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Juul is going to be in a hard spot to ever get their product approved

Discussion in 'FDA Regulations' started by Rossum, Jun 21, 2019.

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  1. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    Over and over I've said I wish ecigs were around when I was a kid. Freaking out about the kids is short sighted. But if pods were unavialable to kids how many of them would go for the bigger traditional systems. May be size matters?
     
    • Creative Creative x 1
  2. marianna

    marianna Senior Member ECF Veteran

    Jun 30, 2012
    Netherlands
    I think that's correct: suicide pills like Chantix / Champix make orphans
     
    • Like Like x 3
  3. nomore stinkies

    nomore stinkies Gee, Who did that? ECF Veteran

    Feb 23, 2014
    IL
    I've been off this site for awhile and am trying to get a handle on the current regs. Not sure what your comment selling in US market but not manufacturing means. So they cant sell it in the US if they mfr it in US but it can be sold in the US if it comes offshore? I need guidance here. I see it is still a mess. Thanks
     
  4. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    The way I understand things is US manufacturers can make their products but not for sale in the US. How hard will the FDA try to interfere with off shore mail order? Will the FDA interfere wiith access to concentrated nic? I rarely go to vape shops but the last time I did they all seemed to be selling (see be dee) CBD? Is that s they can say their vape gear is sold for that purpose so the FDA nic rules don't apply?
     
    • Like Like x 1
  5. nomore stinkies

    nomore stinkies Gee, Who did that? ECF Veteran

    Feb 23, 2014
    IL
    Well they havent changed have they? Are the PMTA applications still as complicated as first introduced? Probably. But if one submits a PMTA then the deadline does not apply if the FDA hasn't reviewed it? Sorry for all the questions. So I should load up again correct? Government. Jeez
     
  6. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    Yes, they're as complicated as ever. One problem is the FDA hasn't clearly stated everything that's required, and they keep changing some things they have stated, like the list of potentially harmful things in vapor that an applicant is supposed to test for!

    Sort of. The Deeming specifically states that submitting a PMTA gets the applicant an additional year on the market while the FDA reviews the application. This is interesting because the Tobacco Control Act, which what gave the FDA got statutory authority to do any of this specifically requires them to complete these reviews within six months. Yet the only PMTAs that have ever been approved (Swedish Match snus and IQOS) took more like two years.

    If I were a betting man, I'd say it will take several years for any PMTA to be approved, but the FDA won't enforce against a vendor for however long it takes to review their application(s).

    If I weren't fully stocked already, I certainly would. :)
     
    • Useful Useful x 1
  7. nomore stinkies

    nomore stinkies Gee, Who did that? ECF Veteran

    Feb 23, 2014
    IL
    Wow. Thank you for the info. So when is the deadline? Any idea of companies that filed? I'm just trying to catch up.
     
  8. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    The deadline is currently May 11, 2020. I do not think anyone has filed yet. If you file and the FDA rejects your application, your product is off the market immediately, so better to wait until the last minute.
     
    • Like Like x 1
  9. nomore stinkies

    nomore stinkies Gee, Who did that? ECF Veteran

    Feb 23, 2014
    IL
    Makes sense...waiting to submit that is. But they are open and selling until they pass or fail. Thank you it's easier to ask someone who has been following than going through all the threads.
     
  10. Sugar_and_Spice

    Sugar_and_Spice ECF Guru Verified Member ECF Veteran

    Supporting member
    Sep 11, 2010
    between here and there
    Have you seen this yet?
    FDA’s Center for Tobacco Products: 10 Years of Tobacco Regulatory Science and Research

    Had not seen this posted anywhere yet. Seems that FDA is covering their bottoms
    directed towards the new lawsuit filed lately.
     
  11. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    My browser does not like that link at all. Seems to be some kind of tracker:
    http://s2027422842.t.en25.com/e/es?s=2027422842&e=245685&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=b4be5c8317e44e92a41ab2caffe2cfd6&elqaid=9161&elqat=1
     
    • Agree Agree x 1
  12. somdcomputerguy

    somdcomputerguy vaper dedicato Verified Member ECF Veteran

    Supporting member
    • Agree Agree x 2
  13. Sugar_and_Spice

    Sugar_and_Spice ECF Guru Verified Member ECF Veteran

    Supporting member
    Sep 11, 2010
    between here and there
    Sry everyone. Let me get the url correct.
     
  14. Sugar_and_Spice

    Sugar_and_Spice ECF Guru Verified Member ECF Veteran

    Supporting member
    Sep 11, 2010
    between here and there
    Still working on it. Here is another one i found interesting.
    PATH Study Findings on Flavors and E-Cig Health Effects


    Since it was sent as an email, I was not able to find it on the website.. Here is a copy/paste of it.

    FDA’s Center for Tobacco Products: 10 Years of Tobacco Regulatory Science and Research
    In 2009, FDA’s Center for Tobacco Products was formed with the mission to reduce disease and death from tobacco use through science-based regulation.

    And science is the foundation of all that we do.

    FDA regulates products in a complex and changing tobacco landscape, one where products reside on a continuum of risk with deadly combustible products on one end and effective medicines and treatments on the other. New and novel products have entered the marketplace over the last decade, many with unknown longer-term effects on the overall, population-level health of U.S. residents.
    To help FDA regulate tobacco products most effectively and ensure maximum benefit to public health, the agency funds research in critical areas of tobacco science. In 2011, together with NIH, FDA launched the Population Assessment of Tobacco and Health (PATH) Study . This long-term, ongoing study follows about 46,000 adults and teens over time, helping scientists learn how and why people start using tobacco, quit using it, and start using it again after they’ve quit. This important study offers unique insights into, among other things, youth use of flavored tobacco products, the health effects of e-cigarettes, and adult use of cigars and hookah.

    The National Youth Tobacco Survey (NYTS), funded by FDA and CDC, tracks use of tobacco products among U.S. middle and high school students. It offers key information on which tobacco products youth are most commonly using, how often they are using them, and patterns of using multiple products. Data from the 2018 NYTS revealed that e-cigarette use increased by 78 percent among high school students and 48 percent among middle school students from 2017 to 2018.
    In 2013, in an effort to expand its knowledge base and support research pertinent to tobacco product regulation, FDA partnered with NIH to award grant funding to 14 institutions throughout the country to study areas of tobacco science that are crucial to informing FDA’s ongoing and future regulatory activities. This program, known as Tobacco Centers of Regulatory Science (TCORS), has funded more than 500 research projects and produced more than 800 publications to date. CTP awarded nine more grants in 2018 to fund further research on topics such as toxicity of tobacco smoke and aerosol, addiction, and the influences of tobacco marketing. You can find new video interviews of some of these researchers describing their projects, expressing why regulatory science is so important to public health and why it matters to them.

    TCORS, PATH, and NYTS are just three examples of the research that helps FDA make important decisions regarding tobacco product regulation. The collective research done by FDA scientists and collaborators inform all areas of FDA’s regulatory actions, including proposed and final rules, industry guidance, tobacco product marketing application reviews, marketing guidelines for manufacturers, and public health education campaigns.
    Science is at the heart of a groundbreaking advance notice of proposed rulemaking that FDA published in March 2018 about a potential regulation to lower nicotine levels in combusted cigarettes to minimally addictive or non-addictive levels . FDA is relying on research to determine the appropriate maximum level of nicotine for this regulation. Relevant research helps us understand how a low-nicotine cigarette would make it easier for currently addicted smokers to quit, would not pose a risk for youth who experiment with cigarettes to become addicted, and would not lead to unintended consequences (such as causing people to smoke more cigarettes).

    Research is critical, as well, to CTP’s work in educating the public about the dangers associated with using cigarettes and other tobacco products: on Aug.15, 2019, FDA issued a proposed rule to require new cigarette health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking. The proposed warnings, which feature photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, stand to represent the most significant change to cigarette labels in 35 years. Health warnings first appeared on cigarette packages in 1966 and were most recently updated in 1984 to include the Surgeon General’s warnings that appear on packages and in advertisements today. However, research found that these warnings have become virtually invisible to both smokers and nonsmokers. Additionally, research shows substantial gaps remain in the public’s knowledge of the harms of smoking. To address these gaps in public understanding, FDA undertook a science-based approach to develop and evaluate the 13 new proposed cigarette health warnings. These warnings focus on serious health risks – such as bladder cancer, diabetes, erectile disfunction and conditions that can cause blindness – that are less known by the public to be caused by smoking.
    Science serves as the roadmap for how we review new products before they may come to market. In fact, science plays a role in FDA decisions regarding the manufacturing, distribution, and sale of tobacco products. When manufacturers want to market a tobacco product, they must submit an application to market their product. The applications types are:

    Each application to market a tobacco product goes through a rigorous scientific review process to ensure the product meets the legal standards required for each marketing order. The premarket tobacco product application (PMTA) process is the most rigorous, since it involves bringing a new tobacco product to market that is not substantially equivalent to any product already sold in the U.S. To provide additional information to industry and the public about the PMTA process, FDA finalized a PMTA guidance for manufacturers of electronic nicotine delivery systems in June 2019. FDA has also published several guidances to explain the agency’s current thinking about substantial equivalence reports.
    FDA also uses a science-based approach to review tobacco products that may pose reduced risk or harm. To make these claims, a manufacturer must submit a “modified risk” tobacco product (MRTP) application, providing scientific evidence that marketing the product will reduce harm and risk for the U.S. population as a whole, including users and non-users of tobacco. To date, no product has met the scientific standard to be marketed as a MRTP.

    Another way in which science informs FDA’s efforts to help keep the public safe from the harms of tobacco use is by informing the agency’s public health education campaigns. FDA’s tobacco prevention campaigns for youth and young adults, as well as its adult smoking cessation campaign, undergo extensive scientific research into the perceptions, beliefs, and behaviors of each target audience before the campaign is tested and launched. Once a campaign has launched and its target audience has been exposed to its messaging, it is then evaluated for its effectiveness in meeting its messaging and education goals. FDA’s “The Real Cost ” youth tobacco prevention campaign, which was launched in 2014, was found to have prevented 350,000 kids from starting to smoke cigarettes from 2014 to 2016, ultimately saving these youth, their families, and society more than $31 billion in smoking-related costs like early loss of life, lost wages, costly medical care, lower productivity, and increased disability.

    With each year, FDA’s science and research base gets more robust, providing the building blocks for a comprehensive tobacco regulation program aimed at protecting the health of the public from the harms of tobacco use.
     
    • Informative Informative x 2
  15. susieqz

    susieqz Super Member ECF Veteran

    Dec 11, 2018
    high plains
    you guys forget how much the govt is dependent on tobacco.
    the social security system is in big trouble that pols can't fix.
    benefits can;t be touched,
    if everyone switches to vaping, the actuarial tables will have to be redone.
    it's important that a certain amount of people die every year,
    vapers will stress the system too much.
     
  16. Sugar_and_Spice

    Sugar_and_Spice ECF Guru Verified Member ECF Veteran

    Supporting member
    Sep 11, 2010
    between here and there
    We are totally aware of it.
     
  17. marianna

    marianna Senior Member ECF Veteran

    Jun 30, 2012
    Netherlands
    Perhaps you can write a letter to president Trump ?
     
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