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

[Stubby]

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).

The 2009 law that gave the FDA authority over tobacco products essentially stymies all innovation in tobacco. Many of the lowest risk tobacco products as in snus, dissolvables, and electronic cigarettes came on the market after February 15, 2007, so are not grandfathered. The law freezes the market so what we end up with is the Status Que. It is nearly impossible to bring new low risk products to the market.

This could very easily end up being the worst law in the history of the US as far as public health goes.

 

[soba1]

I think the key is that an ecig is not a tobacco product and the FDA states clearly that they were not provided enough information to make that determination.

Yes that's exactly what my thinking was.

 

[DrBeaker]

What about this part?
• Tobacco Type.Inadequate information on the type of tobacco used in the cigarette. This is a.significant deficiency because the type of tobacco can alter the levels of harmful.and potentially harmful constituents. This information is needed to understand if.any changes in these characteristics are present and, if they are, whether the.new product raises different questions of public health..

doesn't this pretty much say that they can't even determine whether it's a tobacco products?

 

[soba1]

What was written was extremely clear to me, and it couldn't be any worse.

It basically says that unless the new regulations exempt electronic cigarettes from the 2007 grandfather date in Section 910 there will be no electronic cigarette products allowed on the market unless they are pretty much EXACTLY the same as something that was available and on the market in 2007 here in the United States. It even goes so far as to make it clear that a different flavor, or any changes in the level of ingredients will cause that product to be determined to not be substantially equivalent, and therefore banned. Even a change in airflow characteristics would cause the product to be banned.

What this basically says is that virtually all electronic cigarettes will be removed from the market.
This is essentially game over, a death sentence.

Bill has been right all along, the deeming regulations WILL nearly ban electronic cigarettes unless there are certain exemptions.
So now we better hope and pray that the FDA does make such exemptions regarding (or changes to) the grandfather requirements.

All that will be left is small, weak cigalikes, and nicotine refill juice will be a thing of the past.

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.

 

[Ranic85]

I already have all the mods and equipment I want or need. They cannot ban VG, or flavorings. I already vape 0mg nicotine levels. Worst case scenario, I want a bit of "kick" to my juice. I will just look to the new thriving black market! Even if something is totally banned, and their is a demand for it. It will not just disappear!

 

[DC2]

Let me just put it this way...

For a long time now Bill Godshall has been saying that the deeming regulations could essentially ban electronic cigarettes.
And to be honest, I did not really believe that was going to be true, because I thought substantial equivalence would be reasonably easy to satisfy.

What was posted in the original post shows that satisfying substantial equivalence is not only NOT reasonably easy, it is as hard as it can possibly be.

It is now painfully clear that if the FDA does the following...

1) Applies the grandfather requirements as currently written to electronic cigarettes
2) Applies the same level of scrutiny in satisfying substantial equivalence to electronic cigarettes as it has to other tobacco products thus far
3) Does not make any specific exemptions for electronic cigarettes

Then vaping will be shoved all the way back to 2007 and will basically not be allowed to move forward from that point.

WILL THIS ALL HAPPEN? We don't know yet. But one thing is now clear to me...
The FDA most certainly CAN essentially ban vaping as we know it, and they can do so very easily, if that is what they want to do.

My entire view of the situation has changed drastically after reading that post.

 

[Pickleskunk]

They could cripple the industry, but not get rid of it alltogether. Look how well their banning of drugs has gone. If the science is there to support that this is much safer than cigarettes, then eventually we shall prevail. FDA regulations will drive the industry underground. People will smuggle nicotine into the country. Vaporizors(ecigs) will be hard to ban since they can be used with no nicotine and marketed for non-nicotine purposes. Even if they do ban them, they are not hard to make. Anyway you look at it, if/when the FDA makes a ruling, this little hobby/habit is going to get expensive. Likely more expensive than regular cigarettes. Such a shame the government, as a whole, has no interest in our health and well-being. Only money and control. This is why there needs to be a massive campaign to educate the public, research ecigs and lobby politicians. We need to hire lobbyists and propaganda experts and fight back with the same tactics they are using to demonize ecigs.

 

[twgbonehead]

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?

 

[DC2]

I wonder how "substantially equivalent" these are to what was on the market back then...

--the Vuse (RJ Reynolds)
--the MarkTen (Altria)
--the Blu (Lorillard)

 

[Petrodus]

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.

 

[Lavaca5]

If only we could vape M16's or AK-47's ... they're never gonna regulate those.

 

[twgbonehead]

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.

They probably can't impose regulations on flavorings themselves (meaning that those who are willing to DIY can still get flavorings).

But "flavorings" in "Tobacco products" certainly are not safe from regulation! Note that the recent EU regulations DO put stringent regulations on flavorings, INCLUDING Menthol! So a tremendous amount depends on which items are considered tobacco products, and how the laws are actually written. E-cigs with 0-nicotine juice could very well come under the umbrella of "tobacco products", and saying "That doesn't make any sense" isn't the real issue. The real issue is what the wording, and enforcement of the laws is going to be.

Better public awareness is key! Respond to online articles (both the positive ones AND the negative ones!) with comments. Talk to people about vaping. Join CASAA, and contribute financially if you can!

 

[Cool_Breeze]

...Better public awareness is key! Respond to online articles (both the positive ones AND the negative ones!) with comments. Talk to people about vaping. Join CASAA, and contribute financially if you can!

If responding to ecig articles in the general media, try not to rant.

 

[soba1]

You know I just play conspiracy theorist on ECF lol.
But I imagine they will fall in line with their brethren in the EU who ruled in
favor of ECigs.
New World Order lol

 

[footbag]

This doesn't seem so bad to me.

Wouldn't it be worse if they determined e-cigs to be a tobacco equivalent? In that case, you would no longer be able to buy online and the market we know of would disappear.

The whole report seems to give reasons why e-cigs are different from tobacco and thus why the FDA need to treat them differently.

 

[WillyZee]

Me too! I wonder what they are talking about?
I do not speak gibberish.

Gibberish -
1. Unintelligible or nonsensical talk or writing.
2. a. Highly technical or esoteric language.
b. Unnecessarily pretentious or vague language.

I am fluent in Gibberish ... and I don't know what to make of their ramblings

 

[williebb123]

i think the reason the FDA speaks in such confusing jargon is that its worded in the greasy palm language when you grease their palms they will tell you what it means

 

[dave8944]

They probably can't impose regulations on flavorings themselves (meaning that those who are willing to DIY can still get flavorings).

But "flavorings" in "Tobacco products" certainly are not safe from regulation! Note that the recent EU regulations DO put stringent regulations on flavorings, INCLUDING Menthol! So a tremendous amount depends on which items are considered tobacco products, and how the laws are actually written. E-cigs with 0-nicotine juice could very well come under the umbrella of "tobacco products", and saying "That doesn't make any sense" isn't the real issue. The real issue is what the wording, and enforcement of the laws is going to be.

Better public awareness is key! Respond to online articles (both the positive ones AND the negative ones!) with comments. Talk to people about vaping. Join CASAA, and contribute financially if you can!

Did anyone notice that Wizard Labs has stopped selling any nic juice higher than 36mg for the past few months? That, along with the obsequious note they had on their website about the FDA after their recent FDA inpsection leads me to believe they will at least limit the nicotine content available to the public. I'm sure flavors will be included too "for the kids". I just worry that internet sales will be banned too, given all the recent leaks.

 

[DC2]

This doesn't seem so bad to me.

Wouldn't it be worse if they determined e-cigs to be a tobacco equivalent? In that case, you would no longer be able to buy online and the market we know of would disappear.

The whole report seems to give reasons why e-cigs are different from tobacco and thus why the FDA need to treat them differently.

No, the original post is not about electronic cigarettes, it is about how the FDA has been responding to applications for products claiming substantial equivalence...

The FSPTCA gave the FDA the authority to regulate tobacco products.

Part of those regulations have to do with what a company has to do in order to introduce a new tobacco product.
New tobacco products are defined as being introduced after February 15, 2007 and products on the market prior to that are grandfathered in.

New tobacco products, however, can escape the new requirements by showing that they are substantially equivalent to a product on the market prior to that date.
If and when the FDA decides that electronic cigarettes are tobacco products, electronic cigarettes will be subject to the new regulations.

At that point each electronic cigarette product will be considered a new tobacco product unless it was marketed in the United States prior to the 2007 date.
Anything introduced after that date will have to show substantial equivalence.

The original post outlines various reasons why the FDA has been denying substantial equivalence claims for new tobacco products currently covered by the FSPTCA.

The FSPTCA currently covers cigarettes and smokeless tobacco, but that will be expanded to other tobacco products when the FDA gets around to it.
That is what the "deeming regulations" you keep hearing about are are all about.

 

[Big Orange Country]

What's the anticipated timeline between proposal and final enactment?

I've got enough 100mg nic in deep freeze to last about a year and still buying, but I would like to get a general idea of how much time I would have to purchase a few more mods. Provided they go after devices as well.