FDA SE (substantial equivalent) FDA application..... an eye opener

[nomore stinkies]

The FDA deeming regulations are confusing. The following link is to the TMA conference held on 5-19-14 to deliver information for FDA comments (and other topics). It was an eye opener! The complexity of this application is astounding. Dr. Wilcox from Lorillard presented comments on how this application process works (along with previously employed lawyers from the FDA). I was dumbfounded. Unless we can get the FDA to change the proposal or introduce a 3rd option we are dead in the water. Go to the May 19th discussions and check this out. For those that do not think that this is a serious threat listen to their comments. But be seated when you listen because you just may fall down. Where did the FDA come up with the Feb. 15, 2007 date? You will find out how and what this means. I had no concept of the depth of this deeming regulation. I have to go lay down.....................................

5,000 pages on the first go round and another 3,000 on the second. 5k hours.............................................................................................



This was found on vaping.com in case it doesn't work.


TMA's 99th Annual Meeting & Conference

 

[Kent C]

“Swedish snus is very well scientifically documented and our application consists of more than 100,000 pages,”

Press release: Swedish Match submits a Modified... - Swedish Match

 

[nomore stinkies]

Dead ducks we are.

 

[Oliver]

“Swedish snus is very well scientifically documented and our application consists of more than 100,000 pages,”

Press release: Swedish Match submits a Modified... - Swedish Match

Indeed, although for the sake of accuracy, the vast majority of the 100k pages were print outs of supporting studies.

Furthermore, this was a MRTP application, not a PMTA or SE

That said, the main application was, from memory, 5k pages long!

Source - Jim Soylst, Swedish Match: presentation and discussion at Global Forum on Nicotine, Warsaw.

 

[Kent C]

Indeed, although for the sake of accuracy, the vast majority of the 100k pages were print outs of supporting studies.

Furthermore, this was a MRTP application, not a PMTA or SE

That said, the main application was, from memory, 5k pages long!

Source - Jim Soylst, Swedish Match: presentation and discussion at Global Forum on Nicotine, Warsaw.

Thanks for the 'refinement' The FDA does want supporting studies for ecigs applications as well, of course. (and of course you know that How much and exactly what, is likely a problem for any vendor intending to submit. Esp. when they see to the extent that some have gone.

 

[pamdis]

Thanks for the 'refinement' The FDA does want supporting studies for ecigs applications as well, of course. (and of course you know that How much and exactly what, is likely a problem for any vendor intending to submit. Esp. when they see to the extent that some have gone.

From Swedish Match press release:

Consistent with FDA recommendations, the Company has actively engaged with the FDA on its submission, meeting with FDA representatives on several occasions regarding the format and data requirements for the MRTP application.

Now picture every....single....mfg (e-cigs, mods, e-liquids, and especially vapor shop that mixes their own liquids) calling FDA, asking for clarification, meetings, etc.

"OK, so now what do you need me to do? How do I do that? What does that entail exactly?"

And FDA is only allowing two years for them all to get their applications in. There isn't even enough time in two years to have one phone call with each of them!

Funniest thing ever!

Probably best legal defense after FDA pulls a product because application wasn't submitted: "But, your honor, I tried to call them to get some clarification, but the line was always busy!"

 

[Kent C]

From Swedish Match press release:


Now picture every....single....mfg (e-cigs, mods, e-liquids, and especially vapor shop that mixes their own liquids) calling FDA, asking for clarification, meetings, etc.

"OK, so now what do you need me to do? How do I do that? What does that entail exactly?"

And FDA is only allowing two years for them all to get their applications in. There isn't even enough time in two years to have one phone call with each of them!

Funniest thing ever!

Probably best legal defense after FDA pulls a product because application wasn't submitted: "But, your honor, I tried to call them to get some clarification, but the line was always busy!"

You know Pam, this is part of the reason why I ask why anyone would be 'reasonable' with the FDA. And I'd guess why Bill's most common words were how they lied about almost every press release or study they cited.