A question often discussed here on ECF. Here's what Kristin Noll-Marsh (Pres. of CASAA and our very own kristin) has to say. Thought-provoking read for every vaper:
Stop the ANTZ
Stop the ANTZ
Are nicotine e-cigarettes a tobacco product?
- Thread starter AgentAnia
- Start date
- th_trl_thread_readers 0
- Status
God?
(Edit: just so people don't get all up in arms, it's a joke. I'm an evolutionist, not a creationist!)
Last edited:
Are e-cigarettes a tobacco product? OK, is a drink with caffeine in it a coffee product? Just sayin'.
Nicotine can be synthetically made now, so it doesn't have to come from the nightshade family of plants (of which tobacco is a member).
Not a viable option for Vapers though
"Most studies regarding synthetic nicotine were conducted in the 60's and 70's by tobacco companies looking for a way to add nicotine on the manufacturing level instead of on the agricultural or botany level. Purely synthetic nicotine is made with a combination of Niacin, Ethanol, Sulfuric Acid and a few other nasty chemicals. When adjusted for inflation, the cost of the process is prohibitively expensive when compared to modern extraction methods."
Christian Berkey
Chairman & CEO
Johnson Creek® Enterprises, Inc
Exactly! Getting the FDA to classify E-cigs as a completely different category looks to be a futile effort. It would appear they are simply lazy and don't want to deal with the legal ramifications of making low risk nicotine products into a new category. That is sad.
There have been advances since then. Look at the inhalers from the pharma companies. They aren't using tobacco extracts to get their nicotine.
There have been advances since then. Look at the inhalers from the pharma companies. They aren't using tobacco extracts to get their nicotine.
They're not ?!?
Permalink to the blog post:
Stop the ANTZ: Are nicotine e-cigarettes a tobacco product?
Kristin is absolutely right and the Court's ruling couldn't be more clear. Nicotine is regulated based on intended use as marketed, not what it is or where it comes from.
Some regulation is inevitable. However, an outright ban of the products we use simply isn't going to happen. As I've written before, it would be a quick target for an equal protection cause and would create an enforcement nightmare. Commercially available liquid nicotine will remain legal because of other "intended uses" of the product that have nothing to do with vaping. PG and VG will remain legal for the same reason, as will food flavorings.
Even if FDA manages to get a flavored eliquid ban to stand (and it won't), nothing stops you from buying a bag of pipe tobacco, a box of cheap cigars or a few packs of cigs, shredding them all and steeping it in a warm crock pot to extract the nicotine yourself.
Even the devices we use would survive the attempt. When I buy my V3 or Sigeli for my birthday present next month (we WANTS it), it won't contain one milligram of any substance over which EPA has jurisdiction.
We have the upper hand, thanks to District Judge Richard Leon and the three member panel from the DC Circuit Court of Appeals.
Stop the ANTZ: Are nicotine e-cigarettes a tobacco product?
Kristin is absolutely right and the Court's ruling couldn't be more clear. Nicotine is regulated based on intended use as marketed, not what it is or where it comes from.
Some regulation is inevitable. However, an outright ban of the products we use simply isn't going to happen. As I've written before, it would be a quick target for an equal protection cause and would create an enforcement nightmare. Commercially available liquid nicotine will remain legal because of other "intended uses" of the product that have nothing to do with vaping. PG and VG will remain legal for the same reason, as will food flavorings.
Even if FDA manages to get a flavored eliquid ban to stand (and it won't), nothing stops you from buying a bag of pipe tobacco, a box of cheap cigars or a few packs of cigs, shredding them all and steeping it in a warm crock pot to extract the nicotine yourself.
Even the devices we use would survive the attempt. When I buy my V3 or Sigeli for my birthday present next month (we WANTS it), it won't contain one milligram of any substance over which EPA has jurisdiction.
We have the upper hand, thanks to District Judge Richard Leon and the three member panel from the DC Circuit Court of Appeals.
They may not be able to, given the authority granted by Congress in the 2009 Tobacco Act. That act spells out exactly how FDA is to promulgate regulations and I don't recall such leeway being in the legislation. I could be wrong and I'm headed back to my copy to see.
Edit: As I feared, there is no such leeway in FSPTCA. However, there is a provision delaying the required registration for small tobacco product manufacturers (95% of our favorite e-juice vendors) for two years after any deeming regulations are imposed. So, we are at least four years away from anything threatening our juice.
There is also a provision that allows the Secretary (HHS) to determine that a specific tobacco product need not be registered/reported if it does not increase or maintain the risk to public health or if the Secretary determines that the registration/report is not necessary to protect the public health. That doesn't mean they can create a new category per se, but it does mean FDA has some wiggle room.
"Small" as defined by the legislation means any enterprise with 350 or fewer employees. I don't think even Johnson Creek is that big yet.
Last edited:
It would be more accurate for the analogy to ask if coffee is a caffeine product, which it is.
I think the best answer appears to be creating sub-categories within the tobacco product category for different levels of risk. Assuming of course that they don't just leave us alone. Hey, I'm a dreamer.
I'm going Policy Wonk on y'all so if it annoys you, my apologies in advance.
The emphasized portion of the FSPTCA is where we can make the most progress, especially with any ongoing or to-be-started clinical research.
‘‘(g) MARKETING.—
The worst thing you can do to any bureaucrat is tell him that he has huge problem and his .... is hanging in the wind. No beauracrat--government or private sector--wants trouble on his watch and if it does happen, he needs to have his .... fully armored.
The best thing you can do is tell him that, while he has a huge boinking problem, you have a solution. You explain to him the risks of going forward with the bold new plan that your opponents have proposed or support. Include the high likelihood of public backlash and litigation. Remind him that there is little science or precedence for what he has been asked to do and that it could significantly affect interstate commerce or company shareholder value. Abuse of discretion arguments are especially affective because they scare bureaucrats more than anything else. The more negative impacts you can identify and describe in exquisite detail, the better. It's better even still if you can directly tie those impacts to him and make him see that all of this is going to be his fault.
Then, you carefully explain the benefits of your plan, which gives the bureaucrat a way out of this dangerous, hot mess that is both consistent with the authority granted him by Congress (or the Board, in private sector) and is supported by the best available scientific evidence. Explain that by promoting commerce, you are improving the economic condition and following the intent of his superiors. The more beneficial effects you can describe, the better, and better still if you can assure him that he'll get credit for it.
The emphasized portion of the FSPTCA is where we can make the most progress, especially with any ongoing or to-be-started clinical research.
‘‘(g) MARKETING.—
‘‘(1) MODIFIED RISK PRODUCTS.—Except as provided in paragraph
(2), the Secretary shall, with respect to an application
submitted under this section, issue an order that a modified
risk product may be commercially marketed only if the Secretary
determines that the applicant has demonstrated that
such product, as it is actually used by consumers, will—
(2), the Secretary shall, with respect to an application
submitted under this section, issue an order that a modified
risk product may be commercially marketed only if the Secretary
determines that the applicant has demonstrated that
such product, as it is actually used by consumers, will—
‘‘(A) significantly reduce harm and the risk of tobacco related
disease to individual tobacco users; and
‘‘(B) benefit the health of the population as a whole
taking into account both users of tobacco products and
persons who do not currently use tobacco products.
disease to individual tobacco users; and
‘‘(B) benefit the health of the population as a whole
taking into account both users of tobacco products and
persons who do not currently use tobacco products.
‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.—‘‘(A) IN GENERAL.—The Secretary may issue an order
that a tobacco product may be introduced or delivered
for introduction into interstate commerce, pursuant to an
application under this section, with respect to a tobacco
product that may not be commercially marketed under
paragraph (1) if the Secretary makes the findings required
under this paragraph and determines that the applicant
has demonstrated that—
that a tobacco product may be introduced or delivered
for introduction into interstate commerce, pursuant to an
application under this section, with respect to a tobacco
product that may not be commercially marketed under
paragraph (1) if the Secretary makes the findings required
under this paragraph and determines that the applicant
has demonstrated that—
‘‘(i) such order would be appropriate to promote
the public health;
‘‘(ii) any aspect of the label, labeling, and advertising
for such product that would cause the tobacco
product to be a modified risk tobacco product under
subsection (b) is limited to an explicit or implicit representation
that such tobacco product or its smoke
does not contain or is free of a substance or contains
a reduced level of a substance, or presents a reduced
exposure to a substance in tobacco smoke;
‘‘(iii) scientific evidence is not available and, using
the best available scientific methods, cannot be made
available without conducting long-term epidemiological
studies for an application to meet the standards set
forth in paragraph (1); and
‘‘(iv) the scientific evidence that is available without
conducting long-term epidemiological studies demonstrates
that a measurable and substantial reduction
in morbidity or mortality among individual tobacco
users is reasonably likely in subsequent studies.
the public health;
‘‘(ii) any aspect of the label, labeling, and advertising
for such product that would cause the tobacco
product to be a modified risk tobacco product under
subsection (b) is limited to an explicit or implicit representation
that such tobacco product or its smoke
does not contain or is free of a substance or contains
a reduced level of a substance, or presents a reduced
exposure to a substance in tobacco smoke;
‘‘(iii) scientific evidence is not available and, using
the best available scientific methods, cannot be made
available without conducting long-term epidemiological
studies for an application to meet the standards set
forth in paragraph (1); and
‘‘(iv) the scientific evidence that is available without
conducting long-term epidemiological studies demonstrates
that a measurable and substantial reduction
in morbidity or mortality among individual tobacco
users is reasonably likely in subsequent studies.
The worst thing you can do to any bureaucrat is tell him that he has huge problem and his .... is hanging in the wind. No beauracrat--government or private sector--wants trouble on his watch and if it does happen, he needs to have his .... fully armored.
The best thing you can do is tell him that, while he has a huge boinking problem, you have a solution. You explain to him the risks of going forward with the bold new plan that your opponents have proposed or support. Include the high likelihood of public backlash and litigation. Remind him that there is little science or precedence for what he has been asked to do and that it could significantly affect interstate commerce or company shareholder value. Abuse of discretion arguments are especially affective because they scare bureaucrats more than anything else. The more negative impacts you can identify and describe in exquisite detail, the better. It's better even still if you can directly tie those impacts to him and make him see that all of this is going to be his fault.
Then, you carefully explain the benefits of your plan, which gives the bureaucrat a way out of this dangerous, hot mess that is both consistent with the authority granted him by Congress (or the Board, in private sector) and is supported by the best available scientific evidence. Explain that by promoting commerce, you are improving the economic condition and following the intent of his superiors. The more beneficial effects you can describe, the better, and better still if you can assure him that he'll get credit for it.
Last edited:
Here is an 'un common sense' idea on a realistic way forward for what I personaly would describe as "one of the most important inventions of the 20th century" -I'll be watching future Nobel prize nominations for Hon Liks name to appear (wishfull thinking)-anyway
From someone who is very much 'a man of the moment' Clive Bates
Because you’re worth it – are there ideas from cosmetics regulation useful for e-cigarettes? « The counterfactual
ps, I suggest reading this, and then re reading it, as at first it seems 'radical'-but hey,,, he gets my vote!
From someone who is very much 'a man of the moment' Clive Bates
Because you’re worth it – are there ideas from cosmetics regulation useful for e-cigarettes? « The counterfactual
ps, I suggest reading this, and then re reading it, as at first it seems 'radical'-but hey,,, he gets my vote!
Cosmetics are regulated under the same authority that FDA tried to use in the Soterra case--the Food, Drug and Cosmetic Act. That attempt was shot down by a US District Court and the decision was upheld on appeal. FDA's only choice now is to attempt regulation under the FSPTCA, the 2009 Tobacco Act.
By way of comparison, FDCA is like a seven pound maul. The authority granted under FSPTCA is a tack hammer.
My understanding from reading Vocalek is that it sounds like the requirements for being classified as a modified risk tobacco product are going to be pretty much as cumbersome and expensive as the requirements for becoming an FDA-approved drug. If I remember correctly this was only her opinion, and it was formed by hearing some of the comments from certain FDA personnel.
Uh, no. You misunderstood. E-cigarettes is to tobacco as a caffeine drink(such as an energy drink) is to coffee(the coffee bean).
Last edited:
- Status
Similar threads
- Locked
