FDA acts against electronic cigarette distributors

[Lil' Lou]

I think D103 is right on - sellers needs to get their websites cleaned up including removing any customer testimonials that suggest e-cigs/juice have helped them quit/reduce their tobacco use. The letter from the FDA to JC references several quotes from customers to 'prove' the products being sold are 'drugs'.

 

[frisco]

Are we doing all that we can do as consumers? Has everyone contributed to CASAA? Have you signed the petitions and done the surveys. They need to hear from us in mass! We are the proof that it is an effective alternative to tobacco. We can sit here and gripe about how stupid the FDA is, and I'm all for discussion, but we also have to take action. So if you haven't contributed or signed petitions or posted comments then please do what you can.

 

[kristin]

OK I found it in the FDA's press release.

Johnson Creek was also one of the few companies to contact the FDA and ask to work with them. This is how they are repaid for attempting compliance.

I think D103 is right on - sellers needs to get their websites cleaned up including removing any customer testimonials that suggest e-cigs/juice have helped them quit/reduce their tobacco use. The letter from the FDA to JC references several quotes from customers to 'prove' the products being sold are 'drugs'.

A federal court judge has already ruled that "intended use" is what the company advertises, NOT how the consumer is using the product. Just because people are using e-cigs to quit smoking doesn't automatically define "intended use." If that were the case, then Juicy Fruit gum, straws and toothpicks could be defined as "smoking cessation devices" too.

Additionally, the FDA apparently defines "smoking cessation" as "nicotine cessation" because it'd be hard to argue that a smoker who has switched 100% to vaping hasn't "quit smoking." No smoke = no smoking. The only particular in question is "nicotine cessation."

 

[humarock]

What still irkes me is their totalitarian method. These products shouldn't be banned until proven safe; that's not how or government is 'supposed' to work. We should be left to our own devices unless they are found to cause harm.

And to add, even though Cigarettes are FOUND TO CAUSE HARM, they still let THOSE be sold...so if they are banning our e-cigs, shouldn't they be banning cigarettes then too? Forgive me if I sound naive here, but how can they have one and not the other? So why not just leave us the heck alone and if we want to use these devices let us? They let tobacco companies use Nicotine and 3,999 other chemicals and God knows what ELSE that we don't know about...so what is SO wrong with what we are using?

 

[PlanetScribbles]

I would suggest that everyone here find every little piece of dirt they can on the FDA, and post a tangible link to their Twitter or Facebook account.
Drag their corrupt butts thru the mud, in the public arena. With enough bad press, the FDA will hopefully not be trusted by the American people ever again.
It's been a long time since I saw a similar example of a Govt agency that is supposed to be protecting people's health, that in fact tries so hard to murder the very people it says it is protecting. Utter .......s. They act like a Federal court ruling doesn't mean jack
Does it mean jack? I'm starting to wonder. I'm wondering whether the cards are so abundantly stacked in their favour that public protest, or the Federal court system, is of any consequence to them.

 

[Lil' Lou]

A federal court judge has already ruled that "intended use" is what the company advertises, NOT how the consumer is using the product. Just because people are using e-cigs to quit smoking doesn't automatically define "intended use." If that were the case, then Juicy Fruit gum, straws and toothpicks could be defined as "smoking cessation devices".
"

I'm kind of new to all this, so please bear with me. So the ruling you mentioned, allows sellers to leave consumer comments (incl/ those with health claims) on their websites, where they can use it as a form of 'advertisement' without being held liable for those claims? Would it be wise (or make a difference) if the sellers had a disclaimer stating that

All comments are the experience of the user and is no way indicative of any health claims.

 

[voltaire]

Yup, you're free to go buy some Jack Daniels and some Marlboros at the store, both of which aren't considered drugs, yet have MUCH greater psychological and physiological effects than ecigs. Both will not only endanger your health, but also possibly the health of those around you.
Yet ecigs are drugs and drugs are BAD, mmmkay? That about sums up the FDA's argument, even though they already have the framework established to simply consider ecigs as a reduced-harm tobacco product, and regulate them as such.

 

[GregH]

Would it be wise (or make a difference) if the sellers had a disclaimer

It probably would have been wise but, really, wouldn't make much of a difference when it comes to the FDA.

If they are allowed to continue with this precedent, however, more makers of consumer goods had better watch out. Because I was remembering....

Years ago, I enjoyed running and fitness walking but suffered from knee pain. I switched to New Balance 851 running shoes, and my pain went away. I was so thrilled, I even posted a comment on the New Balance site stating how their shoes helped stop the pain and allowed me to continue my activities.

Now, New Balance does not advertise their shoes as a cure for chronic knee/leg pain. But my comment could have brought them to the attention of the FDA. Then their shoes could have been pulled from the market until years of extensive testing had been done to confirm that, yes indeed, my knee had stopped hurting.

It's a very slippery slope.

 

[voltaire]

I would suggest that everyone here find every little piece of dirt they can on the FDA, and post a tangible link to their Twitter or Facebook account.
Drag their corrupt butts thru the mud, in the public arena. With enough bad press, the FDA will hopefully not be trusted by the American people ever again.

Every bit helps, but hopefully we'll have the incomparable blowhard skills of Rush Limbaugh and his media empire on our side. The FDA may just rue the day...

 

[Enigma32]

I can't admonish you guys for reacting negatively to this news, I did at first as well. Step back, forget about the anger we've had brewing at the FDA, and read it all again.

They are basically throwing in the towel, but they were very careful about how they worded it all. You need to read between the lines here.

including unsubstantiated claims and poor manufacturing practices

...toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed

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.

On the surface, and of course given the history we have with them, its easy to assume they're targeting electronic cigarettes as a whole. Read those quotes carefully, they surprisingly did not say electronic cigarettes need approval. They said nicotine addiction is a disease, and claiming to treat that disease is marketing it as a drug. Go through NDA process or stop marketting it as a drug.

Market it as a drug, get treated as a drug. It's actually good news. Just sucks that they go so far as to make us silence our customers.

 

[kristin]

I'm kind of new to all this, so please bear with me. So the ruling you mentioned, allows sellers to leave consumer comments (incl/ those with health claims) on their websites, where they can use it as a form of 'advertisement' without being held liable for those claims? Would it be wise (or make a difference) if the sellers had a disclaimer stating that

A disclaimer wouldn't hurt, but acording to Judge Leon, not necessary. Testimonials are not a health claim. If a bunch of smokers went onto the Juicy Fruit web site and stated that chewing Juicy Fruit helped them quit smoking, that is still not INTENDED USE.

Look at cranberry juice. It's a well-used remedy for urinary tract infections, but the FDA doesn't go after cranberry juice products. The intended use is a tasty beverage.

 

[Chasm]

It probably would have been wise but, really, wouldn't make much of a difference when it comes to the FDA.

If they are allowed to continue with this precedent, however, more makers of consumer goods had better watch out. Because I was remembering....

Years ago, I enjoyed running and fitness walking but suffered from knee pain. I switched to New Balance 851 running shoes, and my pain went away. I was so thrilled, I even posted a comment on the New Balance site stating how their shoes helped stop the pain and allowed me to continue my activities.

Now, New Balance does not advertise their shoes as a cure for chronic knee/leg pain. But my comment could have brought them to the attention of the FDA. Then their shoes could have been pulled from the market until years of extensive testing had been done to confirm that, yes indeed, my knee had stopped hurting.

It's a very slippery slope.

I'm beginning to think it's less a slippery slope
\
.\
..\
...\

than a carefully crafted set of (small) steps leading to the same undesirable destination.
__
...|__
........|__
.............|__
..................|__

 

[D103]

To each his own, of course, but if it were me selling e-cigs, in the current climate and given the FDA's track record, I would error on the side of caution and limit my advertising/promotion to "alternative to traditional smoking" only....at least until we are on much firmer legal ground and that may be awhile yet, if at all. Also I would definitely not want to leave myself open to challenges from the FDA and others that my "consumer testimonials" were fabricated and were an attempt at doing an end run around the law and surreptitiously and illegally promoting 'health claims.' Even in the event we should prevail in the current litigation and e-cigs are determined to be a tobacco product, the FDA will have complete control over the manufacturing, safety standards, allowable substance content-likely to include nicotine levels, and the marketing/packaging.

 

[voltaire]

.........

 

[MoonRose]

I think D103 is right on - sellers needs to get their websites cleaned up including removing any customer testimonials that suggest e-cigs/juice have helped them quit/reduce their tobacco use. The letter from the FDA to JC references several quotes from customers to 'prove' the products being sold are 'drugs'.

That's exactly what the FDA is now doing, they are using our own testimonies against us to declare that e-cigs are actually drug delivery devices and smoking cessation products.

 

[DemonCowboy]

Nope, dietary supplement. But since we are not eating our e-juice, I don't think we will fall into that catagory. Unless some genious lawyer could argue that vaping is "Consuming" and is therefore part of the dietary intake. Not sure if that will work.

maybe we should start getting our nic from tomatoes, then perhaps the FDA would leave us alone as then it'd b even closer to a dietary supplement...lol we could call it tomato essence juice....

I think the best thing for every company to do is to remove all heath claims. It feels like we are at a very vulnurable time in our fight. I for one do not want to loose my PV, my juice or my nic.

don't worry smilin, if they ban it, they'll all be available anyway in 1 form or another, the FDA really has no claim here and they know it, they're just trying to make something out of nothing

 

[Bahnzo]

In part, some of this is warranted. Companies should know better than to make unsubstantiated health claims. They should know better than to add actual drugs (either approved or not) in another form and sell them. Not sure what Johnson's Creek's issue was, but like Kristin said, they actually worked with the FDA and got smacked for it. I'm actually more interested in what JC's problem is/was than the others. The others sound like they got what was coming to them.

What I don't understand however, is there is a lot of this kind of thing that goes around. You see it on late night TV and magazines; companies advertising weight-loss products and health pills, but with the disclaimer "These claims not evaluated by the FDA". And they get away with it....so what is the difference?

 

[rothenbj]

I agree with you that it would be good to get rid of unapproved drugs being added and products that might be tainted. All of that can be accomplished if the FDA regulates those products that do not make any health claims as tobacco products under the Tobacco Act.

But if by "Work with them" you mean companies should start the New Drug Approval process for regulation under the FDCA, then you don't understand what we are up against......... [/COLOR]

Thanks Elaine, you responded to the first post I saw after getting home tonight and saved me a lot of words. Basically, the translation to what the FDA is saying is get them off the market, pony up millions and maybe a decade or so from now we'll reach a decision.

I just want to make one additional point. The FDA and our friendly ?non-profit?"health" organizations have so clouded this issue of smoking cessation. Once a point in time, that was the topic. The nazis have taken the eugenic approach, all use of tobacco/nicotine, other than sold to you by your friendly neighborhood pharmacy, must be eradicated. The FDA hasn't approved stop smoking products, they have approved Nicotine Replacement Therapies. In other words, they are selling products to get you off nicotine. At the same time Big Pharma is looking at nicotine to treat various other maladies.

They have declared nicotine addiction to be an ailment and they are looking at nicotine to cure not only that addiction but other physiological ailments. The whole theory boggles my mind. I'm waiting for Chargemalot Pharmaceuticals to provide me with low alcohol scotch to cure my alcohol addiction next and making it very ineffective and costly.

In my opinion (if I ruled the world), any company that provides nicotine and tobacco that doesn't involved consuming combustible material should be able to say it is safer than cigarettes and they should be able to say that they may help you stop smoking. In most cases, smokeless tobacco, Swedish snus, E Cigarettes and all the other varieties of alternative all fit into this category and all would help alleviate the majority of the health risks associated with tobacco consumption.

It is becoming very clear that eliminating smoking is really not the goal, only the appearance of eliminating smoking so they various industries can continue to survive on the backs of the smoker. Rant over

 

[rothenbj]

I also generally agree with what you say.........

Some possible suggestions for our suppliers:

- Get organized among themselves.
- Set up some basic guidelines that all members agree to comply with.
- Provide basic labeling on your bottles stating who made it and where
- Accurately label the content and sources of your ingredients in your Juice
- Start determining appropriate expiration dates and include that information on each bottle
- Hire some independent companies to periodically verify that what you say on the bottle is true.......

I've been saying that about fast food for years........ just sayin

 

[VapnChief]

Folks, I've said it before and I will say it again. None of this action is about concerns for your health. The FDA have read the E-cig health studies.

This is about the Obama regime gaining TAXING authority on e-cigs.