Tag Archives: Challenge

Coordination with the FDA: Hartland, Wisconsin Holds Public Hearings

fraud

Imagine

Imagine for a moment that the Food and Drug Administration (FDA) has overstepped their authority in “deeming” anything to do with e-cigarettes.

Imagine there’s a little-known process used to challenge regulations imposed when the federal authority, by law, did not coordinate with state and local municipalities.

Now, imagine there’s a small town in the United States willing to take it upon themselves to challenge the authority having jurisdiction over these regulations.

Imagine.


The Village of Hartland, Wisconsin has done just that. They have hosted three days of public hearings and testimony of what is called “coordination” with Hearing Officer Fred Kelly Grant, Esq. at the helm.

The Electronic Vaping Coalition of America (EVCA) has explained what “coordination” is here.

WHAT IS “COORDINATION” IN FEDERAL LAW?


Three days of testimony

Testimony in Hartland was presented by Cory Winston, Azim Chowdhury, Shaun Casey, Antonio Lauria, Lou Ritter, Jeff Stier, Aaron Biebert, Johnson Creek Vapor Company, Bill Godshall and more.


Thursday, April 27th, 2017


Friday, April 28th, 2017


Saturday, April 29th, 2017



MONDAY, May 1st, 2017:

The decision is in:




THIS is how you can fight.

Via EVCA, the funding to FIGHT the FDA with this board if it goes to court:

Next Steps After FDA Coordination Hearing

Added 5/13/17

 



Imagine

Imagine the businesses who are going out of business.

Imagine the health implications of the imposed regulations by the FDA and the organizations who have supported them.

Imagine the person who walks into a vape shop and can’t be helped properly, if the vape shop will even exist within the next year.

Now imagine taking the time to listen, to ask questions, stand UP, question the lack of integrity and frankly, DO something.

Imagine saying enough is enough.


If the videos below do not play, you can access them here:


Related:

This article from Kathy Hoekstra:

Small-town America takes on FDA over e-cigarette regulations


WHILE this challenge is ongoing, it is imperative in the United States to visit CASAA:

First, the Cole-Bishop bill, (H.R. 1136) via CASAA

Out of the budget but, still in the fight!


Meanwhile

Duncan Hunter (R,CA)  has introduced one of his own, taking tobacco OUT of the description completely.
From my friend, Daniel Hall of Guide To Vaping:
Also From Mr. Hall: (added 5/2/17)


NEWS from my friends across the pond: Vapers.org.uk.

You can find me here trying to be cordial on Facebook

You can find me here being a bit more evil on Twitter

You can also find me on LinkedIn

You can follow me on this blog!


Medical, Research, Science Professionals:

Research:


Politics:

E-Cigarette Politics 


Your comments are NEVER filtered, always encouraged and welcome on this blog.

More to come.

Keep ON #Vaping On.

Kevin

Save

Save

Save

Save

Nicotine Addiction: An Open 30-Day Public Health Challenge

nicotine

Foreword:

For decades, Public Health, Tobacco Control, and Government experts have agreed in unison, that nicotine is the addictive chemical in cigarettes with comparisons and statements that nicotine is as or more addictive than heroin.

This “Public Health Challenge” is to show scientific proof that the assertions of addiction are true.


I have decided to put (our) money where your assertions are by taking you, the health, tobacco control, science and research communities, to literal task on nicotine addiction.

This is a 30-day challenge for anyone in public health to show nicotine addiction in humans, without MAOI’S, ammonia, or any other non-nicotine additive or any form of tobacco, without question.

You don’t need to prove me wrong, you need to prove yourselves right.

That’s it.


Nicotine Addiction

An Open 30-Day Public Health Challenge:

Addiction to a habit-forming substance is defined by Merriam-Webster:

Medical Definition of addiction

  1. :  compulsive physiological need for and use of a habit-forming substance (as heroin, nicotine, or alcohol) characterized by tolerance and by well-defined physiological symptoms upon withdrawal; broadly: persistent compulsive use of a substance known by the user to be physically, psychologically, or socially harmful [emphasis added.]


Criteria:

To show proof of nicotine addiction with existing clinical trials, case studies, data, and scientific documentation of addiction to nicotine alone, without any form of tobacco or Monoamine oxidase inhibitors (MAOI’S), ammonia, or any other non-nicotine additive, in humans.

Documentation submitted (either as a text file or in the form of a web link) must be accessible and not be behind a “paywall”.


Documentation:

Unacceptable documentation:

  • Animal studies (rats, mice, monkeys, etc.) are not acceptable.
  • Submissions not published in professional or scientific journals or government websites are not acceptable.
  • Anything inaccessible by the public, including “paywalls” via the internet, are not acceptable.
  • Oral presentations, press releases are not acceptable.
  • Existing clinical trials, case studies, data, in vitro studies, self-reported surveys and scientific documentation in humans that claim probabilities or hypothetical possibilities as they do not show nicotine “is” addictive and are not acceptable.
  • Existing clinical trials, case studies, data, in vitro studies, self-reported surveys, and scientific documentation cannot include words and phrases like “hand to mouth, dependent, habitual, ritualistic” or words like “can, conceivably, could, likely, may, might, perhaps, possible, possibly, possibility, probably, probability” and cannot include tobacco or MAOI’s, ammonia, or any other non-nicotine additive for this challenge.

Acceptable Documentation:

  • Documentation must be accessible to the public.
  • Documentation must show the acceptable definition of addiction in existing clinical trials, case studies, data, or science and include characteristics of addiction such as increased tolerance, and withdrawal symptoms of nicotine alone, in humans, without any form of tobacco or MAOI’s, ammonia, or any other non-nicotine additive.
  • Documentation showing addiction in clinical trials or case studies with 3% or 2 subjects, whichever is greater.
  • Documentation must include a clear description of methodologies and results.
  • Peer-reviewed submissions must include names and affiliations of reviewers.

Documentation submitted (either as a text file or in the form of a web link) must be accessible and not be behind a “paywall”.

Documentation submitted must also include proof of existence with at least three of the following compulsive use or behaviors identified and defined, such as:

  • Physical addiction
  • Loss of job
  • Erratic or deviant behavior
  • Decreased social activities
  • Increased tolerance of nicotine and use over time
  • Harm to the patient or others around them
  • Withdrawal symptoms, phases

Submission:

Documentation must be submitted to this blog publicly and directly in the comment section below.


Reward:

money6

If addiction to nicotine is proven according to the criteria above, 5% of the funds donated during this 30-day challenge (minus processing fees) will be donated to The Campaign for Tobacco-Free Kids.

The remaining 95% (if proven) will be donated as follows:

In the absence of or lack of documentation submitted per the criteria stated above, or if this Public Health Challenge is deemed uncontested, any and all funds donated during this 30-day challenge (minus processing fees) will go to ecigarette-research.org for further research by Dr. Farsalinos and his colleagues.


To *donate any amount, please go here to the GoFundMe page:

Nicotine Addiction: An Open 30-Day Public Health Challenge


*If you cannot donate with GoFundMe (due to bank fees, country of origin or other reasons), please message me. I can accept your donation of any amount securely via PayPal here and I will then transfer it with your name or initials  (please specify) so there is a receipt for both of us.


Save

Save

Save

Save