Per the blog 0nic apparently will not be considered a tobacco product as long as it is packaged differently.
FDA deeming rule could happen tomorrow
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Your favorite B&M may be a tobacco manufacturer.
"Vape Establishments Acting as Manufacturers--Several comments asked FDA to clarify whether e-cigarette retail stores and vape establishments are considered "tobacco product manufacturers" under the FD&C Act. In response, FDA has explained that establishments that mix or prepare e-liquids or create or modify aerosolizing apparatus for direct sale to consumers are tobacco product manufacturers under the definition set forth in the FD&C Act and, accordingly, are subject to the same legal requirements that apply to other tobacco product manufacturers."
Mike
"Vape Establishments Acting as Manufacturers--Several comments asked FDA to clarify whether e-cigarette retail stores and vape establishments are considered "tobacco product manufacturers" under the FD&C Act. In response, FDA has explained that establishments that mix or prepare e-liquids or create or modify aerosolizing apparatus for direct sale to consumers are tobacco product manufacturers under the definition set forth in the FD&C Act and, accordingly, are subject to the same legal requirements that apply to other tobacco product manufacturers."
Mike
I've got about 800ml of 100mg base on ice right now. I will buy another 1,000ml if the regulations are released before they go into effect. I've dropped from my original 24mg down to just 2mg, so 1,800ml of 100mg base would last me quite a few years. More than long enough for me to wean myself off the nic entirely.
I just need to drop my wife a little lower. She's a tootle puffer that sips juice, but she's still at 15mg. If I can gradually step her down then we should be fine.
I just need to drop my wife a little lower. She's a tootle puffer that sips juice, but she's still at 15mg. If I can gradually step her down then we should be fine.
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With all this coming down, I am hoping that all threads concerning this can be funneled into one thread, as I feel there are going to be many threads popup, and will be too difficult to keep up with.
Has anyone figured out whether there is any clarification about the sale of bulk nicotine, if not marketed as being for vaping use?
It opens up a huge amount of room for those that DIY their liquids. Basically I would only have to worry about acquiring nic base, nothing else would be regulated.
If I read it correctly, there will be a 30-36 month window before enforcement takes place, allowing manufacturers time to decide which applications to submit and go through the process. Sort of good news for the near term?
The nicotine in approved patches is good. Ours is not.
"The Surgeon General also noted "all forms of nicotine delivery do not pose an equal risk in establishing and maintaining addiction" and this may be because the pharmacokinetics of various nicotine containing products differ (id.). The FDA-approved nicotine patch is an example of slow absorption and once-a-day dosing which results in minimal potential for addiction (Ref. 2 at 113). In 1988, the Surgeon General recognized that the ultimate levels of nicotine absorbed into the blood from tobacco products on the market at that time can be similar in magnitude regardless of the product forms used to deliver nicotine (Ref. 1). For example, research has shown that oral use of smokeless tobacco products that do not emit smoke results in "high venous concentrations of nicotine equal to those for use of cigarettes" (Ref. 2 at 113). FDA believes that the inhalation of nicotine (i.e., nicotine without the products of combustion) is of less risk to the user than the inhalation of nicotine delivered by smoke from combusted tobacco products. However, limited data suggest that the pharmacokinetic properties of inhaled nicotine can be similar to nicotine delivered by combusted tobacco products. Thus, inhaled nicotine from a non-combustible product may be as addictive as inhaled nicotine delivered by combusted tobacco products. '
Mike
"The Surgeon General also noted "all forms of nicotine delivery do not pose an equal risk in establishing and maintaining addiction" and this may be because the pharmacokinetics of various nicotine containing products differ (id.). The FDA-approved nicotine patch is an example of slow absorption and once-a-day dosing which results in minimal potential for addiction (Ref. 2 at 113). In 1988, the Surgeon General recognized that the ultimate levels of nicotine absorbed into the blood from tobacco products on the market at that time can be similar in magnitude regardless of the product forms used to deliver nicotine (Ref. 1). For example, research has shown that oral use of smokeless tobacco products that do not emit smoke results in "high venous concentrations of nicotine equal to those for use of cigarettes" (Ref. 2 at 113). FDA believes that the inhalation of nicotine (i.e., nicotine without the products of combustion) is of less risk to the user than the inhalation of nicotine delivered by smoke from combusted tobacco products. However, limited data suggest that the pharmacokinetic properties of inhaled nicotine can be similar to nicotine delivered by combusted tobacco products. Thus, inhaled nicotine from a non-combustible product may be as addictive as inhaled nicotine delivered by combusted tobacco products. '
Mike
Could you clarify, please? Does this mean as of May 20, I cannot order anything from Greece or Germany if I am in the US?
Just ordered another gallon of 100mg from Heartland. That gives me almost 2 gallons in the freezer. More than enough to last me.
If the FDA determines it meets it's definition of a tobacco product,
it is a tobacco product and is immediately covered under the deeming reg's.
"(Comment 1) Generally, the comments did not challenge FDA's authority under section 901 of the FD&C Act, but at least one comment argued that section 901 does not grant FDA the authority to deem, "in a sweeping manner," all products (excluding accessories) that meet the statutory definition of "tobacco product." The comment argued that Congress intended to grant FDA discretion to deem products only on a product-by-product basis, or at best, a category-bycategory basis, and that FDA lacks authority to "simply swallow all extant and future tobacco products up in its authority[.]" (Response) FDA disagrees. Section 901 grants FDA the authority to deem "any. . . tobacco products that the Secretary by regulation deems to be subject to [chapter IX of the FD&C Act]." There is no provision in the statute that restricts FDA's authority to deem all tobacco products that meet the statutory definition or requires FDA to deem products on an individual or product category basis."
Mike
it is a tobacco product and is immediately covered under the deeming reg's.
"(Comment 1) Generally, the comments did not challenge FDA's authority under section 901 of the FD&C Act, but at least one comment argued that section 901 does not grant FDA the authority to deem, "in a sweeping manner," all products (excluding accessories) that meet the statutory definition of "tobacco product." The comment argued that Congress intended to grant FDA discretion to deem products only on a product-by-product basis, or at best, a category-bycategory basis, and that FDA lacks authority to "simply swallow all extant and future tobacco products up in its authority[.]" (Response) FDA disagrees. Section 901 grants FDA the authority to deem "any. . . tobacco products that the Secretary by regulation deems to be subject to [chapter IX of the FD&C Act]." There is no provision in the statute that restricts FDA's authority to deem all tobacco products that meet the statutory definition or requires FDA to deem products on an individual or product category basis."
Mike
And of course the fact that there is no evidence of harm is precisely
why e-cigs have to be regulated.
"Although FDA is not required to meet a particular public health standard to deem tobacco products, regulation of the newly deemed products will be beneficial to public health. The Agency has concluded, based on scientific data, that the newly deemed products should be regulated due to their potential for public harm (e.g., 79 FR at 23154-23158) and regulation is necessary to learn more about that potential."(Orwell makes Nostradamus look like a cub scout.)
Mike
why e-cigs have to be regulated.
"Although FDA is not required to meet a particular public health standard to deem tobacco products, regulation of the newly deemed products will be beneficial to public health. The Agency has concluded, based on scientific data, that the newly deemed products should be regulated due to their potential for public harm (e.g., 79 FR at 23154-23158) and regulation is necessary to learn more about that potential."(Orwell makes Nostradamus look like a cub scout.)
Mike
Herbal shisha that contains no tobacco got a pass. Zero nic liquid and the hardware used to vape it are currently in the clear. Get ready for mods and atties to be labelled: never to be used with nicotine, flavor vape only.
Meanwhile at the state level ...
Meanwhile at the state level ...
0mg liquid is not a covered tobacco product, however it is considered to be a component(not an accessory), so the warning labels don't have to be there, but the FDA maintains regulatory authority. I haven't figured out what the regulations for components are yet though. I wasn't actually planning on reading all this when I got up to pee at 5am.
For now, my general light reading tells me: you think it's bad now, just wait until it's in effect and we can start issuing guidances.
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