Deeming Regulations have been released!!!!
- Thread starter Oliver
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Man, and I thought the TPD was excessive...
Live and learn - there is noting any government can do to hurt its people that the US government cannot top, Should it deem necessary.
Actually they do, so long as they are authorized by congress to do so. This is not something that was voted on by congress. Instead, congress previously authorized the FDA to regulate tobacco products as they see fit, and this new regulation "deems" vaping products to be tobacco products, so no further approval from congress needed.
After the effective date, no manufacturer, packager, importer, distributor, or retailer of cigarette tobacco, roll-your-own tobacco, cigars, or other covered tobacco products may advertise any such product if the advertisement does not comply with this rule;After the effective date, no person may manufacture for sale or distribution within
the United States any such product the package of which does not comply with this rule;
Beginning 30 days after the effective date, a manufacturer may not introduce into domestic commerce, any such product, irrespective of the date of manufacture, if its package does not comply with this rule(i.e.,non compliant products manufactured prior to the effective date may not be distributed for retail sale after 30 days following the effective date);
After the effective date, a distributor or retailer may not sell, offer to sell, distribute,
or import for sale or distribution within the United States any such product the
package of which does not comply with this regulation, unless the covered tobacco
product was manufactured prior to the effective date; and (ALL VAPE SHOPS IN 90 DAYS)
After the effective date, however, a retailer may sell covered tobacco products in
packages that do not have a required warning if the retailer demonstrates it falls
outside the scope of this rule as described in21 CFR1143.3(a)(3) and 1143.5(a)(4).
the United States any such product the package of which does not comply with this rule;
Beginning 30 days after the effective date, a manufacturer may not introduce into domestic commerce, any such product, irrespective of the date of manufacture, if its package does not comply with this rule(i.e.,non compliant products manufactured prior to the effective date may not be distributed for retail sale after 30 days following the effective date);
After the effective date, a distributor or retailer may not sell, offer to sell, distribute,
or import for sale or distribution within the United States any such product the
package of which does not comply with this regulation, unless the covered tobacco
product was manufactured prior to the effective date; and (ALL VAPE SHOPS IN 90 DAYS)
After the effective date, however, a retailer may sell covered tobacco products in
packages that do not have a required warning if the retailer demonstrates it falls
outside the scope of this rule as described in21 CFR1143.3(a)(3) and 1143.5(a)(4).
Ya, the enemy of my enemy is my friend...so I guess we're now friends with this giant d-bag
http://i.kinja-img.com/gawker-media/image/upload/s--K7zbTpFd--/pq0debyq2luv01cv50pu.gif
In this, I believe we need to learn from the experiences of another group that has had to fight tooth-and-nail for years to avoid having their rights taken away: gun owners. Whether you agree or disagree in regards to the Second Amendment, the lessons learned will be valuable. We need to concentrate our power in one group for maximum effect, and we must be vocal and uncompromising. The National Rifle Association can show a membership of five million plus souls, and every politician in Washington knows these people, as well as their families and many of their friends, always vote "single issue" at election time. No matter how much good a candidate might be thought to do in other areas, for the NRA member, supporting legislation that restricts the law-abiding citizens rights under the Second Amendment is an absolutely disqualifying flaw in the character of that candidate, and that candidate will become a pariah to the entire membership, and anyone else they can convince as well. Also, every Washington politician knows damn well that EVERY NRA member votes, every time, every election. We need to organize that sort of centralized entity for the vaping community, and not let ourselves be divided into too many small groups. That is the only way to build the clout necessary in Washington.
Also--look at what happens every time some gun-control scheme starts getting press--gun and ammunition sales go through the roof. I would expect the same thing will happen to vaping very soon!
Also--look at what happens every time some gun-control scheme starts getting press--gun and ammunition sales go through the roof. I would expect the same thing will happen to vaping very soon!
I dont see any wiggle room on page 222. They will evaluate on a case by case but in the meantime, they fall under the Final Rule.
This is from page 222 of the Final Rule:
FDA is aware that, although some ENDS and e-liquids are marketed as nicotine free, as stated in section VIII.D, studies have found that certain types of ENDS do not have consistent quality and the labels may not accurately reflect the amount of nicotine in the e-liquid.The World Health Organization (WHO) also has noted that the level of nicotine delivered in currently marketed ENDS varies widely depending on product characteristics, user puffing behavior and nicotine solution concentration, leaving smokers unaware of the nicotine levels they are receiving (Ref.163).
In addition, FDA agrees that many factors influence the delivery of nicotine. For example, an experienced ENDS user may be exposed to amounts of nicotine similar to those delivered by cigarette smoking (Ref.114). Also, as stated earlier, nicotine-free-eliquid that is intended or reasonably expected to be used with or for the human consumption of tobacco products in most cases would be a component or part of a tobacco product and,therefore, within the scope of this rule. These products will be evaluated on a case-by-case basis.
This is from page 222 of the Final Rule:
FDA is aware that, although some ENDS and e-liquids are marketed as nicotine free, as stated in section VIII.D, studies have found that certain types of ENDS do not have consistent quality and the labels may not accurately reflect the amount of nicotine in the e-liquid.The World Health Organization (WHO) also has noted that the level of nicotine delivered in currently marketed ENDS varies widely depending on product characteristics, user puffing behavior and nicotine solution concentration, leaving smokers unaware of the nicotine levels they are receiving (Ref.163).
In addition, FDA agrees that many factors influence the delivery of nicotine. For example, an experienced ENDS user may be exposed to amounts of nicotine similar to those delivered by cigarette smoking (Ref.114). Also, as stated earlier, nicotine-free-eliquid that is intended or reasonably expected to be used with or for the human consumption of tobacco products in most cases would be a component or part of a tobacco product and,therefore, within the scope of this rule. These products will be evaluated on a case-by-case basis.
PG/VG/Flavors will remain widely available for anyone who wants to mix their own. These products have been around forever and are multi-purpose. There is no way efficiently police the purchaser's intent nor is there any reason to anyways. If bottled nic is available and open systems permitted to be sold then unflavored nic base will certainly be on the shelves. At a high cost of course. If unflavored bottled nic is available then the workaround for making your own flavored stuff will be simple. If open systems don't get approved in the end then we're even more screwed than how we feel today.
With that being said, the regs are every bit the disaster we all feared. Not one single meaningful concession after 2 years, over 100,000 comments, and numerous efforts from industry proponents. It really shows that everything was in fact a foregone conclusion. Which is a disgrace.
Said by a new member with 3 posts since 2014
Sent from a dark, twisted corner of the back porch, covered in cobwebs and slightly damp.
100% agree, I've been saying the same thing for years. I know groups like CASAA are doing good work, but I feel like they haven't been as tough as they should have been. It's going to take a group with money, paid lobbyist, and staff. That means a significant portion of vapers are going to have to step up and pay membership dues, and make donations, along with contributions from the industry.
Exactly, sales of aluminum, plastic hoses, those masks people where when they wheeze at night, the van that brings the tanks, the paperwork that must be done by secretaries, the paper mills, pencils, computer equipment, programmers, hospital staff, carpet they walk on, glue that holds it down, insurance companies / employees, regulators which concoct strange health insurance rules, insurance agents, their houses and the repair people that hang their fancy lamps, light bulbs, china would truly suffer. And start selling US bonds, no one would be buying the US debt for amortization returns, traders losing their minds and jumping off curbs because there are no windows only bricks, oh and lumber for closing all the shop windows, buy lumber stock! lol..............and this does not require Core Math.
The Anti establishment collapse alone would send thousands to the unemployment line.
Sales of Oxygen tanks and support equipment down the drain....etc.
Here's another contrasting example of the extortionate prices e cig vendors charge.
Muji unbleached Cotton pads (180 pack) on Ebay :
60mm x 50mm
£5
Muji Unbleached CUT Cotton Pads 5x6cm • 180 Pads • Free Fast Airmail Shipping | eBay
In contrast :
Muji unbleached cotton pads (5 pack) that's 5 pads
Japanese Cotton Wicks Muji - eVAPING UK
60mm x 50mm
£2.99.
From a first quick review, two things popped out at me. 1) The FDA never had any intention of passing anything else all along. They have been using all presentations of REAL scientific studies as their personal bum-wipes, while committing to the ignorant junk science that supports their payoff from BT, BP - and other prostitutes who rely on the dwindling stream of cigarette taxes for their salaries (all that "may" "might" "perhaps" BS). Not one piece of real evidence has even be read by the FDA.
2) The FDA has flat out overreached it's authority by shoving this ludicrous drivel through BEFORE (and this might be our best hope) our senators and congress have had an opportunity to determine the active bill currently before them. The FDA believes its personal payoff by BT/BP is above the judicial process of our nation. I would recommend that all senate and congress be told in no uncertain terms what the FDA is up to. Edit - see my repost of Katya's post below.
2) The FDA has flat out overreached it's authority by shoving this ludicrous drivel through BEFORE (and this might be our best hope) our senators and congress have had an opportunity to determine the active bill currently before them. The FDA believes its personal payoff by BT/BP is above the judicial process of our nation. I would recommend that all senate and congress be told in no uncertain terms what the FDA is up to. Edit - see my repost of Katya's post below.
.... the FDA. .... those ....ing ....s.The only answer to this is massive social disobedience. Ghandi demonstrated it very effectively. And the constant "in your face" that others around us need from us to understand how government is victimizing smokers. The shoe must be on the other foot now. They must truly be made to appreciate just how miserable this is and we are. It's not whether we're going to be inconvenienced or put upon now. There's no doubt. We are being ground under the boot. If you're a vaper, you need to get that this is personal. Every vaper must be an activist for their own freedom of choice.
Good luck.
2 gallons of nic in the freezer and a ton of hardware. My family and friends will vape as much as we want until we don't want to any more. Meanwhile we advocate for what is right.
We won't go gently into the night. We'll rage against the dying of the light.
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Talk about being being bombed back into the stone age. Thanks FDA you've done it! Everything designed and produced past 2007!? Back to the Ego stick and tiny atomizer with a crappy little coil. We'll have every vaper hobbyist with a lathe turning out 510 connections and atomizers for personal use or selling them in the local head shops as something else.
What the Tobacco industry will offer is going to be from the same Chinese manufacturers as are producing today and charge 10 - 20 times what is currently paid. How many designs are they going to pay to have approved and where is any innovation going to come from? Not from thousands of enthusiasts but a select few bonehead corporate engineers collecting a paycheck. Its all about the bottom line and the bottom lime just got a lot bigger for the tobacco industry.
The only decent things will come from a black market again for a steep cost. Ever heard of bathtub gin that was made during prohibition well get ready for the same only for this time it'll be e-juice and just as dangerous. Great job FDA. I feel for the new vapers that will be coming into the community in 3 years or so.
What the Tobacco industry will offer is going to be from the same Chinese manufacturers as are producing today and charge 10 - 20 times what is currently paid. How many designs are they going to pay to have approved and where is any innovation going to come from? Not from thousands of enthusiasts but a select few bonehead corporate engineers collecting a paycheck. Its all about the bottom line and the bottom lime just got a lot bigger for the tobacco industry.
The only decent things will come from a black market again for a steep cost. Ever heard of bathtub gin that was made during prohibition well get ready for the same only for this time it'll be e-juice and just as dangerous. Great job FDA. I feel for the new vapers that will be coming into the community in 3 years or so.
Here is the final response to those that ask well what about all the other harmful chemicals in the house. I have seen those posts here forever. Prior to this comment there are eliquid poisoning statistics.
(Comment128) Some comments compared the poison risks of nicotine against other household products, noting that the incidence of nicotine poisoning is significantly lower than for other household products(Ref.168).
(Response) Regardless of the incidence of nicotine poisoning in comparison to
poisonings attributed to other household products, the dramatic rise in nicotine poisoning from e-224 liquid exposures is very concerning. FDA is taking under advisement the submitted data regarding nicotine poisoning and suggestions for measures that FDA can take in a separate rule making to address the issue, including establishment of tobacco product manufacturing practice regulations under section 906(e) and tobacco product standards under section 907 of the FD&C Act. In addition, as stated previously, FDA issued an ANPRM prior to this deeming rule seeking comments, data, research, or other information that may inform regulatory actions FDA might take with respect to nicotine exposure warnings and child-resistant packaging.
Moreover,elsewhere in this issue of the Federal Register, FDA has made available draft guidance,whichwhen final will describe FDA's current thinking regarding some appropriate means of addressing the pre market authorization requirements for newly deemed ENDS products, including recommendations for exposure warnings and child-resistant packaging that would help support a showing that the marketing of a product is appropriate for the protection of public health.
(Comment128) Some comments compared the poison risks of nicotine against other household products, noting that the incidence of nicotine poisoning is significantly lower than for other household products(Ref.168).
(Response) Regardless of the incidence of nicotine poisoning in comparison to
poisonings attributed to other household products, the dramatic rise in nicotine poisoning from e-224 liquid exposures is very concerning. FDA is taking under advisement the submitted data regarding nicotine poisoning and suggestions for measures that FDA can take in a separate rule making to address the issue, including establishment of tobacco product manufacturing practice regulations under section 906(e) and tobacco product standards under section 907 of the FD&C Act. In addition, as stated previously, FDA issued an ANPRM prior to this deeming rule seeking comments, data, research, or other information that may inform regulatory actions FDA might take with respect to nicotine exposure warnings and child-resistant packaging.
Moreover,elsewhere in this issue of the Federal Register, FDA has made available draft guidance,whichwhen final will describe FDA's current thinking regarding some appropriate means of addressing the pre market authorization requirements for newly deemed ENDS products, including recommendations for exposure warnings and child-resistant packaging that would help support a showing that the marketing of a product is appropriate for the protection of public health.
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.)
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