FDA issues Brief Summary of “Not Substantially Equivalent” Determinations delineating why deeming reg would ban all e-cigs

[Luisa]

Luisa inquired


This document is the FDA's explanation for why they've rejected 10 SE applications so far (for cigarettes, smokeless tobacco, RYO tobacco and/or paper, which are regulated by Chapter IX).

But more importantly, this document explains why the FDA has only taken final action on 19 (approving 9 and rejecting 10) of the 4,321 SE applications that were filed with the agency from 2010 to February, 2013.

This document also explains why 69 SE applications were withdrawn by manufacturers (as FDA has demanded a truck load of research/data for each SE product application, and it appears that FDA keeps demanding more and more new data after previous data requests were satisfied).

Although this FDA document has nothing to do with e-cigs at the moment (since e-cigs aren't regulated by Chapter IX), it delineates the process that every e-cig product manufacturer and importer will face (if FDA imposes the deeming regulation) for every single one of their products. Even if FDA extends the 2007 grandfather date to 2013 for e-cigs (to avoid litigation), every e-cig manufacturer and importer would have to file an SE application for every new (i.e. even slightly different) e-cig product (or file a New tobacco Product application, which has even greater hurdles and costs than SE applications) before it could be legally marketed in the US.

And if an e-cig company sells 5 different flavored products at 3 different nicotine strengths, 15 SE applications would have to be submitted to the FDA. So even if FDA exempts e-cigs from the 2007 date, and even if FDA's regs don't ban/restrict flavorings, nicotine levels, or other characteristics of e-cig products, no more than a few of the thousand plus e-cig products now on the market are likely to be on the market five years from now (if FDA imposes the deeming regulation).

JohnnyRoBato wrote



Precisely.

In an attempt to protect Big Pharma's unsafe and ineffective "smoking cessation" drugs from market competition, the Obama administration's unstated policy has been to prevent ALL new tobacco products from being marketed, which primarily protects cigarette markets and threatens the lives of smokers (and vapers if FDA imposes the deeming reg).

Thank you for the explanation. I,also find it odd that Dr. McAfee of the CDC received an e-mail in mid August with questionable( in my opinion) statistics concerning e-cigarette use among young people. I wonder who might have sent this e-mail. McAfee does not elaborate. It sounds like something Glantz would contrive.

 

[Petrodus]

Thank you for the explanation. I,also find it odd that Dr. McAfee of the CDC received an e-mail in mid August with questionable( in my opinion) statistics concerning e-cigarette use among young people. I wonder who might have sent this e-mail. McAfee does not elaborate. It sounds like something Glantz would contrive.

Wouldn't come as a surprise to me !!

 

[AngiBe]

We now have 6 B&M's in the state of N.J that I know of. I have been to five of them and have had LONG conversations with all. Not one of them have any concerns of the upcoming regulations. Some are already talking about their "work arounds". None of them have mentioned that they are actively participating in the fight in any way! This is what sucks! I would like to hear that they will fight, I just don't get that feeling from any of them. I truly hope I am reading them wrong!

I've noticed this too in my area, which is very odd. I mean this is their livelihood after all, you'd think these guys would be more in touch w/reality. A lot of these guys are not on forums like this so maybe not informed or rather be under the radar versus voicing opinions afraid that their shops would be then scoped out? Who knows

Anything that contains nicotine will be considered a tobacco product due to the FSPTCA definition of tobacco products.
The only exceptions are nicotine products that are approved drug/drug delivery devices.

In other words the patch, inhaler, gum, and lozenges produced by Big Pharma are exempt by definition.
And any "nicotine based" drugs they come up with in the near future will also be exempt.

This is what is irritating me. Again, can't really tell what the FDA is going for to try and squash vaping (but of course allowing cig a likes in gas stations) but I know with Nico gum (I've used it too many times to count..epic failure) and obviously cigs, cig a likes..anything with nico, there's warning labels.

Now, that doesn't mean I can't go homes and pop like 20 pieces of gum in my mouth. I wouldn't because that would be just plain stupid. Just like people who vape are not dumb and would use super high nic! if they think we are dumb enough, label it...end of story. So, if they mandate all nic suppliers/vendors to put a warning label on nic, wouldn't this virtually be the same concept?

Ya, you bought nicotine, ya it maybe harmful to your health, ya don't OD and use too much. Blah, blah blah and every other longwinded, typed word they put on those labels.

Are they implying that we're too ignorant to figure that out ourselves? I haven't heard of anyone that vapes that has OD'ed on nic. If nic is the big issue here, all they need is a warning label. That's basically all they do for other nic products- drugs or tobacco.

 

[ut1205]

Something everyone should be very worried about. Regardless of what is said about the product, the FDA is going to do exactly what it wants to do. Want an example? Here's one from yesterday.

Here we have the FDA going against its own panel's recommendations and doing the exact opposite of what it recommended. In other words, it approved a drug that it's own outside panel didn't give a stamp of approval.

We can already see that it's not the tobacco companies we have to worry about. It's the pharmaceuticals that are going to drive the end result. Regardless of the information that's out there saying how safe e-cigarettes are, I suspect the FDA is going to do everything it can to ensure the pharmacy companies continue to rake in their ill gotten gains.

It is interesting to me that the opponents of this drug reference "killing children". I thought that argument was reserved for tobacco.

 

[Cool_Breeze]

I've noticed this too in my area, which is very odd. I mean this is their livelihood after all, you'd think these guys would be more in touch w/reality. A lot of these guys are not on forums like this so maybe not informed or rather be under the radar versus voicing opinions afraid that their shops would be then scoped out? Who knows...

Perhaps the circle of dealers is a little different than that of ECF users and maybe they know something(s) that we don't.

 

[Berylanna]

Perhaps the circle of dealers is a little different than that of ECF users and maybe they know something(s) that we don't.

Not the ones I've talked to. The "old hands" know and are keeping at least one eye on ECF and/or CASAA, even if not as members. The new ones are clueless.

 

[NorthOfAtlanta]

Something everyone should be very worried about. Regardless of what is said about the product, the FDA is going to do exactly what it wants to do. Want an example? Here's one from yesterday.

Here we have the FDA going against its own panel's recommendations and doing the exact opposite of what it recommended. In other words, it approved a drug that it's own outside panel didn't give a stamp of approval.

We can already see that it's not the tobacco companies we have to worry about. It's the pharmaceuticals that are going to drive the end result. Regardless of the information that's out there saying how safe e-cigarettes are, I suspect the FDA is going to do everything it can to ensure the pharmacy companies continue to rake in their ill gotten gains.

Here's the money quote (literally) from the article:

Shares of San Diego-based Zogenix, Inc. jumped in trading Friday, climbing 80 cents, or 36 per cent, to close at $3.04. Earlier shares set a 52-week high of $3.45.

Makes one wonder how many of those who voted yes on this had stock in this company.

 

[aikanae1]

Nic refill juice will always be available.
You think they want to loose that revenue, also there will be people there to argue against banning EJuice.
You must remember people that support us are just as smart if not smarter than the oppositions.
I learned that from going to the LA thingie.
Folks that stepped up in favor of ECigs were quite eloquent and intelligent.
Know this there will be people fighting for us, heavy hitters.

I don't think it's about what you (or anyone else) knows, it's all about WHO you know and that's what worries me.

Nutritional suppliments have been in a battle against FDA regulations (per BP's request) for at least a decade now. It's grown from a tiny grass roots movement into a fairly well-oiled lobbying effort (partially fueled by some large corporations that grew with the industry).

However, public opinion was changed from "well gee, I don't know what's in these" to "hands off my vitamins!". I'm sure there are other factors involved; larger and broader market, lack of medical care, organized specialists (naturopath's) etc. but I think there's some lessons. Opinion's and pressure can make a difference.

This isn't good. I'm not hearing from this even a tiny opportunity or willingness from FDA to negotiate it's stance against ecigs. It appears that minds are made up and the market has been carved up (why BT only invested in cig-alikes). Back door deals. I'll almost bet that BT and BP have already shook hands.

This basically prevents ANY product that might assist smokers to quit from coming onto the market that isn't from BP. What's good for public health about that?

I honestly don't think the Obama admin had much to do with this since the FDA appears to be headed by BP and BP has more cash anyway (follow the money). Unfortunatley, BP has even less reason to care what the public thinks. The only way I can think of to stop this is for everyone to become lobbyists.

I hope more cases can be filed against illegal funding of "anti-smoking" campaigns that ban ecigs (to raise public awareness).

Somehow non-smokers need to get involved.

​

 

[aikanae1]

Well, first of all, the courts have determined that e-cigs are a "tobacco product". Not a medicinal product (which would be worse) but don't fool yourself that there is any confusion whatsoever in the FDA's mindset as to e-cigs being covered under this legislation.

To those who would say "They can't regulate battery holders" or (even more tenuous IMHO) they can't regulate atty's, etc.

You aren't supposed to be able to buy a nebulizer without a prescription, even though it's just an air compressor with some custom plastic fittings on it. The FDA might well decide that iTastes, provaris, etc. are all "Tobacco products" and try to regulate them.

And although much of the language being discussed would seem to apply mostly to gas-station cigalikes (where the battery, head, and juice are all lumped together as a single product) you should expect that any final language that gets adopted could well have an effect on your favorite battery tube as well. (Particularly given the penchant to slip in "last-minute clarifications", and for generally broad latitude in deeming which products are eligible for seisure).

I got back into e-cigs at an opportune time, while I can still try out different PV's, heads, and juices. Will new vapers a year from now be able to say the same thing?

They can require all products need to be purchased through tobacco warehouses, which BT already control, making it very unlikely anything but BT's products are available. I think some areas have attempted local legislation to do that and it's faied so far.

Essentially everything without a state stamp would be illegal including a garage mod. Sorta like "drug parphenelia" found at a traffic stop. As it is, some cops get confused with some mods and "dry herb atomizers".

And don't forget, ecigs are already illegal in Mexico.

It is strange that Groupon and Ebay and PayPal can sell "dry herb atomizer" and they have bans on ecig products. I hate to say this, but if the illegal herb industry felt their products might be in question, they'd be a vocal ally. Most opinion polls are favorable to legalization.

No matter what, this will limit the market from reaching smokers that want to and need to quit. There is no doubt that this is more about marketplace control, and reducing competition, than it is about public health. No one has ever been harmed by vaping.

​

 

[aikanae1]

There's a huge canyon separating what the FDA can do
and what it will do.

I suggest the FDA will not propose any grandfather stuff
and will focus on nicotine ... and possibly flavors.
However, I don't think they will impose regulations on flavors.

Vuse cartridges include a chipset so that vapers can't DIY and refill them.
How long do you think it'll take for others to adopt the same strategy and if backed by federal regulations, make it illegal to tinker with products like other products (phones, dvr's, watermarking, etc)? That's extreme, but do able.

At one time it was fairly easy to buy drugs online from India, etc. That's clamped down, it's still possible (so I've been told) but there's a lot of scams, risky, expensive and most people don't want to get involved in things like Silk Road (gone anyway) or Bit Coins.

Payment processing is another successful gateway that can be closed. Internet sales tax requires cc's to send reports to states of all online purchases. That process is under way right now. Fight that if you want to buy anything anonymously.

It doesn't matter who the president is when the industry is bigger than the gov't.

​

 

[NorthOfAtlanta]

Vuse cartridges include a chipset so that vapers can't DIY and refill them.
How long do you think it'll take for others to adopt the same strategy and if backed by federal regulations, make it illegal to tinker with products like other products (phones, dvr's, watermarking, etc)? That's extreme, but do able.

At one time it was fairly easy to buy drugs online from India, etc. That's clamped down, it's still possible (so I've been told) but there's a lot of scams, risky, expensive and most people don't want to get involved in things like Silk Road (gone anyway) or Bit Coins.

Payment processing is another successful gateway that can be closed. Internet sales tax requires cc's to send reports to states of all online purchases. That process is under way right now. Fight that if you want to buy anything anonymously.

It doesn't matter who the president is when the industry is bigger than the gov't.

​

Or when they can afford to buy the needed votes.

 

[LDS714]

Every quit banner in a sig line is a hit to the bottom lines for Big Tobacco, Big Pharma and taxing entities.

These are smart people in search of more money, power and control. You expect them to take this sitting down, irrespective of the health consequences to the sheep they shear?

 

[Uma]

That other industry stepped in over sb648, and Corbett dropped it after discussions with them. I often wonder what was discussed, especially after leafly blogged an article that actually demonizes us. I was shocked, so I complained. Twice. But the article remains without correction, & as far as I know, no other article has voiced differently.
One of the sore spots in the article:
"But it’s an unlikely partnership; manufacturers of e-cigarettes don’t want to be connected with the “illegal drug” stigma of grass and grass doesn’t want to be associated with the dirty industry tactics or negative health effects of tobacco, whether or not e-cigs can actually be classified that way." (Note, I changed the proper name to a nickname).
Of further interest, is a new article about tobacco getting into the grass business, even though they (BT) vehemently deny that ever happening.

Which, to me, explains the attempt of the ANTZ and media to divide the safer alternative groups. As long as they believe we are BT, & we believe they are oh so evil, half the battle is lost.

 

[aikanae1]

Which, to me, explains the attempt of the ANTZ and media to divide the safer alternative groups. As long as they believe we are BT, & we believe they are oh so evil, half the battle is lost.

I think a lot of society's divisions are manufactured to keep the status quo. This is more of the same.

 

[Cool_Breeze]

I think a lot of society's divisions are manufactured to keep the status quo. This is more of the same.

...like the imperial system of weights and measures.

 

[jwhyde1]

i dont understand it either, but, if they delay the decision, the longer they take to rule on it the better for us, there are alot of studies being done on health effects of e- cigs and the more research info and positive feed back from credible sources like doctors the better chance the e cig industry as we know it might survive

 

[aikanae1]

This isn't science based.

 

[Uma]

It's not health based, it's of financial interest importance.

 

[hlk]

It's not health based, it's of financial interest importance.

Bingo... Taxing e-cigs as Tobacco is exactly what will happen.

 

[Petrodus]

E-cigarettes are here to stay !!
And that includes power vape machines, flavors, and nic levels.

Fights over esmoking bans and taxes will be around for the foreseeable future.

Yeah-Yeah-Yeah ... I know all the hand-ringing arguments.
Just bookmark this post for review this time next year.