FDA Not e-cigs, but someday we'll see lots of e-cig articles like this

[pianoguy]

FDA shuts down four R.J. Reynolds Tobacco products - Altria Group, Inc. (NYSE:MO) | Seeking Alpha

 

[DC2]

Substantial Equivalence has been discussed here many times over the years.

--There are those that understand
--There are those that close their eyes and hope it's all a bad dream
--There are those that deny that this will happen to electronic cigarettes

But yes, this is exactly how the electronic cigarette market can be destroyed.

 

[rico942]

Sure glad that nothing like this has ever happened before in the US ...

Unless you count that business with Preston Tucker ...

 

[nicnik]

FDA shuts down four R.J. Reynolds Tobacco products - Altria Group, Inc. (NYSE:MO) | Seeking Alpha

The agency concluded that the products have different characteristics than the predicate products and Reynolds failed to show that the new products do not raise different questions of public health when compared to them.

So how do ANTZ' plans for mandating lowering nicotine content in cigarettes jive with this, especially considering the disasterous health consequences of past promotion of low tar and nicotine cigs? Do they think that the resulting increase in intake of smoke by smokers to get their desired/needed nicotine will be safer, since the new plan will deliver more tar when only lowering the nicotine and not the tar? And how does it "not raise different questions of public health when compared to" the predicate products?

 

[nicnik]

Sure glad that nothing like this has ever happened before in the US ...

Unless you count that business with Preston Tucker ...

I don't remember ever hearing about Preston Tucker before. After seeing your post, I read the Wikipedia article on him. Amazing story! There are some disturbing parallels to FDA and vaping.

 

[Katya]

FDA shuts down four R.J. Reynolds Tobacco products - Altria Group, Inc. (NYSE:MO) | Seeking Alpha

Oh, no... They are using the 2007 date? Eww....

 

[Katya]

Substantial Equivalence has been discussed here many times over the years.

--There are those that understand
--There are those that close their eyes and hope it's all a bad dream
--There are those that deny that this will happen to electronic cigarettes

But yes, this is exactly how the electronic cigarette market can be destroyed.

And then there are those who still hope that HR 2058 (moving the grandfather date to the time when the actual deeming regs go into effect) will pass.

If it doesn't, we're screwed...

 

[stevegmu]

e-liquid was around in 2007, was in not?

 

[Kent C]

Oh, no... They are using the 2007 date? Eww....

That grandfather date was in the original Family Smoking Prevention and tobacco Control Act, and has been used against earlier 'new products' in cigarettes and cigars. The 'deeming' is only a 'proposed rule' which would of course use the same date as written.

 

[Katya]

That grandfather date was in the original Family Smoking Prevention and Tobacco Control Act, and has been used against earlier 'new products' in cigarettes and cigars. The 'deeming' is only a 'proposed rule' which would of course use the same date as written.

Exactly. The FDA didn't even consider e-cigs as 'tobacco products" until some time in 2011... Why on earth would they insist on using the same 2007 date, retroactively, for e-cigs. This is so stupid.

There was almost nothing on the US market prior to Feb. 2007. Nothing.

 

[Kent C]

E-liquid was around in 2007, was in not?

E-cigarettes were originally developed and patented in 2003
by Ruyan Group (Holdings) Ltd., a company based in Beijing.
Since their introduction into the U.S. market around 2006–
2007....

http://www.khlaw.com/webfiles/What_To_Expect.pdf

 

[Kent C]

Why on earth would they insist on using the same 2007 date, retroactively, for e-cigs.

To stop the industry. It's who they are - it's what they do.

 

[stevegmu]

E-cigarettes were originally developed and patented in 2003
by Ruyan Group (Holdings) Ltd., a company based in Beijing.
Since their introduction into the U.S. market around 2006–
2007....

http://www.khlaw.com/webfiles/What_To_Expect.pdf

Nothing to worry about then...

 

[nicnik]

http://www.khlaw.com/webfiles/What_To_Expect.pdf

The author is not only opposed to the 2007 date, he either thinks it's unlikely they'll got through with it, or that somehow they'll do it in a way that won't disrupt the market as much. I not sure how he means the part in bold of the following:

If the FDA imposed this
same Feb. 15, 2007, grandfather date to e-cigarettes, which,
strictly speaking, it is required to do, e-cigarette companies
would be required to submit premarket applications to the
FDA for all of their products sold after the grandfather date—
which would be practically all of the products currently on
the market .Such a rule would immediately disrupt the U.S.
e-cigarette industry and could result in such products being
pulled off the market. We believe this is highly unlikely, how
-ever, for several reasons.

 

[Kent C]

nicnik:
"I not sure how he means the part in bold of the following:

"We believe this is highly unlikely, however, for several reasons. " Azim

Well.... the rest of the article explains the 'several reasons' see a, b, c, etc. after that comment. Basically, he's a pro-ecig lawyer and is laying out his 'case' with some pretty good reasoning. It is who I would pick to be in charge of the case against the FDA IF they stick to the current proposal as written.

And his bit on how any grandfather date would freeze innovation at that point in time is one of the best... and why while we welcome the HR 2058 bill that sets the GF date at final rule, (vs. the Feb 2007 date), it still has the same problem as any grandfather date would have on bringing innovation to a halt in the regular market.

 

[Katya]

The author is not only opposed to the 2007 date, he either thinks it's unlikely they'll got through with it, or that somehow they'll do it in a way that won't disrupt the market as much. I not sure how he means the part in bold of the following:

Nic, we don't really know what the FDA will do--there are many different analyses (tea leaf readings) from different experts, you can just Google it if you want to read more. Here's one from Bill G.

What is the Grandfather Date of the Tobacco Control Act & How Will it Impact the Vapor Industry? - SFATA | Smoke Free Alternatives Trade Association

"Even worse for vapor product industry is that FDA’s proposed deeming regulation would effectively ban the sale of all bottles of nicotine containing e-liquid because FDA would require manufacturers to submit studies and lab tests of each e-liquid product when used with each of the hundreds (or thousands) of different premium vaporizers, or open tank systems on the market."

 

[nicnik]

Well.... the rest of the article explains the 'several reasons' see a, b, c, etc. after that comment.

Yeah, I read it, but still not clear.

 

[nicnik]

Nic, we don't really know what the FDA will do--there are many different analyses (tea leaf readings) from different experts, you can just Google it if you want to read more. Here's one from Bill G.

What is the Grandfather Date of the Tobacco Control Act & How Will it Impact the Vapor Industry? - SFATA | Smoke Free Alternatives Trade Association

"Even worse for vapor product industry is that FDA’s proposed deeming regulation would effectively ban the sale of all bottles of nicotine containing e-liquid because FDA would require manufacturers to submit studies and lab tests of each e-liquid product when used with each of the hundreds (or thousands) of different premium vaporizers, or open tank systems on the market."

I believe that putting up major roadblocks to e-liquid has been a big part of their plan.

 

[nicnik]

Yeah, I read it, but still not clear.

He's basically saying that they have no choice but to do it, but he doesn't believe they will.

 

[Kent C]

Yeah, I read it, but still not clear.

Not the first time you've posted that :- ) If Media Matters hasn't posted anything on it, sometimes people don't know what to think.