FDA demands review of newer tobacco products- Front Page MSNBC

[D103]

yvilla, please correct me if I am wrong but is this not the FDA 'having it both ways?' By that I mean this appears to me to be the FDA following Justice Garland's "suggestion" and establishing further internal regulatory provisions/definitions which seriously challenge electronic cigarettes being classified as a "tobacco product" and in the event the courts still rule in our favor the FDA can claim that e-cig manufacturers have not gone through the legal process of gaining FDA approval for the introduction of a "new tobacco product". When I read through these provisions, the requirements for "approval" are daunting to say the least and I would guess that NO current e-cig manufacturer(except possibly BT or Bp) has all the documentation, studies, analysies, and clinical trials completed, in addition to all the other requirements necessary, to satisfy these provisions. I see no clear way around this trap - am I missing something?

 

[jagstang]

Damn! This reads like something out of Atlas Shrugged: Directive 10-289. I don't know whether it will impact vaping or not; I still don't like it!

I think PVs will continue to be a target until the FDA gets paid. This could be their white flag saying "Ok, Ok ... We can't get away with banning it but you have to pay up so we can approve it".

The day one of the BT companies steps in, this all disappears.

 

[maxx]

The WebMD version of this story specifically says it does not apply to e-cigs:

Jan. 5, 2011 – Makers of tobacco products that have been changed since Feb. 15, 2007, must show the "new" products are no worse for public health or see the products banned in the U.S., the FDA today ruled.

The rule applies to cigarettes, smokeless tobacco products, and roll-your-own tobacco products. It does not apply to electronic cigarettes (e-cigarettes). Tobacco companies have until March 22, 2011, to submit evidence to the FDA that new or changed products are "substantially equivalent" to those made before

FDA Challenges Tobacco Companies

 

[slappy]

I see a vision (if the FDA "wins") of pv's sold as they are, mods and all separate from ejuice. Ejuice sold as it is without nicotine. Nicotine additive being the regulated product. So us, the users, could buy pv's, juice and nicotine separate and DIY it... The hitch being the nic juice heavily regulated AND taxed... Hopefully by then I'll be a 0 nic vaper...

As long as the PV and ejuice are marketed as something other than nicotine delivery, it seems they could sell to their hearts content. The key ingredient in this FDA move is the tobacco derived nicotine... By the way can't you derive nicotine from something else?

 

[rachelcoffe]

The WebMD version of this story specifically says it does not apply to e-cigs:

Jan. 5, 2011 – Makers of tobacco products that have been changed since Feb. 15, 2007, must show the "new" products are no worse for public health or see the products banned in the U.S., the FDA today ruled.

The rule applies to cigarettes, smokeless tobacco products, and roll-your-own tobacco products. It does not apply to electronic cigarettes (e-cigarettes). Tobacco companies have until March 22, 2011, to submit evidence to the FDA that new or changed products are "substantially equivalent" to those made before

FDA Challenges Tobacco Companies

Aaaahhh, that makes much more sense, maxx. The FDA & BT have been on for a while about mandating lower nic levels in tobacco cigs (which is bizarrely a recipe for even heavier smoking amongst smokers - smokers will just smoke more deadly tobacco to get their nic fix).

But yeah - if the WebMD article's assertion is true, then this whole thing is about testing these stupid new lower-nic cigs & the like. And not about vaping. Praying WebMD was right!

P.S. slappy, e-juice w/nic contains the exact same nicotine found in tobacco & NRT. Smoking is justifiably sin-taxed because smoking places a proven burden on society in many ways. NRT costs a fortune because pharmaceutical companies are out to make obscene profits. E-juice with nicotine, conversely, does not burden society (it actually relieves burden, by getting people away from tobacco). In short...as long as tobacco cigarettes & NRT are legal, e-juice with nicotine should be too.

 

[yvilla]

yvilla, please correct me if I am wrong but is this not the FDA 'having it both ways?' By that I mean this appears to me to be the FDA following Justice Garland's "suggestion" and establishing further internal regulatory provisions/definitions which seriously challenge electronic cigarettes being classified as a "tobacco product" and in the event the courts still rule in our favor the FDA can claim that e-cig manufacturers have not gone through the legal process of gaining FDA approval for the introduction of a "new tobacco product". When I read through these provisions, the requirements for "approval" are daunting to say the least and I would guess that NO current e-cig manufacturer(except possibly BT or Bp) has all the documentation, studies, analysies, and clinical trials completed, in addition to all the other requirements necessary, to satisfy these provisions. I see no clear way around this trap - am I missing something?

No, D103, I really don't see it that way. Garland's suggestion had to do with the fact that the FDA's position on ecigs as "drug devices" was not a high level agency determination; for purposes of the case against Njoy, it was just based on the import seizure orders.

Further, if the FDA thought this grandfathering provision was a bar to ecigs being sold as tobacco products, you have to think it would have come up, in some way, in almost two full years of litigation on that very issue. Not to mention, as I posted above, that the attorneys for Njoy and SE had to have been aware of it as well.

Finally, this whole issue is not being brought up in the media as being specifically related to ecigs in the first place. It is being brought up as it relates to traditional tobacco products, as expected ever since the legislation was passed.

 

[yvilla]

But yeah - if the WebMD article's assertion is true, then this whole thing is about testing these stupid new lower-nic cigs & the like. And not about vaping. Praying WebMD was right!

This makes sense - as the FDA still denies ecigs are tobacco products at all! That will change though, if and when the FDA is forced to concede they are.

 

[trying]

I believe WebMD is towing the government line that E-cigarettes
are drug devices and that is why the tobacco regs. do not apply.

 

[slappy]

The WebMD version of this story specifically says it does not apply to e-cigs:



FDA Challenges Tobacco Companies

This seems like an assumption to me... From what source does this statement derive.

 

[Vocalek]

Directly from the FDA web site:

FDA to require substantial equivalence reviews for new tobacco products
The U.S. Food and Drug Administration announced today that certain tobacco products introduced or changed after Feb. 15, 2007 must be reviewed by the agency. In FDA guidance published today, the agency outlines a pathway for marketing a product whereby the company marketing the product must prove that it is “substantially equivalent” to products commercially available on Feb. 15, 2007.

“Substantially equivalent” means the products must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health.

Substantial Equivalence

 

[D103]

Thanks yvilla, I appreciate your expertise.

 

[Vocalek]

This writer appears to believe that the entire thing is about e-cigarettes, which is incorrect. It is about tobacco products which would include strips, orbs, lozenges, etc, in addition to traditional tobacco products.

FDA Cracks Down E-Cigarettes and Smokeless Tobacco - Yahoo! News

 

[yvilla]

This seems like an assumption to me... From what source does this statement derive.

From the fact that the FDA still claims ecigs are "drug devices", not "tobacco products".

 

[slappy]

P.S. slappy, e-juice w/nic contains the exact same nicotine found in tobacco & NRT. Smoking is justifiably sin-taxed because smoking places a proven burden on society in many ways. NRT costs a fortune because pharmaceutical companies are out to make obscene profits. E-juice with nicotine, conversely, does not burden society (it actually relieves burden, by getting people away from tobacco). In short...as long as tobacco cigarettes & NRT are legal, e-juice with nicotine should be too.

I agree, however, I also see the FDA playing this card to further their agenda... In addition nicotine in it's pure form is a dangerous poison... and marketing it for ejuice additive could be another card in their hands... Playing devil advocate.

 

[rachelcoffe]

Awesome, Vocalek & yvilla! Then the upper hand in our struggle remains ours!

 

[rachelcoffe]

I agree, however, I also see the FDA playing this card to further their agenda... In addition nicotine in it's pure form is a dangerous poison... and marketing it for ejuice additive could be another card in their hands... Playing devil advocate.

I hear ya, slappy.

But the truth is we vapers have little to fear on the nicotine count. The nicotine itself (in tobacco, NRT, and e-juice...which all contain comparable levels) is at safe levels. At safe levels, nicotine is known to be no more harmful than caffeine. Both are deadly at unsafe concentrations. Both are delightful at safe ones.

Not to mention any attack on the consumption of safe levels of nicotine (which would be unjustifiable) would if successful, also doom big tobacco & big pharma. We stand together, or we fall together. They can't allow the exact same nicotine, at comparable levels, to be sold in deadly tobacco & ineffective NRT...but not in harmless e-juice.

 

[yvilla]

Thanks yvilla, I appreciate your expertise.

Thanks for the vote of confidence D. But I do agree with your earlier post about the daunting nature of the requirements for approval as either a "new" tobacco product, or for showing "substantial equivalence".

Don't get me wrong - I'm not saying there aren't potentially huge hurdles still to be gotten over and barriers to be broken down. I've actually been worried about this grandfathering provision all along. So all I'm saying is that 1) I cannot believe this hasn't already been thoroughly researched and reviewed by the big players like Njoy and its attorneys, and that they don't already have a strategy in place to deal with it, and 2) that this wasn't what Garland was referring to.

 

[kristin]

Thanks for the vote of confidence D. But I do agree with your earlier post about the daunting nature of the requirements for approval as either a "new" tobacco product, or for showing "substantial equivalence".

Don't get me wrong - I'm not saying there aren't potentially huge hurdles still to be gotten over and barriers to be broken down. I've actually been worried about this grandfathering provision all along. So all I'm saying is that 1) I cannot believe this hasn't already been thoroughly researched and reviewed by the big players like Njoy and its attorneys, and that they don't already have a strategy in place to deal with it, and 2) that this wasn't what Garland was referring to.

+1

As I've been saying - the FDA still hasn't conceded that e-cigs are even tobacco products. They are still insisting they are drug delivery devices.

 

[Traver]

Originally Posted by rachelcoffe
P.S. slappy, e-juice w/nic contains the exact same nicotine found in tobacco & NRT. Smoking is justifiably sin-taxed because smoking places a proven burden on society in many ways. NRT costs a fortune because pharmaceutical companies are out to make obscene profits. E-juice with nicotine, conversely, does not burden society (it actually relieves burden, by getting people away from tobacco). In short...as long as tobacco cigarettes & NRT are legal, e-juice with nicotine should be too.

I don't know how smokers place a burden on society since they die younger and save society money.
Just a quick search:
http://joedawson.com/Interests/SmokersRights/Essays/issues2.html

 

[D103]

I just now read an article in Bloomberg news where they interviewed FDA officials regarding these new rules and the article indicated that FDA officials stated these new rules do not apply to electronic cigarettes. Thank God!