Why so many members take issue with the FDA

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Coastal Cowboy

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Aww... now ur just hurting my feelings! Ok, I'll leave you to this circle jerk in an echo chamber. I'm sure all your opinions will be so much more solid and well informed when this thread is done.

I've spent the last 25+ years (and made a handsome living) as a policy analyst, consultant and lobbyist. When it comes to understanding how things work in Washington DC, there ain't many people who know how the sausage is made better than me.

Congrats, Tre. You're the very first person to earn a spot on my iggy list.

Another thing that's on topic and of note: Mitch Zeller is a lawyer. The head of FDA's tobacco commission isn't issuing any regulations that he knows will land his ... in court. He's read the Brown & Williamson decision. He's read FSPTCA, and he's read the Soterra decision. He's a smart guy, and I'm assuming that he likes his job.
 

EvilZoe

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I just picked up my prescription of Effexor (Venlafaxine) and it came with this wonderful new 2 sided sheet (6 pt. type) of warnings that was revised in Dec 2012. December 2012. Mighty white of someone to notify me of these additional DANGERS almost a year AFTER the FACT. The pharmacists said they just received these from the FDA.
Wait....most of these "dangers" are exactly what I'm taking Effexor to prevent........?:blink: And didn't the FDA originally approve this medication in 1993 based on the BP's "thorough testing" of this product?:glare:

At the very end of this 2 sided, "get out your magnifying glass", head ache causing, fear wrenching "list", right above the "Revised December 2012" is:
"This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants."

Seriously............why would ANYONE TRUST the FDA?:2c:

Effexor is one of the few meds that is helping me stay even and sane. :( I think I'd rather risk the side effects than go through what I have for so many years.
 

cookiebun

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It is sad to me that I see some defending the FDA here by calling posters names, marginalizing any person who questions the FDA, and refusing to see what a real threat to the vaping community the FDA represents. Many of the posters have legitimate gripes with the FDA.

The purpose of this thread is to illustrate why certain members of this community are distrustful of the FDA. I really would like to keep the content of this thread strictly to what the FDA is doing with vaping. True, with my "statement" example I do swerve off course and get into a food example, but I hope everyone can see it is simply an example of use of language. In any case, here is part of my issue with the FDA. I had no opinion at all of the organization prior to vaping.

Here are two concrete examples of why I think the FDA is not acting as a good steward of public health on this issue. This sort of rubbish the FDA is stating creates a general contempt for the organization and makes people legitimately nervous.











Big, Big snip


Every one of us is entitled to our opinions. While I do skewer the FDA, they are my employee, and I am giving them needed feedback. Trust me, I have let them know my displeasure with their web site directly. My repeated written requests to review the site information has gone without any effect on the content of the website.

So when they are distorting facts, they make vapers angry. Given their past activities, I think we should all be a bit distrustful.[/QUOTE


Worst Drug Recalls in the History of the FDA | 10 Worst Drug Recalls in the History of the FDA | Comcast.net

That's just for starters. They let all that stuff on the markets, sometimes for decades but they tried to block e-cigs because of POSSIBLE UNKNOWN side effects.
:vapor:
 
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Anjaffm

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As Europe is not exactly tiny, I wonder whether the FDA will consider the vote by the European Parliament on 8 October (not to regulate e-cigs as medicines)

This may be interesting in that respect:
The Rest of the Story: Tobacco News Analysis and Commentary: EU Parliament Rejects De Facto Ban on Electronic Cigarettes; Tide Starting to Turn

What caused this turn of events and the turning of the tide regarding opinion on electronic cigarettes?

The answer is ...

... the vaping community.

It is the actual users of these products who are responsible for the changing attitudes toward electronic cigarettes, including the EU Parliament's rejection of the de facto e-cigarette ban and the WHO's change of heart on e-cigarettes.

The voices of the actual people who use these products have drowned out the ideological hysteria of anti-smoking groups and officials.

Has the FDA also heard the voices of the vaping community? We'll find out momentarily, as the proposed regulations should be released shortly.
 

NiNi

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Effexor is one of the few meds that is helping me stay even and sane. :( I think I'd rather risk the side effects than go through what I have for so many years.

Count me in the same boat, Zoe. We're damned if we do and damned if we don't. Let's pray we don't suffer any of the side effects *fingers crossed*:(
 

ut1205

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cmdebrecht

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I just picked up my prescription of Effexor (Venlafaxine) and it came with this wonderful new 2 sided sheet (6 pt. type) of warnings that was revised in Dec 2012. December 2012. Mighty white of someone to notify me of these additional DANGERS almost a year AFTER the FACT. The pharmacists said they just received these from the FDA.
Wait....most of these "dangers" are exactly what I'm taking Effexor to prevent........?:blink: And didn't the FDA originally approve this medication in 1993 based on the BP's "thorough testing" of this product?:glare:

At the very end of this 2 sided, "get out your magnifying glass", head ache causing, fear wrenching "list", right above the "Revised December 2012" is:
"This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants."

Seriously............why would ANYONE TRUST the FDA?:2c:


No amount of drug trials can possibly reveal all potential side effects of meds. It isn't until a drug/device is used by the general population that many issues come to light. At this point the FDA can either recall the drug/device or issue more information on it.

Frankly this gives me comfort. Pharmaceutical companies, I suspect, will do just about anything to get a drug approved so they can at least break even on it, If not make a huge profit. I trust the FDA more than pharma.
 

Bronze

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These are the type of posts I choose to not be associated with. They make us all look bad.


Have a good fight friends, common sense tells me they can't ban a metal battery tube with a switch.

The gov't makes me buy health insurance so they are capable of doing any damn thing they want. Turncoat Justice Roberts just confirmed that.

Sorry Lion, I don't know how we can disassociate the FDA from politics. But I will try going forward.
 

Uma

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These are the type of posts I choose to not be associated with. They make us all look bad.


Have a good fight friends, common sense tells me they can't ban a metal battery tube with a switch.

And that has nothing to do with what the FDA is proposing, which means your comment makes no sense.

Actually, yes, the FDA can do whatever they please with batteries, switches, tubes... They are the components of what make up an ecig.
The FDA regulates the rolling paper that the cigarette is rolled in, and the rolling paper company has to disclose all ingredients, even though the paper is not a component until it is bought by the cigarette manufacturers.
Cigarett3 components are filters, paper, tobacco,
Ecig components are battery tubes, batteries, led light, switch, tank, atomizer, nicotine liquid, and possibly zero nic liquid.
 

Bronze

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Bronze

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cmdebrecht

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Effexor is one of the few meds that is helping me stay even and sane. :( I think I'd rather risk the side effects than go through what I have for so many years.

This is a recent revelation of mine: The biggest anti e-cig argument is arguably about the unknown risks associated with vaping. Yet we do indeed know the risks associated with smoking.

Every day in America, health consumers choose potential side effects over the risk of greater harm. Millions of health-related decisions are made on a daily basis that offer a threat of less harm than the alternative. Kids use inhalers despite side effects of albuterol; but then again they don't die due to asthma. People go under the knife despite risks and possible complications of surgery for conditions ranging from rhinoplasty to open heart surgery. I take Advil so I can make it through my shift without back pain, but risk kidney and liver damage.

This is not a new concept ;in fact, it is the basis of an overwhelming majority of medical decisions. That's why this whole argument against e-cigs is illogical.
 

Jman8

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FDA has what control it has over e-cigarettes it has due to it's failed attempt to ban them.

Based on the 'history link' it was a failed attempt to ban the import of them, while classifying them as drug delivery devices.

They seized property and attempted to snuff vaping out. They were stopped in court, where the US Circuit Court Judge found them to be tobacco products. This is at the core of the mistrust of the FDA. When the first action of an entity is to seize property and usurp authority from the people, it is quite telling.

Again, as the history shows, other countries including WHO had spoken on the issue prior to FDA issuing an import alert. So, if we are honest, let's not limit the mistrust to only FDA, as it wasn't first, nor last entity, on this planet, to call for ban on import of these devices.

Also to be clear/honest, the eCig hardware are drug delivery devices. FDA requires "preapproval, registration and listing with the FDA" as a matter of law, or I would say common sense. The history notes that in 2006-2007 eCigs are introduced into the U.S. I think clarification is needed there to say, "illegally introduced."


I would say that history is much more important when we try to understand why vapers have antipathy towards the FDA. Again, the point of this thread is to illustrate WHY the FDA is mistrusted by our fellow vapers.

And on open forum, I think it is (perhaps) helpful to address that mistrust, as that position matters going forward. I don't support the position of FDA on this topic, but because I understand their position, doesn't mean I fully trust them. Frankly, if I don't have trust in someone/something, I'm not sure what the wisdom is in making that public. When I see that (on any forum, or medium), it comes off as an emotional reaction that when addressed with reasoning, often leads to those who have expressed lack of trust as shouting down those who care to have a rational discussion on the matter. The "I hate government, can't trust FDA" people occupy the discussion and ultimately lead it nowhere constructive.

The FDA is key player in going forward. A general statement of mistrust offers nothing useful in how to address this key player.


Black Market? You feel this is an acceptable resolution to a flavor ban? I do not feel going underground is a winning play. In any case, you continue to steer further an further away from the point of the thread.

No, bringing up Black Market as way to address impending changes to the eCig market is not off topic. It is not the best way, I agree, but it is a reasonable response to whatever is deemed 'worst case scenario that FDA may institute with regards to eCigs, specifically eJuice.' It is why the FDA can't win on this issue. To ignore this and harp on the emotional plea for mistrust is going off topic with regards to the FDA discussion. Tell me, what's your mistrust of FDA adding to the discussion to help vapers understand options for all of us going forward?

You are blaming vapers? That is an interesting perspective. Your attack on vapers as a group is quite telling.

It would be interesting and telling if you spin it with your misinterpretation of what I said when I say, "I see this battle as one we have brought on ourselves." I believe I was clear in follow up to that statement by saying ANTZ is reason why we are in the place we are. It is why FDA has a leg to stand on with FSCPTA. Some vapers (who carry the torch for ANTZ) are a drop in the bucket. My point was with regards to Americans' position toward smoking/using nicotine. We've done a complete 180 on that issue, and as such it has lead us to a point where devices that remotely resemble smoking are to also be treated as 'extremely dangerous.' If you are a vaper who doesn't take issue with that classification being applied to smoking, then I find that to be an ignorant position. It also shows up as naive when the eCig debate is considered for all of 10 seconds as a matter of national discourse outside of a vaping forum.

The sound bite version of what I just said in previous paragraph is - if we (Americans) rolled over on the rights of smokers in our society, it ought to be no surprise that the same Americans will roll over on rights of vapers.

I see this as a fight started by the FDA

History link doesn't exactly back this up. IMO, it precedes what the history document chose to start with, and does relate to smoking rights. The fight as I think you are presenting it deals with FDA wanting to control eCigs either through classification as drug delivery devices or as tobacco products. Now (in 2013), many vapers aren't too happy with the classification as tobacco products and how that relates to control via FSCPTA. That act deals with smoking and, indirectly, with rights of smokers. Reality is, most Americans are happy to see rights of smokers decimated. I believe many vapers are happy to see those rights decimated as well. I am not and think that has gone so far overboard, I'd be pleasantly surprised if vaping is allowed to continue in America.

Science is on our side, the rule of law is on our side, only the brainwashing of anti-smoking zealots is against us.

I honestly feel the science is still in question. I've seen enough anecdotal evidence to convince me that the discussion is definitely on our side. I've seen mixed scientific research, and thus it is still in question. I think it favors our position, but hard to say for certain.

When you say "rule of law" is on our side, I'm curious what you mean by that? If eCigs are classified as tobacco products, I don't think I agree with you that the law is on our side. And it is because of ANTZ and the nearly lost war on smoking that has gotten us to where we are today. Where products that are classified as 'tobacco' are plausibly deemed by vast majority of Americans as unwanted in our public places, and best if they are regulated, hopefully out of existence. As I know smoking will NEVER be regulated out of existence, I'm certain it won't happen with vaping.
 

FlamingoTutu

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I've spent the last 25+ years (and made a handsome living) as a policy analyst, consultant and lobbyist. When it comes to understanding how things work in Washington DC, there ain't many people who know how the sausage is made better than me.

Interesting that you used the word sausage. :lol:
 

DC2

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Has the FDA also heard the voices of the vaping community? We'll find out momentarily, as the proposed regulations should be released shortly.
Has the FDA heard the voice of the vaping community?
Well, I don't know how to say this any other way then yes, damn sure they have, loud and clear.

They heard our voices in the first White House petition where they provided a completely bull.... response...
http://www.e-cigarette-forum.com/fo...on-administration-recognize-e-cigarettes.html

They heard our voices once more in the second white house petition where they were too scared to answer us still to this day...
http://www.e-cigarette-forum.com/forum/legislation-news/370130-sign-petition-whitehouse-gov.html

And they heard our voices again in the 5,000 comments they received regarding long-term use of NRT products...
http://www.e-cigarette-forum.com/fo...-fda-e-cigarettes-your-action-needed-now.html

Again, to this day, almost none of our comments have been posted on their website.
I still don't understand how they are getting away with that, as I thought it was pretty much mandatory for them to post our comments.

The FDA has heard our voices again and again.
There is no question about that.

The question is, what are they going to do?
 

B1sh0p

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Actually, yes, the FDA can do whatever they please with batteries, switches, tubes... They are the components of what make up an ecig.
The FDA regulates the rolling paper that the cigarette is rolled in, and the rolling paper company has to disclose all ingredients, even though the paper is not a component until it is bought by the cigarette manufacturers.
Cigarett3 components are filters, paper, tobacco,
Ecig components are battery tubes, batteries, led light, switch, tank, atomizer, nicotine liquid, and possibly zero nic liquid.

You guys are truly hopeless. I'm very grateful for vaping. I'm very embarrassed by the politics of the community. I'll just stay out of these threads. There aren't enough tin foil hats for all of us.
 

Anjaffm

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Well, with medication, I would say that - depending on the ailment - it is possible / recommendable to weigh the benefits and the risks.
If the benefits outnumber the risks in an individual case, I would say to the person: go for it.

However, in the case of Chantix, we are talking about ;
benefit: "stop smoking and avoid possible health risks later, including but not necessarily, premature death"
and risk: death by suicide within weeks of starting to take the pills". Which is then very premature death indeed.

In the case of Lipobay, we are talking about:
benefit: "reduce your blood cholesterol". period.
risk: "get a severe muscle disease and die as a result" (Cerivastatin (Baycol) | 10 Worst Drug Recalls in the History of the FDA | Comcast.net )
.. Yeah.. high blood cholesterol has been "linked" to higher incidence of heart attacks. "Linked", but not proven. Which is enough to sell a lot of (possibly dangerous) pills to otherwise completely healthy people.

While taking medication for a serious ailment may well be worth the risk of side effects, I personally find it more than unnecessary to take medication for a "frivolous" ailment or something that has not been proven to be any "ailment" at all.

"Medical science is making such remarkable progress that soon none of us will be well." ~ Aldous Huxley

And I find it more than questionable to push through one unnecessary / me-too "medication" after another, to do a favor to a certain industry. And then being forced to pull some "medication" from the market that killed thousands of people.

Nope.. no trust in that agency...
 

NiNi

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No amount of drug trials can possibly reveal all potential side effects of meds. It isn't until a drug/device is used by the general population that many issues come to light. At this point the FDA can either recall the drug/device or issue more information on it.

Frankly this gives me comfort. Pharmaceutical companies, I suspect, will do just about anything to get a drug approved so they can at least break even on it, If not make a huge profit. I trust the FDA more than pharma.

^^^^^^That, in bold, is why I don't trust the FDA. The FDA doesn't do independent studies, they rely on BP for the studies.....
 

Bronze

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You guys are truly hopeless. I'm very grateful for vaping. I'm very embarrassed by the politics of the community. I'll just stay out of these threads. There aren't enough tin foil hats for all of us.

Certainly not one big enough for your head.

Oops, there I go again. :facepalm:

Consider this my official report Retired!!!
 

DC2

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HWe have our own opinions of the "Left Coast" but we keep them to ourself.
Please don't lump all of of us "Left Coast" folks together.
There are lots of places in California that aren't "like that" at all.
:)

Basically, it's just San Francisco (the New York of the west coast) and Los Angeles.
Most of the rest of the state leans in a different direction.

DISCLAIMER: I'm not saying that anyone in SF or LA is one of those people
 
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