It's not just you. It seemed like council for the FDA was really struggling during this session. She could have been the best attorney in the world, but there isn't really much for her to work with here.
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Need help from former MFS (MyFreedomSmokes) customers
Has any found a supplier or company that has tobacco e-juice like or very similar to MFS Turbosmog, Tall Paul, or Red Luck?
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SE, NJoy vs FDA -- Discussion
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After reading the transcript of the oral arguments, I found it to be quite bizarre. 95 percent of the proceeding was a Q&A about what the Supreme Court meant by 'tobacco products' in Brown & Williamson. The passage of the tobacco Act created a new regulatory scheme and the tobacco Act clearly defines tobacco products as "...any product made or derived from tobacco that is intended for human consumption..." So what was the point of the whole proceeding?
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Alisa Klein's arguments seem to rest heavily on the FDA's interpretation of the Supreme Court ruling in FDA v. Brown & Williamson. Klein claims that tobacco products were limited to cigarettes and smokeless in B&W. FDA has regulated every other nicotine product as if it were a drug. She gives as examples nicotine gel, nicotine water, and Favor smokeless cigarette. Therefore, her reasoning goes, since e-cigarettes contain nicotine and are neither tobacco cigarettes nor smokeless tobacco, they should be regulated as a drug (because we said so!). Therefore, much of the time in the oral agruments was spent with the judges questioning Klein about her interpretation and logic.
One thing Klein ignores is the fact that just because the FDA did choose to regulate the other nicotine products as drugs doesn't necessarily mean that they should have been regulated as drugs. The e-cigarette companies were the very first to challenge FDA in court over this question.
One thing Klein ignores is the fact that just because the FDA did choose to regulate the other nicotine products as drugs doesn't necessarily mean that they should have been regulated as drugs. The e-cigarette companies were the very first to challenge FDA in court over this question.
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Which, even if true, is sort of moot after the FSPTCA came into effect. But in addition, she kept saying things like "but this only applies to 'tobacco products', not ecigs" over and over again. You can't use that kind of (ill)logic to determine whether or not a product fits into the tobacco category...otherwise it never will!
In other words, Klein's argument leaves no room for new types of tobacco products ever, which was clearly not Congress's intent when passing the Tobacco act.
I have to say that I'm hoping that the gov't ends up being forced to go with the status quo, and just leave things as they are. As it stands now, with the two options available, we'll be forced to flavor our own juices if we get regulated as a tobacco product (can't be enticing kiddos with the tasty flavors, now!)... or we just get our products banned.
Perhaps you know the answer to this about Favor. As far as I was able to determine, Favor never got to market because they used the same approach and I suppose the developer didn't have the money to go the NDA route or the legal route. That was over 20 years ago so the information seems pretty sketchy. I did find that it was sold to a company in Sweden and seems to have vanished. That seems like exactly what the FDA would like to happen with E cigs.
Of course ten years later, the Nicotrol Inhaler was approved for Pharmacia and UpJohn. That technology bears a strange resemblance to what the Favor cigarettes were. I can see history repeating itself with the PV. Look at that technology reported a few months ago being developed by Duke or NC (can't recall) and studied in NZ. Very similar concept that I could see replacing the PV if the FDA manages to make them disappear. Of course after going through the tremendous expense of developing, studying, clinical trials, getting approval and marketing the cost will be prohibitive, the nicotine level will be minuscule and the ultimate effectiveness will be negligible.
Of course after being a scripted product for a suitable length of time (patent expiration), it could be sent into the TCA (FSPTCA is just too long an acronym) as a nicotine maintenance product. Maybe they'd even lower the price a bit, increase the nic a bit and add some yummy flavoring to make them more appealing to the "...... like" addicted adult nicotine addicts. At least they'd be able to advertise them on television and name sporting events after them.
This is exactly right, imo. Basically, a line was drawn in Brown, and nobody is arguing that the Tobacco Act changed that line . . . it's just a question of where that line was drawn to begin with, which requires an interpretation of the original Brown ruling.
Elaine, I don't think I've thanked you for all your time and effort ~ Add me to the already huge group that appreciates you!
Lollipops and water are food products, and it would seem to me that nicotine gel could be considered a hand sanitizer, which places all of these items in categories that were obviously under the FDA's jurisdiction prior to the Tobacco Act.
I know I'm preaching to the choir, but if I put a carrot in a blender and strain it to extract the juice, does it cease to be a carrot product?
Klein's position appears to be that "if it contains nicotine, it is automatically a drug." Judge Leon (District Court judge) hung his decision to grant the injunction based on the "intended use" question. If the intended use is to treat or prevent a disease or condition, it's a drug. Otherwise, it isn't, regardless of what it contains.
And I think the B&W decision hinged on that point: FDA could not regulate cigarettes and smokeless tobacco as drugs/drug delivery devices because the intended use was not to treat or prevent a disease or condition. I think that's why Judge Williams (Appeals Court judge) cautioned Kline, "I think if you're focusing on that that's not a good move for interpretation of Brown & Williamson."
The FDA has, indeed, applied the "intended use" benchmark to such products as Cheerios. Oat bran can lower cholesterol, which in turn can lower risks of heart disease. Cheerios contains oat bran. The FDA left General Foods alone until Cheerios packages started carrying statements about lowering risks of heart disease. So just containing a substance that could be used to treat a disease doesn't necessarily make a product a drug. But stating that the intended use of a product is to treat or prevent a disease makes it fall under laws regulating drugs.
And I think the B&W decision hinged on that point: FDA could not regulate cigarettes and smokeless tobacco as drugs/drug delivery devices because the intended use was not to treat or prevent a disease or condition. I think that's why Judge Williams (Appeals Court judge) cautioned Kline, "I think if you're focusing on that that's not a good move for interpretation of Brown & Williamson."
The FDA has, indeed, applied the "intended use" benchmark to such products as Cheerios. Oat bran can lower cholesterol, which in turn can lower risks of heart disease. Cheerios contains oat bran. The FDA left General Foods alone until Cheerios packages started carrying statements about lowering risks of heart disease. So just containing a substance that could be used to treat a disease doesn't necessarily make a product a drug. But stating that the intended use of a product is to treat or prevent a disease makes it fall under laws regulating drugs.
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I don't know about Favor (as that was more than 20 years ago).
But it is important to note that when the FDA declared nicotine water, a nicotine skin cream, and a so-called nicotine lollipop unapproved drug devices in 2002, and when the FDA delared Nicogel an unapproved drug device in 2007, none of those manufacturers challenged the FDA in federal court (as did SE and NJOY last year).
Alisa Klein appears to have misled the DC Court of Appeals to believe that those manufacturers had similarly challenged the FDA in court, and that the FDA prevailed in court against each of those legal challenges.
Also, Alisa Klein misled the DC Court of Appeals to believe that, if the FDA loses this case, that there would be no FDA regulation of nicotine injection products. But in fact, injection syringes have long been regulated by the FDA as drug delivery devices, and as such, nicotine injection products would continue to considered as unapproved drug delivery devices.
Ms. Klein also misled the DC Court of Appeals to believe that the FDA has consistently banned the sale of unapproved nicotine drug delivery devices. But in fact, when then FDA Commissioner David Kessler asserted authority to regulate cigarettes and smokeless tobacco products in 1995, he repeatedly insisted that the FDA would NOT ban these products (in response to tobacco industry claims that the FDA would ban these products) just because they were being reclassified and regulated as nicotine drug delivery devices.
But it is important to note that when the FDA declared nicotine water, a nicotine skin cream, and a so-called nicotine lollipop unapproved drug devices in 2002, and when the FDA delared Nicogel an unapproved drug device in 2007, none of those manufacturers challenged the FDA in federal court (as did SE and NJOY last year).
Alisa Klein appears to have misled the DC Court of Appeals to believe that those manufacturers had similarly challenged the FDA in court, and that the FDA prevailed in court against each of those legal challenges.
Also, Alisa Klein misled the DC Court of Appeals to believe that, if the FDA loses this case, that there would be no FDA regulation of nicotine injection products. But in fact, injection syringes have long been regulated by the FDA as drug delivery devices, and as such, nicotine injection products would continue to considered as unapproved drug delivery devices.
Ms. Klein also misled the DC Court of Appeals to believe that the FDA has consistently banned the sale of unapproved nicotine drug delivery devices. But in fact, when then FDA Commissioner David Kessler asserted authority to regulate cigarettes and smokeless tobacco products in 1995, he repeatedly insisted that the FDA would NOT ban these products (in response to tobacco industry claims that the FDA would ban these products) just because they were being reclassified and regulated as nicotine drug delivery devices.
As an aside:
I'm so *proud* of this community. All of you remind me of the linux community involved in SCO VS. *everybody*- which is more or less settled.
It's like groklaw.net all over again.
I'm so *proud* of this community. All of you remind me of the linux community involved in SCO VS. *everybody*- which is more or less settled.
It's like groklaw.net all over again.
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Elaine wrote
Klein's position appears to be that "if it contains nicotine, it is automatically a drug." Judge Leon (District Court judge) hung his decision to grant the injunction based on the "intended use" question. If the intended use is to treat or prevent a disease or condition, it's a drug. Otherwise, it isn't, regardless of what it contains.
Elaine is basically correct, although I think the legallly correct term in the FDCA is something like "intended to affect the structure or function of the human body".
In fact, after David Kessler left the FDA, he wrote a book entitled "A Question of Intent" about his efforts to regulate "tobacco products" (which was what Kessler and everyone else referred to at that time, unlike Alisa Klein's repeated claim to the DC Court of Appeals that it was only to regulate "cigarettes and smokeless tobacco products").
Klein's position appears to be that "if it contains nicotine, it is automatically a drug." Judge Leon (District Court judge) hung his decision to grant the injunction based on the "intended use" question. If the intended use is to treat or prevent a disease or condition, it's a drug. Otherwise, it isn't, regardless of what it contains.
Elaine is basically correct, although I think the legallly correct term in the FDCA is something like "intended to affect the structure or function of the human body".
In fact, after David Kessler left the FDA, he wrote a book entitled "A Question of Intent" about his efforts to regulate "tobacco products" (which was what Kessler and everyone else referred to at that time, unlike Alisa Klein's repeated claim to the DC Court of Appeals that it was only to regulate "cigarettes and smokeless tobacco products").
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Rolygate wrote:
Option 3 is the least-worst choice for us (community and trade) as it means that for a while at least, the status quo will prevail. Before long though we'll see taxes plus an attempt by the FDA to reduce the appeal of ecigarettes as far as possible, by regulating any and all aspects they can, such as nicotine strength, flavors and so on. There might also be some postal sales implications eventually. This option is simply the lesser of two evils.
I agree with Rolygate's first sentence. But if/when the DC Court of Appeals rules against the FDA (which I still consider likely), it will take an additional 1-2 years (from the time FDA proposes regulation e-cigarettes as tobacco products) for the FDA to finalize those regulations (during which there would be no FDA regulation of the e-cigarettes unless a company markets its products as a smoking cessation aid).
But during the next several years, it is very likely that e-cigarette prohibitionists will advocate legislation in many states to ban the sale of e-cigarettes, as well as many local/state bills to ban e-cigarette usage where smoking is banned.
Meanwhile, in addition to urging the FDA to reasonably regulate e-cigarettes as tobacco products, e-cigarette companies and consumer groups should proactively advocate states legislatures to ban the sale of e-cigarettes to minors (by amending existing tobacco sales prohibitions to minors statutes to include e-cigarettes in the definition of tobacco products), which is also the most effective way to fend off state e-cigarette sales bans to adults.
The 1-2 year process of FDA promulgating regs for e-cigarettes as tobacco products is likely to be another contentious battle, but the FSPTCA is on our side because it requires the FDA to rely upon scientific and empirical evidence in order to impose regulations. As such, the burden of proof will be on the FDA to demonstrate the validity of their claims about e-cigarettes in order to impose specific regulations. In sharp contrast, for drug devices, the burden of proof is on each company to demonstrate that its product(s) is/are "safe and effective" as smoking cessation aids before they can be marketed.
Regarding taxes, once e-cigarettes are regulated as tobacco products by the FDA, we will likely face tax battles in states (and we may face battles in some states before FDA regulates e-cigs as tobacco) and perhaps in US Congress. We'll need to oppose excessive taxation (e.g. >10%) by pointing out e-cigarettes should be taxed at a much lower rate than cigarettes because e-cigarettes are far less hazardous than cigarettes, impose no costs on governments, and that high tax rates on e-cigarettes will protect cigarette markets and keep many smokers smoking cigarettes.
Regarding the mailing of e-cigarettes, Congress would need to enact the PACT Act (which now prohibits the mailing of cigarettes or smokeless tobacco products, and was enacted to reduce tax evasion) in order to ban the mailing of cigars, pipe tobacco or e-cigarettes.
But please remember, if e-cigarette sales continue to increase by 3, 4, 5 or more times annually, there will be increasingy more e-cigarette consumers (and e-cigarette companies will have more money) to advocate for reasonable and responsible regulations and laws for e-cigarettes, and to oppose draconian legislation.
Option 3 is the least-worst choice for us (community and trade) as it means that for a while at least, the status quo will prevail. Before long though we'll see taxes plus an attempt by the FDA to reduce the appeal of ecigarettes as far as possible, by regulating any and all aspects they can, such as nicotine strength, flavors and so on. There might also be some postal sales implications eventually. This option is simply the lesser of two evils.
I agree with Rolygate's first sentence. But if/when the DC Court of Appeals rules against the FDA (which I still consider likely), it will take an additional 1-2 years (from the time FDA proposes regulation e-cigarettes as tobacco products) for the FDA to finalize those regulations (during which there would be no FDA regulation of the e-cigarettes unless a company markets its products as a smoking cessation aid).
But during the next several years, it is very likely that e-cigarette prohibitionists will advocate legislation in many states to ban the sale of e-cigarettes, as well as many local/state bills to ban e-cigarette usage where smoking is banned.
Meanwhile, in addition to urging the FDA to reasonably regulate e-cigarettes as tobacco products, e-cigarette companies and consumer groups should proactively advocate states legislatures to ban the sale of e-cigarettes to minors (by amending existing tobacco sales prohibitions to minors statutes to include e-cigarettes in the definition of tobacco products), which is also the most effective way to fend off state e-cigarette sales bans to adults.
The 1-2 year process of FDA promulgating regs for e-cigarettes as tobacco products is likely to be another contentious battle, but the FSPTCA is on our side because it requires the FDA to rely upon scientific and empirical evidence in order to impose regulations. As such, the burden of proof will be on the FDA to demonstrate the validity of their claims about e-cigarettes in order to impose specific regulations. In sharp contrast, for drug devices, the burden of proof is on each company to demonstrate that its product(s) is/are "safe and effective" as smoking cessation aids before they can be marketed.
Regarding taxes, once e-cigarettes are regulated as tobacco products by the FDA, we will likely face tax battles in states (and we may face battles in some states before FDA regulates e-cigs as tobacco) and perhaps in US Congress. We'll need to oppose excessive taxation (e.g. >10%) by pointing out e-cigarettes should be taxed at a much lower rate than cigarettes because e-cigarettes are far less hazardous than cigarettes, impose no costs on governments, and that high tax rates on e-cigarettes will protect cigarette markets and keep many smokers smoking cigarettes.
Regarding the mailing of e-cigarettes, Congress would need to enact the PACT Act (which now prohibits the mailing of cigarettes or smokeless tobacco products, and was enacted to reduce tax evasion) in order to ban the mailing of cigars, pipe tobacco or e-cigarettes.
But please remember, if e-cigarette sales continue to increase by 3, 4, 5 or more times annually, there will be increasingy more e-cigarette consumers (and e-cigarette companies will have more money) to advocate for reasonable and responsible regulations and laws for e-cigarettes, and to oppose draconian legislation.
If you haven't seen it yet-- The Rest of the Story: Tobacco News Analysis and Commentary: FDA Guidelines for Determining Eligibility for Advisory Committees are Ridiculous and Ensure that Conflicts of Interest Will Continue to Plague Agency -- Dr. Siegel speaks to another reason why there could be "no room for new types of tobacco products ever.
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I do not remember if the Njoy attorney challenged her on the misleading statements. If not,will the Court research her statements if their ruling is based on her misleading statements or will they just take her testimony as fact since they were not challenged?
That is really great to hear.
And based on how other tobacco products are taxed, we should not really expect electronic cigarettes to be taxed too highly.
And the main reason for the PACT Act was to stop people from evading the excessive taxes on cigarettes.
And since electronic cigarettes should not be taxed to excessive levels, it seems unlikely they would amend the Pact Act.
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At the bottom of the particular blog post is the time it was posted. That is a clickable link and will take you to a page that contains only that particular blog posting. That's generally how I link to one of Dr. Siegel's blog posts.
The Judges did such a good job at challenging her theory and logic that the NJOY attorney didn't have to do much work. I don't think we need to worry about these Judges taking the Agency's word for it on anything.
Bill Godshall wrote: [/QUOTE] But please remember, if e-cigarette sales continue to increase by 3, 4, 5 or more times annually, there will be increasingly more e-cigarette consumers (and e-cigarette companies will have more money) to advocate for reasonable and responsible regulations and laws for e-cigarettes, and to oppose draconian legislation.[/QUOTE]
We may be in our infancy as an industry, but here in the UK, this is precisely what ECITA is doing, and we are taking it up to Europe in the coming weeks. This is, we believe, the ONLY way to achieve sensible and proportionate regulation of these products - because it is abundantly apparent that the assorted regulatory agencies around the world do not have the first clue how to do it. It is up to us to explain it to them.
We may be in our infancy as an industry, but here in the UK, this is precisely what ECITA is doing, and we are taking it up to Europe in the coming weeks. This is, we believe, the ONLY way to achieve sensible and proportionate regulation of these products - because it is abundantly apparent that the assorted regulatory agencies around the world do not have the first clue how to do it. It is up to us to explain it to them.
I've always been curious as to why "electronic cigarettes" can be considered one thing/unit... because they aren't.
#1 - Battery
#2 - Atomizer
#3 - Nicotine (juice) and possibly other liquids
"Medicine not safe!" =/= "Tylenol sold in Chicago drug stores and supermarkets laced with cyanide!"
#1 - Battery
#2 - Atomizer
#3 - Nicotine (juice) and possibly other liquids
"Medicine not safe!" =/= "Tylenol sold in Chicago drug stores and supermarkets laced with cyanide!"
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