IMPORTANT - email from FDA to a supplier.

[cowgal]

Thanks everyone for posting all the info. I am so depressed to hear it though, just want to cry.

I was in tears too, after I heard the final vote. I am very heartened by all the optimistic talk though... please keep up the pep-talks y'all. And thanks so much for the translations from legalese to plain English.

EDIT: oops, I'm on the wrong thread. Talking about the Burr amendment that just got s***-canned. Sorry!! I'm following this thread too though, equally interested.

 

[eric]

I was watching TV tonight and noticed that on yet another one of those inappropriate ads talking about male enhancement that the drug they were hocking obviously effects a structure of the body *do I need to say it? LOL* and has not been tested or approved by our illustrious FDA. Why? Isn't over-population a big problem too these days? For example, when two people from ASH get together and spawn, their offspring uses up resources and the last time I checked, this effects others just like secondhand smoke. LOL

Robbie

Very insightful observation, Robbie.

You're now on my awesome list.

 

[nebraskapuffer]

I wanted to post but when I talk about politicians I'm sure my language will get me banned from this forum and this is a great forum.

 

[Socomredbull]

This is just a huge ploy to get u back to smoking cigs 24-7.It is proved and rightfully so massively destructive smoking cigs period.Your telling me 4000-5000 chemicals found in a cig were approved by the FDA ? and its safe.......Um no I dont think so not safe at all FDA.They are killing us softly with there bogus regulations and doing this purposely so you will go back to smoking cigs.You can thank your buddy Obama for allowing this to be pushed since he allowed such power the FDA has over this situation.Dont believe its Obamas fault still go read your legislation and articles for the fact Obama is apart of everything going down bad in this country along with mr bush prior to Obamas election into the presidents seat.For those who voted for Obama your just votes are comming up short of what you would figured they would account to.Sadly so I knew it was comming.A NWO you say hmm did not Bush Senior say that a NWO then Obama said we need to put a stake into this world order that we all wanna see do we Mr Obama do we thanks for being a smoker and also smoking an ecig then allowing us to get raked over the coals your so great Obama you wait your time is comming every dog has it day and yours will come one way or another.And no I did not vote in any presidential races and no im not a democrat or republican so lets not take it there.I just see these so called presidents treating us like rats and not caring at all.We are all the flies on Obamas sleave as he slaps us down and kicks us to the rug.Funny it sounds but its true.Allow them to walk all over us allow them to destroy are freedom allow them to control us and say we know whats better for you go get these yummy chemical filled to the brim cigs and enjoy oh thank you Obama oh thank you.This country thrives off cigs because every year they need 40,000 new smokers or more to fill the shoes of the ones who die off and go asked the cancer society they will tell you the facts if u dont trust me but then u will find oh your right.Everything I say is fact and truth.These cig taxes are for a reason taxes justify paying for other things like illegals and so forth.So happy days thanks FDA thanks Obama for trying to choke us to death.I wont stop i got 15 unused atomisers and will continue to smoke the cigs and juice for years to come.Just get a passthru and stock up on atomisers and u will be fine getting the juice can be masked by companies they cant stop us fight damit fight !Your body knows better then they do find all means to not smoke cigs ! I have the last laugh u wont stop me u cant stop us so find the back doors get it every way u can hope is here ! I know countries that have banned it and people still getting the juice so dont be scared just dont smoke it in public be wise.

 

[lordmage]

now i see why people have had issues following my earlier postings.

socom suggestion please break up long running post with periods and line breaks.

 

[Alexander]

I have the last laugh u wont stop me u cant stop us so find the back doors get it every way u can hope is here !

In either case, analogues or e-cigarettes, people are frankly still indulging a fruitless addiction. If you want to really "stick it to the man," I'd say quit altogether and focus your energy on important and meaningful civil issues.

 

[robbiehatfield]

Very insightful observation, Robbie.

You're now on my awesome list.

That in and of itself is awesome to me! I'm usually on other people's $&^% list.. LOL

Robbie

 

[squigbrain]

In either case, analogues or e-cigarettes, people are frankly still indulging a fruitless addiction. If you want to really "stick it to the man," I'd say quit altogether and focus your energy on important and meaningful civil issues.

I believe this to be trolling, when pitched at a forum entirely created to discuss vaping.

 

[happily]

In either case, analogues or e-cigarettes, people are frankly still indulging a fruitless addiction. If you want to really "stick it to the man," I'd say quit altogether and focus your energy on important and meaningful civil issues.

It's far from fruitless.........it keeps a lot of us from choking the **** out of self righteous know it all's(counter productive maybe because the world could stand to be rid of a couple million of ya)

 

[sherid]

In either case, analogues or e-cigarettes, people are frankly still indulging a fruitless addiction. If you want to really "stick it to the man," I'd say quit altogether and focus your energy on important and meaningful civil issues.

Alexander, your efforts and your posts would be more in line with a forum at ASH or SmokeFree sites. I cannot imagine why you would choose this forum other than one must pay to post at ASH and SmokeFree sites censor posts.

 

[TheUltimateG]

Frank Lautenberg truly desires to reduce smoking, but he's been misinformed about e-cigarettes.

The ACS, AHA, ALA also need to hear from e-cigarette users (who also should let them know they won't receive any more contributions until they change their position), as a top priority of those organizations is fund raising. I used to work at the ACS, which is very concerned about public criticism (of their organization) and negative press coverage.

This is where you got it all wrong my man. They will back e-cigarettes if we make massive donations to their cuase. Thats how our corrupt government works. You make massive donations and lobbyists get to work on your behalf. Its all about the money and since they aren't seeing any from the e-cig manufacturers they have deaf ears.

 

[wezzie]

I just rec. this today via e-mail...
Dear Ms. Walzer

Thank you for making your opinions known to the Agency. We appreciate your thoughts and experiences regarding electronic cigarette, cigar, and pipe products.
At this time, we are not aware of any data establishing electronic cigarettes, cigars, or pipes as generally recognized among scientific experts as safe and effective. Based upon our investigation of these products, they are drug/device combinations that require approval by FDA before they may be legally marketed in the United States.

None of these so-called electronic cigarettes, cigars, and pipes, or their components, has been approved by FDA. Therefore, the marketing of them in the United States is subject to enforcement action. As a matter of policy, however, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions.

There may be a perception among some users that electronic cigarettes, cigars, or pipes are safer alternatives to conventional tobacco products. There may also be a perception that these products are a safe and effective means to quit smoking conventional forms of tobacco. However, FDA is not aware of any scientific data to support those perceptions. Since these products have not been submitted to the FDA for evaluation or approval, the agency has no way of knowing the amounts of nicotine or the kinds and amounts of other chemicals that the various brands of these products deliver to the user. FDA is concerned that electronic cigarettes, cigars, or pipes may introduce young people to nicotine use which may lead to an increase in the use of conventional tobacco products with well-known, adverse, health consequences. Additionally, it is unclear what health effects these products could have on users or if misuse or product failure could lead to nicotine poisoning or other serious adverse health consequences.

There are a number of proven safe and effective cessation aids that smokers can use to quit smoking. The U.S. Public Health Service’s, Treating Tobacco Use and Dependence: 2008 Update recommends using a combination of proven cessation interventions including FDA approved nicotine replacement therapy and/or non-nicotine medications and counseling to more than double a smoker’s chances of quitting successfully. Free help is available to smokers in all states by calling 1-800-QUIT-NOW or by visiting Smokefree.gov.


Again, we appreciate the time that you have taken to contact us.

Best regards,

Division of Drug Information 7
Center for Drug Evaluation and Research
Food and Drug Administration



This communication is consistent with 21CFR10.85(k) and constitutes and 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.

 

[wezzie]

I let "them" know how the e-cig has allowed me to quit smoking analogs. I also told them how much better I feel, etc.

 

[smiley7]

Wezzie, just got the very same reply today in my inbox! Seems like I sent my email about 2 mo.s ago. Doesn't sound too good does it. Guess they just ignored my initial mail that explained that I had tried the other smoking cessation stuff & nothing worked!!! haha. Alot lot of us will probably get this same generic email.

 

[LaceyUnderall]

Here is a very interesting article from about.com that might give some insight as to why the FDA must walk a fine line and also, why they would be so keen on not giving a product that isn't from a pharmaceutical company any kind of approval whatsoever.

Basically, in a nutshell, it notes that since there isn't much money to fund the FDA, they rely heavily on pharmaceuticals to pay their bills. This isn't new news, but it is a good article.

Healthcare Reform - The Role of Medical Research in Healthcare Reform

 

[StudioKraft]

Wezzie, just got the very same reply today in my inbox! Alot lot of us will probably get this same generic email.

I got the exact same reply from them as well. Looks as though they were collecting them for a time and just decided on how to respond to them all.

What got me was:

Therefore, the marketing of them in the United States is subject to enforcement action. As a matter of policy, however, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions.

So, does this mean that the FDA won't tell you about their "enforcement actions" unless you have already become a victim of them, or in other words, we won't tell you what the law actually is until you have broken it?

 

[ladyraj]

I received the same form letter response. The disclaimer at the bottom appears to negate the body of the letter!

 

[Krakkan]

Yes seems they never cared enough to read our emails lol

 

[wezzie]

So...is there an alert to let us know that a "storm" is brewing? The majority of us have stopped or seriouly reduced smoking analogs AND have had positive health benefits. I do appreciate that some doctors are concerned about what we are inhaling... ! But, we are not smoking known cancer causing agents.

 

[Plodder]

WoW!!! This thread is great! All that keeps running through my head is, I once was blind, but now I see. I, unfortunately, tend to go through life either oblivious to, or subsconsciously avoiding issues like these. Ussually around election time, I get a bit interested, but quickly become disuaded by other events in my immediate environment such as focussing on my family or paying the bills etc... I have to say though, this topic has me revved up! I am disgusted my what seems to be such a tangled web of corruption.

I am very new to this PV concept, but it seems promising, I have tried every other stop smoking measure, and this one seems to be the ticket for me. I just can't hardly believe that the one product that is tried and tested by a guy like me, who has attempted to quit analog cigarettes more times than I care to share, is not an approved device in the U.S. and is meeting so much resistance.

I have made note of some very valid points brought up such as, regulations and what not. I have to say, I agee with this point. I have read a few articles elsewhere of companies overseas that have cut their product with hazardous chemicals to cut costs. I for one am really okay witha possible slight inflation in the cost, as a consumer, to insure I do not recieve products such as this. I also agree that quik fix's like child proof lids would be a big plus.

Okay, enough of that stuff.

I have a few questions, thoughts.

The main reason I tried a PV in the first place is because I recieved a big business company email that they would be selling a line of this product. My question is, if the FDA knows that a company like this in carrying the product that they supposedly want stopped from entering the U.S. at customs, why do they not seize evey item being shipped through to the company, until they find the "item in question", and prevent it from ever making it to the stores shelves? I understand that a small companies shipment can slide through, but I would think this would be one area they could really crack down on the movement of product to the U.S. Why aren't they?

I am also wondering about big companies and their possible research on this type of product. It seems like the companies such as Nicorette and what not would put some money into this effort, since smoking cessation is their bag. I personally would like to support the MOM and POPS as much as possible, but aside from that, wouldn't these large companies with the bankroll for the necessary research really benefit from the investment?