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

[Elokin6]

This is insane. I really hope that there is some sort of negotiations going on behind the scenes that is delaying this ruling. If it's just chillin' out on Judge Leon's desk, that's total bs.

Thanks for the update, Sun.

[AngelVapor]

True that.

[Sun Vaporer]

Gals and Guys, the Problem with that is you can not just ask the Judge to hold up on his ruling if you are negotiatiing unless you file a Joint Motion to Stay the Proceedings Pending Negotiations---In other words the Docket Sheet would show the parties actually Motioning the Court to stay its ruling and that simply is not there.


Sun

[PhiHalcyon]

PH wrote:
"I think that nicotine-containing e-liquid (apart from all labeling and advertising considerations) is clearly a modified risk tobacco product."

While the courts and/or the FDA could (and should in my view) redefine e-cigarettes as tobacco products, under the new FDA tobacco law, there aren't any "modified risk" tobacco products, but rather "modified risk" claims, which are banned unless/until a manufacturerer (and perhaps an importer) applies for making the claim and the FDA approves. Each manufacturer/importer would have to apply separately (and FDA would approve separately) for making a "modified risk" claim.

As such, if e-cigarettes are legally defined as tobacco products, it would be illegal for any e-cigarette manufacturer/importer to truthfully claim that they are less hazardous alternatives to cigarettes unless/until an application to make a "modified risk" claim was applied for and approved by the FDA.

Although smokeless tobacco products are about 99% less hazardous alternatives to cigarettes, the new FDA law specifically prohibits smokeless manufacturers from truthfully claiming that their product is a less hazardous alternative to cigarettes, as doing so would be making an unapproved "modified risk" claim. Simply put, the FDA will order any tobacco product that make unapproved "modified risk" claims removed from all stores.

You are in large measure correct; although 'claims' can be implicit as well as explicit, and how can you state what is in the e-liquid without implicitly communicating what is not in it?

You make a great point in regards to the truth about some smokeless tobacco products, but what would an ecig ad look like if you couldn't talk about what is not in the vapor, or why it is less harmful than smoking regular cigarettes? What's the point in having a product with such benefits and not being able to tell consumers about them?

Like Star Scientific (maker of Ariva and Stonewall dissolvables), ecig manufacturers/importers should want to seek FDA approval to market their product as a modified risk tobacco product. (See: Star Scientific Breaks New Ground, Plans FDA Filing for Approval of First )

So if/when the courts and/or the FDA defines e-cigarettes as tobacco products, Ruyan, NJoy, SE and perhaps others (that were on the market before February 2007) would be grandfathered in as tobacco products.

E-cigarette products that began marketing in the US since 2007 probably could/would become "substantially equivalent" to e-cigarettes marketed before 2007 (although its uncertain if companies would have to obtain FDA approval and/or the specific criteria FDA would utiziled in determining/rejecting a tobacco product as "substantially equivalent" to another tobacco product already on the market).

I don't believe there is any contention regarding whether or not the ecig (or e-liquid in particular) is a tobacco product under the FSPTCA (the contention is whether or not it is a tobacco product that should be regulated as a drug product); but in order for an ecig product that was commercially marketed in the U.S. as of February 15, 2007 to be considered a valid predicate tobacco product for a substantial equivalence claim, it would have had to have been a legal tobacco product (and not an unapproved drug product) at the time it was introduced. So, even though the ecig is a tobacco product under the broad definition in the FSPTCA, the question is: What was the ecig before the FSPTCA?

All things considered, I believe that the most honest, straight-forward, and promising course of action is for an ecig/e-liquid manufacturer to register with the FDA as a tobacco product manufacturer, and submit an application for approval as a modified risk tobacco product. The FDA does not need to be challenged; just proactively engaged with.

[Sun Vaporer]

All things considered, I believe that the most honest, straight-forward, and promising course of action is for an ecig/e-liquid manufacturer to register with the FDA as a tobacco product manufacturer, and submit an application for approval as a modified risk tobacco product. The FDA does not need to be challenged; just proactively engaged with.

There are some right here on this Forum PhiHalcyon who have tried to registaer and go thought the approval process only to find they are getting the full run around.


Sun

[PhiHalcyon]

There are some right here on this Forum PhiHalcyon who have tried to registaer and go thought the approval process only to find they are getting the full run around.

That's probably because the FDA has already asserted its position, and is not interested in regulating the ecig as anything other than a drug product. So, unless and until the courts dictate otherwise, it's not changing its position. Government agencies do not give up power easily, and the FDA has the most power as a drug product/device regulator.

This is one of the reasons why I shifted my agenda from seeking an ecig approval to developing a product that didn't need an FDA approval. For, who knows how long it is going to take before the courts will be able to settle the matter?

[Legal One]

It is not possible to make a product that is a replacement for a conventional cigarette without it being considered a drug/device combination or medical device by the FDA. This is their position straight from the Center Director and one they will fight to the end. This case is "all in." No settlements, no negotiations, no compromises. It is about an Agency interpreting the law that confers power to it and it has staked out its position clear as day. Read the briefs - they explain it quite simply. If anyone believes they can obtain FDA approval for a drug/medical device that provides all of the effects and attributions of a regular cigarette but can still pass the requirements for proving safety and efficacy for a defined therapeutic benefit - good luck.

The Judge will rule and it will go from there. It is not ordinary but it is also not unusual for a ruling to sit for months even years in some cases before publication. The reasons are many but the reasons do not matter - a ruling will issue and when it does the delay will be a distant memory.

[Sun Vaporer]

It is not possible to make a product that is a replacement for a conventional cigarette without it being considered a drug/device combination or medical device by the FDA. This is their position straight from the Center Director and one they will fight to the end. This case is "all in." No settlements, no negotiations, no compromises. It is about an Agency interpreting the law that confers power to it and it has staked out its position clear as day. Read the briefs - they explain it quite simply. If anyone believes they can obtain FDA approval for a drug/medical device that provides all of the effects and attributions of a regular cigarette but can still pass the requirements for proving safety and efficacy for a defined therapeutic benefit - good luck.

The Judge will rule and it will go from there. It is not ordinary but it is also not unusual for a ruling to sit for months even years in some cases before publication. The reasons are many but the reasons do not matter - a ruling will issue and when it does the delay will be a distant memory.

Thanks Legal for chiming in. So there you have it striaght from Counsel--no settlement, all in, and the ruling will come. So lets just wait it out and see what Judge Leon has to say with an Appeal on the horizon.


Sun

[PhiHalcyon]

It's not that the battle to have the ecig regulated as a tobacco product cannot be won, but whether or not the battle is worth the cost. And if the FDA is so firmly adamant as Legal One says, then the answer is probably not.

On 18 June, 2006, a notice published by the State Food and Drug Administration of the PRC proclaimed that “Nicotine electronic vaporizer: to be used to help smokers quit smoking, reduce physical requirement of nicotine by them and relieve conditions caused by nicotine withdrawal and therefore is not subject to the regulation of medical appliances.”

It looks like part of the land of liberty has moved to China.

[JerryRM]

Just my two cents worth, but I have been around long enough to be very cynical. In the end it will boil down to money, not our health.

Thanks guys for keeping us informed as to what is going on.