FDA Bill Godshall commentary on FDA deeming proposals

[Roger_Lafayette]

<sniip>

I agree with 99% of what you say, with a few caveas:

1) "Medicalizing" vaping could be in the interests of all the deep-pocketed players: BT + BV + BP. (BV = "big vapor" viz. NJOY and LOGIC). You Europeans know better than we Yanks that this was the original goal of the TPD and what the MHRA wants to do. An unappealing-but-highly-profitable prescription alternative puts money into all the big players' pockets - directly or indirectly. BP keeps making money off of ill tobacco cigarette smokers who will continue to be BT's customers and pay huge sin taxes (did I mention gov'ts as important players?).

2) Both the US FDA and the US TPD regulatory scheme have one important loophole that may be relevant to some vapers: the lack of regulation for devices that cannot be used to vaporize nicotine. A manufacturer would have to design proprietary non-user-refillable cartridges and not offer nicotine-containing e-liquid. Some EU member states and the US FDA would undoubtedly try to exercise jurisdiction over these devices under the "e-cigarette" rubric, if there was any practicable way for a consumer to alter them so that nicotine-containing e-liqud could be vaporized with them. However there is a very real possibility that some courts will find the "can be used" language in para 16 of TPD artcle 2 overbroad - ditto any such interpretation by the FDA using its own tobacco products jurisdiction. (In the EU case, it's important to remember that the TPD is not itself law, but a framework for member states to use: some may not adopt or enforce every nuance of the TPD, such as regulating common household batteries under Art. 18).

3) There's one other US regulatory nuance that doesn't exist in the TPD: nicotine derived from non-tobacco sources - if practical to market (and that is a big "if") - cannot be regulated under the FDA's tobacco products rubric unless offered for therapeutic purposes. Only the US DEA could do so, and that presents the question of whether the DEA could regulate a drug legally sold over-the-counter based soley on its origin (i.e. distinguish nicotine derived from e.g. eggplant versus that derived from tobacco based on molecular structure differences, such as isomers).

4) Last, but not least: I hope there will be "millions of vapers" (your words) in the future, and that the oft-repeated phrase "smoking is dead, vaping is the future,and the future is now" comes to fruition. However only time will tell whether any significant number of smokers are able to quit using whatever dreadful cigAlikes that BT and BV decide to (and are permitted to) offer in the US. If non-cigAlike equpment is effectively eliminated from the non-black market in the US as it will almost certainly be in the EU, then I have my doubts about whether vaping as we know it will thrive. Not everyone has the time and dedication to build a "flashlight mod" out of an Altoid tin. Currently, the only types of equpment that have a semi-permanent lifespan are mechs, RDAs and rebuildale tank atomizers. But most of these have proprietary non-metal parts that will wear out. Vaping as we know it may go the way of "home (beer) brewing" - a practice limited to a small group of dedicated hobbyists.

 

[Tekn0ph1sh]

Eloquently put Rolygate.

@Randyith basically any the first phase possibly goes into play in 75 days which is when they approve the regulations or make changes to it. And then everyone has 24 months to comply. Anything derived from Tobacco must carry a warning label in as big of letters as possible WARNING: This product was derived from whole Tobacco leaf. Or WARNING: This product contains nicotine. The label must also include the address of the manufacturer of said product. And they are trying to write this to cover existing and all future tobacco products. No one under 18 can buy tobacco products. They specifically mentioned classifying Flavored PV cartridges as tobacco products. There was no mention of unflavored nicotine ejuice per se but they are going to try and roll it up under existing and future products but admitted in the text that anything not classified that was on the market before 2007 they technically do not have the right to classify as Tobacco which PVs may fall under this category. They also called out to for help regulating flavors and the industry as a whole. Most of it was rhetoric on how PVs are a gateway for our youth for poly-tobacco source addiction. Ie they would vape, smoke analogs, smoke water pipes and cigars which are all bad because they all contain the evil highly addictive nicotine and contain higher amounts of nic and other carcinogens than analogs. The PV industry is trying to hook our youth on nicotine with Gummy Bear flavor and research shows that if people don't start smoking in childhood or adolescence than they never will. Oh and that expensive Premium Cigars are pretty much exempt from regulation other than the shop owner displaying signs that say cigars are no safer than cigs and 18+ only.

And that substitutes that don't contain nicotine/tobacco with the intent to use as a Tobacco product count under the regulations. But everything is much too vague which is intentional I am sure so they can use this to stop innovation and reign in the industry and further ostracize 52 million more evil addicts without any proper research.

I would be partially for it if they laid out plans for clinical testing and manufacture guidelines but I say partially because there is too much industry regulation already. But instead it is just to lump us in with smokers so they can ban it everywhere except locked in your house. The children may see you! Oh my you are giving me cancer by blowing water vapor in my general direction.

End rant. Sorry I went a little longer than I meant to.
Tekn0

 

[Roger_Lafayette]

So... if equipment is included, then when I buy a 18650 battery for my mod is the vendor going to ask me what am I going to use it for? If I say for a flashlight, they'll quote me one price; if I say for an ecig, they'll quote me a higher price. Guess what my answer will be! [...]

You'll still be able to buy the battery without answering any Qs. The FDA is not going to engage in the absurd exercise of insisting that battery manufacturers file applications, so long as those batteries have other uses (Egos are a different matter).

But if your mod breaks down two years after the regulations become finanlized, you may not be able to purchase a replacement. And unless you use a rebuldable of some kind (or buy whatever cigAlikes are permitted), you won't be able to vape even if your mod is still working. No tanks, carts, tankos, antomizers etc. will be allowed unless the FDA approves them - those are considered "components" and will be regulated as "tobacco products," just as cigarette papers are now.

 

[wv2win]

Very informative, albeit a bit premature. Mr. Godshall appears to believe that these proposals would decimate the vaping industry as we know it, but the deeming proposals aren't regulations just yet, and we have plenty of time to get our point across....................................

Considering the FDA's past actions in conjunction with who runs the FDA and what his priorities are and the specific politicians who want vaping eliminated, there is virtually no reason to believe they are interested in the least in "our points". Just wishful thinking.

 

[Tekn0ph1sh]

Lol. Serious vapors better buy an easy to maintain metal mechanical mod and a couple of RTAs and RDAs that are stainless steel. They can't regulate organic cotton, Kanthal wire and batteries.
Could also be a DIY retailers dream. I carry food flavorings. I carry unflavored nicotine. I carry VG and PG. I have no idea how you are using those products but if you check on this website you can find out how to make a decent

 

[aikanae1]

Sounds like another game of "whack-a-mole" they are getting themselves into. I have little doubt that even drafting regulations has caused some creative minds to start thinking of alternatives for the essentials (nic).

 

[Roger_Lafayette]

Lol. Serious vapors better buy an easy to maintain metal mechanical mod and a couple of RTAs and RDAs that are stainless steel. They can't regulate organic cotton, Kanthal wire and batteries.
Could also be a DIY retailers dream. I carry food flavorings. I carry unflavored nicotine. I carry VG and PG. I have no idea how you are using those products but if you check on this website you can find out how to make a decent

I have similar thoughts, but let's keep three things in mind:

1) Most mechs and rebuldables contain proprietary non-metal parts that may eventually wear out. I'd be curious to know which ones don't (some of the O-rings are standard). Kicks will likely have an even shorter lifespan. I wouldn't hold my breath for any of these manufacturers to seek FDA approval.

2) Water-soluble nic will definitely be regulated and quite likely high concentrations will not be available over the 'net.

3) Regardless of those two points, it will not help us much if the current population of non-cigAlike vapers can never expand. Theoretically there's a 2-year window for the availability of equipment, but I suspect manufacturers and distributors will start bailing out as soon as the reg.s are finalized.

 

[3mg Meniere]

Sounds like another game of "whack-a-mole" they are getting themselves into.

That is just the point. It is so open-ended simply because the whole vaping industry is the wild West, growing so fast that tobacco use is predicted to disappear within fifty years. And the two years that they have set for themselves is unrealistic for that very reason.

No nic or extremely low nic use is going to grow by leaps and bounds because of the uncertainties involved. That is not a bad thing. DIY in both hardware and juice will become the norm. High nic users have plenty in their freezers in case it gets too expensive with sin tax.

Given the ineffectiveness of the cigalike for quitting smoking, their presumption that vaping is a problem rather than a solution is going to result in the restriction of PV purchase and use. As a story about the regulations played on TV, I noticed cigalikes were dominant, while I only saw glimpses of PV's. Not good. Even though the audio (if I remember right) did mention our claims that the PV is much better.

 

[sqirl1]

What I don't get is how they can get away with the SE clause in the first place, it just has so many red flags to it and their reasoning for putting it in place is a paper thin cover for protecting an existing market. I think that especially since they seem to be biased about who they're enforcing it on, that whole section of FSPTCA is unquestionably challengable and very possibly beatable in court. I say Substantial Equivalence is the most threatening part of FSPTCA for us and we should focus on either demanding e-cigs be 100% exempt from it or trying to get the courts to strike it down entirely, we can negotiate everything else normally.

 

[Vaslovik]

But five years ago, FDA spokesperson Rita Chappelle revealed the agency's unscientific, unethical and inhumane policy to deceive Americans about e-cigs to defend the FDA's unlawful e-cig ban: "We don't want the public to perceive them as a safer alternative to cigarettes."

Translation: We don't want the public to know the truth because we've lost sales and taxes on a billion packs of cigarettes already, and we need them to start smoking again so we can be as filthy rich as we like while they are dying of lung cancer and emphysema.

They are pure EVIL.

 

[aikanae1]

Will these regs apply to "dry herb atomizers" too - essentilly an ego with a very similar atomizer and I guess, even ce4's can be modded for use? That's a legit use.

 

[WaynesWorld]

Just saw this article on Linkedin ---- FDA Says Product Containing No Tobacco is a “Tobacco Product” -- FDA Expands Authority to Include E-Puffing

https://www.linkedin.com/today/post...-include-e-puffing?trk=nus-cha-roll-art-title

 

[Tekn0ph1sh]

I would say yes dry herb PVs would be included. It can be used for tobacco. However that would be another arguable thing because they do not contain nicotine or refills that contain nicotine. But TBH most of the "dry herb" PVs are used for illicit substances and maybe some may actually use them for tobacco. Which I am sure the FDA and other agencies are perfectly aware of. So in all likelihood they would fall under regulation as well. If it looks like smoking it must be smoking. And it must be stopped.

 

[grandmato5]

We've waited over 3 years to see the FDA's proposed deeming order and regulations and we'll be waiting again to see what their final regulations actually are before anything changes.

IMO they have written so many "we don't know what to do, tell us what you think" scenarios into the proposed regs that IF they really don't know what to do they won't be making any decisions for quite some time and we'll again be in limbo for a lengthy period of time. IF we see their final regulations in a relatively short period of time after the comment period that would simply mean they already had made their decisions and simply chose to pretend not to know so they didn't have to deal with our outrage in the initial comments period that they are required to have. It shall be interesting to see how long we wait after the comment period for their final regs.

I'd like to hear Bill's guess now that he's had a chance to read the proposal as to how long he thinks it will take before we see final regs.

 

[Gato del Jugo]

IMO they have written so many "we don't know what to do, tell us what you think" scenarios into the proposed regs that IF they really don't know what to do they won't be making any decisions for quite some time and we'll again be in limbo for a lengthy period of time. IF we see their final regulations in a relatively short period of time after the comment period that would simply mean they already had made their decisions and simply chose to pretend not to know so they didn't have to deal with our outrage in the initial comments period that they are required to have.

That's been my concern, too.. Is this already pre-determined & they're just placating us? Or are they honestly not sure & open to stuff?

Given the vaping industry's size & diversity at this point, as well as the speed of change & innovation, I'm leaning towards the latter (a little) since I could see them having trouble "keeping up" & making up their minds in a pretty gray area...


Anyway, I'm not all that familiar with the FDA process, but apparently they are bound to at least read (& consider?) every comment at this stage...

 

[Gato del Jugo]

Sounds like another game of "whack-a-mole" they are getting themselves into. I have little doubt that even drafting regulations has caused some creative minds to start thinking of alternatives for the essentials (nic).

In the FDA teleconference (YouTube link is floating around these parts somewhere), I seem to recall somebody asking in the Q&A portion about the nicotine in eggplant..

FDA's answer was that eggplant is not tobacco, and wouldn't fall under these regulations...

 

[MD_Boater]

I would say yes dry herb PVs would be included. It can be used for tobacco. However that would be another arguable thing because they do not contain nicotine or refills that contain nicotine. But TBH most of the "dry herb" PVs are used for illicit substances and maybe some may actually use them for tobacco. Which I am sure the FDA and other agencies are perfectly aware of. So in all likelihood they would fall under regulation as well. If it looks like smoking it must be smoking. And it must be stopped.

These things ar a prime example of what I am thinking. I really don't care what the FDA does, we will still be able to buy our equipment. We are going to see companies making components that are dual use, and labeling them with the non-vaping function as the primary use. We will just order them and use them "wrong" for vaping. Pyrex glass tubes, end caps, bases, coils, drip tips, etc.. They will all be available, just as you have always been able to go into a "smoke shop" to buy your "dry herb" supplies forever. The FDA has just created huge grey and black markets. There are no hardware components that they will truly be able to stop. Will they be "illegal"? Yes. Will we be able to get them? Absolutely.

You don't think that Kanger, Innokin, etc. aren't going to take this to court since their products at most can be classified as "accessories"? Kanger (generic example) does not make tobacco products. They make glass and metal tanks. Obviously not a tobacco product. This is going to go to court, and the regulations will be changed again.

There is no way the government can stop this train... Nic is going to be the #1 issue.

 

[Roger_Lafayette]

Will these regs apply to "dry herb atomizers" too - essentilly an ego with a very similar atomizer and I guess, even ce4's can be modded for use? That's a legit use.

p.7 would imply that if they can be used for tobacco products, then they are "components or parts." The language is broad enough to include 863xx batteries that are sold in kits w/ APVs or mechs. (Obviously they're not crazy enough to go after generic batteries. Just Egos.)

My concern is that manufacturers like SmokTech or Vision aren't going to spend the gobs of money needed to apply to the FDA, nor are they going to risk investment in R&D if they think that the US market will be closed to them (along w/ EU countries). The FDA will likely "make an example" out of distributors in the US, Canada, or Europe who dare to sell these devices after the 2-year window is closed. FastTech or other Asian distributors beyond FDA reach will have to decide whether to add a premium to cover seized shipments, not bother, or let buyers take the risk of seizure.

Of course, if user modifications are needed to make the product work for tobacco/e-liquid, then we get into a gray area. This is similar to the Q of semi-automatic weapons that could be modified easily to be automatic. I believe that the ATF eventually decided that they had to leave those alone. But the NRA has serious throw weight. Vapers who prefer non-cigAlikes are gadflies by comparison - we are competely disorganized, and have no lobby or deep-pocketed interest on our side. No small manufacturer is going to even think about producing non-cigAlike products for us. The penalties aren't just civil, they'll start throwing people in prison. That said, there may be hit-and-miss access to fly-by-night Asian manufacturers who set up temporary facilities, and ship to the US market for a few months until all their shipments get snagged by US customs. It'll be like illegal name-brand knockoffs. Get one of your friends to travel to a major city and see if they can find someone selling illegal mechs (etc.) out of the back of a truck.

 

[blueGrassTubb]

I do think the FDA is earnest about the discovery proceedings it outlined in its proposal regarding the health and safety of vaping.

You're kidding, right?

The only thing the FDA is earnest about is doing what they can to eliminate competition for the biggest players to take over the industry completely.

 

[buffaloguy]

Honestly I dont understand the issue with any of this. For the purposes of my vaping habits none of it applys to me and alot of other vapers I know. Im a diy guy. I can see how all this can effect new vapers, small shops and even mid size businesses. For them I am concerned and I get the issues.

But can someone please tell me how it impacts me? I use mech mods, use tanks, rba's, and make all of my own eliquid. As I can see it, all I ever buy is components. Liquid nicotine itself will still be available for sale, and even if its not in 2+ years Ill be vaping 0 nic less than a year from now.

For those that buy components only and are total diy'ers... how are we impacted by any of this? Im not trying to be ignorant here but I just dont see how they could stop or even impact someone like me.