Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
- Thread starter Sun Vaporer
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Again today--no movement on the Docket Sheet---but it is Father's Day weekend. It is very frustrating to see a TRO request get consolidated into a Preliminary Injuction and still not have a ruling on the Motion that was heard over a month ago on May 15, 2009. But I am sure Judge Leon has his reasonings. Time will tell.
njoy having product again to sell for Father's Day is interesting. I checked there website and they do have inventory. ---------Sun
njoy having product again to sell for Father's Day is interesting. I checked there website and they do have inventory. ---------Sun
Today, SE filed a supplemental brief in support of not rendering their case moot due to the newly signed legislation.
We will now await a reply from the FDA
-------------Sun
We will now await a reply from the FDA
-------------Sun
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Today, Judge Leon granted SE's Request to file their Supplemental Motion and Brief in Support thereof and further ordered the FDA to file any Reply by July 6, 2009.
---------Sun
---------Sun
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OK well in honor of my 200th post - I'll just be mostly optimistic - I see a lot of wording that I really like in there -
I'll just go happily work in my garden for a while now and let the dark clouds roll in and rain on me later -
At which time I'll just dust off my trusty umbrella
What I think you're saying, here, Sun - is this is simply a rehash of what the court case is about, given additional thought to how the new legislation affects this particular case.
This is not a ruling... the case goes on...new deadlines have been established.
We wait longer.
Thanks SM--that is the section I was trying to remember whereby e-cigs could continue to still be manufactured, but studies must begin on the safety of the product--BUT while still allowing manufacturing of the product. Thus, no outright ban. SE's law firm did address this issue, but it clearly is not their main argument. The FDA are attacking e-cigs as a drug, a new drug, a new nicotine delivery device. SE's attorneys say "Can't do that." And that makes the assertion even stronger with their interpretation of the new Act- as they just argued.
I agree Sun as this was really a formality. SE's "Instanter" brief (never even heard of "instanter" before now) was well drafted, but it was generally not very persuasive--more like playing the name game which we all know as semantics.
Sun: Do you mind telling us your legal background? You seem to have a firm grasp of all things legal including proper interpretations.
I merely went through a paralegal program offered by the community college several years ago. I never practiced law--except my own filings pertaining to only me. In CA, paralegals must be supervised by an attorney to even call oneself a paralegal. And even then, offering legal advise is considered Unlawful Practice of Law (UPL). Paralegals were taking business away from CA attorneys. CA attorneys said no more legal advice for paralegals.
Same thing is going on in Florida right now. Paralegal shops at every corner. For yvilla: Me thinks I was wrong!
As I said, happens a lot. 
For yvilla: Me thinks I was wrong!
Mike, we can all be wrong at times - no worries there.
But yes, now that we see the whole of SE's supplemental brief, it is crystal clear that they are explicitly claiming "tobacco product" status for ecigs as I thought, and claiming that the new legislation supports their original argument that ecigs should not be regulated as "drug-devices" or as a "drug". The heart of that argument is this paragraph from their brief:
"While the electronic cigarette falls within the definition of a "tobacco product" under the new authority provided by 21 U.S.C. § 321(rr) and the new Section 901, as noted above, the Act explicitly specifies that a "tobacco product," such as the electronic cigarette, cannot be treated by the FDA as a drug, a device, or a combination product. Accordingly, the FDA's decision to classify E-cigarettes as a drug-device combinationa decision made without public notice or opportunity for commentand to ban the importation of E-cigarettes as an unapproved drug simply lacks any prior statutory basis and directly contradicts the plain language of the new Act."
It will certainly be interesting to see if Judge Leon agrees with them or not. And of course, even if he does and they win this skirmish with the FDA, the battle would be far from over. Next up would be the proper interpretation of the new Act, and how ecigs get treated under that.
Well now we have to wait for the FDA response. The FDA I am sure has their best lawyers working on this just as hard as SE does. They will take the SE statements and twist them around to the FDA s benefit. Hopefully the judge will not fall for it but with they way politics are these days I can see him ruling for the FDA. The FDA has alot of influence whether SE likes it or not so we have to play the wait and see game. I hope it goes in SE favor but only time will tell.
Today, SE filed it Brief supplementing the legal authority it cited in its original pleadings to the Court in light of the passage of the new Tobacco Control Act.
The FDA has until July 6, 2009 to respond. I would expect NJOY to also file supplements. After that the Court will issue a ruling.
Sun
The FDA has until July 6, 2009 to respond. I would expect NJOY to also file supplements. After that the Court will issue a ruling.
Sun
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I agree that it belongs in a new category -- not drug, not tobacco. It's a novelty. A toy. The problem for us is that too many sellers advertised false claims for too long, drawing regulatory attention and initiating that letter from Sen. Lautenberg to the FDA demanding a full ban. It is probably too late now to change the stripes on this skunk.
The only real issue I think this suit contains is whether the FDA followed protocol before and at seizure of shipments. And it's hard to think they'd make a mistake. This was not a precipitous action, after all. It had been considered for many months; emails were carefully worded after the law was studied, etc. The FDA knew exactly what it was doing.
I believe Sun has hinted that the lack of a quick decision for injunctive relief means the judge knows his ruling will have a major impact on this new industry. His judgment will become e-smoking law. I'm glad he's taking his time. I hope he offers clear guidelines on what is and is not allowed into the country.
The only real issue I think this suit contains is whether the FDA followed protocol before and at seizure of shipments. And it's hard to think they'd make a mistake. This was not a precipitous action, after all. It had been considered for many months; emails were carefully worded after the law was studied, etc. The FDA knew exactly what it was doing.
I believe Sun has hinted that the lack of a quick decision for injunctive relief means the judge knows his ruling will have a major impact on this new industry. His judgment will become e-smoking law. I'm glad he's taking his time. I hope he offers clear guidelines on what is and is not allowed into the country.
TBob, you ask how is the ecig different from NRT drug products. The answer to that is their intended use. The pharmaceutical nicotine lozenge, gum, nasal spray products are all specifically designed, formulated and intended for use solely for smoking cessation purposes. They are all packaged with instructions to that effect, and are recommended only for short term use.
Of course someone could and people do use them for longer than intended, but that is not the issue. It is the intended use that makes them drug products, not the unintended uses.
The ecig, on the other hand, is intended to be used as a smoking alternative - for long term use and enjoyment. Harm reduction, yes for sure, but smoking cessation no. Again, some people may decide to use them only as a short term aid to total smoking cessation, but that is not their primary intended use.
This is in fact the same difference between your Stonewall dissolvables and the pharmaceutical lozenge - the Stonewall is a tobacco product, intended as a smoking alternative, and the lozenge is an NRT drug product, intended for smoking cessation.
As for the fact that there is no actual tobacco in ecigs, and they use only the liquid nicotine extracted form tobacco, how is that any different from the fact that there is no coffee bean or plant material in a cup of coffee, which uses solely the liquid extracted from the bean? Liquid coffee is most definitely still a "coffee product".
And those who have experimented with making their own eliquid from rolling tobacco, or from cigars or snus, you included, are they not using a "tobacco product" with their ecigs? The majority using commericially extracted nicotine liquid are not automagically using a "drug" just because they buy it already extracted rather than going DIY.
I think it's time to trot the FDA email to suppliers one more time, for those who missed it (and it was weeks ago). It defines the device, the liquid and the intended use, citing applicable laws. It's worth a read and ponder. This is not what I'd like to read, but it's the FDA speaking, so we best listen:
This email was repeatedly sent, so it constitutes de facto policy. Not a nice thing to read, but it's what we have to live with until a court rules against this policy. No one here is making up the FDA's position. To that agency, we use unapproved medical devices that deliver an unapproved drug cocktail to treat a medical condition called nicotine addiction.
Nit-pick it if you want, but to me the intent of these words is quite clear on the legality of our product. And that will guide their future action.
This email was repeatedly sent, so it constitutes de facto policy. Not a nice thing to read, but it's what we have to live with until a court rules against this policy. No one here is making up the FDA's position. To that agency, we use unapproved medical devices that deliver an unapproved drug cocktail to treat a medical condition called nicotine addiction.
Nit-pick it if you want, but to me the intent of these words is quite clear on the legality of our product. And that will guide their future action.
I'm glad you reposted that letter TBob, because reading again it illustrates the beauty of SE's current argument (in their Supplemental Brief posted by Sun) that the new tobacco legislation actually supports their position.
Take a look at this excerpt from the FDA letter:
"Please be aware that electronic cigarettes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action.
In this regard, these products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body."
Okay, so we see the FDA regards ecigs as very like conventional cigarettes. And indeed, in FDA V. BROWN & WILLIAMSON TOBACCO CORP., the FDA argued that cigarettes were a combination drug-device under section 503(g)(1) of the FD&C Act (21 U.S.C. 353(g)(1)), precisely the same provision they cite in their letter now as to ecigs. They would have regulated cigarettes as such had the Supreme Court not decided cigarettes were simply wholly exempt from FDA regulation.
So now fast forward to the new tobacco legislation. Recognizing the unalterable fact that all tobacco products are nicotine delivery devices and could easily fit the drug and drug-device definitions already found in Chapter V of the Food and Drug Act, the new legislation specifically covers this by providing that tobacco products will be regulated by the new provisions only, and not by the drug provisions in Chapter V of the exisiting law. So as SE writes in its brief:
"The Act explicitly provides that "tobacco products" will be regulated by the FDA under the new Chapter IX of the Food, Drug, and Cosmetic Act, and "shall not be subject to the provisions of" Chapter V ("Drugs and Devices"). Id. at § 101(a) (adding a new Section 901 to the Food, Drug, and Cosmetic Act)."
So, if the FDA regards ecigs as so much "like conventional cigarettes" as they say in their letter, then the new legislation certainly does support SE's arguments that they should not be considered a drug-device combination subject to Chapter V of the FD&C Act, but rather a "tobacco product" under the newly passed Chapter IX.
Take a look at this excerpt from the FDA letter:
"Please be aware that electronic cigarettes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action.
In this regard, these products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body."
Okay, so we see the FDA regards ecigs as very like conventional cigarettes. And indeed, in FDA V. BROWN & WILLIAMSON TOBACCO CORP., the FDA argued that cigarettes were a combination drug-device under section 503(g)(1) of the FD&C Act (21 U.S.C. 353(g)(1)), precisely the same provision they cite in their letter now as to ecigs. They would have regulated cigarettes as such had the Supreme Court not decided cigarettes were simply wholly exempt from FDA regulation.
So now fast forward to the new tobacco legislation. Recognizing the unalterable fact that all tobacco products are nicotine delivery devices and could easily fit the drug and drug-device definitions already found in Chapter V of the Food and Drug Act, the new legislation specifically covers this by providing that tobacco products will be regulated by the new provisions only, and not by the drug provisions in Chapter V of the exisiting law. So as SE writes in its brief:
"The Act explicitly provides that "tobacco products" will be regulated by the FDA under the new Chapter IX of the Food, Drug, and Cosmetic Act, and "shall not be subject to the provisions of" Chapter V ("Drugs and Devices"). Id. at § 101(a) (adding a new Section 901 to the Food, Drug, and Cosmetic Act)."
So, if the FDA regards ecigs as so much "like conventional cigarettes" as they say in their letter, then the new legislation certainly does support SE's arguments that they should not be considered a drug-device combination subject to Chapter V of the FD&C Act, but rather a "tobacco product" under the newly passed Chapter IX.
Today there was no movement on the Docket Sheet. We are still waiting for the FDA to submit their Reply Brief to SE's Supplemental Brief. The FDA's Brief is due by July 6, 2009.-------Sun
Just posting a reply so I get notified of updates. If someone knows of a better way to do this, please PM me.
~~Cheryl
~~Cheryl
Thanks Sun, but sometimes I forget to check, so an email update is helpful in that regard. You rock!
~~Cheryl
~~Cheryl
As expected, today NJOY (Sottera, Inc. As Invervenor) also filed a Supplemental Brief again arguing that this is a case of the FDA overstepping its jurisdiction even with the passage of the new legislation of the the Family Smoking Prevention and Tobacco Control Act of 2009
It will be very interesting to see the FDA's response that is due by July 6, 2009.
------------Sun
It will be very interesting to see the FDA's response that is due by July 6, 2009.
------------Sun
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I'm about ready to start a pool on how long they can keep this going without any sort of ruling.....
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