AP: FDA Sending Warning Letters

[lmrasch]

I know that I'm jumping into this discussion kinda late, and I'm sorry the I haven't taken the time to read each and every post yet (whew!!), but I did make sure that nobody had posted this article yet...
E-cigs: E-cigarette companies get FDA warning - latimes.com

It pretty much goes over the same things that most of the other ones do/did, except that the author points out the fact that the letter the FDA sent to the ECA (Electronic Cigarette Assoc.) was addressed to a person who resigned 9 months ago!! And when interviewed, said that he thought the group had disbanded... Just shows what a bunch of IDIOTS the FDA are!!!

Personally, I think that they are just grasping at straws, because they know they can't ban the liquid... the ingredients are too easy to get and/or manufacture. So they are going after the devices themselves and the companies that they think have some violations that they can actually site codes on.
It's sort of like the RIAA did with the downloading of music... They realized it was fruitless to try to drag every college kid into court for downloading the latest CD's, so they went after the file sharing sites and the software developers instead.

I live in CA and the anti-smoking laws are getting tougher all the time!! We narrowly escaped a ban on e-cigs recently, but the Governator came thru for us... and it was changed to just prohibit the sale to minors, which I'm all for!!

I have read that beautiful letter, and seen talk of petitions, but I fear that anything sent to the FDA will just fall on deaf ears... I think part of the blame lies with President Obama for giving the FDA more control over the tobacco industry last year, so why not get a letter writing campaign and/or petition going to him?? Or maybe the Surgeon General, too?? Let them just slap a warning on e-cigs like they do on the Cancer Sticks and be done with it... LOL!!

If anyone is interested, there is a really good Free Petition site here:
http://www.thepetitionsite.com/create.html

You can not only post it here (or where ever else you want), but it will get a lot of exposure just by being on there, too, with all of the members they have... and everyone has a chance to add their own personal message to the letter when it is sent!!

Ok, I'll shut up now...

Here's a direct link to one that has already been set up:
http://www.thepetitionsite.com/1/keep-life-saving-electronic-cigarettes-available/

Thanks for sharing Spacekitty

 

[spacekitty]

Here's a direct link to one that has already been set up:
http://www.thepetitionsite.com/1/keep-life-saving-electronic-cigarettes-available/

Thanks for sharing Spacekitty

I saw that one, but it has already been closed...

 

[PoliticallyIncorrect]

Well this thread has gone up to 177 posts, including mine, and I have a question that I wonder if anybody at all out there can answer definitely -- without a wild guess, LOL. What Does This Mean To We Who Are Already Stocked Up for the Next Two Years?
1. Will it be illegal for us to vape with the materials we have stored up -- will we have to hide it all?
2. Will we be closet vapers?
3. If I vape on the road, will I be pulled over and have my PV confiscated?
4. If I leave my PV in my car, and it is seen, will my car be towed to the police lot?

I could go on and on with silliness, but I want to know if possession of vaping materials is going to be a criminal offense. Please and thank you.

If you're going to confiscate and destroy my WAGs, don't expect much of an answer, Seabrook. There's too many imponderables to permit anything definitive. Perhaps we'll know more after the 23rd. Or perhaps not. But certainly until then, there's only room in the house for conjecture. For whatever it's worth, here's mine:

An outright ban ain't gonna happen, and enforcement of whatever measures are taken will be limited to interdiction (seizure of Chinese shipments at ports of entry, and of domestic inventories of e-liquid). If not excluded entirely from whatever legislation is drafted, the existing materials in the hands of users will be ignored. The primary, if not sole item to be rigorously controlled by stateside manufacturers will be pre-mixed (with nicotine) liquids and undiluted nicotine solutions. It's probable that production rights will be licensed, and in such a manner that only the pharmaceutical giants will be able to afford the certification process--and the elevated level of quality control--which will make production much more expensive. The end product, of course, will be taxed in a draconian manner.

Bottom line: you ain't going to jail. The cost of e-liquids will be seen zipping away into deep space.

 

[Vocalek]

I saw that one, but it has already been closed...

Please sign this one: E-Cigarettes Save Lives - A Petition for Policy Change

 

[Poppa D]

Please sign this one: E-Cigarettes Save Lives - A Petition for Policy Change

I've signed this petition a few times but have not ever gotten the confirmation e-mail. I hope that its just me and not every one who signs it, isn't getting confirmed.

 

[spacekitty]

Please sign this one: E-Cigarettes Save Lives - A Petition for Policy Change

Thank you... I signed that one, as well as posting a reminder for people when the deadline (Sept. 1) was getting close: http://www.e-cigarette-forum.com/forum/new-members-forum/117530-shame-you.html

It didn't get a lot of replies, but got over 400 views, so I know I helped to gather a few more signatures...

I might be a newbie, but I am trying to remain informed and stay as active as I can!!

 

[spacekitty]

I've signed this petition a few times but have not ever gotten the confirmation e-mail. I hope that its just me and not every one who signs it, isn't getting confirmed.

Although the deadline for signing the petition has passed, they did/do have this notice on the page, if it helps you out:

"IMPORTANT!! SOME EMAIL PROVIDERS (SUCH AS AOL) AUTO-BLOCK PETITION SITES!! PLEASE CHECK YOUR SPAM FOLDER OR USE AN ALTERNATE WEB-BASED EMAIL SERVICE (GMAIL, YAHOO) IF YOU DO NOT RECEIVE THE CONFIRMATION EMAIL!"

(the caps are theirs, not mine... lol!!)

 

[Vocalek]

I've signed this petition a few times but have not ever gotten the confirmation e-mail. I hope that its just me and not every one who signs it, isn't getting confirmed.

Check your Junk email folder. That's where I find mine. Can't tell what your mail program's spam filter will keep away from you.

Ooops...leave it to the Special Kitty to beat me to it.

 

[Vicks Vap-oh-Yeah]

The biggest problem I have with the letters the FDA sent out, is they are still trying to regulate the products as a drug-delivery device under the FDCA (Food, Drug and Cosmetic Act), when Judge Leon specifically said they have all the authority to regulate these under the FSCPA (Family Smoking Control Protection Act) that they need. I'm inclined to agree with Leon's opinion.

If they (the FDA) really wanted to, they could drop this absurd appeal, and be regulating the products RIGHT NOW, as tobacco alternatives or a reduced risk product. Think on this - they have the authority, granted them by Congress, to hold manufacturers to quality and purity standards...all they have to do is come up with WHAT standards are acceptable.

Instead, they continue to push the appeal, they continue to make noises that these are drug delivery devices, they have now stepped up to harass local distributors, and they continue to waste the taxpayer's money while doing so. This could be OVER, folks, if the FDA would accept the premise that has been laid down by Judge Leon, that PV's are recreational nicotine consumption products, JUST LIKE CIGARETTES, and regulate the marketplace accordingly.

Why will the FDA not yield to this? Face. To back down now, to state that 'we were wrong,' would cost the FDA face, reputation, status.

 

[Vocalek]

The biggest problem I have with the letters the FDA sent out, is they are still trying to regulate the products as a drug-delivery device under the FDCA (Food, Drug and Cosmetic Act), when Judge Leon specifically said they have all the authority to regulate these under the FSCPA (Family Smoking Control Protection Act) that they need. I'm inclined to agree with Leon's opinion.

If they (the FDA) really wanted to, they could drop this absurd appeal, and be regulating the products RIGHT NOW, as tobacco alternatives or a reduced risk product. Think on this - they have the authority, granted them by Congress, to hold manufacturers to quality and purity standards...all they have to do is come up with WHAT standards are acceptable.

Instead, they continue to push the appeal, they continue to make noises that these are drug delivery devices, they have now stepped up to harass local distributors, and they continue to waste the taxpayer's money while doing so. This could be OVER, folks, if the FDA would accept the premise that has been laid down by Judge Leon, that PV's are recreational nicotine consumption products, JUST LIKE CIGARETTES, and regulate the marketplace accordingly.

Why will the FDA not yield to this? Face. To back down now, to state that 'we were wrong,' would cost the FDA face, reputation, status.

If the FDA loses, they lose face/reputation/status. If the FDA wins, the losers are the smokers who might have switched to this much safer product and the former smokers who rely in e-cigarettes to maintain their smoking abstinence. Ergo, if the FDA wins, more people die.

 

[Hudsonkm]

Sorry but that describes how I feel about all of this without me having to type lines and lines of ranting text.

 

[PoliticallyIncorrect]

Sorry but that describes how I feel about all of this without me having to type lines and lines of ranting text.

The appropriate smiley face icon is worth a thousand words. From the looks of the one you picked out, most of those words would have been trapped in the profanity filter, anyway.

 

[Aceyboogie]

The biggest problem I have with the letters the FDA sent out, is they are still trying to regulate the products as a drug-delivery device under the FDCA (Food, Drug and Cosmetic Act), when Judge Leon specifically said they have all the authority to regulate these under the FSCPA (Family Smoking Control Protection Act) that they need. I'm inclined to agree with Leon's opinion.

If they (the FDA) really wanted to, they could drop this absurd appeal, and be regulating the products RIGHT NOW, as tobacco alternatives or a reduced risk product. Think on this - they have the authority, granted them by Congress, to hold manufacturers to quality and purity standards...all they have to do is come up with WHAT standards are acceptable.

Instead, they continue to push the appeal, they continue to make noises that these are drug delivery devices, they have now stepped up to harass local distributors, and they continue to waste the taxpayer's money while doing so. This could be OVER, folks, if the FDA would accept the premise that has been laid down by Judge Leon, that PV's are recreational nicotine consumption products, JUST LIKE CIGARETTES, and regulate the marketplace accordingly.

Why will the FDA not yield to this? Face. To back down now, to state that 'we were wrong,' would cost the FDA face, reputation, status.

Well said Vicks...this whole mess is depressing

 

[rothenbj]

He, of course, had his opinion this morning-

The Rest of the Story: Tobacco News Analysis and Commentary

My Comment-

"Treating Tobacco Use and Dependence: PHS Clinical Practice Guideline

When clinicians provide treatment to patients dependent upon tobacco, the following diagnostic codes can be used. They can be found in the ICD-9-CM (International Classification of Diseases, 9th Revision, Clinical Modification) coding manual under the section on Mental Disorders (290-319).
305.1 Nondependent Tobacco Use Disorder

Cases in which tobacco is used to the detriment of a person's health or social functioning or in which there is tobacco dependence. Dependence is included here rather than under drug dependence because tobacco differs from other drugs of dependence in its psychotropic effect. Tobacco Dependence—See Tobacco Use Disorder above Excludes: History of tobacco use (V15.82)
V15.82 History of Tobacco Use

Excludes: Tobacco dependence (305.1)"

Nicotine Replacement Therapy (NRT) has had successful clinical trials and been approved for people who wish to have their dependence on nicotine altered. The idea of NRT is not to quit smoking, but to quit the use of nicotine. Tobacco dependence is what is being treated, not smoking. If SNUS or Swedish Snus (two entirely different products) or E cigs or Smokeless tobacco wish to advertise, promote or declare that they can reduce your desire to smoke, it shouldn't be within the realm of the FDA as a drug.

The disease ( if you are going to call it that) is Tobacco dependence and all of these products are tobacco products by definition (tobacco or derived from tobacco). The FDA, in its efforts to appease their client, the pharmaceutical industry, is stepping beyond what congress has empowered them to do in the realm of drug treatment. They might as well declare SUVs as drugs needing to need go through clinical trials because they promoted them safer than compact cars.

 

[DC2]

why not?

Here is a link that explains it better than I could...
Why can't plaintiff's sue the FDA for approving ... - JustAnswer

The basis for the immunity is under the theory of Sovereign Immunity, meaning that a government entity cannot be sued unless the government gives specific permission or authority to be sued. This is a common law provision that has been applied in the US and many other countrys, such as England where the Crown is immune from civil suit.

 

[DC2]

I don't think you can charge people for each post but how about a subforum where things are sold like on the classifieds but all proceeds go to CASAA? I would buy/sell to help the cause.

I have a hundreds of dollars worth of stuff that I will never use that I could sell.
And if the proceeds went directly to CASAA I would certainly do that.

Producers and manufacturers will have to deal with the necasary guide lines at some time. It would be so much better if they got busy doing it sooner. Its the businesses that effect all of us here, and the many to come. We need the bussinesses involved to responsibly deal with doing business in the USA.
It is unavoidable, we need move on and figure out if, how, and when, just plain get it done.

The problem is, they are mainly small business owners, and the cost of doing these things would be difficult to bear.

Why would anyone jump through those hoops, spending hard-earned dollars, to do those things now?
Hanging over their heads is the threat of banning these products and putting them out of business.

It makes no sense for most of them to do these things at this time.

 

[Poppa D]

DC2,
From what I've read here the reg's aren't in place because the product isn't classified, so be it. Cant hold a candle to that.
When it does get classified, it will be a different story.

I found it frustrating being a small business owner and having plenty of regulations, that any one would be fighting so hard to avoid what everyone else has to do in business.

My error, every thing has a learning curve at ECF.

 

[DC2]

From what I've read here the reg's aren't in place because the product isn't classified, so be it.

Oh yeah, I forgot about that.
I guess that would qualify as a small obstacle too.

 

[Vicks Vap-oh-Yeah]

And the only reason the product isn't classified? The FDA don't want it to be a recreational consumable. And, by inference, their 'handlers' being the Pharma houses don't want it classified it thusly, because it's in direct competition with their billion-dollar NRT industry.

The price of this mule-headedness - millions of smokers' lives. They're more concerned with their (Pharma's) profits, and the FDA's face, than with an alternative that WORKS.

 

[cozzicon]

I respectfully submit these comments, to the community.

YouTube - Commentary on FDA letters to Juice Vendors 9/13/2010