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

[Sun Vaporer]

This is true. Look at all of the "reduce risk" products currently in the tobacco category, including a product that doesn't include tobacco at all: Tobacco Free Snuff I think it is. It contains absolutely no tobacco, no TSNA's and is a tobacco product. Now how is that? It is that way because a tobacco company put it onto the market.

The original quote from Matt was also based off of scientific data as presented by Dr. Nitzkin.

There appears to be some confusion in writing styles and quoting as the ECA's message is that the electronic cigarette is a Reduced Risk Product and should be warranted the same rights as the Reduced Risk Products put out by Big Tobacco. The issue here is that there are only two thought processes: Tobacco or Pharmaceutical and according to the ATF way back when, they did not want the risk reduced products UNLESS they are produced by Tobacco companies, of which manufacturers/suppliers of Ecigs are not.

In order to fall into the Pharmaceutical group, claims would have to be made in order to fall into FDA jurisdiction. The FDA is arguing (rightfully so) that the electronic cigarette sold by Smoking Everywhere is in fact under their jurisdiction due to the marketing claims. nJoy is arguing that electronic cigarettes fall into the tobacco category more so than the pharm category if claims are not being made.

This all comes down to claims and unfortunately, the FDA made the assumption that the electronic cigarette is offered by one company and unfortunately, the company that made the biggest impression was a company that was making claims.

Lacy--I know you are hung up on the marketing ---but you should not be. It really does not matter how these were marketed. The law looks at the totality of the circumstances: To be specific, the law states:

The FDA defines “Intended Use” as:
The term "intended uses" refers to the objective intent of the persons legally responsible for the labeling of the device. The intent is determined by their expressions or may be shown by the circumstances surrounding the distribution of the device. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such representatives. It may be shown by the offering or the using of the device, with the knowledge of such persons or their representatives, for a purpose for which it is neither labeled nor advertised. (21 CFR 801.4)

How these devices were and are marketed is not going to save the day. If that was the case, there would be no reason for Judge Leon to call a second hearing about the different legislation schemes. If Judge Leon was going to zero in on the "intended use" --he would not be looking at other legislation.

Sun

[Sun Vaporer]

Today the Docket Sheet showed no filings or advancment. There is only 5 days until the Hearing on the Preliminary Injunction. The request for this "immediate relief" by and for SE and NJOY was filed coming on 4 months ago.


Sun

[deewal]

Today the Docket Sheet showed no filings or advancment. There is only 5 days until the Hearing on the Preliminary Injunction. The request for this "immediate relief" by and for SE and NJOY was filed coming on 4 months ago.


Sun

Maybe Lionel Hutz is still on holiday.

So what brand of Cigarettes are you going to be smoking next month ?

[TropicalBob]

Once again, Sun is right that claims are not going to be and never were a factor in the FDA's decision to halt e-cig shipments. The core consideration is how these are used. Call them anything; it makes no difference. Deny the reality; it makes no difference. Claim absolutely nothing; it makes no difference.

Every seller of e-cigs has his/her fate hanging on this court decision. Either way, of course, e-cigs lose, whether tobacco or drug product, the FDA will control them. But the fact is that they have always been a product to deliver a drug with psychological and physiological impact, meeting the full definition of what the FDA has authority to regulate.

One way or another, FDA regulation is coming. Yes, ECA should have been involved to get the best deal possible. Too late now. At the moment, we're like the passenger in the 15th row of a crashing airplane asking if he can talk to the pilot about the pre-flight check.

Too much time was wasted on denial. Not enough was spent on tests and studies.

[Territoo]

TB--there is no way that anyone but the Manufactures that are going to be paying for the requisite studies. That is set in stone.

Sun

Trouble w/ this is that the manufacturers will fund the research, pass the cost to the consumer on a product that will be taxed like tobacco. Double whammy!

[TropicalBob]

That's not called "trouble". That's called abiding by regulations. We can shop where we want and buy or not buy at prices we deem satisfactory. But there is no right to import and sell an unapproved drug product and device. That's the "trouble".

[lotus14]

Trouble w/ this is that the manufacturers will fund the research, pass the cost to the consumer on a product that will be taxed like tobacco. Double whammy!

Does anyone here hope the FDA does the testing? Given their track record, I certainly don't.

Given the recent legislation by congress, the FDA has regulatory authority over e-cigs whether they are deemed tobacco, a "reduced risk" product, or a drug delivery device. It would seem to me that the reduced risk classification would speed the approval process greatly. No need to prove "perfect" safety, just substantially safer than cigarettes. No need to prove long term abstinence rates as an NRT treating the disease of addiction.

[CattMurry]

Trouble w/ this is that the manufacturers will fund the research, pass the cost to the consumer on a product that will be taxed like tobacco. Double whammy!

I agree that the cost of research and testing required for FDA approval will be passed on to the consumer, I just don't see how they can place higher taxes on them if they prove to have no significant health risk.
It has always been my assumption that the higher taxes on tobacco products were "justified' as a way to offset the increased cost to health care and/or fund government projects like education and such. (at least that's what some of the taxes where I live are used for).

Are products like the patch and nicotine gum taxed at higher than normal rate ? I always thought their high price was due to the fact that they are made and marketed by the drug companies.

If e-cigs are harmless, how will they justify higher taxes on them?

Nicotine (in low dosage) is available at the checkout of almost every drug store and " 2nd hand vapor" is no more harmful than the FDA approved "smoke/fog" used at any concert.

My big fear is that they will be off the market just long enough for me to fail "Quitting'" once again , and go back to analogs just long enough to get cancer while they sort this out.

[robbiehatfield]

My big fear is that they will be off the market just long enough for me to fail "Quitting'" once again , and go back to analogs just long enough to get cancer while they sort this out.

Didn't the FDA deny allowing patients dying from AIDS to try AZT because they hadn't approved it yet? Safety first!

There's too much red tape today and this is largely because most people are afraid to even consider being responsible for their own decisions. It seems that everyone wants some kind of large government agency or a large business to blame should their decision to vape be a perilous one. This all comes at a price. A big one.

Robbie

[Duckies]

"2nd hand vapor" is no more harmful than the FDA approved "smoke/fog" used at any concert.

Playing devil's advocate here, but are you completely sure that '2nd hand vapor' only contains PG like fog machines?

We all know that nicotine is not a carcinogen, but it is not a good idea to post things as facts until we know the full story about trace elements that may linger in a vaping exhale (especially if someone vapes without inhaling ala like one might do with a eCigar).

Personally, I do not vape around non-vapers (other than requested demonstrations by Docs/family/friends) just like I wouldn't smoke around non-smokers because I simply don't know.

YMMV