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

[Sinless1]

It's time to get back to our roots here, It is really simple Rights and responsibilities, If i exercise my rights then i have to be prepared and except the responsibility.

There are many many products on the market that make all kinds of claims and are not FDA (permission) approved! A free market economy should be free! but it isn't cause we have sat back and allowed these bloated government agencies to over regulate and tax us to death. how many energy shot products are on the market for human consumption that do not even list there full ingredients! They are selling by the millions with a simple little sticker that says "NOT APPROVED BY THE FDA" .

This whole case is a farce in my opinion. ecig a tobacco product give me a break, ecig a medical device cause you can deliver a stimulant BS!

They are just fighting over 2 BS classifications they can fit it into so either Big PHARMA GETS CONTROL OR BIG TOBACCO GETS CONTROL!

The truth is it is an electronic device period, but no they aren't gonna let it be cause they won't be able to give it a special extortion tax if they classify it as what it really is!

(Pharma) Our $20.00 pills won't sell anymore if we let that happen!

(BIG Tobacco) We might loose our monopoly!

(Government State and Federal) OH no We can't let that happen or we loose our BILLIONS in EXTORTED TAX dollars, Well that's ok we will just print more money and get our tax money thru our hidden inflation tax when the dollar drops

Like i said many times here before I can't wait untill some idiot actually passes a real Ban LAW!
I AM READY TO GO TO COURT AND FIGHT FOR MY RIGHTS!

and that concludes my rant for the day

[Our House]

Pumaman,

A lot to say, and will try to get to it later if I have time. (maybe in a different thread...our discussion appears to be getting long and will further derail this thread)

[oldlady]

Thank you for the advice to stock up. Could someone suggest the period of time that might be involved. Should we stock up for a few months, a year, two years. . .? Anybody know approximately how long it might take for e-cigs to go through the health and safety testing and approval process?

[PhiHalcyon]

It was clear from the beginning that if nicotine-containing e-liquid was not a tobacco product, then the only other thing it could be considered was a drug. So it was patently clear that anyone who wanted to see the ecig product continue to flourish, evolve, and remain available, also needed nicotine-containing e-liquid to be classified and regulated as a tobacco product. Thus, for the last several weeks of my involvement in the quest to assess the legal status of nicotine-containing e-liquid (and the ecig device used to vaporize it), I have been working under the assumption that nicotine-containing e-liquid was a tobacco product. This assumption ultimately led to the conclusion that, even as a tobacco product, all e-liquid containing one or more derivatives of tobacco was misbranded and/or adulterated, and thus, illegal to sell. The only way I seen to change this was for an e-liquid manufacturer or importer to register with the FDA as a tobacco product manufacturer, and apply for a modified risk tobacco product approval and/or marketing authorization.

I was, however, recently informed by Sun that one or more importing suppliers had already sought to go down this path, to no avail. Then I was informed by LegalOne of the FDA's "all in" determination to regulate the ecig and its e-liquid as a drug/device combination product. Neither of these two facts seemed to square with the whole modified-risk-tobacco-product-approval conclusion I had come to. This forced me to re-examine the belief that e-liquid could be regulated as a tobacco product.

After taking a closer look at the definition of tobacco product, I recently stated that I had concluded that e-liquid is not a tobacco product. Then, in rather short order, LegalOne contested this conclusion with an 'active ingredient' argument. And, as much as I would have preferred to have been able to return to the more promising position of nicotine-containing e-liquid being a tobacco product, I have found the following to be far more persuasive:


Section 201(rr)(4) of the FDCA states that:
"A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement."

According to the FDA's draft guidance of this prohibition, this includes a situation where:
"A tobacco product and a non-tobacco product regulated under the FDCA are physically, chemically, or otherwise combined or mixed to produce a single entity that is marketed as containing both products."

An example given is: Nicotine that is derived from tobacco is added to water, juice, or soda (which are regulated under the FDCA) and the water, juice, or soda is identified as containing a tobacco product.

Simply replace the words "water, juice, or soda (which are regulated under the FDCA)" with the words "propylene glycol and/or glycerine (which are regulated under the FDCA)", and it becomes clear that e-liquid is a prohibited combination product that cannot be regulated as a legal tobacco product. The only circumstance under which nicotine-containing e-liquid could be considered a legal product is if it were to be approved as a drug product subject to chapter V of the FDCA. Consequently, nicotine-containing e-liquid is an unapproved drug product; and the ecig, an unapproved drug delivery device.

Since nicotine-containing e-liquid cannot be regulated as a legal tobacco product, the equal protection argument that I have made in the past (regarding intended uses and classification) does not apply. As a result, the nicotine content of e-liquid is all that is needed to classify e-liquid as a drug - regardless of what claims are, or are not, made.

[Sinless1]

Since nicotine-containing e-liquid cannot be regulated as a legal tobacco product, the equal protection argument that I have made in the past (regarding intended uses and classification) does not apply. As a result, the nicotine content of e-liquid is all that is needed to classify e-liquid as a drug - regardless of what claims are, or are not, made.

and now we have a judge who can't make up his mind which lobby to go with.
Big Tobacco or Big Pharma!

file the decision already so we can move on to court case number 2

[oldlady]

While the fear of the unknown is killing me, I am a newbie and need time to stock up. Therefor, I don't care if the judge sits on this f-o-r-e-v-e-r!

[JerryRM]

NEW THREAD I just set up a new thread in the Law and the E-cigarette forum. It's titled "To Vape or not to Vape". Feel free to use it, especially for the lengthy legal discussions.

[Sun Vaporer]

It was clear from the beginning that if nicotine-containing e-liquid was not a tobacco product, then the only other thing it could be considered was a drug. So it was patently clear that anyone who wanted to see the ecig product continue to flourish, evolve, and remain available, also needed nicotine-containing e-liquid to be classified and regulated as a tobacco product. Thus, for the last several weeks of my involvement in the quest to assess the legal status of nicotine-containing e-liquid (and the ecig device used to vaporize it), I have been working under the assumption that nicotine-containing e-liquid was a tobacco product. This assumption ultimately led to the conclusion that, even as a tobacco product, all e-liquid containing one or more derivatives of tobacco was misbranded and/or adulterated, and thus, illegal to sell. The only way I seen to change this was for an e-liquid manufacturer or importer to register with the FDA as a tobacco product manufacturer, and apply for a modified risk tobacco product approval and/or marketing authorization.

I was, however, recently informed by Sun that one or more importing suppliers had already sought to go down this path, to no avail. Then I was informed by LegalOne of the FDA's "all in" determination to regulate the ecig and its e-liquid as a drug/device combination product. Neither of these two facts seemed to square with the whole modified-risk-tobacco-product-approval conclusion I had come to. This forced me to re-examine the belief that e-liquid could be regulated as a tobacco product.

After taking a closer look at the definition of tobacco product, I recently stated that I had concluded that e-liquid is not a tobacco product. Then, in rather short order, LegalOne contested this conclusion with an 'active ingredient' argument. And, as much as I would have preferred to have been able to return to the more promising position of nicotine-containing e-liquid being a tobacco product, I have found the following to be far more persuasive:


Section 201(rr)(4) of the FDCA states that:
"A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement."

According to the FDA's draft guidance of this prohibition, this includes a situation where:
"A tobacco product and a non-tobacco product regulated under the FDCA are physically, chemically, or otherwise combined or mixed to produce a single entity that is marketed as containing both products."

An example given is: Nicotine that is derived from tobacco is added to water, juice, or soda (which are regulated under the FDCA) and the water, juice, or soda is identified as containing a tobacco product.

Simply replace the words "water, juice, or soda (which are regulated under the FDCA)" with the words "propylene glycol and/or glycerine (which are regulated under the FDCA)", and it becomes clear that e-liquid is a prohibited combination product that cannot be regulated as a legal tobacco product. The only circumstance under which nicotine-containing e-liquid could be considered a legal product is if it were to be approved as a drug product subject to chapter V of the FDCA. Consequently, nicotine-containing e-liquid is an unapproved drug product; and the ecig, an unapproved drug delivery device.

Since nicotine-containing e-liquid cannot be regulated as a legal tobacco product, the equal protection argument that I have made in the past (regarding intended uses and classification) does not apply. As a result, the nicotine content of e-liquid is all that is needed to classify e-liquid as a drug - regardless of what claims are, or are not, made.

Phi--good summation.


Sun

[JerryRM]

I'm hoping it will be a companion thread to this one.

[PhiHalcyon]

I think you have more initiative than consultation. There is a reason why the legal issues get discussed in this thread, and that is because this is the thread that members turn to for this sort of information. At least that is why I post here. Just because the conclusions have been becoming more and more grim is no reason to hide the word in some low-traffic corner of the legal section. People need to know.