FDA Proposed regulation is available
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It wouldn't be classified as a tobacco product. The nicotine that is used in e-liquid is derived from tobacco. Tobacco is the only readily available source of nicotine.
Considering that 1,000,000 nanograms = 1mg; there's not much nicotine in common vegetables:
Eggplant - 100 nanograms of nicotine / gram of eggplant
Green Tomatoes - 43 ng/g
Ripe Tomatoes - 4 ng/g
i have been searching the google trying to find out why tobacco pipes are not deemed tobacco.
cant seem to find out.
so aren't the components of a e-cig basically the pipe?
they are not consumed by using the juice as a cigarette consumes itself when using it.
minus the filter of course.
regards
mike
cant seem to find out.
so aren't the components of a e-cig basically the pipe?
they are not consumed by using the juice as a cigarette consumes itself when using it.
minus the filter of course.
regards
mike
This was the stance the reporter at the AP i spoke with had following the media call.
He left that call with the impression that the devices themselves, and any no-nic liquid would not be regulated because they don't contain tobacco-derived nicotine... he specifically used a "wooden tobacco pipe" as an example
That would make a lot of sense, I'll believe it when the final regulations are published. Trust but verify...
In a nutshell, as I see it, what they've done is create some fat incomes for lawyers and one h#ll of a black market. You would think they had already learned prohibition, not matter what its guise or how its attempted, doesn't work.
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I hope someone here can help me understand why this would be a basis for a successful court challenge. The deeming regulations have to be approved by Congress. That approval is a Congressional sanction of a specific limited change in authority for the FDA and an explicit expression of a change in Congressional intent, with a granting of a 2 year grace period for industry players to play catch-up. This seems to parallel actions that have occurred within the domain of other governmental agencies such as EPA, MSHA and OSHA.
I don't think agency regulations have to be approved by Congress.
I see you picked up on that too. What I thought strasnge about those figures, if I remember correctly, they estimated 160 apps a year. The only way that number would be that low is if the number of suppliers decreased substantially. The other thing about that number that I wondered was if they took into account the amount of time it wiould take a novice staff to understand what the FDA was asking for. An Altria would go out an hire an FDA expert to handle the process. Even a decent sized e cig business would have challenges in getting the type of help they'd need to handle FDA filings.
this is what confuse's me.
"substantial equivalence" (SE) pathway for a new tobacco product to
enter the market if it is substantially equivalent to a "predicate product,"
the predicate product.battery,check.container to hold the juice,check.
wick or other material to soak up said juice ,check.
coil to use the power from the battery to heat before mentioned juice into vapor,check.
broken down to the component level how are the newer products substantially different?
i have a ten speed bike.
i see some guy all the time on the bike path that has a recumbent bike.
neither looks any thing like the other but,they are still both bikes.
regards
mike
Let's put it this way Mike. A cigarette is a cigarette, right? However, quite a few SEs were submitted for new cigarettes and only recently Lorillard got approval for two new cigarettes, the first since the FDA took over. In fact, I believe there was a new company that developed a cigarette with significantly less nitrosamines that has not been approved for years now. The last I heard of it was at least a year or two ago. They may have gone belly up by now.
Impressions are always dangerous, especially when dealing with the wordsmiths from a government agency. The FDA may not intend to regulate wooden pipes et al, but they have included 2 very specific specific sections of language that would give them the right to do so.
From page 7: "Components and parts of tobacco products, but not their related accessories, would also be included in the scope of this proposed rule. Components and parts are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product."
From page 11: "FDA is proposing to deem those products meeting the definition of "tobacco product" in section 201(rr) of the FD&C Act, except the accessories of proposed deemed tobacco products to be subject to chapter IX of the FD&C Act. FDA is seeking comment on how its proposal to exclude accessories from the scope of the deeming rule would impact the public health. We also ask for comments, including supporting facts, research, and other evidence, as to whether FDA should define components and parts of tobacco products and how those items might be distinguished from accessories of tobacco products."
If the FDA decides that an item such as a wooden pipe or a battery is an accessory, then it will not be regulated. If the FDA decides that an item such as a pipe or a battery is a component, then it will be regulated. At this point in time, the FDA holds total discretion in determining whether an item is an accessory or a component and do not seem to be interested in giving up that discretion unless there are comments that convince them they should do so.
The devil is always in the details no?
I strongly suspect the intention is to get this into law now then later come down hard on the whole shebang. Not just ecig gear but closing that loophole for head shops as well as tobacco pipes etc.
Do I have any proof? No not really but that is what this is starting to feel like and not exactly unknown behaviour with government agencies.
Also remember it is fairly well know that when taken to court government agencies are famous for keeping up appeals until one of 2 things happen: either the person bringing the suit runs out of money or the government finally gets a judge that agrees with them (judge shopping).
Actually no. E cigs are a tobacco product because the nicotine is derived from tobacco and that is the reason that Judge Leone ruled against the FDA back in '09. Now if someone figured out how to economically get their nicotine extracted from a tomato or egplant and use it for vegetable derived e cigs, the FDA could declare those to be drugs and drug delivery systems and ban them outright without drug testing for "safety and efficiency". Isn't government by agency beautiful? You can't even vote them out of office.
I'm thinking this has to be where we argue from...
I know we don't talk about it here... but non-cig-a-like ecigs are used for other things besides eliquid.
And a case can be made, as a result, that they are no different than pipes.
The only item the FDA could conceivably deem to be tobacco derived is eLiquid... specifically eLiquid containing Nicotine.
perhaps someone at CASAA needs to give NORML a call.
I'm thinking this may be a win for us.
Because, it would seem to me that even if they push forward the Regs with devices included in the regulations... They'd lose in court on the basis of the pre-existing pipe exemption.
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Silly, silly man -- we're talking about a government agency here.In the case of Hestia Tobacco, they had to do a detailed and precise predicate comparison of the length and diameter of the paper tube, the filter paper, the composition of the paper, composition of the filter, design of the filter, composition of the glue, gluing process, manufacturing process of the paper, manufacturing process of the filter, tobacco sourcing, aging and curing processes, grinding process, blending process, rolling process blah blah blah.......all the way up to (not kidding here) "heating source" -- i.e. how, exactly, is it lit? Do a Google search for Hestia Tobacco for all the dirty details. I would not expect the FDA to take a different approach for e-cigs.
This article gives some pretty good insight into SE processing and the FDA.
How the FDA Is Keeping New Cigarettes Off the Market - Jacob Grier - The Atlantic
1) It's not clear to me, that the '07 date would by itself be the basis for a court challenge, but surely Congress didn't intend the statute that refereneces that date to apply to vaping. So the '07 date would be part of a larger objection that the FDA is exceeding the scope of its authority as evidenced by congressional intent. That's all I was saying.
2) There is no question that the FDA has the authority to regulate "components of a finished tobacco product." And also that they have expressed the intent to do so, both in the PDF. I don't know what the reporter who listened to that conf. call heard, but listen to this starting at 14:07 (Greg Conley's Q): FDA Deeming Teleconference 4/24/2014 - YouTube Zeller's language was "anticipated or intended use" - so products that are usable for other purposes are still covered. It is probably correct that they can't regulate 0% e-liquid.
Besides we have to get back to motive. If the goal is to help BT and BV (big vapor) then of course they're going to want to get rid of non-cigAlike products. That doesn't mean they're going to start regulating O-rings, 186xx batteries, or Kanthal wire: it's silly and impractical. But APVs and mech mods? Yep, they have the power to get rid of them, and all the incentive in the world to do so.
2) There is no question that the FDA has the authority to regulate "components of a finished tobacco product." And also that they have expressed the intent to do so, both in the PDF. I don't know what the reporter who listened to that conf. call heard, but listen to this starting at 14:07 (Greg Conley's Q): FDA Deeming Teleconference 4/24/2014 - YouTube Zeller's language was "anticipated or intended use" - so products that are usable for other purposes are still covered. It is probably correct that they can't regulate 0% e-liquid.
Besides we have to get back to motive. If the goal is to help BT and BV (big vapor) then of course they're going to want to get rid of non-cigAlike products. That doesn't mean they're going to start regulating O-rings, 186xx batteries, or Kanthal wire: it's silly and impractical. But APVs and mech mods? Yep, they have the power to get rid of them, and all the incentive in the world to do so.
I'm a bit more pragmatic than most in this thread, but that's probably due to first hand experiences with the EPA, MSHA, OSHA and a few others over the course of my career plus, perhaps, my age (yes, I'm a retired senior).
All the agencies I've had to deal with shared a few common traits -- the senior management viewed their work as being on a mission, completion of the mission was more important than any impact on the rest of the world including consumers and producers, the onus was on the producer/consumer/etc to convince them to change course on how to achieve their mission, and the lower level employees executed the mission via punch lists and forms.
The mission of the FDA, as it impacts us here, is to move towards a tobacco product free world for what they believe to be the overall health benefit accruing to the general public and to protect children in a manner that they deem most effective. Period, full stop, end of story. That translates to making life as difficult as politically possible for the producers and consumers of tobacco products.
The email from Mitch Zeller that many received:
https://petitions.whitehouse.gov/response/regulation-electronic-cigarettes-fda
"Some background, which you may already know: The Family Smoking Prevention and Tobacco Control Act that Congress passed in 2009 gave the FDA immediate authority to regulate certain tobacco products -- cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco -- under the Federal Food, Drug, & Cosmetic Act. And while it didn't apply right away to other tobacco products, such as electronic cigarettes, the law gave the FDA authority to cover those products through regulation.
We've issued a proposed rule to allow the FDA to regulate those products in the April 25, 2014 issue of the Federal Register. Electronic cigarettes containing nicotine derived from tobacco would meet the statutory definition of "tobacco product" and so they'd be subject to the FD&C Act when the proposed rule is finalized."
because congress ha delegated the authority to the regulating agency.
regards
mike
And also translates into thousands of kids and millions of adults seeking to get their hands (and mouths) on this product, partially because it is banned, partially because it is just so darn cool/fun, and partially cause it satisfies cravings that the government has been lying about for days, months and years.
My supporting evidence is (utter failure of) war on drugs.
Period. Full stop. End of story for all who think prohibition might just work.
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