CASAA Call to Action: The FDA Workshops on Electronic Cigarettes and the Public Health were held on December 10, 2014 and December 11, 2014 in Silver Springs, MD. I captured the entire two days of audio which you can listen to on this page. Although I have not listened to all of the recordings, I’ve heard enough to offer some candid thoughts for your consideration. During these workshops, Vapers also enjoyed a dedicated Workshop thread which was lively and fact filled on ECF. I suggest you read this thread which even includes comments from a few Vaping rock stars. I should warn you that I intened to point fingers with inflammatory language. If this bothers you, then please don’t read any further.
I have always maintained and documented that the FDA is a corrupt buracracy. Systemic in nature, this history of corrupt behavior is easily traced and documented for at least the last 20 years. These Workshops served to reinforce my belief. They are lairs, bloviaters, twist the facts, omit facts, beholding to the Pharmaceutical industry and Big Tobacco, arrogant, and not genuinely concerned with public health. They are “Desk Murders” who’s primary intention is to inflate their own ego, build an out of control buracrycy, grab more “power” and use the “Revolving Door” technique to enrich themselves when they move to the private sector. Many of their employees could never work in the private sector. The file FDA6.mp3 begins (Around 2:15) with “…The FDA is not looking for advice…” Think about that statement for a minute. You spend all this money, time, and resources to hold these Workshops but the FDA is not interested in advice which might help them not only understand Vaping but draft legislation that is reasonable and equatible. What they are interested in doing is giving their “favorites” the opportunity to secure more money, PR, and media coverage. The Public Comments were limited to 3 minites per speaker and a total time of only about one hour. If you have listened to this Workshop or a significant segment, it should be crystal clear to you that the FDA intends to obliterate Vaping off the face of the planet, If you don’t come to these conclusions, I’m sorry but you weren’t paying attention.
Here is just a small sampling of conflicts and dirty laundry from a few FDA employees, presenters, and speakers who appeared at the Workshops:
The FDA‘s Michael Trehy (who did the 2009 e-cig test that was misrepresented to the public to say e-cigs contain toxic DEG and carcinogens) is now presenting. He also did a study in 2011 that found that some e-cigs (of many tested) were mislabeled for nicotine content. Most of those mislabeled e-cigs were because the manufacturer didn’t include “per ml” on the label (and just listed the amount of nicotine in mgs). He’s wasting everyone’s time by talking about e-cig products that were sold 3-6 years ago, and are no longer on the market. Trehy: “some contained trace levels of nitrosamines, which raises concerns” Except that FDA NRT products also contain trace levels of nitrosamines. But even more importantly, there’s no evidence that nitrosamines have ever caused cancer in any human (rats aren’t men). Source
Prue Talbot’s coconspirator Monique Williams is now presenting. This will be yet more fear mongering about e-cigs citing highly questionable studies conducted 3-4 years ago. She’s also urging the FDA to take action to reduce or eliminate constituents in e-cigs, which can only occur if FDA imposes the deeming regulation. So while the FDA said the purpose of the workshop wasn’t about the deeming reg, many/most of the invited ANTZ presenters are urging the FDA to impose the deeming regulation (by grossly misrepresenting the risks of e-cigs, and failing to compare them to cigarettes to scare everyone). Source
Note that the moderator of this panel Carolyn Dresler (who is asking the panel lots of fear mongering questions), is an ANTZ who used to work for Big Pharma and the American Heart Association (promoting FDA approved drugs as the only effective way to quit smoking) before she began working at the FDA. Source
Shayne Gad, former employee of Allergan, manufacturer of Botox. During the 3-week Oklahoma trial, the plaintiff’s expert witness, toxicologist Shayne Gad, PhD, was publicly humiliated when it was revealed by Allergan’s counsel that Gad had misstated his military record. Gad was convicted of a misdemeanor for falsely claiming that he had been awarded a number of medals, including 3 Purple Hearts. In a plea bargain with the US District Court for eastern North Carolina, Gad avoided prison time and was placed on an 8-month probation, from February to April of last year. A dramatic courtroom apology from Gad to Chester and the plaintiff was printed by the OC Register last month. Source His entire presentation was specious, self serving, full of lies, and only designed to generate more revenue for his consulting business.
Mitch Zeller’s opening remarks falsely claimed that FDA relied upon scientific evidence for all of its regulatory decisions (as FDA didn’t base its unlawful 2009 e-cig ban or its proposed deeming regulation on scientific evidence, but instead has misrepresented the scientific evidence on e-cigs since 2009). Source
Kathleen Hoke from the Tobacco Control Legal Consortium failed to acknowledge that TCLC has received lots of Big Pharma funding to lobby for unwarranted state and local e-cig usage bans and sales restrictions, and has urged the FDA to ban all e-cigs. Source
Please trust me. I could post dozens more of these little factoids. So how was this Workshop organized and what was it’s real purpose? The FDA tightly controlled everything. They primarily invited and or authorized Presenters and speakers who would not only support their Deeming Regulations but also provide enough “evidence” to permit them to significantly expand their regulations. Disclosures were incomplete and a joke. The FDA even managed to choose a few of their “favorites” during the Public Comment period (See FDA6.mp3 which starts around 3:26). In Vegas, we call this entire dog and pony show…”Stacking the Deck”. Please stay tuned for my Part 2 on these Workshops, where I will talk about the few bright spots and individuals who support our cause.