Associated Press: Swedish Match seeks FDA approval as 'modified risk' tobacco product

[ClippinWings]

APNewsBreak: Firm seeks to say tobacco cuts risk

good news... if they manage to win.

Some takeaways from the article:

1. the modified risk application is over 100,000 pages long.

2. the author seems to have some cause/effect issues with regard to eCigs

3. eCigs mentioned... but only as a product of Big tobacco.

 

[DrMA]

This is groundbreaking! Thanks for posting. If approved, it would be the world's first official endorsement of tobacco harm reduction ever.

 

[ClippinWings]

well it would be the FDA's first...

THR through snus is well known and proven in Sweden.

 

[AgentAnia]

1.
One hundred thousand pages! All of which have to be read and evaluated by FDA CTP staff. While they are busy reviewing the hundreds (thousands?) of existing Substantial Equivalence and PMT applications for existing tobacco products. While they are busy moving their offices. While they are busy reading and reviewing the thousands of deeming comments already received. While they are no doubt gearing up for all the additional PMTAs they expect to receive once the deeming rule is finalised.

I'm betting CTP's next appropriations request will include increased funds for additional staff to handle this avalanche. Ah, the smell of empire building in the morning!

2.
Well done, Swedish Match! Love the timing. Wonder *how* this precedence will be set by FDA. Will they reject out of hand? Will they reject on technicality? Will they reject on thinly-veiled ideology? Will they [gasp] approve?

 

[NorthOfAtlanta]

1.

Snip.........

I'm betting CTP's next appropriations request will include increased funds for additional staff to handle this avalanche. Ah, the smell of empire building in the morning!

2.
Well done, Swedish Match! Love the timing. Wonder *how* this precedence will be set by FDA. Will they reject out of hand? Will they reject on technicality? Will they reject on thinly-veiled ideology? Will they [gasp] approve?

With the excellent way the FDA has been handling FSTCA paperwork we should have an answer to your question in less than 10 years.

 

[Bill Godshall]

I started a thread about this on the FDA thread section (since it relates directly to FDA) at
http://www.e-cigarette-forum.com/fo...0-page-mrtp-application-general-snus-fda.html