Inside the FDA.......

[UntamedRose]

Ya'll have done a wonderful job contacting politicians, blasting blogs...but with recent events I'm thinking it's time to raise it up a notch.

Jobs, there are several job Opening at the FDA...Getting an insider would be great.
So if your needing looking for a job anyway...take a look over them, lot of different levels needed. Working at FDA

"The Ombudsman is available to provide an empathetic ear to listen to your issues and concerns even if they do not rise to the level of a complaint or dispute. He can also help to facilitate a dialogue or discussion between stakeholders and CTP staff."
This is who we are suppose to be talking about "concern and issues" to.
Contact info
How to Contact an Ombudsman

Lets give the enemy a face......


Margaret Hamburg, M.D.


Dr. Joshua M. Sharfstein

I cant find contact info for these two....but if we can get ahold of either of them and sway them it would likely End this.
These two have to power screw us..or drop the issue.


thoughts?

 

[MoonRose]

Two different email letters already sent to the Ombudsman. But if that position is open and they are looking for one, then that means the email letters that I sent are probably not going to be read.

 

[cruisedoc]

Also, vote republican this Nov. Although I'm a dem, that's what I'm doing. Let's get big gov out of our faces & from trying to control all aspects of human behavior. Let's cut the FDA budget by 50%. I'm a practicing physician, and have seen far too many people quit tobacco cigarettes using this 'life saving' product ...including myself. Let's show these control freaks the highway.

 

[Luisa]

You are right but---it is the President who appoints the Commissioners to the agencies. Those 2 are determined to ban ecigs. So---how can we remove them from their positions? Obama has 2 more years and then in all probability he will will be re-elected for 4 more years. Depressing---

 

[CtryBoy]

looks like the posted jobs have passed the due date.

also considering the salary, you might just be giving aid and comfort to the enemy by sending vapers in they might be corrupted and decide it's easier to just go along to get along. Cant see any promotion opportunities for boat rockers or open vapers. Guess you could just be a mole and keep your mouth shut while slipping us the goods on their bag of dirty tricks or what was coming around the corner.

Can just see it now. ecig spy caught vaping in bathroom while emailing details to buddies from ECF. Sentenced to firing squad for high treason.

Now that I think about working for the FDA, I suddenly feel the need to take a shower.

 

[lonercom]

Also, vote republican this Nov. Although I'm a dem, that's what I'm doing. Let's get big gov out of our faces & from trying to control all aspects of human behavior. Let's cut the FDA budget by 50%. I'm a practicing physician, and have seen far too many people quit tobacco cigarettes using this 'life saving' product ...including myself. Let's show these control freaks the highway.

Registered Republican here, even ran for state office once. Republicans tend to prefer more Local Government and less Federal Government. The older I get the more I find myself leaning Libertarian. Most folks would refer to them as "Pot smoking (not me) Republicans" but one of the main planks in their platform is less government at all levels.

 

[MoonRose]

This is the official reply that I received from the FDA today in regards to the two seperate email letters I had sent them:

Dear Dorothy,

Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.

Please note that the FDA has not issued a "ban" on electronic cigarettes. The U.S. Food and Drug Administration issued warning letters to five electronic cigarette distributors for various violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices.

In a letter to the Electronic Cigarette Association, FDA said the agency intends to regulate electronic cigarette and related products in a manner consistent with its mission of protecting the public health. The letter outlines the regulatory pathway for marketing drug products in compliance with the FDCA.

For a drug product to gain FDA approval, a company must demonstrate to the agency that the product is safe and effective for its intended use. The company must also demonstrate that manufacturing methods are adequate to preserve the strength, quality and purity of the product.

"FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed," the letter to the association read.

FDA has determined that the electronic cigarette products addressed in the warning letters to the distributors, and similar products, are subject to FDA regulation as drugs. Under the FDCA, a company cannot claim that its drug can treat or mitigate a disease, such as nicotine addiction, unless the drug’s safety and effectiveness have been proven. Yet all five companies claim without FDA review of relevant evidence that the products help users quit smoking cigarettes.

The companies receiving warning letters today are: E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson’s Creek Enterprises LLC.

Certain companies received warning letters for additional reasons. For example, E-Cig Technology markets drugs in unapproved liquid forms, such as tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug that has not been approved for use in the United States. These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so that the drugs can be vaporized and inhaled.

You can locate more information at FDA acts against 5 electronic cigarette distributors.


Best regards,

CAO
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info


This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

 

[Vocalek]

Margaret Hamberg and Josh Shafstein have worked together for years. I am told that they are "nicotine prohibitionists". In other words, they do not believe in the concept of tobacco harm reduction. I know it is mind-boggling to contemplate, but they honestly believe that if they just stick to their guns, eventully all the smokers will give up the evil habit. If not, then they deserve to die.

How's that been working for them? The number of smokers has hovered around 46 million with very slight ups and downs since 1999. The percent of adult smokers is unchanged since 2004. From where I sit, that doesn't spell success. But wait. These are the same people who tell us that we should just use one of the 7 the "safe and effective" medications approved by the FDA for smoking cessation. If they believe that less than 10% success with these products = effective, then I guess that the number of smokers failing to be reduced for the past 19 years = a successful tobacco control program.

Oh, and their idea of "safe" is it's OK if the drug makes people very, very ill, causes deaths, and gets people jailed by causing delusions, paranoia, and inciting violent bahavior -- as long as it is an FDA-approved drug. But a product that has caused no significant adverse events in 7 years? Well THAT might be dangerous. "We just don't know."

Well take a freakin guess!

"FDA said the agency intends to regulate electronic cigarette and related products in a manner consistent with its mission of protecting the public health." Taking away the lifeline of hundreds of thousands who rely on these products to remain smoke-free is inconsistent with FDA's mission of protecting public health. And make no mistake, if FDA is allowed to regulate all e-cigarettes as though they were some new type of NRT, that does constitute a ban.

Rant Over

 

[UntamedRose]

I got the exact same message Moonrose, just a copy paste BS formal letter.


Vocel, there must be some other avenue we can take in all this...

 

[D103]

In my opinion, the FDA is NEVER going allow e-cigarettes, as we know them, to continue in the marketplace, unless they are forced to by the courts. One only has to read and scrutinize the entire body of their comments and strategies over the last year to see that. Any notion of "working with the FDA" on this is seriously misguided. The idea that the recent "warning letters from the FDA" were somehow 'generous' and their itemizing the various manufacturing, safety and quality assurance violations was in any way a "sincere" offer of help and guidance towards keeping this product, as we know it, in the marketplace is ludicrous given the long established stance the FDA has taken and what they explicitly stated in those letters where they frequently referenced FDCA guidelines. The FDA's position is to see to it that this product be classified as a "drug delivery device" which requires years of testing and clinical trials and millions of dollars (not to mention the ethical dilemmas involved-read Dr. Siegel's views on this) and so serves as a de-facto ban. These letters were no more than the FDA flexing its muscles and a deliberate legal maneuver for the court case (notice how they quickly informed the courts that they sent those letters). I agree that invariably we will have to work with the FDA as they are "the only game in town" I just feel strongly that now is not the time.

 

[D103]

As a follow-up I agree with what many have posted that suppliers should be working to establish acceptable safety, manufacturing and quality assurance standards and some sort of concerted effort on suppliers' part seems to be a reasonable tactic but I'm not a supplier so it is not for me to say.

 

[UntamedRose]

On the suppliers...we are likely to find some Massive changes in the next few years(or sooner) even if we "win" and get the FDA to see ecigs as a tobacco product. The days of mom and pop US made by order in someone house will be over. I'm surprised it has gone on as long as it has.

There are only three biz's models(regarding eliquid production) I can see from here on out......
Get Big enough you can, play the FDA games...and right now there are only a handful who possibly could.(places like johnson creek and puresmoker comes to mind, places that have true Labs and the equipment needed)
Or
Make money while you can and get the Heck out. when push comes to shove, they drop and run.(which seems to be the stance of many right now)
Or
These smaller biz's could co-op a lab to create their juice for them. power(and funding) in many. (beer mirco brews do something like this)

Just my take on it.

 

[MoonRose]

Maybe it's time we started considering protest marches in D.C., nothing else seems to be working right now.

 

[CtryBoy]

Maybe it's time we started considering protest marches in D.C., nothing else seems to be working right now.

Best advice I've seen so far is to hold out till Obama gets the boot and lobby for a change in leadership at the FDA. Out with the thugs and in with some common sense. Given the response to the tea party, I can only imagine what the anti's in the media would call a bunch of protesting vapers. Not that anyone around here is crazy or out there in any way.

Someone suggested coordinated local protests could get more attention considering most of us work for a living and do not have the time or funds to drop everything and shout at capital hill. Not that they seem to listen much anyway. Still fear we are just the runt of the litter when it comes to the groups that have issues with the FDA, congress, etc. Hard to tell how we will fair in the struggle to get the government off our backs, just hope the FDA gets new bosses soon. Although not even sure that would help change their high minded approach. But few tactics better than cutting the head off the snake.