Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[JamieJ]

Danno5717 thanks for posting that link I and my family posted comments on the ecig and keeping it available to the public. I hope if they get enough posts they will reconsider pulling them from the market.

[misterME]

Cheryl---The issue is one of "intended use". That is a question Judge Leon is going to answer. IE--what is the product in Judge Leon's mind really being used for---it is his call.


Sun

Okay, if he gets to decide that, then doesn't that bring up a whole new set of questions?

Clearly, the case is about whether or not the FDA has jurisdiction over the e-cigarette as a combination drug/drug-delivery device, which is what they are claiming based on cessation claims made by SE (NJoy never made those claims, though, did they?) Since the cessation claim was made, it gives the FDA jurisdiction because anything marketed as a smoking cessation product is inherently a drug, and hence falls under the FDA's jurisdiction.

If Judge Leon decides that the FDA's claim of "intended use" does not apply to all e-cigs, and states instead that the product can be used as a "smoking alternative" when companies do not market under the cessation claim, doesn't that mitigate the need to classify the product at all? Isn't it irrelevant then whether the e-cig is a tobacco product?

I don't think I'm making my question clear...

Nicotine is not a controlled substance; you can buy it from labs with no special license or affiliation (see Blip Labs). Absent any claims of "smoking cessation", the e-cig is nothing more than a smoking alternative, using ingredients that are either FDA approved (PG, flavoring) or not subject to FDA jurisdiction (liquid nicotine). Their only argument is that the e-cig is under their juridiction because "smoking cessation" is the intended use of the device in every instance (which is ridiculous, since many people still smoke a few analogs a day after taking up vaping).

So, if that "intended use" argument is throw out, don't they pretty much lose any regulatory power over them? It's not a food. And if its intended use cannot be implied as they claim, it's not a drug. So isn't it out of their grasp at that point?

Or am I missing something?

[TheScrye]

FDA Seeking Public Comment on Tobacco Regulation

In case anyone wants to share their feelings directly to the FDA

Has this link been posted in it's own thread? I think everyone should take the time to flood their comment boxes.

[Webby]

Forgive me for getting all "Rod Serling" on this whole debate, but I’ve tried to remain sidelined for fear of alienating anyone who may be riding the fence on CASAA.

What we are in is an episode of the Twilight Zone. If logic truly dictated law, analogs would simply be banned as they are a proven health hazard. Since the world’s economy would come crashing down around our collective knees, that obviously isn’t going to happen.

Enter the surreal world of the E-Cig Zone. We can argue semantics only to a point, because the FDA always gets to play the legal card, or the “public good” card or whatever devil-quotes-scripture-do-as-I-say-not-as-I-do card that trumps your argument’s hand. However you feel you may have won the intellectual debate, you will ultimately lose as the rules are set on a sliding scale to always favor those who stabilize political coffers or grease the wheels that keep this country afloat.

So what do we do?

1) We plan for the best and keep up visual efforts to show e-cig users aren’t closet nicotine junkies. It’s easy to sit here in the forums and pontificate about how the non-smoker world isn’t giving us a fair shake. How many of you actually witness to the public? I don’t mean being an obnoxious a**, I mean proudly show off your e-cig and educate those you run across in everyday life as to what these mean to you and how they’ve helped? Most people are curious. If they don’t smoke, they drn sure know someone who does – someone they probably care about and wish they didn’t smoke analogs. Answer questions, refer people to this forum, be an active proponent.

2) We stay positive. It’s hard not to like a stranger with a sense of humor or someone who is passionate about their “thing” Instead of opening every conversation negatively with how the FDA is putting us down, take the opportunity of someone’s undivided attention to extol the virtues of e-cigs. Be prepared with a logical and factual explaination (yeah Bob, but the FDA study only found trace amounts of that bad stuff in one sample from one manufacture, did you quit eating peanut butter after last year’s problem with one plant?)

3) We Become ACTIVE. There is an incredibly talented and untapped world of e-cig users both on ECF and (especially) offlist. We rally, organize and actually start doing something in the public eye. The combined efforts of the ECA, RtV, CASAA and the vast population of supplier’s customers compile thousands of activists who are all just looking for a flag to fly.

4) Finally, we prepare for the worst. In our case, it would be a anti-e-cig decision from Judge Leon. California has vetoed it’s bill, but it is a wasted effort if the FDA is upheld. In that case, we continue our efforts and extend our resources toward public persuasion and appeal.


Am I too naïve? Mock me. GANG MOCK ME if you must…

[HaploVoss]

ouch... man... GANG mocked... that just sounds nasty! Count me out!

[Webby]

ouch... man... GANG mocked... that just sounds nasty! Count me out!

LOL...it was ONCE.. it was in college. I still carry the scars.

[jvapor]

I couldn't agree more Webby. As it is, our fight is difficult because it is an uphill battle. The number of ecig users just are not concentrated enough to have much of a public image yet. However, that number will grow and everyone of us is a spokesman for the industry. It is up to us to work to make ecigs acceptable in the public eye and to show how they are better than analogs and that we are not closet junkies. We must all continue to become more educated in order to accomplish this. As we get more support from the public we will have a much stronger position to try to keep defending ecigs. This is important because even if ecigs are not banned, this is just the beginning of the problems. The FDA and ASH will not simply give up and go away. Each separate entity will regroup in its own way and attempt an appeal or try a new tactic altogether. This is nothing that will be over soon and I see a fight for years to come. On another side note; Many of us are eager for CASSA membership to open up. Thank you for all your efforts Webby.

[Mister]

Forgive me for getting all "Rod Serling" on this whole debate

Forgive you? Never, I want to thank you!

[C2Girl]

Dam that was well said WEBBY

[Thulium]

The piece of this that is confusing me is the scope of this decision over the entire market. FDA's case rests entirely on the premise that e-cigarettes are a "new drug/device combo" and therefore under there jurisdiction. What about companies that are not involved in this lawsuit that do not sell a drug/device combination?

To my knowledge, FDA has not taken legal action against Johnson Creek and as a domestic producer, JC is not really subject to FDA's border seizures. Since Johnson Creek does not sell a device, their product can hardly be called a "drug/device combo".

What would prevent a company from selling a "theatrical prop" or even a "novelty" device for ex-smokers can use as a replacement for their former habit. After all, Once you have quit smoking, you still may have smoker friends and you don't want to feel left out!

The "e-cigarette" as defined in this case, are the family of products marketed by SmokingEverywhere and ostensibly marketed as an aid in smoking cessation. If a computerized virtual reality simulator included the ability to make your avatar appear to be smoking when in fact the user is not actually smoking or even ingesting ANY pharmacologically active ingredient, could the FDA call that a drug/device combo subject to their regulation?

This is why I've suggested the furtherance of "Smoking Replacement" as a therapeutic method. Even if you follow the FDA...er..I mean Big Pharma's advice and use a Nicotine Replacement Therapy or start taking pro-psychotic medication...er...Chantix, you are still instructed to speak with a doctor who will in all likelihood tell you that the reason that most quit smoking attempts fail is because the most critical aspect of cigarette addiction is psychological, and most people are ONLY able to successfully quit smoking if they use some sort of behavioral modification as part of their smoking cessation plan.

To my understanding of the law and jurisdiction, behavioral therapies such as exercise or even diet plans do not constitute a food or drug that can or should be regulated by FDA. I believe that CASAA or similar organizations could or should study the effectiveness of various behavioral modification programs. My educated guess is that behavioral modification would be most effective when used in conjunction with some sort of nicotine replacement. Considering that most attempts to quit smoking end in failure, I would venture to guess it means there is more to smoking than just the addiction to nicotine.

Even Smokefree.gov says this about addiction:

Quitting is also hard because smoking is a big part of your life. You enjoy holding cigarettes and puffing on them. You may smoke when you are stressed, bored, or angry. After months and years of lighting up, smoking becomes part of your daily routine. You may light up without even thinking about it.

Conspicuously missing from this statement is any implication that it is nicotine that makes it difficult to quit smoking. For as much as FDA claims that e-cigarettes can make smoking tempting to people under-age, despite the price barrier to entry...nothing was said about the fact that studies show that nicotine without the synergy of MAOIs is NOT particularly habit forming--the basis for the effectiveness of NRT as a smoking cessation. While I'm on the subject, do you seriously think that if a kid did get hooked on nicotine because of candy flavored vapor he would be tempted by unflavored smoke?

To back up my claim, I cite the British Medical Journal (here: http://www.bmj.com/cgi/content/full/335/7609/37?fmr ) that claims the most effective smoking cessation includes behavioral therapy. The Surgeon General's report shows that Nicotine Replacement alone has only a 7% success rate, but behavioral therapy increases the odds of success to 30% (and that is with OR without nicotine replacement!!).

Back on topic, however, if a business is not selling both a drug (or tobacco product) and a device and is not marketing them under the pretense of any sort of medical claim, I don't see how a ruling in this case could be applied. Maybe I'm an optimist, but I don't want to believe we live in a country where a court ruling giving FDA jurisdiction over one product gives them the authority to legislate products that don't fit the narrow definition used to justify the import embargo against Smoking Everywhere?