FDA's new regulations for e-cigarettes 08-08-16 - End of vaping devices 2018 in the US?

Bad Ocelot

Well-Known Member
I welcome good regulation, like what herbivore mentioned, as well as things like labeling product ingredients, & having said ingredients be held to a GMP or USP standard as well. However the current regulations seem to do little to that end and look like they will deliver a good bit of market share to Big Tobacco. As it was designed to do, since they were basically written by tobacco lobbyists :bang:

Hopefully something good will come out of this, but not holding my breath at the moment :\
 

Eatrocks

Well-Known Member
Ive been a nic vaper aince 2008...there has ALWAYS been talk of the fda banning. They claimed its worse than smoking analogs....ok...

The fda is not in the business of keeping you healthy...

Shoot...theres this certain crest mouthwash that literally burns the skin off your gums/tongue...they still have that shit on the shevles.
 
Eatrocks,
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Hippie Dickie

The Herbal Cube
Manufacturer
...The fda is not in the business of keeping you healthy...

yes, that is a personal responsibility ... but the FDA does provide tools and information to make (more or less) informed decisions. it's still my decision. even if FDA approves some vaporizer, i will still make and use my own device ... i just don't like what i see out there.
 
Hippie Dickie,

Deleted Member 1643

Well-Known Member
It's remarkably perceptive of @Hogni to have noticed this point. The FDA's draft guidance to industry on Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) states:

A. Products to Which This Guidance Applies
There are many types of ENDS products (including, but not limited to, e-cigarettes, e-cigars, e-hookah, vape pens, personal vaporizers, and electronic pipes), all of which are subject to FDA’s tobacco product authorities as of the effective date of the final deeming rule because they meet the definition of “tobacco product” under section 201(rr) of the FD&C Act and are not accessories of newly deemed products.​

Vape pens and personal vaporizers could very well be subject to FDA regulation under the U.S. Family Smoking Prevention and Tobacco Control Act. Specifically, manufacturers will apparently be required to meet the standard of "appropriate for the protection of the public health" with regard to tobacco. That is, they will need to show that use of vape pens or personal vaporizers for tobaccco reduces users risk compared to other tobacco products. It may not matter that these products are mainly used for cannabis.
 

Hogni

Honi soit qui mal y pense
Thx, but working with laws is my buisiness . So I can read the danger for our favourite tools between the lines. I'm pretty sure this danger is real. Have started this thread some weeks ago and I'm wondering that no producer/vendor has started an inquiry to the FDA how the new law could inpact their buisiness. If this would be the case it would be the end of all smaller companies who are not able to pay hundredthousands or millions for a exemption for just one product. As a producer I would be highly alerted by this existential threat und would instantly react. Some of you are connected to producers. What are they doing? Just waiting what will happen?
Is staying so "cool" a kind of american mentality? In Germany all interested persons would hear alarm bells ringing and would react immediately.
As american customer I would fill my war checkout to buy all american devices I want to have the next two years. As german customer I will do so too. There are some cute american devices I want to have.
If any company should be able to pay the money for an exemption prices for their devices have to and will dramatically increase for sure.
 

KeroZen

Chronic vapaholic
AFAIK only Haze and Magic Flight have expressed concerns and made public moves, but we don't know what the other companies are doing behind the curtains.

For small businesses the answer is simple: they won't be able to afford it whatever the outcome, so I guess they hope to pass through the net unnoticed maybe....
 

Deleted Member 1643

Well-Known Member
FDA's intentions regarding enforcement are ambiguous, but may offer hope. From the deeming rule:

...at this time, FDA intends to limit enforcement of the premarket authorization provisions to finished tobacco products.​

Vape pens and personal vaporizers are components of tobacco products, not finished tobacco products. Elsewhere, FDA clarifies that components are covered and tries to steer manufacturers toward marketing finished products.

In the case of ENDS hardware/apparatus components, FDA expects that it may be difficult for manufacturers to make the showing necessary to meet the statutory standard, given the great extent of possible variations in combinations of hardware components, if all are considered and sold separately. Thus, with respect to apparatus, FDA expects that manufacturers will be most successful where authorization is sought for entire delivery systems, rather than individual components.​

Manufacturers of vape pens and personal vaporizers may be hoping that FDA won't enforce its marketing authority against them. Still, surprised there isn't more concern in the cannabis industry or among advocates.
 

Hippie Dickie

The Herbal Cube
Manufacturer
cannabis is illegal at the federal level, so there is no way to talk to the FDA about a cannabis vaporizer.

also, re: reduced tobacco taxes ... health care costs related to tobacco far exceed any taxes collected. So, it is far better to encourage people to stop tobacco use ... not only cheaper for society, but also better health for the individual.

i think it is the addiction aspect of tobacco that drives this need for regulations ... cannabis is not addictive.
 

syrupy

Authorized Buyer
AFAIK only Haze and Magic Flight have expressed concerns and made public moves, but we don't know what the other companies are doing behind the curtains.

For small businesses the answer is simple: they won't be able to afford it whatever the outcome, so I guess they hope to pass through the net unnoticed maybe....

I noticed Dynavap is now listing their vapes as "aromatherapy devices".
 

Hogni

Honi soit qui mal y pense
If it would be so simple every vap producer could declare so - for nicotine stuff too. Do you really mean with success?
@Hippie Dickie: I agree with you. Would be wondering if FDA would be more forbearing with MJ-Stuff than with nicotine stuff if there is a possibilty to hit both markets, MJ + nicotine.
We'll fuck these liberalization states with fed laws!
 
Hogni,

Tranquility

Well-Known Member
I noticed Dynavap is now listing their vapes as "aromatherapy devices".
Selling paraphernalia is still a felony. Ask Tommy Chong.

https://www.law.cornell.edu/uscode/text/21/863

Read the whole text to see how pervasive the definition of paraphernalia is. The following might be a reason why the disclaimer (Emphasis mine):
(e)Matters considered in determination of what constitutes drug paraphernaliaIn determining whether an item constitutes drug paraphernalia, in addition to all other logically relevant factors, the following may be considered:
(1)
instructions, oral or written, provided with the item concerning its use;
(2)
descriptive materials accompanying the item which explain or depict its use;
(3)
national and local advertising concerning its use;
(4)
the manner in which the item is displayed for sale;
(5)
whether the owner, or anyone in control of the item, is a legitimate supplier of like or related items to the community, such as a licensed distributor or dealer of tobacco products;
(6)
direct or circumstantial evidence of the ratio of sales of the item(s) to the total sales of the business enterprise;
(7)
the existence and scope of legitimate uses of the item in the community; and
(8)
expert testimony concerning its use.
 

Tranquility

Well-Known Member
That was unprecedented, ashcroft spearheaded that to make an example...they broke the law because they took money from a small place in PA where its a felony to sell bongs. They begged chong to ship them but theh refused.
Perhaps to the attorneys at the manufactures that claim the devices are for aromatherapy, the fact there is a statute already on the books is more important than relying on the discretion of the prosecutor.
 

QuittingVegas

Well-Known Member
I have used ecigs since 2012, quit smoking analogs 2015. This is what lead me towards vaping MJ. I have been very concerned about the deeming regs that we are currently facing. There are many supporters for the industry. Attorney General Tom Miller just spoke very highly of the harm reduction. We just need a few bills to pass. Cole Bishop and HR2058. There is also a documentry out called A Billion Lives. Excellent film and I highly suggest anyone affected by smoking attend.
 

AVENTUS

Well-Known Member
I for one actually want to see US vape manufacturers regulated. It'd get rid of some of the questionable materials/design decisions we often see with vapes so far. Whether these regulations in particular go any way towards this is another question though!

I have noticed a few vape manufacturers mentioning the regs might effect them too but nobody has seemed especially clear.
Absolutely.
This industry is still very much in it's infancy.
And I think we will be fine, as long as the stupid words are on the packaging.
Although Jeff Sessions is our god damn attorney general now, so that is a big known unknown.
 

cannabis.pro

aka 420EDC
Accessory Maker
cannabis is illegal at the federal level, so there is no way to talk to the FDA about a cannabis vaporizer.
While cannabis is illegal at the federal level you have to remember that the US Gov't holds patents on it, they've issued patents to others geared towards the industrialization of cannabis. They are the sole legal grower in Mississippi for now under international treaty producing for domestic research and let's not forget about the Federal IND program providing 7g(or more) per day in pre-rolled joints to the surviving patients of the program.

I'm sure many are talking to the FDA about their vaporizer geared towards cannabis. The sharks are in the water and whales with deep pocketbooks.
 

little maggie

Well-Known Member
My logs have always advertised themselves as aromatherapy and even come with aromatherapy cups. I'm most concerned about those making my current favorite vapes which are handmade by 1 or 2 people: MVT, Tubo, Nomad, RBT's.
And will it even be legal to buy from another country? The Nomad, the Tubo and the Dobbywood are not made in the US.
 

Tranquility

Well-Known Member
The items that most concern those here are, from the case, "open-system vaping devices". Closed-system devices defined as "battery-powered products that allow users to inhale nicotine vapor without fire, smoke, ash, or carbon monoxide" were already held to be covered by the order in a previous case in the DC Circuit. This case was about the open-system vapes.

The key argument of the plaintiffs:
And the agency suggests that
the Court should not be swayed by what it sees as a change in position by the industry:
Having insisted in Sottera that e-cigarettes are regulable as tobacco
products, manufacturers cannot now avoid that conclusion simply by
making their products refillable. Indeed, while the question presented in
Sottera was whether e-cigarettes should be regulated as drugs/devices or
instead as tobacco products, the choice Plaintiffs offer here is markedly
different: whether refillable e-cigarettes should be regulated as tobacco
products, or, as Plaintiffs urge, not at all.​
Id. at 24–25. But plaintiffs have conceded that most ENDS products may be lawfully regulated
under the TCA, and notwithstanding Sottera, the Court must go on to utilize the Chevron analysis
to determine, as a matter of first impression, whether the agency has interpreted the statute
properly.​
A "Chevron analysis" is a procedure where the courts look to regulations in two steps in order to see if the regulation should be given deference. (Where the court goes by enforcing agency decisions unless they are plainly unreasonable.) Guess how the analysis came out here.

Early decisions by the agencies and two courts are making it clear we should start planning for FDA regulation of much of the kit used here.

The court's theory of why some should not worry:

The Court wishes to reassure the many worried vapers who followed these proceedings closely that this case is not about banning the manufacture or sale of the devices. That is not what the Deeming Rule does or what it was intended to accomplish. In the Deeming Rule, the FDA simply announced that electronic cigarettes, or electronic nicotine delivery systems (“ENDS”) would be subject to the same set of rules and regulations that Congress had already put in place for conventional cigarettes.​

Um...hmm. That is certainly good news for us, right? In a case to see if things that have nothing to do with tobacco or nicotine products are covered by rules for tobacco and nicotine products, we are assured by the court that we shouldn't worry because--reasons. That being said, the courts have long ago given up against the regulatory state. There are few regulations they don't like--even if there is little rational basis for making the regulation. It is not going to get better in our lifetimes.
 

KeroZen

Chronic vapaholic
How to regulate 'plant material heaters' while pipes are still sold?

From one of the comments in the article linked above:

"In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including pipe tobacco. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of pipe tobacco. This includes components and parts such as pipes, but excludes accessories such as lighters."

https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm482580.htm

Again we're not talking about stopping sales here, it's about regulating.
 
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