FDA Pushes Back 2018 PMTA Deadline to 2022

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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Fine work mate. The same stuff stood out to me on my flip-thru, and on its own this release is very promising. I’m not really kept up on this topic tho, except I know from experience elsewhere never to get too hopeful just because a paper sounds good XD.

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Here is the quote that I see as a sign of hope.

"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.”

FDA Commissioner Scott Gottlieb, M.D.

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louiesquared6h
Here is the quote that I see as a sign of hope.

"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.”

FDA Commissioner Scott Gottlieb, M.D.

I too would also like to take hope in Gottlieb statements, but first you should read that last actual ‘deeming rule’ as published. The last step in the Administrative Procedure that gives the bureaucracy rules the force of law is to publish that rule in the Federal Register. This can only occur after the public comment period. In the following published ‘deeming rules’ you can get a glimpse of the clever shuck and jive dance of the FDA when responding to the comments. Phase two of these rule set is, for sure, going to be control of nicotine, as this is the thrust of Gottliebs statements so far.

(warning! before you click the document link:
it contains extreme legaleze and high shuck and jive BS factor!)

Federal Register Published FDA deeming rules.

I think Gottlieb is a pretty good salesman. He may even have his heart in the right place. But the huge FDA and its long term agenda will just, eventually, roll over him. He is here today, but probably will be gone tomorrow.

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I was just about to post this same link.
All opinions aside. This is a great opportunity for us all to grow stronger and keep vaping alive. Some one up in the stratosphere is voting for vaping. Testify!! :japanese_ogre::fist:

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Speech by Dr. Scott Gottlieb, FDS Commissioner, yesterday July 28, 2017

https://www.fda.gov/NewsEvents/Speeches/ucm569024.htm

Sounds to me like he has good intentions. He has acknowledged just how hard it is for an adult smoker to quit and seems as if he is open to exploring vaping as a legitimate alternative to other methods that are currently available to quit smoking. Or it could be that he is just a good salesman as @50YearsOfCigars has stated!

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This is definitely a win. As Tom Howard put it in MyVaporium’s Zoom room last night "This is vaping’s Gettysburg" -Tom Howard/2017

This battle is won but not the war. This announcement is a sign that people in and out of the vaping community need to start pushing harder to making sure the public knows that this is “harm reduction” and a safer alternative to traditional cigarettes.

Live Video Feed: FDA Announces Regulatory Plan to Shift Trajectory of Tobacco-related Disease and Death -
** USFoodandDrugAdmin**

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This is definitely a win. As Tom Howard put it in MyVaporium’s Zoom room last night “This is vaping’s Gettysburg” -Tom Howard/2017

Before everyone gets in the ‘fan-boy mode’ about Gottlieb, you might want to do a:
Google Search for “scott gottlieb conflicts of interest”

You will come up with hundred of links that might cool off your fan-boy rally cap !

I think the drill will go like this:

1.) FDA promulgates new ‘nicotine’ rules that make it a classified drug in the context of a newly created and highly tailored schedule with very specific regulation to nicotine so that it can tailor the use of the newly classified drug in very specific and ways unheard of previously for other drug classification. This would allow the FDA to, on the fly, take nicotine out of certain uses, out of certain delivery systems, but selectively include it in others.

2.) This ‘other delivery systems’ will be for sure Big Pharma patches and delivery systems engineered and manufactured, patented, and advertised and sold by Big Pharma which might also be allowed to have as a newly approved delivery system’ certain ’vaping like devices’. Big Pharms would get approvals but of course, Joyetech, or Svoe Mesto, or Geek Vape might not make the approval because they are not meeting the newly promulgated regulation that now requires ‘drug trial like’ testing. The Big Pharma companies could ‘hit the ground running’ with such new regs because they have already existing infrastructure to do this type of compliance testing. Dr. Richard Friedman, a clinical trial expert and professor of clinical psychiatry at Weill Cornell Medical College said it was “alarming” to hear Gottlieb’s positions, adding that “it would put the public at serious potential risk, elevating the financial interests of the drug companies over public health.”

One of the links from the Google Search, turned up the following: Please do your own search and spend a few minutes reading the results:

188 Companies: New Enterprise Associates, the venture capital firm where Gottlieb is a partner, is currently or has been invested in 188 health care companies.

8 Boards of Directors: Gottlieb serves or served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.

8 Drug and Device Companies: Eight pharmaceutical companies disclosed payments to Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco and London.

9 Recusals: In a memo, Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche and Sanofi-Aventis.

The recusals generated some headlines during the avian flu scare because Gottlieb had to recuse himself from some of the planning efforts around vaccines.

Gottlieb also spent the past seven years as an adviser to drugmaker GlaxoSmithKline’s product investment board, according to his LinkedIn page.

when Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier, but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.

$414,000: Pharmaceutical companies paid Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel and meals. That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco. Only one other doctor received more money toward promoting the drug. The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.

Nearly $30,000: Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.

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Thank you for doing that!! That is exactly how I was reading it and what I have been saying the last few days lol stock up on nic just in case… they can put in regulations for that pretty quick if they so choose

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While this sudden turn of events is certainly a shift to the positive, I’m going to keep my celebrations on a leash. If this showed us one thing, it’s how quickly the FDA can change course. Things could change again, just as suddenly, and the pendulum swing back in the other direction.

Sign me,
Cautiously optimistic, and still stocked up.

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LOL. I’m not “fan boying” and I’ve done my own reading and research - I’m well aware of the power of Google, and have read comments and articles from the FDA, CASAA, & American Vaping Association, listened to Podcasts, etc.

I’m well aware of Gottlieb’s conflicts of interests, however it does not change my standing on what this announcement means to me. I have commented on this topic not just on this thread but on other threads regarding this topic on ELR. You might want to do your OWN search on my previous comments on ELR regarding the FDA announcements before you come up in this thread with your chest up and your chin high.

Thanks for the Google Search though. I know it was hard work.

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Leilani16m 50YearsOfCigars
LOL. I’m not “fan boying” and I’ve done my own reading and research -
(…)what this announcement means to me. …(…) before you come up in this thread with your chest up and your chin high.

Leilani:

Please do not take my comments as directed at you personally… I am just trying to present a viewpoint from “the other side” I should have just posted my comment as a general reply to the topic and not as a reply to your post. For any offense this might have created i apologize.

A healthy debate on this topic is good for everyone concerned. You have your viewpoint as to “what the comments mean to you”, and I also have a point of view, which, in this case is very different from yours. . The meaning I derive from all this activity at the FDA and their obvious interest in recently vigorously exercising the Administrative Procedures Act is a red warning flag to be careful. Troubled waters and storm clouds ahead!

I am just trying to present a balanced point of view. Many vapers and people reading this and other forum may be younger than I and have had no specific experience in how the Federal Agencies proceed. Unfortunately, I have suffered through 35 years of this type of thing.

You know, the verb “to deem” is an interesting turn of phrase, that shows up in legal-speak in many Federal Agencies now. I always think of the definition by example that my grade school teacher told us: An all powerful King sits on his throne of Gold and waves his jewel incrusted scepter in the air with a sweeping motion and declares 'I now DEEM that all lowly serfs in my Kingdom will do as I instruct and command…"

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Got it. No problems man. I understand both sides of the table and I understand your viewpoint. Thank you for clarifying. :+1:

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I’m not sure if anyone linked the NBC News version of the story or not. A bit more mainstream, as far as reaching the ignorant ones, constantly swayed by the fake news of years past :slight_smile:

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Whatever it takes to sell a Cok-A-Cola!

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