SE, NJoy vs FDA -- Discussion

[JonnyVapΣ]

If FDA officials really cared about public health and safety, they would end the agency's quixotic litigation strategy.

Not to mention our wallets. Apparently thery're paid quite well for them not to notice the rest of us are friggin broke!

 

[JerryRM]

No news on the docket today.

Thank you and Happy Birthday, Julie.

 

[JustJulie]

njoy has filed "Opposition to Motion for Stay Pending Disposition of Petition for Rehearing and Rehearing En Banc."

Note that njoy is not responding to the FDA's request for a rehearing/hearing en banc (which njoy is not permitted to do absent the Court of Appeals asking for a response). Rather, NJOY is arguing about the FDA's request that the stay of Judge Leon's injunction be reinstated until the Court of Appeals disposes of the FDA's request for a rehearing/hearing en banc.

Basically, NJOY is arguing that regardless of what the Court of Appeals does in terms of the FDA's request for a rehearing/hearing en banc, Judge Leon's injunction against the FDA should stand.

Clear as mud?

Oh, and thank you for the birthday wishes, Jerry.

 

[JerryRM]

Thanks Julie, it looks like NJOY is not afraid of the FDA.

 

[sang k]

thanks just julie

fda is so screwed- we have the law behind us boys and girls

merry christmas and happy newyear

 

[D103]

happy belated birthday JustJulie! Is it just me or is that not an extremely thorough, succinct and persuasive document filed by the attorney's for Soterra - very powerful and impressive. Excellent work once again!!

 

[jj2]

Happy B-day JustJulie!!!

 

[wave42]

Not to mention our wallets. Apparently thery're paid quite well for them not to notice the rest of us are friggin broke!

That's what happens when you own the printing presses and the power of taxation. We become the servants of government.

 

[JerryRM]

thanks just julie

fda is so screwed- we have the law behind us boys and girls

merry christmas and happy newyear

I wish I had your optimism.

 

[sang k]

imo, no way fda can prove it is a drug device/product

regulate/tax ecigs as a tobacca product

only the good ecig comp/products survive

we all know ecigs are safer and healthier. let BT to get in the ecig market . competition is good.

public safety and health should be first

 

[thephoenix]

NJOY is so bad ... that I feel partially obliged to send some of my customers their way so they can stay in the fight!

Love that they filed an opposition.

 

[JonnyVapΣ]

I have 2 nJoy 4081's, and proud of it!

 

[dee5]

My first ecig was an Njoy Npro and I still keep it as a backup or loaner. It's a solid product and I'm so thankful to them for fighting this idiocy.

 

[cracker75]

I hope this isn't the wrong place to put this, but has anyone requested the full report and all the metrics used their studies from the FDA via an FOIA query?

 

[cracker75]

I answered my own question this morning. And I can admit that I am not "scientist enough" to understand it. Here's a link if anyone's interested:

http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

 

[bshalaby]

However, in this you are wrong. Neither the court ruling nor the tobacco legislation changes anything with respect to nicotine-based pharma cessation products. The definition of "tobacco product" in the statute, in relevant part, is as follows:

(rr) (1) The term “tobacco product” means any product
made or derived from tobacco that is intended for human
consumption, including any component, part, or
accessory of a tobacco product . . .

(2) The term “tobacco product” does not mean an article
that is a drug under [the FDCA’s drug provision], a
device under [the FDCA’s device provision], or a
combination product described in [the FDCA’s
combination product provision].
21 U.S.C. § 321(rr).

As you can see, section one of the statute is what makes ecigs a "tobacco product". But section two is what keeps pharma nicotine products in the same category - drug products - that they have always been in. As the Court of Appeals decision also says: "The Tobacco Act itself states that it does not “affect, expand, or limit” the FDA’s jurisdiction to regulate products under the drug/device provisions of the FDCA, 21 U.S.C. § 387a(c)(1)."

So long as a nicotine product is developed, approved, and marketed specifically with the intended use of treating nicotine addiction and/or smoking cessation, it can and will be regulated by the FDA under the FDCA as a drug product. And that propostion includes any given ecig brand that wants to market itself specifically as a cessation device. And so said the Court of Appeals decision as well. But ecigs that are marketed solely as a smoking alternative, or as tobacco products are traditionally marketed, solely for recreational use, they are only subject to regulation under the tobacco act (well, so long as the Court of Appeals decision is not overturned, which I doubt will happen).

Thank you Yvilla, that explains it, although there is a loophole. Nicotine is a stimulant that improves muscle and mental performance by about 15-20%. Lets assume a company registers a brand of sport, or energy drink for smokers that contains Nicotine, make no health or smoking cessation claims, purely for entertainment, would that be an FDCA product or a Tobacco Product? I think that it does open a can of worms for the pharma companies, (or at least I hope so). This is not far fetched, they have been selling Nicotine Water in the UK!

 

[bshalaby]

I answered my own question this morning. And I can admit that I am not "scientist enough" to understand it. Here's a link if anyone's interested:

http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

The FDA report proves what Dr. Laugeson of Health New Zealand proved, and what has recently been published by Dr. Siegel in Boston (excellent review of safety of E cigarettes in comparison to Tobacco published in the Journal of Public Health Policy Dec 22nd 2010). E Cigarettes do contain some questionable substances in the vapor, stuff like Acetaldehyde (especially when the formula contains Alcohol) but in insignificant quantities.

If you analyze the air in a downtown busy metropolis, it will contain carcinogens and stuff like mercury. It is the quantities that are significant. In the case of e cigarettes not one lab analysis out of 16 showed any questionable substance that is present in any quantity to be of concern.

If the FDA logic is applied to the air you breathe, it would be banned.

 

[Vocalek]

The FDA report proves what Dr. Laugeson of Health New Zealand proved, and what has recently been published by Dr. Siegel in Boston (excellent review of safety of E cigarettes in comparison to Tobacco published in the Journal of Public Health Policy Dec 22nd 2010). E Cigarettes do contain some questionable substances in the vapor, stuff like Acetaldehyde (especially when the formula contains Alcohol) but in insignificant quantities.

If you analyze the air in a downtown busy metropolis, it will contain carcinogens and stuff like mercury. It is the quantities that are significant. In the case of e cigarettes not one lab analysis out of 16 showed any questionable substance that is present in any quantity to be of concern.

If the FDA logic is applied to the air you breathe, it would be banned.

The court would rule that the FDA could only ban the air if the purveyors were making medical claims about it, such as "prevents asphyxiation."

 

[yvilla]

Thank you Yvilla, that explains it, although there is a loophole. Nicotine is a stimulant that improves muscle and mental performance by about 15-20%. Lets assume a company registers a brand of sport, or energy drink for smokers that contains Nicotine, make no health or smoking cessation claims, purely for entertainment, would that be an FDCA product or a Tobacco Product? I think that it does open a can of worms for the pharma companies, (or at least I hope so). This is not far fetched, they have been selling Nicotine Water in the UK!

Yes, there will probably have to be lines drawn by the FDA and the courts in the future. But my best estimation is that the drink you mention, and other potential nicotine-laden products that could be imagined, will fall over that line into the "drug-product" category. Nicotine water is marketed here in the US as well, but classed as a "homeopathic" product (and with such infinitessimally small amounts of nicotine that it is laughable, IMO). Ecigs in contrast are truly the "substantial equivalent" of traditional cigarettes - designed and intended to mimic so well the hand-to-mouth action, the drawing in and exhaling of a substance, etc, and that is precisely why we have won this court victory so far. Also note the language throughout the opinion regarding the fact that Njoy's products are marketed "as traditional tobacco products are marketed". A drink or a gel just wouldn't be able to fit into that class of products.

 

[JustJulie]

Ecigs in contrast are truly the "substantial equivalent" of traditional cigarettes - designed and intended to mimic so well the hand-to-mouth action, the drawing in and exhaling of a substance, etc, and that is precisely why we have won this court victory so far. Also note the language throughout the opinion regarding the fact that Njoy's products are marketed "as traditional tobacco products are marketed". A drink or a gel just wouldn't be able to fit into that class of products.

I agree 100%.

By the way, didn't have time to post yesterday, but there was no movement on the docket.

I've decided that I don't mind the cold on Christmas . . . especially when it's accompanied by a nice snowfall. Merry Christmas to those who celebrate the holiday.