Proposed FDA Rules

[kemishdo]

Are they going to start banning flavored alcohol? There are plenty of candy fruit and bakery flavored vodkas out there that can appeal to children? But alcohol is legal for 21 and over. I don't see any difference. It's up to adults to keep them out of the hands of minors and same should apply to flavored e-juices. If they ban the flavors I may have to go back to cigarettes, something I vowed I would never do again.

 

[Bob Chill]

Another point about FDA regs is that the fee levels will eventually be set high enough to remove all the small businesses from the market. This is after all the reason for the regs: they can't ban ecigs but they can gradually regulate them out of existence.

I've read most of the reg package and lean towards disagreeing here. The FDA specifically addresses the fact that ecigs are non-combustible and "potentially" much less harmful than other tobacco products. They hinted at a more streamlined process for juice and also protecting smaller firms from being squeezed. It may be window dressing because of all the meetings with industry people. But it might not.

I tried to copy and paste from the proposed regs but it wasn't formatting properly. I recommend everyone read pages 125-130.

 

[Bob Chill]

Are they going to start banning flavored alcohol? There are plenty of candy fruit and bakery flavored vodkas out there that can appeal to children? But alcohol is legal for 21 and over. I don't see any difference. It's up to adults to keep them out of the hands of minors and same should apply to flavored e-juices. If they ban the flavors I may have to go back to cigarettes, something I vowed I would never do again.

They aren't proposing a ban on flavors. They are covering the kid card through warning labels. There was no mention of restricting flavored liquid. I posted this in another thread:

I scanned the proposed regs. It sucks that cigars and such are intermingled so you have to pick and choose what you read. From what I'm seeing, here's the short story:

Flavors are not banned. The worries of them appealing to kids is addressed through warning labels.

Hardware isn't addressed anywhere nor will it likely be. All eyes are on the juice because that is "the tobacco product". Disposables or pre-fillled carts are the only things that contain both hardware and "tobacco product".

In 2 years juice sellers will be required to be registered and licensed. At a reasonable expense I imagine.

Then it gets really grey. There is no mention about nic base specifically. My guess is it will no longer be available in any strength above "an approved amount" that must be applied for then approved. We just won't know where that leads for a couple years. Pre-mix will require approval as well with a list of ingredients that are "tested" with data. That's going to hurt the small juice shops for sure unless there is some piggy backing of FDA approval with flavors already on the market. I'm not well versed at all in FDA approval for substances so hopefully someone else can chime in.

I do see a gaping hole though if flavor and nic base are sold separately. As long as unflavored nic base is available people can buy that and then go to a "flavor shop" and mix their own. A flavor shop would not fall under the regulations because there is no tobacco shop involved.

Online sales of premix aren't banned yet but they will be once the state tax men sweep in hard and fast. Imo- it's pretty obvious how that will shake out. It will be brick and mortar only in a couple years. And I'm good with that. However, a gaping hole for online sales is the flavors. All these boutiques with loyal followings can just sell their flavors online. We'll just have to buy unflavored nic base from a store.

I think we're going to be "ok" in the big picture. Prices are going up. There is no doubt about that. Mostly due to taxes and partly due to increased cost of doing business. I didn't get into vaping to save money anyway. I did it to save my life. My life is valuable to me. I will pay more to keep it.

 

[HDMontana]

I wish CASAA could post a generic letter that you could input your name and address and hit a submit button to send it to the appropriate politicians. Ruger did this on their site last spring when the gun rites scare was going around. Would be a lot easier and I could see many more people doing this than having to look up where to send letters or emails themselves. Just IMO.

HD.

 

[Kryyptyk]

Okay, so just to make this clear: the FDA is using this rule to 'open the door' for vaping regulations. They will NOT stop with warning labels and prohibitions to minors. Don't be fooled.

Moving on, I've had a quick look at the unpublished PDF of the proposed rules, and thought I'd share this:

"To deem products that meet the definition of "tobacco product" under the law except accessories of a proposed deemed tobacco product and subject them to the tobacco control authorities in the FD&C Act"

From: https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf

The wording used here is really murky, so I'll delve deeper and see what I can find. Reading through the rest of the PDF shows the wording throughout, plus a definition of 'accessories' as:

"FDA considers accessories of proposed deemed products to be those items that are not included as part of a finished tobacco product or intended or expected to be used by consumers in the consumption of a tobacco product, and we expect that they will not have a significant impact on the public health. In addition, FDA considers accessories to be those items that may be used in the storage or personal possession of a proposed deemed product."

Those keywords are going to see a lot of play, "finished tobacco product" especially. Further down they give a formal definition of 'tobacco product':

"Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term "tobacco product" to mean "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)."1 Products that meet the statutory definition
of "tobacco products" can include currently marketed products such as certain dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco."

Now there are two things that I can see here. One: a more firm definition that encompasses anything used for the actual act of vaping into the rule, such as mods, toppers, and drip tips; and Two: A gaping loophole for DIY.

Anyone else find anything interesting?

 

[kemishdo]

They aren't proposing a ban on flavors. They are covering the kid card through warning labels. There was no mention of restricting flavored liquid. I posted this in another thread:

I scanned the proposed regs. It sucks that cigars and such are intermingled so you have to pick and choose what you read. From what I'm seeing, here's the short story:

Flavors are not banned. The worries of them appealing to kids is addressed through warning labels.

Hardware isn't addressed anywhere nor will it likely be. All eyes are on the juice because that is "the tobacco product". Disposables or pre-fillled carts are the only things that contain both hardware and "tobacco product".

In 2 years juice sellers will be required to be registered and licensed. At a reasonable expense I imagine.

Then it gets really grey. There is no mention about nic base specifically. My guess is it will no longer be available in any strength above "an approved amount" that must be applied for then approved. We just won't know where that leads for a couple years. Pre-mix will require approval as well with a list of ingredients that are "tested" with data. That's going to hurt the small juice shops for sure unless there is some piggy backing of FDA approval with flavors already on the market. I'm not well versed at all in FDA approval for substances so hopefully someone else can chime in.

I do see a gaping hole though if flavor and nic base are sold separately. As long as unflavored nic base is available people can buy that and then go to a "flavor shop" and mix their own. A flavor shop would not fall under the regulations because there is no tobacco shop involved.

Online sales of premix aren't banned yet but they will be once the state tax men sweep in hard and fast. Imo- it's pretty obvious how that will shake out. It will be brick and mortar only in a couple years. And I'm good with that. However, a gaping hole for online sales is the flavors. All these boutiques with loyal followings can just sell their flavors online. We'll just have to buy unflavored nic base from a store.

I think we're going to be "ok" in the big picture. Prices are going up. There is no doubt about that. Mostly due to taxes and partly due to increased cost of doing business. I didn't get into vaping to save money anyway. I did it to save my life. My life is valuable to me. I will pay more to keep it.

I understand that they are not banning the flavors in themselves. Just relating the fact that there is no difference between flavored alcohol and flavored nicotine juices. Both can be appealing to children, but where is the hype over the possible banning of flavored alcohol? Both are a legal drug, but only one is being considered for banning (the flavored, premixed nicotine juices).

 

[deegal]

As alluded to earlier, nic-free flavors shouldn't be included in the product review/regulation-at least one would hope.

Does anybody know what kind of stuff the product review process would be testing/looking at? I've been in one of the eliquid manufacturer's shop, and I'm curious what it would actually take to pass. Seems like a pretty scary thought for the smaller liquid companies that make great products.


Sent from my iPhone using Tapatalk

 

[guambred]

Their plan is warning labels and banning sales to minors. If that's all they do I can live with that.

Trust me it will not stop at that. this is just the tip of the iceberg. stock up on supplies and learn to DYI your juices.

 

[GreenEyesDon'tLie]

It will be brick and mortar only in a couple years. And I'm good with that.

I'm not. The nearest B&M's that I know of are over an hour away from me, not something I can find the time for very often. Online sales are what makes vaping viable for me.

Warning labels and age restrictions are fine. Price increases don't even bother me that much. But I really need online sales

 

[Kryyptyk]

"In addition, FDA realizes that there are distinctions in the hazards presented by various nicotine-delivering products. Some have advanced views that certain new tobacco products that are noncombustible (such as e-cigarettes) may be less hazardous than combustible products given the carcinogens in smoke and the dangers of secondhand smoke from combustible products. Accordingly, FDA is seeking comment in this proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products. We welcome comment on how to implement the provisions in the FD&C Act with respect to e-cigarettes. We also welcome any health and behavioral data about the effects of using e-cigarettes."

From: https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf

I suppose it's time to start compiling all those studies, since the FDA apparently can't do its own research.

 

[paigekoontz]

Here we go: FDA to begin regulating e-cigarettes - latimes.com

TVECA posted proposed regulations from FDA today. Check it out TVECA.com.

 

[hcour]

The fact that the media as well as government officials have referred to the e-cig market as "The wild-west of smoking" indicates their ignorance.

Hey, idiots! There's no tobacco. There's no smoke. It's water vapor.

 

[Bob Chill]

I'm not. The nearest B&M's that I know of are over an hour away from me, not something I can find the time for very often. Online sales are what makes vaping viable for me.

Warning labels and age restrictions are fine. Price increases don't even bother me that much. But I really need online sales

Good point. If juice is required to be purchased from brick and mortar then availability will go way beyond the vape shops at least. If there is demand, convenience stores and even places like Wallmart will carry it. But limitations on brand and selection will suck.

I'm pretty uncertain where this is all going. Luckily 2 years is a pretty big window to gain more understanding of the product. One thing is for sure, if there was an easy out in regards to health and safety it would have been plastered all over the news. All you ever see referenced by ANTZ is flawed studies from nearly half a decade ago and of course the "children and unknown" cards. Concrete evidence of harm has yet to be found and it's certainly been sought after heavily.

 

[kristin]

I wish CASAA could post a generic letter that you could input your name and address and hit a submit button to send it to the appropriate politicians. Ruger did this on their site last spring when the gun rites scare was going around. Would be a lot easier and I could see many more people doing this than having to look up where to send letters or emails themselves. Just IMO.

HD.

As I said, we will post a CTA (Call to Action) on our web site regarding making public comments once the rules have been thoroughly reviewed. Dr. Phillips, Julie and Elaine are doing the review and answering media calls as we speak. I'm "manning the desk" for other CASAA business while they are working.

 

[Kryyptyk]

As I said, we will post a CTA (Call to Action) on our web site regarding making public comments once the rules have been thoroughly reviewed. Dr. Phillips, Julie and Elaine are doing the review and answering media calls as we speak. I'm "manning the desk" for other CASAA business while they are working.

I'm glad you guys are covering this. Thanks for all your hard work! It's not easy being on the front lines.

 

[anthropus1]

Why is this FDA, where does the BATF stand on their power to control so called tabacco products, usurped and abused. Im not a huge fan of either agency but is there any way to get this tied down with their own red tape... and i want to strongly recomend that anybody in the juice game get in board with AEMSA they have a working relationship with FDA already and are likely to be involved in keeping the new regs more towards the sane side.

 

[pmcode]

The fact that the media as well as government officials have referred to the e-cig market as "The wild-west of smoking" indicates their ignorance.

Hey, idiots! There's no tobacco. There's no smoke. It's water vapor.

And you know what, it doesn't help when users perpetuate false information. It is not water vapor. Unless your liquid is diluted with distilled water, you are releasing PG/VG vapor. Completely different. As a matter of fact, may even be better than water vapor, as vaporized PG has been proven to kill influenza virus in a controlled setting*

*don't have the source, but basically, back in the day, a test was done where a set amount of PG was vaporized into a closed container of live mice, then influenza virus was released into the same container. All the mice lived. Another container of mice was subjected to the same concentration of influenza without the PG, and they all died.

 

[anthropus1]

And propylene glycol in an aerosol form has been approved as an "air sanitizer" for more than 50 years. Center for disease control and prevention did a study on its antibiotic effects in hospitals (i think it was children's hospitals but i would have to find the duke and check) but it clearly showed that a room treated with a "light mist" of pg will have less airborne bacteria.

 

[hcour]

I stand corrected. Thanks for the info.

 

[Kellin]

I hope we aren't all stuck vaping Blu and NJoy in a few years.

I don't think many Chinese companies would bother with applying to the FDA for new, or even existing, products, especially with mods and so forth. I also don't think American companies like ProVape can afford that, either.

I don't see how they can be required to for stand alone devices that can be used for other purposes (ie. 0 nicotine liquids). The FDA doesn't approve hookahs and "other glass devices" used for tobacco. I think that this would apply to cig-a-likes sold with nicotine cartridges as a kit or unit - but we shall see, I suppose. By the time this all shakes out, this may wind up being very different in the implementation from how it appears today in the blueprint.