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Thread: The FDA has a new boss & with him a new direction for the Deeming regs on vaping

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    The FDA has a new boss & with him a new direction for the Deeming regs on vaping

    FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

    The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.

    Tobacco use remains the leading cause of preventable disease and death in the United States, causing more than 480,000 deaths every single year. In addition to the devastating human toll caused mainly by cigarette smoking, tobacco also causes substantial financial costs to society, with direct health care and lost productivity costs totaling nearly $300 billion a year. A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.

    “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users,” said FDA Commissioner Scott Gottlieb, M.D. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”

    The FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. The agency intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. Because almost 90 percent of adult smokers started smoking before the age of 18 and nearly 2,500 youth smoke their first cigarette every day in the U.S., lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.

    “Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating, addiction crisis that is threatening American families,” said Commissioner Gottlieb. “Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly-regulated products. To be successful all of these steps must be done in concert and not in isolation.”

    The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes. To make this effort successful, the agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. For example, the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children’s exposure to liquid nicotine. It also will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.

    The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.

    Importantly, the anticipated new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly-regulated tobacco products such as cigars and e-cigarettes. This approach also will not apply to provisions of the final rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors. It also will not affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., "light," "low," or "mild," or similar descriptors.

    In order to further explore how best to protect public health in the evolving tobacco marketplace, the agency also will seek input from the public on a variety of significant topics, including approaches to regulating kid-appealing flavors in e-cigarettes and cigars. In particular, the FDA intends to issue ANPRMs to: 1) seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery; and 2) solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars, which were included in the FDA’s 2016 rule. Additionally, the agency plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.

    “This comprehensive plan and sweeping approach to tobacco and nicotine allows the FDA to apply the powerful tools given by Congress to achieve the most significant public health impact,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use.”

    To complement these larger policy considerations, the FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission. Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents.

    The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


    The main points as I see them are :
    1. PMTA date extended until Aug 2022, this means current products can be sold without any impact to vendors for another 5 years.
    2. "Grandfather" date unchanged, this means no new products are allowed to be sold but IMO this is not going to be widely enforced, already some vendors in the US sell prodocts made after the cut off date (New Chinese made tanks/atties/mods etc).
    3. Reduced nicotine cigarettes are a bad idea, this part of the plan should be scrapped. Nicotine is not the enemy, smoke is the enemy.
    Nicotine absobed through vaping is anecdotally less addictive, also a lot less harmful & most people that vape don't go back to smoking. So I hope they don't enforce nicotine strength limits on ejuice & allow it to continue with the strengths we have available now ie. as per the vendor's surrent line ups.

    Overall I like the new direction the FDA is taking, it is far more sensible - at least on face value, we can only hope that the PMTA process is made easier & cheaper for vendors than the previous FDA muddle would have been.
    Unfortunately points 2 & 3 above are a little negative, although if new atties & mods are allowed to be sold without enforcing the Grandfathering date, then it's business as usual for the next 5 years at least.
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    I'm really concerned about the "lowering nicotine" approach. It's already been shown to be a bad idea because smokers just smoke more to compensate. I think this shows a disconnect between yet another batch of ideologists and the real science.

    If they are going to attack the addictiveness of tobacco I don't understand why they don't make it illegal to treat tobacco with ammonia chemistry. I'm not convinced that this will not have the same effect of increasing smoking, but it would go much further to reducing the addictiveness of combustible products.

    We've known about ammonia chemistry since it blew up in the 90's, but they've done absolutely nothing to curb the practice: encouraging it by default.

    It looks damn stupid to me.

    Pushing back the PMTA process another four years is just avoiding the problem. By that time there will be a different administration in the whitehouse, and most likely a different head of the FDA appointed by them. I think it's a cop-out.
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    Chris: Tobacco free since 17:00 15th March 2013.

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    Quote Originally Posted by fabricator4 View Post
    I'm really concerned about the "lowering nicotine" approach. It's already been shown to be a bad idea because smokers just smoke more to compensate. I think this shows a disconnect between yet another batch of ideologists and the real science.

    If they are going to attack the addictiveness of tobacco I don't understand why they don't make it illegal to treat tobacco with ammonia chemistry. I'm not convinced that this will not have the same effect of increasing smoking, but it would go much further to reducing the addictiveness of combustible products.

    We've known about ammonia chemistry since it blew up in the 90's, but they've done absolutely nothing to curb the practice: encouraging it by default.

    It looks damn stupid to me.

    Pushing back the PMTA process another four years is just avoiding the problem. By that time there will be a different administration in the whitehouse, and most likely a different head of the FDA appointed by them. I think it's a cop-out.
    So if it went to 20mg/ml how mls are required in a 30ml rtv to acheive a 3mg nic level

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    Quote Originally Posted by JakeFloyd View Post
    So if it went to 20mg/ml how mls are required in a 30ml rtv to acheive a 3mg nic level
    5.3 ml, which might be too much dilution for some people, perfectly fine for others. It would probably be easier just to buy your RTV in 3mg/ml. For DIY at higher levels you would still have to import. At this point there is no reason to believe that importation would be banned any more than it is now - that's a whole 'nuther can of worms.
    Last edited by fabricator4; 29-07-17 at 12:14 PM.
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    Chris: Tobacco free since 17:00 15th March 2013.

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    Quote Originally Posted by fabricator4 View Post
    5.3 ml, which might be too much dilution for some people, perfectly fine for others. It would probably be easier just to buy your RTV in 3mg/ml. For DIY at higher levels you would still have to import. At this point there is no reason to believe that importation would banned any more than it is now - that's a whole 'nuther can of worms.
    Thank you for clearing that up

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    Quote Originally Posted by fabricator4 View Post
    5.3 ml, which might be too much dilution for some people, perfectly fine for others. It would probably be easier just to buy your RTV in 3mg/ml. For DIY at higher levels you would still have to import. At this point there is no reason to believe that importation would be banned any more than it is now - that's a whole 'nuther can of worms.
    Not much fun for nic lovers, 9mls of nic even for 6mg. in 30 mls. you would have to cut the nic down or go broke.
    I dont know why they dont omit the addictive additives in cigarettes either--it's all part of the lies the public gets fed.
    They dont care about Public Health, it's a secondary issue for the Politicians,
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    Back on the FDA situation, here's Dr F's take on it.
    FDA announcement: a policy change of endorsing harm reduction?
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    Chris: Tobacco free since 17:00 15th March 2013.

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    I'm not sure this FDA announcement is anything to jump up in glee about other than the $26 bil the tobacco industry lost on the stock market on Friday from the annoucement. I think their good intentions might be trying to come out, but their research and knowledge still stinks.

    Reducing nicotine in tobacco is not going to work. We all know smoking is not just about the nicotine. To get rid of something it's usually always replaced with something else and currently that seems to be vaping as it's the closest thing without most of the harmful affects. So it seems pretty clear the only way to get rid of smoking is to promote vaping and let it grow then smoking will run it's own course into its grave as BT reduce it's productivity due to lack of interest and make it unviable as a commodity. What needs to be done it to pressure the country's that have vaping banned to unban it, otherwise BT will continue their dirty work on those countries regardless. Especially third world, where smoking is climbing by the year.

    I'm personally sick of hearing about 'worrying about children'. This is a cop out. We already have provisions in place to reduce that risk. Some kids will always test control and therefore smoke or hopefully a better choice is vape. For them it's about education and like anything in this world kids need to know some things are adult behaviours and some are kid behaviours and vaping is adult behaviour, so can't do it as a kid. Like driving, drinking, sexting (as my daughter once called it) dating as examples. That's up to parents/educators to teach and parents to take responsibility for.

    Vaping also protects kids by their parents vaping instead of smoking and living longer to look after them.

    As for flavours, good grief! The flavours they have allowed into alcohol now and how they have allowed alcohol product to be produced, such as the new frozen Sorbet pouches https://www.google.com.au/search?q=S...w=1270&bih=827 is no different to e liquids in my opinion and a lot more harmful. So the only thing I see as needed here is a bit of common-sense on advertising and labelling rules.

    The way I see it, most governments and health bureaucrats are fighting 2 things with this. FEAR and GREED. As a trader I know the 2 things that will bring down any trader and most business' and governments is either/both fear and greed. I see the same thing happening with this issue in governments.

    Governments Fear: That they will be wrong again if legalising vaping. They have no idea where they can make up the tax $$ they will loose if all smokers eventually quit. They may also fear the amount of doctors/specialists and other health workers out of work if the nation gets healthier. 'How dare the nation gets healthier, we might have to spend more on the unemployed and pensioner's or, God forbid, education'. I'm sure there are a few other fears also, but I think you get the drift.

    Greed: They will loose $$ in taxes. and their own ego's won't allow them to change their view. And lets not forget, they also need to keep society in 'control'.

    Rant over:
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    Quote Originally Posted by Jemor View Post
    Greed: They will loose $$ in taxes. and their own ego's won't allow them to change their view. And lets not forget, they also need to keep society in 'control'.
    They also have to NOT tax vaping to make it much more attractive to smokers. That may be the hard bit for them if they do legalise it. Don't treat it like tobacco and keep their grubby paws off it so that smokers will see it as a much more attractive alternative. Even if it encourages smokers to just try it, we know that it can be the first step to kicking the habit. I think what we'll see in the UK where the govt. is actually encouraging it is that in a few years time they are going to be making huge inroads into the numbers of full time smokers over there. UK smoking rates are set to dip below the Australian rate for the first time ever, and that's happening right now.


    ETA: Bad grammar LOL. I tend to get a bit incoherent when I get stirred up
    Last edited by fabricator4; 01-08-17 at 05:27 PM.
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    PMSL Let us hope and pray that the new boss of the FDA lasts longer than any of Donald Trumps people, they seem to have a revolving door.

 

 
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