FDA Let's talk legal theory. (Section 910, in particular)

[sqirl1]

Okay so I'm just a paralegal student who took administrative law, but I already see section 910 as worth attempting to challenge once the FDA begins to enforce it. First, let's look at what FSPTCA says about the characteristics that need to BE substantially equivalent:

"....'characteristics' means the materials, ingredients, design, composition, heating source, or other features of a tobacco product."

Pretty broad, right? What does "other features" even mean first of all? I can easily see that alone being struck down as too broad. Also, even though it does say "heating source", that's still vague in and of itself. What's being heated? The tobacco/e-liquid? Water around the the tobacco in a hookah? Aren't hookahs themselves not tobacco priducts? Why is it being heated? To burn? To vaporize? There's no clear definition of a "heating source", so that this is a very weak definition that a judge could easily say "you know what? I'm striking this out as too broad" to. The other thing is, while the law does give the FDA the authority regulate anything not a drug with nicotine as a tobacco product, vapor products as they exist now were not known or understood to congress at the time the law was written. This is important, because when the language of this law was written, congress didn't design the language with modern vapor products in mind, however 7 years after the law was written, the FDA tried to apply this outdated language to a product that grew to become so different from what the law was intended to regulate that it would create an undue hardship to the majority of the indusrty. So in otherwords, the language of FSPTCA could be argued as outdated. Finally, the deadline itself could be challenged as arbitrary as there is no particular reason for why February 15th, 2007 IS the deadline in the law. The court could dismiss that as arbitrary as well. I think the language for section 910 is broad and weak and easily worth challenging. Not to mention whether or not hardware should be applied as if it's like a cigarette filter or like a pipe. A judge could easily say "this is basically a pipe, all you can do is regulate the juice".

So what do you guys think?

 

[edyle]

A judge could easily say "this is basically a pipe, all you can do is regulate the juice".

So what do you guys think?

Bang!

 

[B2L]

Okay so I'm just a paralegal student who took administrative law, but I already see section 910 as worth attempting to challenge once the FDA begins to enforce it. First, let's look at what FSPTCA says about the characteristics that need to BE substantially equivalent:

"....'characteristics' means the materials, ingredients, design, composition, heating source, or other features of a tobacco product."

Pretty broad, right? What does "other features" even mean first of all? I can easily see that alone being struck down as too broad. Also, even though it does say "heating source", that's still vague in and of itself. What's being heated? The tobacco/e-liquid? Water around the the tobacco in a hookah? Aren't hookahs themselves not tobacco priducts? Why is it being heated? To burn? To vaporize? There's no clear definition of a "heating source", so that this is a very weak definition that a judge could easily say "you know what? I'm striking this out as too broad" to. The other thing is, while the law does give the FDA the authority regulate anything not a drug with nicotine as a tobacco product, vapor products as they exist now were not known or understood to congress at the time the law was written. This is important, because when the language of this law was written, congress didn't design the language with modern vapor products in mind, however 7 years after the law was written, the FDA tried to apply this outdated language to a product that grew to become so different from what the law was intended to regulate that it would create an undue hardship to the majority of the indusrty. So in otherwords, the language of FSPTCA could be argued as outdated. Finally, the deadline itself could be challenged as arbitrary as there is no particular reason for why February 15th, 2007 IS the deadline in the law. The court could dismiss that as arbitrary as well. I think the language for section 910 is broad and weak and easily worth challenging. Not to mention whether or not hardware should be applied as if it's like a cigarette filter or like a pipe. A judge could easily say "this is basically a pipe, all you can do is regulate the juice".

So what do you guys think?

I think that I'm a restaurant manager who watches Law and Order every now and then, paralegal student trumps that any day as far as legal understanding goes.

I started vaping right about the same time that the FDA got slapped down for seizing shipments and trying to regulate ecigarettes as medical devices. I believe our best chance of surviving as anything that even remotely resembles what we have now is getting it in front of the right judge with someone who can argue these, and I'm sure numerous other, legal points.

I think that your on the right track and would enjoy any other insight you may have, thanks

 

[sqirl1]

Seriously though, legal professionals weigh in on this here:

1.) Has the FDA made any press releases on how hardware is distinct from a pipe and justifiably treatable like a cigarette filter or paper? What is their argument?

2.) Is there anything in FSPTCA justifying the grandfather date? If they don't specify in the law itself why that date is there or what it's significance is, correct me if I'm wrong but no judge is going to uphold something that arbitrary in the first place.

3.) Has section 910 been challenged by any tobacco companies thusfar regarding cigarettes and smokeless tobacco? If so, what is the case name and bluebook citation?

 

[petrotech]

I think that I'm a restaurant manager who watches Law and Order every now and then, paralegal student trumps that any day as far as legal understanding goes.

One of my good buddies is a cop, and he tells some of the funniest stories about people who watch L&O and CSI. Lol

 

[sqirl1]

I'm sure he does but this is serious stuff right here, don't get the admins to lock it up pls. At least not till we get some feedback to my semi-profressional legal analysis by somebody who's a full professional. I seriously think this law has some serious weaknesses because congress loves to halfa$$ (litterally spelled with dollar signs) the language of their legislation and pass it when it's incredibly vulnerable to being decimated by the United States Court of Appeals. If this is one of those cases, we just might be in really, really good shape because if I AM right, the courts could tell the FDA that congress is going to need to ammend FSPTCA if they want the deeming regulation, and I think we can easily stop that from happening.

 

[Robert Cromwell]

I do not watch any of the law shows nor even stayed at a Holiday Inn Express so I for the most part I will wait for "experts" to analyze this thing.

 

[Taowulf]

Finally, the deadline itself could be challenged as arbitrary as there is no particular reason for why February 15th, 2007 IS the deadline in the law.

That is the date because the Tobacco Control Act that was put into effect in 2009 says that is the date. Seriously.

Here is the section that address that. Funny, how I just happened to be at that section when I saw your thread -

"(Comment 19) A number of comments argued that adoption of a later grandfather date would be an acceptable exercise of FDA's discretion under section 701(a) of the FD&C Act, which provides FDA authority to issue regulations "for the efficient enforcement" of the statute. 74 Others argued that an alternative date would be a permissible Agency interpretation of the statute, subject to deference under the Chevron doctrine. (See Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837 (1984).) (Response) After careful consideration of these comments, FDA concludes that it lacks authority to change the grandfather date for the newly deemed products. The grandfather date is prescribed in the statute. Section 910(a)(1)(A) of the FD&C Act states, in pertinent part, that the term "new tobacco product" means any tobacco product (including those products in test markets) that was not commercially marketed in the United States on February 15, 2007. For purposes of the SE pathway, the statute also clearly states that a predicate product must be commercially marketed (other than for test marketing) in the United States on February 15, 2007, in both section 910(a)(2)(A) and section 910(j)(1). FDA’s authority is not so broad as to allow FDA to issue a regulation that contradicts a clear statutory provision."

 

[Taowulf]

I started vaping right about the same time that the FDA got slapped down for seizing shipments and trying to regulate ecigarettes as medical devices. I believe our best chance of surviving as anything that even remotely resembles what we have now is getting it in front of the right judge with someone who can argue these, and I'm sure numerous other, legal points.

Then I run across something related to this decision. Many people are complaining that vaping devices are being considered a "tobacco product" and I honestly have issues with that as well. And then I read this - BTW, the short version is that the successful argument against the FDA seizing ecigs and regulating them as "drugs" was that they were a "tobacco product" and therefore should be regulated via the Tobacco Control Act and not as a therapeutic medicinal smoking cessation device. We won that battle, but it ultimately may lose us the war.

"The ENDS industry has acknowledged that it was aware of both FDA's intention to regulate ENDS and the applicability of the Tobacco Control Act to e-cigarettes and other ENDS, as evidenced by the litigation in Smoking Everywhere, Inc. v. Food & Drug Administration, 680 F. Supp.2d 62 (D.D.C. 2010), affirmed by Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), which was pending during the passage of the Tobacco Control Act. When FDA attempted to regulate e-cigarettes as a drug-device combination, plaintiffs Sottera (doing business as NJOY) and Smoking Everywhere argued that Congress intended for tobacco products, including their own, to be subject to the Tobacco Control Act and not to the drug and device provisions of the FD&C Act. The district court described plaintiffs' position as follows: "In FDA v. Brown and Williamson Tobacco Corp., the Supreme Court held that tobacco products, like traditional cigarettes, are not subject to FDA regulation as a drug or device. [529 U.S. 120 (2000).] Because electronic cigarettes, as marketed by plaintiffs, are the functional equivalent of traditional cigarettes, plaintiffs contend that FDA cannot regulate their products [as combination drug-device products]. They further contend that Congress's recent enactment of the [Tobacco Control Act] supports their argument. Under the [Act], FDA may now regulate tobacco products, which the Act defines as "any product made or derived from tobacco that is intended for human consumption," . . . but it cannot regulate those products as it would a drug or device under the FDCA[.] There being no dispute that the nicotine in plaintiffs' electronic cigarettes is naturally distilled from actual tobacco and is intended for human consumption, . . . plaintiffs assert that their electronic cigarettes qualify as a tobacco product and are therefore 77 exempt from regulation as a drug-device combination." (Smoking Everywhere v. FDA, 680 F. Supp. 2d 62, 66-67 (D.D.C. 2010).) The district court found that, "it is apparent from Congress's broad definition of 'tobacco product' that it intended the Tobacco Act's regulatory scheme to cover far more than the fixed array of traditional tobacco products[.]" (Id. at 71.) ENDS manufacturers were made especially aware of FDA's authority to deem their products and subject them to the tobacco control authorities of the FD&C Act when the court noted that "… now that FDA has regulatory power over electronic cigarettes through the Tobacco Act, any harm to the public interest or to third parties caused by an injunction that merely forbids FDA from regulating electronic cigarettes as a drug-device combination is greatly diminished." (Id. at 77-78.) On appeal, the D.C. Circuit affirmed, commenting that "the Tobacco Act provides the FDA with regulatory authority over tobacco products without requiring therapeutic claims. …[T]he act broadly defines tobacco products as extending to ‘any product made or derived from tobacco.’" Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891, 897 (D.C. Cir. 2010) (quoting 21 U.S.C. § 321(rr)(1); emphases added by the court). The D.C. Circuit went on to state that "the [lower] court rightly found that the FDA has authority under the Tobacco Act to regulate electronic cigarettes"--authority that, it added, was "unquestioned." Id. at 898."

 

[sqirl1]

I'm well aware of the N-Joy case and the outcome of it. I'm not saying we don't argue e-cigs are tobacco products, or rather that E-liquid is one for sure, the question should be about section 910 specifically and the compatibility of it's language to even apply to e-cigs, and whether or not hardware should even be considered a component of a tobacco product and should instead be considered a type of pipe unless it's a prefilled cartomizer for a cig-a-like. Also whether "heat source" is specific enough to mean atomizers.

 

[Stubby]

That is the date because the Tobacco Control Act that was put into effect in 2009 says that is the date. Seriously.

The date of February 15, 2007 is the there because that is the date the original bill was first introduced to congress. It didn't pass until the spring of 2009, but the original date was kept the same.

Then I run across something related to this decision. Many people are complaining that vaping devices are being considered a "tobacco product" and I honestly have issues with that as well. And then I read this - BTW, the short version is that the successful argument against the FDA seizing ecigs and regulating them as "drugs" was that they were a "tobacco product" and therefore should be regulated via the Tobacco Control Act and not as a therapeutic medicinal smoking cessation device. We won that battle, but it ultimately may lose us the war.

That is a pretty bad interpretation of what actually happened and why.

The bases for the case was about intended use. The FDA was claiming that ecigs where being used as a smoking cessation device, which would mean that ecigs would be classified as a drug and ecigs where an unauthorized drug delivery device (not approved by the FDA). The defense was that the intended use was not a drug, but the intended use was simply the recreational use of nicotine.

It wasn't part of the defense that ecigs should be regulated under the tobacco control act. When the case started the tobacco control act of 2009 had not even passed so it had nothing to do with this and obviously was never part of the argument. How could it be as the tobacco control act didn't exist as of yet.

 

[sqirl1]

FDA concludes that it lacks authority to change the grandfather date for the newly deemed products.... FDA’s authority is not so broad as to allow FDA to issue a regulation that contradicts a clear statutory provision."

And they're correct about that; they CAN'T go against what the law says like that, I'm saying challenge the provision in the statute itself altogether. I'm not saying go for the FDA, I'm saying gun for the actual statutory provision instead. I bet you money that a judge could strike out the grandfather date since there's no clear reason for it at all. It would be one thing if the law said "we're going for this date because this is when this discovery was made" or "we're going for this date because that's when the FDA began research on (whatever)" but it litterally says nothing of the sort. Judges do NOT like that. Arbitrary crap doesn't tend to survive very often.

 

[sqirl1]

It wasn't part of the defense that ecigs should be regulated under the tobacco control act. When the case started the tobacco control act of 2009 had not even passed so it had nothing to do with this and obviously was never part of the argument. How could it be as the tobacco control act didn't exist as of yet.

Exactly! And the fact is, now that E-liquid is established to be a tobacco product, NOTHING puts hardware as a component of a tobacco product except the FDA's arbitrary declaration as such. NOTHING in FSPTCA says hardware is a component of a tobacco product. I know it says "heating source" but we could easily argue that should only apply to prefilled cigalikes and that modern tanks/atomizers are a pipe with a heat source and not a tobacco product themselves. The fact that you can take modern tanks apart, put any atomizer you want in them, and can put any PG/VG based liquid in there would make a compelling argument to a judge.

 

[Stubby]

And they're correct about that; they CAN'T go against what the law says like that, I'm saying challenge the provision in the statute itself altogether. I'm not saying go for the FDA, I'm saying gun for the actual statutory provision instead. I bet you money that a judge could strike out the grandfather date since there's no clear reason for it at all. It would be one thing if the law said "we're going for this date because this is when this discovery was made" or "we're going for this date because that's when the FDA began research on (whatever)" but it litterally says nothing of the sort. Judges do NOT like that. Arbitrary crap doesn't tend to survive very often.

As I had stated above, the February 15, 2007 date was not arbitrary. That was the date the tobacco control bill was first introduced to congress. It didn't pass until 2009, but the original date was kept in bill. It would be hard to argue the date is arbitrary.

It might be an argument that pre-dating a regulation is a problem. The deeming has just happened yet the grandfather date is nine years in the past. Some lawyers up on this type of regulations would have to inform us if this is a weak area that could be argued in court.

 

[sqirl1]

As I had stated above, the February 15, 2007 date was not arbitrary. That was the date the tobacco control bill was first introduced to congress. It didn't pass until 2009, but the original date was kept in bill. It would be hard to argue the date is arbitrary.

It might be an argument that pre-dating a regulation is a problem. The deeming has just happened yet the grandfather date is nine years in the past. Some lawyers up on this type of regulations would have to inform us if this is a weak area that could be argued in court.

I wonder if there's any caselaw where this type of issue has come up before, it seems like letting a product evolve for nearly a decade before applying a law nearly a decade old to it would be a major problem, and again, judges don't like to play that game.

 

[Taowulf]

It wasn't part of the defense that ecigs should be regulated under the tobacco control act. When the case started the tobacco control act of 2009 had not even passed so it had nothing to do with this and obviously was never part of the argument. How could it be as the tobacco control act didn't exist as of yet.

" plaintiffs Sottera (doing business as NJOY) and Smoking Everywhere argued that Congress intended for tobacco products, including their own, to be subject to the Tobacco Control Act and not to the drug and device provisions of the FD&C Act. The district court described plaintiffs' position as follows: "In FDA v. Brown and Williamson Tobacco Corp., the Supreme Court held that tobacco products, like traditional cigarettes, are not subject to FDA regulation as a drug or device. [529 U.S. 120 (2000).] "

So, care to restate?

 

[StormFinch]

First off, I'd say I'm glad that between CASAA, SFATA, AVA, et al. we have more lawyers involved than we can shake a stick at, some who used to work for the FDA so they know how they think.

Secondly, I'm sooooooo hoping that Judge Leon is still sitting on the bench in DC, as cases are typically heard there for challenges like this. Judge Leon seems to love to bat down the FDA every chance he gets, and watching him do it again would be extremely satisfying.

 

[StormFinch]

Exactly! And the fact is, now that E-liquid is established to be a tobacco product, NOTHING puts hardware as a component of a tobacco product except the FDA's arbitrary declaration as such. NOTHING in FSPTCA says hardware is a component of a tobacco product. I know it says "heating source" but we could easily argue that should only apply to prefilled cigalikes and that modern tanks/atomizers are a pipe with a heat source and not a tobacco product themselves. The fact that you can take modern tanks apart, put any atomizer you want in them, and can put any PG/VG based liquid in there would make a compelling argument to a judge.

I believe that the FDA is taking this section quite literally:

[*101] Sec. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) Definition of Tobacco Products.--Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321) is amended by adding at the end the following:

"(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 (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

They've so far been able to get away with regulating rolling machines for heaven's sake. Of course they think they can do what they want.

 

[sqirl1]

But seriously I just thought more about the component argument more and it makes total sense the more I think about it, we should argue or at least shoot for a ruling similar to this.....
a battery/tank/cartridge/atomizer can only be considered a "component" of a tobacco product if:

*the cartridge and heating element are inseparable (cigalike cartos/gas station tanks)

Or

*the unit often is sold prefilled with nicotine e-liquid (cigalike cartos/gas station tanks)

Or

*the battery, cartridge/tank, and heating element are all sold as one, inseparable unit (disposables) and product contains nicotine.

Or

*the cartridge/tank uses polyfil as the primary means of holding liquid rather than letting it hold freely (can't really argue that's anything but exclusively an e-cig)

Basically, those conditions = cigarette tube, not those conditions = pipe. Easily a court ruling I could see happening.

 

[sqirl1]

I believe that the FDA is taking this section quite literally:

[*101] Sec. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) Definition of Tobacco Products.--Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321) is amended by adding at the end the following:

"(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

They've so far been able to get away with regulating rolling machines for heaven's sake. Of course they think they can do what they want.

Those are CLEARLY associated with tobacco though, the issue here is that you don't have to get nicotine in vapor products, just like you don't have to put tobacco in a pipe. Not to mention, Juicy Jays makes flavored rolling papers specifically stating they are NOT to be used for tobacco, exempting them as well. I think the court is going to find that the more you can do with it yourself the less like a cigarette filter it is and the more like a pipe it is.