FDA Pushes Back 2018 PMTA Deadline to 2022

This is big! Very Big!

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm?utm_source=SFATA+Industry+News+and+Updates&utm_campaign=20fe21d859-EMAIL_CAMPAIGN_2017_07_20&utm_medium=email&utm_term=0_bf36667471-20fe21d859-114819645&mc_cid=20fe21d859&mc_eid=d6009ec24e

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I’m not going to let myself get dragged into my issues with the science here because I’m in a pitiful political minority – but I can at least cheer that they’re caving to purely economic pressure.

Seriously, the FDA is a freaking disgraceful unscientific. . .nope, not going there. Just enjoy the victory man, enjoy the victory.

Also, key point from that press release is that they’re focusing on less dangerous applications of nicotine as the key addictive feature, and moving away from cigarettes. I’ve basically accepted cigarettes will eventually be outlawed or be so vilified even I will no longer be comfortable doing it outside the home, so it’s good that they’re entertaining alternatives without the eh. . .what’s that legal phrase used for illegally obtained evidence, something about a tainted apple probably. >.>

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The FDA needs shut down period.

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Eh. …that could be, just, so bad. The FDA is why we don’t have 50000 types of 80% alcohol tonics with maybe a dash of mercury or opium or laudanum or some shit that ‘cure’ like, everything. Emm, anymore. We used to.

The FDA is bad because it refuses to do it’s job, instead being controlled by the corporations and interests it’s meant to manage. But a dysfunctional agency is better than none at all, kinda like street police really – look at what happens every time a police force goes on strike, utter mayhem.

This is one of those cases I could go for “repeal and replace” – but realistically it’d be easier to reform.

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LOL Fruit of the poisonous tree doctrine, Doesn’t mean much to government, law enforcement or courts much anymore. Have not heard that in a long long time.

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That’s the bunny!

And yeah, post 9/11 … well, post Rico. …and War on Drugs. . .dude the 4th Amendment has been going to shit since 1910 with the beginning of the Red Scare.

On the other hand the First Amendment is in it’s hayday since they’ve settled on prohibiting the positive right thru corporate media control rather than limiting the negative right thru libel and sedition laws and literal censors – seriously, just read a book from 1930 summarising the 1920s and, you forget how much power the censors had over culture. …until they didn’t, Youth Culture FTW!. . .says the guy nearing 30 >.>

Yeah, this conversation is going to get SUPER freaking nerdy if we actually get into all of that. But in short, yes, the 4th Amendment has been battered to shit.

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I’m going to choose to look at the opportunities. This is an opportunity for vapers to build their case and grow in numbers. This is an opportunity for manufacturers to take some time in development and put out quality products. This is an opportunity for us to address issues like batteries and develop infrastructure.

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I say, remove all warning labels, repeal and never replace a thing. Anything more needed is just weak and useless except under a small fractional circumstance where the latter cannot be helped. BTW, The FDA helps us about as much as the IRS both holding powers that should never have been granted.

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The power to tax shouldn’t exist?

Look, if you’re an anarchist, fine, whatever. But if you just start destroying individual parts of the government, a lot of people are going to die. It happens every time we get rid of a class of so-called ‘regulations’ (protections). If you have good arguments I’m all ears, but you’re not sounding at all rational. I’d want to start from knowing how it is you think the FDA actually works – what it’s powers are, what it’s purpose is, what the effects are, where the corruption actually comes into play, what incentives support that, and then why in the hell would we be better off without an FDA. Because before we had the FDA people were selling rotten, sometimes lethal, meat. They sold opium as a painkiller for kids. Truth in advertising did not exist, the culture was 100% Caveat Emptor at the time and getting totally and royally screwed by fraud was considered to simply be your fault. It was cutthroat, destructive, dangerous, and totally screwed us on international trade – the last of which was probably the most important economic reason to start restricting business and protecting customers, but of course there were large popular movements from time to time, often Christian lead, shifting the morality more in favor of the whole love thy neighbor thing.

I find the core science the FDA uses for medicine insufficient (5% chance of randomness and no flat requirements for medication other than better than placebo), tho I understand the issue of speeding things to market and how we’ve benefited from the speed of medical breakthrus thereby, but we’ve also got a hell of a lot of medicines we have no idea what even do except in theory. But the core corruption and problems are only in big, big money things and generally show up as protectionist stances and annoying conservatism (to, completely negate my first point >.>)

The obvious example is tobacco, just in general, they seem to always be on the wrong side of things. But my main concern is 100% patents. Patents can be great, but they can also be extortionist. Big Pharma lands firmly in extortionist territory.

I don’t really have issues with the Food part of the FDA tho. There’s some stuff with the Nutrition pyramid, corn subsidies and support, etc. . .but in general the Food part is neither really the FDA’s fault, nor half so serious as the pharma issue.

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Whatever we all think of the FDA, this is good news, let’s celebrate it!

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I bought something from Nic River yesterday, let’s call that my precognitive celebration.

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I agree this is good news but be warned… as I stated in another post it looks like the emediate focus is on nicotine reduction… it seems they are making nicotine out to be just as bad as the other crap in actual cigs… saying Nicotine is the main addictive substance and talking about nicotine reduction… well they may decide to ban/ lower available nic and that can be done before the proposed deadlines… I have to search for it but someone on here has already commented about how the alphabet squads can reclassify a substance and shut it down with in days if they so choose… better safe than sorry is my honest opinion stock up if you need/want nic

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I have no problem admitting if I’m wrong about that, but that is my take on what was recently released… at least that is my take on the two articles I have read today while “working” at my desk at work lol

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I own and operate a medical clinic and I know these days that people don’t rely on the FDA for safety because the have to sue to get that. All the FDA really does today is rubber stamp medicines for big pharma all the while hiding clinical trials or worse, faking the data. Although I do think some rules need to be in place, I only believe the FDA makes up their own as they go.

As far as regulations, I could live without them but if you need them, I’d say right now we are heavily over regulated from all sides. If you don’t see it, you have never ran a business. Regulation kills just as hard or harder as not having it from where I see the truth of it all. The FDA and Big Pharma are both huge and corrupt groups and I’ll be the first to tell you, “They don’t give a damn about you or you’re family or how many people die from the poison they rubber stamp into the market every year.” It’s all common sense and all you have to do is pick a story to read, there are plenty.

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I don’t disagree with any of your premises except one - -you get rid of the FDA and it goes back to pure market forces, pure market forces, with the power of Corporations today, means nobody but the big corporations will have any say whatever in what happens. That is my point, you remove the FDA, which is a (weak) secondary source of power and everything goes to the corporations. Moreover, the owners of corporations are aware of this, that’s why we HAVE things like the FDA, business tycoons understand that pure free-market capitalism leads to. . .suicide basically. And with the power of any one of the Fortune 500 companies? Global suicide.

No, the FDA is not good, my first post was I hate them – but getting rid of the one thing giving you any of the protections you want, including the ability for a small business to exist at all (tho true small businesses died in the 60s, what we call small businesses today are the older idea of firms and corporations) – that’s just absolutely insane, and dangerous.

Ask yourself this: What is the first thing Gilead Sciences does when the FDA disappears? I can thing of a handful of good first steps, and they’re large enough to do all of them concurrently, and the result would be a flood of both medications that really do help people, and medications that kill people, buying out anyone and everyone they can that competes, a total gear shift in marketing, expanded bribery of doctors and pharmacists (already thru the roof), and much, mcuh more.

Every single thing you mean by “it’s all common sense” get’s dramatically worse, within a few weeks, if you take away the FDA.

If you want to make the world a better, saner, place – you have to know wtf you’re talking about, and I mean consider all sides of the problem, not just your own. You only mention what regulations are in your way, not why they’re there, what their knock-ons are, or most importantly – you aren’t even considering what actually happens without an FDA NOW, what would happen if we had never had one in the first place is immaterial even if you were right (and you’re not). Right now we have an FDA, and it exists for a reason, and the corruption is built-in to the incentives system. You can change the incentives system if you can get the people mobilized against, let’s start with Citizen’s United is my suggestion – but again, and I cannot stress this enough – removing regulatory bodies takes us back to the 19th century, where workers and customers routinely died because of corporate actions – you can’t even call it greed because that’s just fucking redundant. Sure, you can point to crap like Flint today, but is the solution to allow EVERY county to pull that shit? Hell no, it’s to fix what’s broken in their politics, and here in at least three towns in Texas, and everywhere else.

The solution to corporate power enslaving people is to take away corporate power, or at least constrain it – constraining or eliminating the only current power that can stand, if not equal, on the same field as them is, once again, bonkers.

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You must me one of those Millennial, “I’m right and you’re wrong, my way or the highway types.” That will get you far. I’m certain something needs changing and being a smart ass is a good start. Hey, how bout we mix for it, LOL.

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In a surprising turn of events…

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@AuraBorealis Thank you for posting.

If anyone wants to watch he is live now talking about the FDA

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Just for my own amusement I edited through the statement from the FDA and took out all the ‘fluff’… I admit what follows is viciously edited and is the classic “taking statements out of context” BUT, if you look at it honestly, this IS what they wrote. All of us must determine for ourselves what we think (or make a best guess…) what the next moves will. be.

For myself, as I have stated in other posts of mine, I have very little confidence in Federal (or State for that matter) agencies to act responsibly. One of the big tip offs for me is the statement about their planned use of Advance Notice of Proposed Rulemaking "… I have a personal historical perspective. In the industry I spent 35 years in the ATF and the DOT were experts at manipulating the spirit of Public input during those types of proceedings, the only reason they held them at all was becace the old Administrative Procedures Act (enacted June 11, 1946,) requires it. Once they bust by that legal hurdle then very little is on the books, legally speaking, that can reign them in.

Here is my super-edited boiled down “concentrate”

.…The U.S. Food and Drug Administration today announced a new comprehensive plan for (…) nicotine regulation that will serve as (…)roadmap… … The approach places nicotine, (…) at the center of the agency’s (…) efforts.
_ … A key piece of the FDA’s approach is demonstrating (…) that nicotine –(…) represent(s) a continuum of risk…_
…nicotine lives at the core of both the problem and the solution…(so therefore) Our approach to nicotine must be accompanied by a firm foundation of rules and standards (…) the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (…) The agency plans to issue this guidance describing a new enforcement policy shortly. (…) “This comprehensive plan and sweeping approach to (…) nicotine allows the FDA to apply the powerful tools given by Congress to achieve the most significant public health impact,”

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