Cease and desisit letters to ecig suppliers?

[leeshor]

Thing is, I'd like the FDA to do MORE in some areas. All these E. Coli outbreaks, the bad eggs, diet and heart drugs that are killing people ... it goes on and on. I don't know how some of the *drugs* on the market were ever approved, with all the crazy "side effects," like the drug for a skin rash that can KILL you in several different ways.

On the other hand there are drugs being used in Europe that have proven very safe and very effective over long periods and the FDA can only study them to death. One problem is the misplaced priorities of the FDA.

With that said, there is still too much influence by big Pharma. They should take Chantix off the market before worrying about the effects of E-Cigs. There's something that can literally drive you crazy.

 

[Xanax]

Sooo I'm confused... Is Vapor4Life affected by this or what? Did they recieve a cease and desist letter? If not, why is this in the V4L forum? And if so, what's gonna happen to V4L as of RIGHT NOW? Anything? Won't they have to stop filling orders? WTF.

 

[bpaulette]

V4L didn't get letters (at least according to all of this info), neither did 99% of the other e-cig related vendors. Only 5 companies

 

[smilin0117]

Why do people keep going back to comparisons with major drugs like prozac?

Prozac (and every other drug people are bringing up) was developed by a major pharmaceutical company that shelled out hundreds of millions of dollars, in order to figure out all the possible side effects, and as required by law, then clearly spell out those side effects wherever its marketed, etc...etc.... Don't you see those annoying commercials where 10 seconds is marketing, then 50 seconds is the list of side effects?! The problem here is that no small e-cig/juice company can afford those tests right now... but if they can be kept in the realm of tobacco-ALTERNATIVE, its harder for the FDA to be as strict

This is really just more of the same (did border seizures ever really stop? no), and its what they've been warning ecig vendors against all along. Whats at the heart of ALL of this is the marketing. They are telling a small handful of retailers that they CAN'T MARKET IT AS A SMOKING CESSATION DEVICE... Easy! OK! So don't f#%#ing do that!!!!. Then other people say "well, those were just customer testimonials!" YEAH - they were customer testimonials on JCreek's effing WEBSITE - as soon as you (the company) put ANYTHING on your own website, regardless of who wrote the content, its being used as marketing. no .... sherlock

The other stuff about e-cig direct offering juice with ...... and weight-loss medication and vitamins, added right into the juice... that's just moronic, and they were practically asking to get shut down - its companies like that which could make the fight much worse

I think all e-cig hardware/juice suppliers need to take a VERY hard look at their website marketing content, and make sure its spelled out crystal clear, that its an alternative, not a cessation device. Even testimonials and reviews... yes, reviews too... if its on your site, its being used as marketing. bring out the fine tooth comb

couldnt have said it better myself!

TAKE THE COMMENTS OFF YOUR SITES GUYS!! WE CAN GET THRU THIS!!

 

[JohnReagan]

Looks like they are deciding that it is drug delivery buy the way it is advertised on the web site. Here is a copy of the letter to Johnson Creek.

Johnson Creek Enterprises, LLC 9/8/10

That letter to Johnson Creek looks like a letter from the Mafia in the 1930's.

 

[rhsmitty]

If e-cigs are a fricken drug delivery device and subject to regulation, then so are cigarettes. Ok to sell a proven known killer with no regs but not ok to sell a simple device that gives people a choice. Fricken Morans!

It is sad that we can not talk about the fact that e-cigs has helped so many people leave the nasty filty cigaretts alone. We should be able to Shout that to the world!

 

[pianoguy]

V4L didn't get letters (at least according to all of this info), neither did 99% of the other e-cig related vendors. Only 5 companies

But it certainly is a shot across the bow. It would seem prudent for all suppliers to remove anything from their sites that supports the positioning of the e-cig as smoking-cessation device, and to include disclaimers.

 

[bpaulette]

It is sad that we can not talk about the fact that e-cigs has helped so many people leave the nasty filty cigaretts alone. We should be able to Shout that to the world!

No, WE CAN shout that to the world. But a vendor can't, and they can't really even repeat what we say on their website (if our statements make claims that haven't been verified).

I could drink some Gatorade, and start telling the world that it gave me Adonis-like pecs and glutes, magically, in only a WEEK! I could post that all over the place, tell the world - I could even create my own website all about how I think its the greatest chance at a cure for cancer ever created. Free speech.

But if the Gatorade corporation put excerpts from my unverified "testimonials" up on Gatorade.com, repeating what I've said about gatorade-muscles and a possible cure for cancer, they are then incorporating my statements into their own marketing, and making unsubstantiated claims. We can say whatever we want about this stuff, but a company that profits from the sale of that merchandise can't - unless its been proven and verified through clinical trials.

 

[TheLordWinter]

But it certainly is a shot across the bow. It would seem prudent for all suppliers to remove anything from their sites that supports the positioning of the e-cig as smoking-cessation device, and to include disclaimers.

And that's the whole point behind all of this, including the FDA's warnings. They're basically saying "Look, you've got the right to sell this crap for now, but we're on the hunt cause we're not getting our way. Watch what you say, because anything that falls within our jurisdiction is going to be met with heavy handed, politically biased, justice."

Now look at that for what it is: You CAN continue to sell as-is, provided that you remove any such claims that put your product in the realm of a drug delivery device. You can't say it's safe, you can't say it is safe-ER, you can ONLY sell these things as a "smoking alternative". You can't put testimonials in as advertising, unless they talk about, and ONLY about the efficiency of the device in producing, and delivering vapor, about the device's longevity, durability, battery life and other things of a electronically technical nature. Heck... use the warranty as a selling point if you have to! lol

Just remember, you can only claim ignorance once. If they ping you again, you're in trouble. Not only that, but we ALL are. Things like this are going to hand the FDA their case in a giftwrapped basket.

Edit: The shame is that you can't even say "E-cigs/Personal Vaporisers taste better than traditional cigarettes!", because right now, the FDA's heavy handed tactics can be used to interpret that as marketing the device as a "stop smoking aid" by the way they interpreted the testimonials on the Johnson's Creek website alone.

 

[Gravity]

Edit: The shame is that you can't even say "E-cigs/Personal Vaporisers taste better than traditional cigarettes!", because right now, the FDA's heavy handed tactics can be used to interpret that as marketing the device as a "stop smoking aid" by the way they interpreted the testimonials on the Johnson's Creek website alone.

TASTES BETTER?!? MUST be for KIDS!

 

[Xanax]

Well why is this in the V4L forum? Shouldn't it be in E-cig news?

 

[Mary Kay]

It is in E-Cig news and everywhere else on the board. Some of our fellow V4Ler's don't cruise the rest of the board and this post is in the right place as it can affect V4L as well as Steve's customers.

 

[jtcaseyjr]

This "Drug Delivery system" thing is really starting to get my goat. I said this in another post, doesnt that make coffee or Red bull a drug delivery system as it contains caffeine. Nicotine is NOT illegal, nor is it a prescription (Except the Nicitrol inhaler). Tobacco compaines sell it in smokes, Snus, Chewing tobacco, Orbs, nicotine sticks...I mean CMON!! I really think the FDA should be looking into the safety of other drugs that they already approved and are hurting people and stop worrying about E-cigs being a "Drug delivery system"

 

[BrockJ]

Tobacco Companies do sell it and they also pay taxes on it. *That's the little stamp on the bottom of the pac and also on liquor bottles*
This isn't about the countries health, it's about money. They call it taxation.. They see that this is a billion dollar industry and they want their piece.

 

[BrockJ]

If e-cigs are a fricken drug delivery device and subject to regulation, then so are cigarettes. Ok to sell a proven known killer with no regs but not ok to sell a simple device that gives people a choice. Fricken Morans!

Cigarettes are regulated and illegal to sell to minors. They now say where you can and cannot smoke them. How soon they should go out if not being smoked, etc..
Pall Mall can't have a website with postings about how good they are or how much the users enjoy them and how everyone should start using them.
*That's regulated* They've been doing it to alcohol and tobacco companies for years.

 

[Arthur Dent]

Cigarettes are regulated and illegal to sell to minors. They now say where you can and cannot smoke them. How soon they should go out if not being smoked, etc..
Pall Mall can't have a website with postings about how good they are or how much the users enjoy them and how everyone should start using them.
*That's regulated* They've been doing it to alcohol and tobacco companies for years.

But interestingly, until this year, the FDA didn't even require tobacco companies to list the "ingredients" in cigarettes, which include flavorings and chemicals to affect taste and burn rate (and allegedly, nicotine absorption). And to my knowledge (again, until changes begun this year) NO testing has been done on the safety of these chemicals as absorbed through cigarette smoke.

It's always been astounding to me that a product that has been so decried for being dangerous has enjoyed a kind of consumable product safety exception. Sure, tobacco's dangerous, but it's seemed like tobacco companies also had a free pass to add whatever other potentially dangerous chemicals they wish. Even now, exact "formulas" will be kept secret from the public as "trade secrets."

Given this, it seems to me that the most that should reasonably done with e cigs is 1) Restrict sales to adults, 2) Ensure nicotine is handled safely, and 3) Ensure ingredients meet normal food safety requirements for purity and (nicotine aside) non-toxicity.

Taxation's another question. I don't see the justification for the enormous "sin tax" levied on tobacco products on the theory that society needs to discourage tobacco use and recoup the costs of tobacco users' health problems, for this product, which, while not yet thoroughly tested, seems likely to be orders of magnitude less dangerous than smoking.

Just seems to me it would be ridiculous to subject e-cigs to the steep testing requirements for "drug delivery devices" when the product they are designed to replace has been loose on the market for decades (centuries) with virtually no requirements to make it safe(er) in any way.

 

[DaDuke]

it was clear what claims could and could not be made early on...
yet these companies continued to advertise thier products as an aid to stop smoking....some of them even promoted vapeable vitamins, ...... or weight control drugs...

(the exception I'll say is johnsons creek (that one was primarily based on customer testimonials)

by those things...it goes back under the classification of drug device which there has been no new drug applications...
companies like that are undermining the headway made in the SE & Njoy VS FDA case.... and they were rightfully stepped on...

Agreed 100% about them undermining the effort even though we all know they are basically true in their claims about smoking cessation... the law doesnt care about truth, only whats technically legal and therefore need to watch what they say.

The JC letter is a more difficult to foresee avenue of attack as most would think "those are merely testimonials". This is all very educational and all eliquid suppliers should take note as to the lengths the FDA is willing to go and the methods they will employ to get their way.

Looks like they are deciding that it is drug delivery buy the way it is advertised on the web site. Here is a copy of the letter to Johnson Creek.

Yes, since nicotine addiction and withdrawal are legally classified as a disease, anything that claims to treat nicotine addiction is legally considered a drug and therefore falls under their jurisdiction and the FDA then has the authority to regulate you and make you conform to a myriad of regulations required for all drugs.

I am dubbing this the "Al Cappone Strategy". Just as in the case of the fed not being able to nail cappone on criminal charges, they used other laws to get him... tax evasion. In that case it was justice by any means and generally a good thing. In this case its an abuse of power by an agency that has far too sweeping and broad range of authority.

On the bright side, the FDA is basically tipping their hand and allowing us to see how to beat them at their own game. A supplier would be wise to not make any claims about the products and just sell the product... period. At most they should direct new customers desiring information to outside sources such as the forums and clearly state a disclaimer that "the opinions of any outside sources are not necessarily those of this company". Even that can be risky if not done properly. The more you say the more can be used against you in a court of law.

This should be viewed as a healthy alternative activity to smoking. The fact that they look similar is all that smoking and vaping have in common. One burns a chemical laden product, one heats a liquid with a fairly harmless substance.

All I am saying is that we as a community need to take it from the place of "this isn't smoking" and while most if not all that vape quit smoking, at least for me its not about that. Its about a healthy alternative. I like the inhaliing and blowing out smoke, so if I can do that with out killing me or ones around me great.

/End Rant Here /

Not slamming you at all but want to show how easy it is for the FDA to use any words against us. I highlighted the sections of your post that the FDA used in one or more of the letters as grounds to classify their products in violation of regulations.

1- healthy alternative: not clinically proven that ecigs are healthy and cause no harm. Not proven that they are any healthier than analogs. Common sense doesn't come into play in a court of law.

2- ecig / smoking similarities: there is no clinical data proving that carcinogens found in analogs are not present in some vapor from the myriad of products available and from a host of suppliers. Face it, many of the suppliers are small kitchen chemists with no oversight so it wouldn't be hard to find some "questionable" byproducts in some liquid.

3- Fairly harmless: again, without clinical evidence even that cannot be claimed.

4- most if not all that vape quit smoking: this was specifically cited as grounds to classify their product as a smoking cessation device which then makes it fall under the classification of a drug delivery device since smoking in itself is considered an addiction and therefore a disease which in turn means your product is claiming to treat a disease which by definition is what some drugs do.

5-a healthy alternative: see answer 3

6- with out killing me or ones around me: Double jeapordy. Not only does answer 3 apply again BUT the FDA specifically cited claims about second hand vapor being harmless as grounds for some regulation violation.

Just pointing out our vulnerability when we say anything.

@Bpaulette: All you points are well spoken. Your points on private citizens right to free speach and how that differs from a companies rights in what they say in promoting their products is spot on.

 

[rver]

I wonder how much money is donated to the FDA by cigarette company's!!!

 

[Arthur Dent]

I wonder how much money is donated to the FDA by cigarette company's!!!

Not shooting down the "powers that be" theory -- totally legitimate -- but the FDA doesn't take donations, so they're probably not directly beholden to tobacco companies. They DO get funding from pharmaceutical corporations for research, however.

 

[CSR]

Has anybody read this FDA letter?
All they're saying is they want confirmation that JC's manufacturing procedures conform to fairly simple quality procedures.
Just like restaurant preparations.
I hate to admit it, but that can't hurt us vapors. The tobacco was bad enough.