think he enjoyed having a partner in crime.

Sorry for rambling, but vaping well turned out to be more complicated (and satisfying) than clicking a bic on a simple, mass-produced commodity. Probably too much for the brilliant people now influencing our government "healthcare" system. Then there's the easy barriers to entry--- we don't like that sort of thing here anymore, now that you need a license to get a license to do anything, plus I'm sure the gov't will soon also want to tax the hell out of vaping products, given they are "tobacco." Can't fix stupid!
 

sofarsogood

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I'm sure the gov't will soon also want to tax the hell out of vaping products, given they are "tobacco." Can't fix stupid!
And I'm certain the controling influence on all this is the money. There are two perspectives. There are government tax revenues and there is the lower cost for the consumer of vaping compared to smoking. I'm sure both perspectives are not as well understood as they need to be, especially the second one. Part of the "hobby" for me now is figuring out how to have a quality vape for the lowest possible cost and how to make it as easy as possible for most vapers to take advantage of that..
 

mcclintock

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    Reading this regulation (summary) was hard, but I managed to isolate the following:
    "FDA does not consider claims suggesting that a tobacco product provides an alternative way of obtaining the effects of nicotine, or that a tobacco product will provide the same effects as another tobacco product—such as “satisfying smoking alternative,” “provides all the pleasure of smoking,” “get your nicotine fix,” or “provides smokers the same delight, physical and emotional feelings”—to fall within its drug and device authority; however, we invite comment on this."

    This appears to contradict some of the alarmism in this thread. It's saying reasonable claims are not saying it's a drug, although it could still saying it's a MRTP. If they turn around and effectively ban the best of those in 3 months with a diff. rule, it doesn't help much.

    While I'm willing to submit a comment to the FDA, so far that's what I have. I'm beginning to get concerned that vapers could come off as hysterical in with unproductive comments. I'd rather see them do nothing too, hate to see it going official in any way, but this may not be the best channel to complain to that effect.
     
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    skoony

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    This appears to contradict some of the alarmism in this thread.
    I for one am alarmed. The FDA is suppressing truthful information. The reason they state one can't make health claims because
    that makes them cessation products is a canard. The real reason is to keep up the appearance that e-cigarettes
    are in need of regulation as they are as bad as cigarettes. It also gives them another nail to hammer. If Congress or the courts
    step in and mess with their deeming reg.s voiding that these are tobacco products they have the medical device route open.
    They may be playing both sides of the field to see who ante's up the most. BT or BP.
    :2c:
    Regards
    Mike
     

    JustJulie

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    Reading this regulation (summary) was hard, but I managed to isolate the following:
    "FDA does not consider claims suggesting that a tobacco product provides an alternative way of obtaining the effects of nicotine, or that a tobacco product will provide the same effects as another tobacco product—such as “satisfying smoking alternative,” “provides all the pleasure of smoking,” “get your nicotine fix,” or “provides smokers the same delight, physical and emotional feelings”—to fall within its drug and device authority; however, we invite comment on this."

    This appears to contradict some of the alarmism in this thread. It's saying reasonable claims are not saying it's a drug, although it could still saying it's a MRTP. If they turn around and effectively ban the best of those in 3 months with a diff. rule, it doesn't help much.

    While I'm willing to submit a comment to the FDA, so far that's what I have. I'm beginning to get concerned that vapers could come off as hysterical in with unproductive comments. I'd rather see them do nothing too, hate to see it going official in any way, but this may not be the best channel to complain to that effect.

    I've put the key point in your above quote in red type . . . they're inviting comment on it, and UCSF has already added their two cents: UCSF TCORS public comment to FDA on when tobacco products should be regulated as drugs/devices or by CTP | Center for Tobacco Control Research and Education

    FDA’s proposal does not go far enough; FDA should also consider claims suggesting that a tobacco product will provide the same “satisfaction” or nicotine hit as conventional cigarettes and/or provides an alternative way to get the same “pleasures of smoking” to fall within its drug and device authority.

    The last thing we want is for only the e-cigarette opponents to comment on that point. Moreover, it is troubling that FDA would even be inviting comment on that point. :(

    As for alarmist, I guess my position on this is perhaps a bit different. FDA has had every opportunity to get this right . . . to propose reasonable regulations regarding quality/production standards and other regulation that would genuinely benefit consumers but not decimate the diverse vapor industry. They have failed on every count.
     

    curiousJan

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    This proposed rule appears to me to be the FDA's regulatory attempt to reclassify ENDS as combination devices for delivery of nicotine as a drug. As much as I attempted to stay away from that aspect in my comment I'm not sure I was successful. I did, however, specifically call them to the mat for the attempt by referencing Sottera V. FDA.

    I can't figure out how to view the other comments to the rule. Is there a way to do so? Or does that have to wait until the comment period ends?
     

    JustJulie

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    The comment docket closed yesterday, but FDA has announced that it will re-open the public comment period in response to requests for more time to submit comments.

    We'll update our CTA when the docket reopens.

    *******************


    FDA to Reopen Public Comment Period for Proposed Rule Clarifying When Products Made or Derived From Tobacco Are Regulated as Drugs and/or Devices



    The comment period for the proposed rule entitled “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding Intended Uses,” closes today after a 60-day comment period from its initial publish date on September 25, 2015. In response to a request for more time to submit public comments, the FDA will be issuing a notice in the Federal Register re-opening the public comment period for the proposed rule.

    We will provide additional information, including the final due date for comments, when the Federal Register notice becomes available.
     

    JustJulie

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    We do indeed have 7,500+ testimonials now . . . well, we will once I finish approving the latest batch. And, yes, we intend to include a link to our Testimonials Project in our comment. (We opted to hold off filing our comment until the docket reopens . . . maybe by then, we'll have 10,000. :) )
     

    Robino1

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    We do indeed have 7,500+ testimonials now . . . well, we will once I finish approving the latest batch. And, yes, we intend to include a link to our Testimonials Project in our comment. (We opted to hold off filing our comment until the docket reopens . . . maybe by then, we'll have 10,000. :) )

    I'm really pulling for that 10,000!!! :D
     

    OldBatty

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    We do indeed have 7,500+ testimonials now . . . well, we will once I finish approving the latest batch. And, yes, we intend to include a link to our Testimonials Project in our comment. (We opted to hold off filing our comment until the docket reopens . . . maybe by then, we'll have 10,000. :) )

    What would be the best way to include my 79 year old father in-law's story? He has no computer and it was with my assistance he was able to quit after smoking for 65 years.

    You do not want my story:ohmy:
     
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    JustJulie

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    What would be the best way to include my 79 year old father in-law's story? He has no computer and it was with my assistance he was able to quit after smoking for 65 years.

    You do not want my story:ohmy:

    If you live near your father-in-law, why not get on the computer with him? You can help him submit his testimonial. In the alternative, you can share the story from your point of view, how you helped your father-in-law make the switch, including as many details as you are able about his past efforts.
     
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