Deeming Regulations have been released!!!!

[Oliver]

OK, I'm tuning out for the rest of the night.

This has been an epic 9 year adventure, but it seems that it's all coming to a close. Very sad days indeed.

We knew this was coming, but now it has, I can't quite believe it.

 

[skoony]

I am one of those vendors that will charge you more for VG than you pay in a store but when you purchase that cheap VG in a store what are you inhaling in to your lungs? Our customers can be assured that all VG and PG purchased from us is "Certified" to be 99.7% Kosher and Pure. I believe that makes the added cost worth it.

any 99.7% pure vg or pg is just as good as your 99.7 pure product ,kosher or
not.
mike

 

[Jazzman]

Keep level headed about this everyone. Now is when the fight will actually start. The grassroots efforts of vapers contacting federal, state, and local officials could never have stopped this. Not that the efforts of individuals like many of us have made was worthless, it was just never really big enough to stop this from happening. Perhaps a better effort by industry trade groups, large activist groups, and a huge amount of small vaping businesses could have made a difference. But unfortunately, the small businesses never took this seriously and didn't choose to make a difference. Most vape shops I've been to never believed anything would happen... head in the sand I guess.

But until the deeming passed, legal challenges couldn't happen. There was nothing to challenge (this doesn't include separate state battles, just the FDA and Fed stuff). Well now we can and I think we will see a lot of legal activity starting now. So now is really when the battle begins. Hopefully an injunction will be the first order of business, and if that can happen we will have a certain amount of protection while the next 3 to 5 years of legal challenges occur. I would bet small vape shop owners will take it a bit more seriously too, which would be the biggest help in the legal battles.

Don't give up on the fight when it is just starting. Dig your trench a little deeper, hunker down, and be ready for a long protracted fight now that we actually have something to legally battle. We're not doomed yet, we're not even bloodied, but now there is at least something to fight.

 

[scotdc]

Negativity serves no purpose here. It ain't over until the fat lady sings. There are people working 24/7 to try to get this overturned through Congress, or, at the very least, persuade them to make concessions. It definitely is NOT over.

I'm sorry, but I have to agree with @WharfRat1976. This is OVER.

It's obvious that the FDA has determined to kill vaping in the USA. They have been very thorough in effectively eliminating any and all avenues where vaping is concerned.

For months, I've heard people cry "I'll just DIY!" Well, the FDA was listening. Not only have they covered nicotine, but they targeted flavors and the vials they come in. No, I don't think "but this is for food use" will work. They have also covered all supplies that can even be remotely associated with vaping, down to batteries, cotton, and wire. "But this is for my flashlight" isn't going to cut it either. Do you think the manufacturers of cheap flashlights will pave the way? No, they will integrate batteries into their devices that allows them to be plugged in to charge because they don't want to get involved in the .... storm that is going to surround the vaping community.

And yes, I'm sorry, negativity DOES have a place here. For years we have all dutifully signed all the petitions, called and emailed our representatives and done whatever has been asked of us to thwart this regulation from coming to pass. Did any of this have even the slightest effect on the FDA regulations? No.

Not one thing was changed in the FDA policies. Not one. In fact, it could be argued that it got even worse than originally imagined. Is it realistic to believe that even 100,000 signatures will make a damn bit of difference against the slick lobbying machine that Big Tobacco has running right now? That machine has been vastly effective in attaching a stigma to vapers, perpetuated by our own fools within this community who insist on blowing massive clouds, labeling their juices in the most cartoonish ways imaginable, and stupidly building crappy mods that catch fire. Every story like that is pumped up by the media so now the majority of the world believes that vaping is not safe at all.

Believe me, that's the next step - strengthen that stigma until we as vapors are as ostracized as the cigarette smoking public. Remember, to the average person we ARE smoking. We are sucking on a device and smoke is coming out of our lungs. It doesn't matter how much we cry "it's only vapor!" or "it's not harmful!" - we are smoking in their eyes.

Make no mistake - we are dead meat in the very near future. Sheer optimism and high hopes will do nothing to save us. We don't have the bankroll, and we don't have a snowball's chance in Hell with congress. Can you find more than 5 or 6 congressmen who support vaping and focus on the health benefits? Do you honestly believe a good percentage of hopeful candidates will stand up and voice their support for us when the majority of the voting public has been swayed by the anti-hype or is plain apathetic?

I apologize for this War & Peace length post, I just needed to rant. I'm sickened as well, and I will stock up on my own DIY supplies and devices and hunker down in my bunker. But that's all any of us will be able to do.

 

[evan le'garde]

Would you say, then, that any bottle of liquid MIXED by a vendor after 90 days
falls under the regulation? (ie: the bottle is "new")

Or... would Flavor X in Ymg sold by Vendor Z be grandfathered?

(I'm almost frightened to see what happens to prices now.)

If the prices e cig vendors charge for a few pads of cotton are anything to go by then whatever vendors raise their prices by they might actually fall in line with the prices they already charge for their cotton.

ie : ridiculously high

 

[crxess]

The following is a nonexhaustive list of examples of
components and parts used with electronic nicotine delivery systems (ENDS) (including e-
cigarettes): e-liquids; atomizers; batteries (with or without variable voltage); cartomizers
(atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings;
clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software.
Similarly, the following is a nonexhaustive list of examples of components and parts used with
waterpipe tobacco: flavor enhancers and the vials in which they are contained; hose cooling
attachments; water filtration base additives (including those which are flavored); flavored
waterpipe tobacco charcoals and the wrappers or boxes that contain the charcoals; and bowls,
valves, hoses, and heads.
FDA is defining "accessory" to mean "any product that is intended or reasonabl

So now I have to pay a Tax and have my Laptop approved as a Device for Vaping because I can use it to find additional parts needed complete my Vaping needs?

* Theoretically plausible

 

[Rt1Rebel]

Can anyone give clarification on the 90 day/2 year window? My local vape shop owner said he needs to close in 90 days. Will this apply to larger online businesses? Thanks

 

[bigdancehawk]

(Also, I've seen at least one person declare that these regulations are "unconstitutional." I'm not really sure where that comes from, since the Constitution clearly empowers the federal government to regulate interstate commerce.)

The regulation prohibits sellers from informing the public that e-cigarettes are intended to help smokers quit smoking, that e-cigarettes are safer than combustibles, and that e-cigarettes reduce the risks of smoking. In essence, the regulation prohibits manufacturers and retailers from telling the truth. This, IMO, is a violation of the right of free speech, as guaranteed by the First Amendment to the Constitution of the United States.

ETA: There are other aspects of this that I think should be deemed unconstitutional, but it's kinda technical and requires some translation from legal-lingo. More later.

 

[Sloth Tonight]

OK, I'm tuning out for the rest of the night.

This has been an epic 9 year adventure, but it seems that it's all coming to a close. Very sad days indeed.

We knew this was coming, but now it has, I can't quite believe it.

Goodnight my friend, and thank you.

 

[Oliver]

One last thought - if you haven't yet done this, do it now: CASAA: Call to Action! Support HR 2058 which would change the grandfather date for vapor products

 

[bigdancehawk]

To each their own I guess. I went from 18mg to 0mg in a few years & enjoy vaping. Like I said, drop the nic & you'll be good.

Maybe so, but this isn't about our little group here. Do you care about the 40 million current smokers in this country who, at least initially, will require nicotine to get off combustibles?

 

[skoony]

I just got caught up in this thread.
Some thoughts.
I believe the 30 day requirements starting today only cover the age restrictions and
measurements to put them in place. Everything else is 2 years plus depending
on which of the 3 avenues to market place the FDA allows.
The manufacturers of raw materials are not covered under the deeming regs.
ie,PG/VG/Flavors and nicotine producers,only manufacturers of Of ENDS and
the components that go into them are. ie,coils,atty's,tanks,batteries,juice,
wicks,etc..,etc.. .
I have not read the whole thing yet. Does anyone know if DIY has been specifically
exempted? From what i have read anyone manufacturing for sale or distribution
is covered. I am uncertain at this point if just manufacturing (diy) is exempt.
Regards
Mike

 

[WharfRat1976]

YOU CANNOT MAKE THIS STUFF UP. THIS COMMENT IN THE RULE IS ABOUT THE DANGERS OF NICOTINE:
(Comment129) Comments were divided as to whether nicotine is dangerous to humans.
Some comments stated that liquid nicotine is completely benign (and that FDA should not regulate e-cigarettes given the lack of harms). They claimed that FDA's findings regarding
NRTs illustrate that nicotine is not carcinogenic to humans. (See"Modifications To Labeling of
Nicotine Replacement Therapy Products for Over-the-Counter Human Use,"78 FR 19718, April2, 2013.) Other comments stated that although nicotine has some side effects, it is significantly less hazardous than the toxicants ingested with combusted products. Still others claimed that nicotine is very dangerous.

Comments that claimed that nicotine is dangerous cited studies showing that although
nicotine may not be a primary carcinogen, it likely promotes cancers established through
angiogenic (promoting of blood vessels in tumors) effects (e.g., Ref.169). The comments also 225 noted that the 2014 Surgeon General's Report stated that the health risks of nicotine are more serious than previously thought and that FDA should consider this when evaluating the impacts of the newly deemed products on vulnerable populations. Others believed that nicotine is so dangerous that individuals should be required to obtain a certification before being permitted to acquire and handle it.
(Response) In the proposed deeming rule, FDA recognized the impact of nicotine on a
youth's brain (see 79 FR 23142 at 23153 and 23154) and also noted poisoning concerns.
The inhalation of nicotine (i.e., nicotine without the production of combustion) is of less risk to
a user than the inhalation of nicotine delivered by smoke from combusted tobacco products.

However,limited data suggests 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.Researchers recognize that the effects from nicotine exposure by inhalation are likely not responsible for the high prevalence of tobacco-related death and disease in this country(Refs.10, 11).

Although nicotine has not been shown to cause the chronic disease associated with tobacco use, the 2014 Surgeon General’s Report noted that there are risks associated with
nicotine (Ref.9at 111). For example, nicotine at high enough doses has acute toxicity (id.).
Nicotine exposure during fetal development has lasting adverse consequences for brain
development (id.). Nicotine also adversely affects maternal and fetal health during pregnancy,contributing to multiple adverse outcomes such as preterm delivery and stillbirth (id.). Further,data suggest that nicotine exposure during adolescence may have lasting adverse consequences for brain development (id.). Some studies also have found that nicotine can have detrimental effects on the cardiovascular system and potentially disrupt the central nervous system (Refs.14,22615). See also section VIII.C discussing the increase in poisoning due to accidental nicotine ingestion. FDA is not stating that nicotine is harmless. Unlike ENDS, which have not been reviewed by FDA, the NRT products mentioned in the comments are regulated and have undergone premarket review by FDA's Center for Drug Evaluation and Research (CDER) and been found to be safe and effective before obtaining authorization to enter the market (sections505 and 506 of the FD&C Act). The Agency does not have sufficient data to be able to conclude that consumers are inhaling only nicotine, and no other chemicals or toxicants, when using ENDS. Although ENDS likely do not deliver the same level of toxicants as cigarettes, studie sshow that there are dangers associated with ENDS use and that exhaled aerosol is not simply"water vapor," as some believe. (See section VIII.C for additional discussion about the toxicants in ENDS vapor.)

 

[Highwayman1224]

Maybe so, but this isn't about our little group here. Do you care about the 40 million current smokers in this country who, at least initially, will require nicotine to get off combustibles?

I doubt 40 million smokers are even thinking about vaping.... Believe me, I'm ...... about this also but I'm going to do what I have to do.

 

[skoony]

Deeming live blog is shutting down for the day. will be back tommorow
with critical analysis.
mike

 

[crxess]

In addition to your support for CAASA-- I hope each and all of you support CAASA-- there is now a White House petition to shut off the deeming regs. It probably won't help much, considering the White House we have, but it can't hurt. If you don't get a confirming email, it didn't go through, and if you don't click the link in the email, it doesn't count:

Overturn the FDA's ruling on ecigarette classification as a tobacco product. | We the People: Your Voice in Our Government

Done and confirmed
Also resent Support request to All representatives for my area and Obama to Support and even co-sponsor HR 2058

 

[skoony]

YOU CANNOT MAKE THIS STUFF UP. THIS COMMENT IN THE RULE IS ABOUT THE DANGERS OF NICOTINE:
(Comment129) Comments were divided as to whether nicotine is dangerous to humans.
Some comments stated that liquid nicotine is completely benign (and that FDA should not regulate e-cigarettes given the lack of harms). They claimed that FDA's findings regarding
NRTs illustrate that nicotine is not carcinogenic to humans. (See"Modifications To Labeling of
Nicotine Replacement Therapy Products for Over-the-Counter Human Use,"78 FR 19718, April2, 2013.) Other comments stated that although nicotine has some side effects, it is significantly less hazardous than the toxicants ingested with combusted products. Still others claimed that nicotine is very dangerous.

Comments that claimed that nicotine is dangerous cited studies showing that although
nicotine may not be a primary carcinogen, it likely promotes cancers established through
angiogenic (promoting of blood vessels in tumors) effects (e.g., Ref.169). The comments also 225 noted that the 2014 Surgeon General's Report stated that the health risks of nicotine are more serious than previously thought and that FDA should consider this when evaluating the impacts of the newly deemed products on vulnerable populations. Others believed that nicotine is so dangerous that individuals should be required to obtain a certification before being permitted to acquire and handle it.
(Response) In the proposed deeming rule, FDA recognized the impact of nicotine on a
youth's brain (see 79 FR 23142 at 23153 and 23154) and also noted poisoning concerns.
The inhalation of nicotine (i.e., nicotine without the production of combustion) is of less risk to
a user than the inhalation of nicotine delivered by smoke from combusted tobacco products.

However,limited data suggests 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.Researchers recognize that the effects from nicotine exposure by inhalation are likely not responsible for the high prevalence of tobacco-related death and disease in this country(Refs.10, 11).

Although nicotine has not been shown to cause the chronic disease associated with tobacco use, the 2014 Surgeon General’s Report noted that there are risks associated with
nicotine (Ref.9at 111). For example, nicotine at high enough doses has acute toxicity (id.).
Nicotine exposure during fetal development has lasting adverse consequences for brain
development (id.). Nicotine also adversely affects maternal and fetal health during pregnancy,contributing to multiple adverse outcomes such as preterm delivery and stillbirth (id.). Further,data suggest that nicotine exposure during adolescence may have lasting adverse consequences for brain development (id.). Some studies also have found that nicotine can have detrimental effects on the cardiovascular system and potentially disrupt the central nervous system (Refs.14,22615). See also section VIII.C discussing the increase in poisoning due to accidental nicotine ingestion. FDA is not stating that nicotine is harmless. Unlike ENDS, which have not been reviewed by FDA, the NRT products mentioned in the comments are regulated and have undergone premarket review by FDA's Center for Drug Evaluation and Research (CDER) and been found to be safe and effective before obtaining authorization to enter the market (sections505 and 506 of the FD&C Act). The Agency does not have sufficient data to be able to conclude that consumers are inhaling only nicotine, and no other chemicals or toxicants, when using ENDS. Although ENDS likely do not deliver the same level of toxicants as cigarettes, studie sshow that there are dangers associated with ENDS use and that exhaled aerosol is not simply"water vapor," as some believe. (See section VIII.C for additional discussion about the toxicants in ENDS vapor.)

Yet not one single case of infant nicotine syndrome has been reported. Not one single
report of nicotine addled juvenile disorder. Where are all the sick chillin'?
Mike

 

[dustinmj]

OK, I'm tuning out for the rest of the night.

This has been an epic 9 year adventure, but it seems that it's all coming to a close. Very sad days indeed.

We knew this was coming, but now it has, I can't quite believe it.

This post hits home in a very real way.

 

[Pamawoman]

Just bought a huge for me order of juice from MOV. After that who knows what I'll be vaping. Thanks FDA. At least the self regulating vendors should be left alone. You know the ones that paid for independent testing of their juices. I guess it will be pg bought at the cvs and vanilla cake flavoring in my cabinet. Yep I am sure that is much healthier then anything MOV makes. NOT!

 

[therussellv]

OK, I'm tuning out for the rest of the night.

This has been an epic 9 year adventure, but it seems that it's all coming to a close. Very sad days indeed.

We knew this was coming, but now it has, I can't quite believe it.

My adventure goes on, it just gets more interesting.

Sent from a dark, twisted corner of the back porch, covered in cobwebs and slightly damp.