FDA may soon propose regulation that could ban many/most e-cigarette products, eliminate many/most companies

[Petrodus]

This is a BP Drug Commercial (period)
The assumption is these "Paid Actors" used to smoke.
The assumption is they used Chantix to help them quit.

It's a TV Commercial presented as some kind of
personal testimony that swallowing this poison is beneficial.

The public sees nice happy Rosa and remembers her name as well a Chantix
and that was the marketing sales plan !!

Obviously its a good commercial ... It works.
Many go to the doctor thinking about sweet Rosa and ask for a Chantix script.

Don't research ... smiling happy Rosa says its wonderful !!
Yeah, right

I still think she ate more than 1 "brownie" before filming that commercial.
She's "on something" and it ain't Chantix.

 

[kristin]

If I may, a question for CASSA.
How far back in time can the FDA regulate products?
Or to say it another way can something invented in 1963 be regulated?
Thanks

When the product was invented is apparently not a factor in whether or not the FDA may regulate it under the FSPTCA, but it does affect HOW the FDA may regulate some products. For example, cigarettes and smokeless tobacco were invented long before 1963 and the FDA now has regulatory power over those products, but it cannot ban them or require all nicotine to be removed.

However, there may be some special requirements for products which did not exist before 2007 (new products), making them much harder to be "approved" for sale by the FDA. FDCA 910(a) defines a “new tobacco product” as any product not commercially marketed in the United States as of February 15, 2007, including any previously marketed products to which “any” modification is made. Products already on the market prior to that date and are still being sold exactly as they were are "grandfathered," so the FDA cannot "unapprove" them.

This is one of the major concerns we have over the FDA deeming regulations on e-cigarettes in exactly the same manner as smokeless products per FSPTCA, because so much innovation has taken place in e-cigarette development since February 2007. It would be horrible if the only grandfathered e-cigarettes were those ineffective cigarette-looking devices and tobacco/menthol only flavors from the early days!

 

[Lisa Belle]

Makes me curious JUDGMENT AFFIRMED

 

[JUDGMENT AFFIRMED]

It would be horrible if the only grandfathered e-cigarettes were those ineffective cigarette-looking devices and tobacco/menthol only flavors from the early days!

But, since we have to fix all this modern stuff anyway, maybe with a little American ingenuity we could make those work. So, there are "grandfathered" e-cigarettes?

 

[TennDave]

Right- those that were here before 2007- Blu and nJoy basically...

 

[kristin]

But, since we have to fix all this modern stuff anyway, maybe with a little American ingenuity we could make those work. So, there are "grandfathered" e-cigarettes?

Well....under that particular section, any e-cigarette that was on the market before February 2007 would be grandfathered as not being a "new tobacco product," but that doesn't mean the FDA won't add additional rules, regulations or standards to them. And no, Herbert Gilbert's 1963 e-cigarette wouldn't be grandfathered because it wasn't being sold before the deadline.

 

[Petrodus]

Soooo ...
An old antique e-cigarette model is OK with the FDA

 

[sonicdsl]

Soooo ...
An old antique e-cigarette model is OK with the FDA

 

[Petrodus]

Don't worry ...
Regardless of what mischief the FDA pulls
the ECF network will find a work around.

 

[JUDGMENT AFFIRMED]

Thanks for the answer Kristin, Your visit raised concerns and my visit is not with evil intent. Through US patents, the history is better understood. Is it possible that there where devices sold for medical purposes? There is a patent from 1988, by two guys from Ohio, that produces vapor with resistance wire. Where does the date 2007 come from?

 

[kristin]

Where does the date 2007 come from?

FDCA 910(a) defines a “new tobacco product” as any product not commercially marketed in the United States as of February 15, 2007, including any previously marketed products to which “any” modification is made. We have no idea why they picked that date - it seems completely arbitrary to us.

Please understand that, even if a product was sold before that date, it cannot be sold again today if it has have modified in ANY way. It would have to be sold EXACTLY as it was sold before February 15, 2007 to be grandfathered. Having a patent filed and being commercially marketed are two very different things. Unfortunately, old patents won't help us if they were never actually sold on the market before 2/15/07.

We're not aware of any e-cigarette-type devices commercially marketed in the U.S. for medical purposes before that date (I'm sure they would have been noticed in the past 5 years if they existed.) The only nicotine inhaler marketed in the U.S. before e-cigarettes, that I am aware of, is the Nicotrol Inhaler.

Hope that helps!

 

[Penner]

Several questions:

1. So, if a physical ejuice with nicotine bottle is considered a tobacco product, any ejuice recipe with nicotine manufactured before 2007 is legal (as it was designed before 2007)?

Ie: if Alien Vision's Bubas Bounty ejuice with nicotine, was created in 2006, could it still be sold with nicotine?

Hope what I am asking makes sense.

Also,

2. If ecigs are banned, couldn't the ecig industry file a lawsuit against the govt claiming discrimination (unfair trade practices) against them, as the govt is still allowing cigarettes to be sold?

Or

3. File an appeal, tying up implementation of this, in court for years?

 

[HarmonyPB]

Several questions:

1. So, if a physical ejuice with nicotine bottle is considered a tobacco product, any ejuice recipe with nicotine manufactured before 2007 is legal (as it was designed before 2007)?

Ie: if Alien Vision's Bubas Bounty ejuice with nicotine, was created in 2006, could it still be sold with nicotine?

I'm no expert, but I think the 2007 rule only applies to devices, not ejuice.
With the ejuice there is no such safety net, otherwise they wouldn't have been able to ban cloves back when they did, they had been on the market for years.

 

[kristin]

Maybe Bill G. could give an opinion, but based on the wording of the Act, bottled liquid sold before 2/15/07 would be grandfathered for sale, but could still have new FDA deeming regulations it will have to follow (nicotine strengths, production standards or whatever the FDA decides e-liquid must do in order to keep selling.)

 

[Petrodus]

When the FDA announces its intended deeming regulations ...
I would love to see a Class Action lawsuit filed to prevent the regulations ...
or at least challenging the FDA's attempt to stifle the industry.

We won our case in court preventing them from banning e-cigarettes.
I suggest challenging the FDA in court will be the only way to
stop or limit deeming regulations.

Otherwise ... The FDA will do as they please !!

We all know the FDA couldn't care less about
Protecting and Promoting Your Health

NOTE: It's understood the odds of such legal action is Nil to Zero
but would bring a smile to my face.

 

[DC2]

NOTE: It's understood the odds of such legal action is Nil to Zero
but would bring a smile to my face.

Bill Godshall has indicated that there are people that are prepared to file lawsuits.

 

[Petrodus]

Bill Godshall has indicated that there are people that are prepared to file lawsuits.

I do remember hearing that ...

Legal action, in my opinion, would be the only way
to stop the FDA from doing as they please !!

Obviously, there are others with the same opinion.

 

[Stubby]

Maybe Bill G. could give an opinion, but based on the wording of the Act, bottled liquid sold before 2/15/07 would be grandfathered for sale, but could still have new FDA deeming regulations it will have to follow (nicotine strengths, production standards or whatever the FDA decides e-liquid must do in order to keep selling.)

I can't remember the exact wording of the law, but I believe the product had to be sold in the US before Feb 15 2007. I would guess a few people buying liquid from China would not qualify.

Was there any liquid being sold in B&M stores, or was their even a US distribution warehouse for internet orders in the US at that date? I have some doubts about that. There certainly was no US manufactures.

 

[MaDeuce]

Maybe I'm over-simplifying things here but to ban one "nicotine delivery device", shouldn't you have to ban them all? Isn't an analog cigarette simply a "nicotine delivery device"? And if you do ban one but not the other, isn't that grounds for an anti-trust lawsuit against the FDA itself and any FDA financial backer associated even remotely with the analog cigarette industry?

 

[DC2]

Maybe I'm over-simplifying things here but to ban one "nicotine delivery device", shouldn't you have to ban them all? Isn't an analog cigarette simply a "nicotine delivery device"? And if you do ban one but not the other, isn't that grounds for an anti-trust lawsuit against the FDA itself and any FDA financial backer associated even remotely with the analog cigarette industry?

That may be one of the many angles that people are looking at.
I have heard from very reliable sources that there are people ready to file lawsuits if the regulations are ugly.