FDA to host webinar Tuesday August 21 on "substantial equivalence" reports, would impact e-cigs if "deeming" regs are issued

[Bill Godshall]

Tomorrow (Tuesday, August 21) at 2:00PM EDT the FDA will host a webinar that I urge e-cig companies to watch/listen.
http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/ucm220111.htm?source=govdelivery

On Friday, the FDA sent out an e-mail notice that stated:

Don’t miss CTP’s upcoming webinar, “Common Issues Identified During FDA’s Scientific Evaluation of SE Reports” on Tuesday, August 21 at 2:00 p.m. EDT. Join us to learn about some of the recurring scientific issues FDA has observed during its scientific evaluation of numerous substantial equivalence reports.

FDA's weblink at
http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/ucm220111.htm?source=govdelivery
then states

Compliance Training for Small Businesses – “Common Issues Identified During FDA’s Scientific Evaluation Reports” - FDA has completed the scientific evaluation of numerous Scientific Evaluation Reports and communicated our findings to the submitters of these reports. This webinar will discuss some of the recurring scientific issues that FDA has observed across many Scientific Evaluation Reports.

The FSPTCA required all cigarette and smokeless tobacco manufacturers to submit "substantial equivalence" reports for products that were not on the market prior to Feb. 15, 2007, but that manufacturers considered to be substantially equivalent to a similar product that was on the market at that time. If the FDA approves an SE report, the product can remain on the market. But if the FDA rejects an SE report, the product is banned and the manufacturer must submit a "new product" application that must be approved by the FDA before the product can be put on the market.

Until now, the FDA hadn't taken any action on any of the several thousand SE reports that were submitted by cigarette and smokeless tobacco product manufacturers, and it will be interesting to find out what action the FDA has taken on the various SE reports (e.g. how many were approved and/or rejected).

If the FDA proposes and then approves the "deeming" regulation (to apply Chapter IX to e-cigarettes and other currently unregulated tobacco products), then e-cigarette companies may also have to submit SE reports to keep their products on the market.

 

[Huntsvappin]

Errrrgh here we go

 

[DC2]

This sounds like it is going to give us a very good indication of the direction the FDA is headed.
And if so, then I really hope I am pleasantly surprised.

 

[Bill Godshall]

The most important statement by the FDA during its "substantial equivalence" report webinar was something like
"There were significant deficiencies in ALL "substantial equivalence" reports that have been submitted."

They also stated that 3,126 SE reports were filed before the March, 2011 deadline (for products that had already been introduced onto the market), and that 390 SE reports have been subsequently submitted.

I submitted a question inquiring how the FDA would deal with SE reports for e-cigarettes and other currently unregulated tobacco products if/when the agency proposes and approves the "deeming" regulation it intends to propose (since the deadline already expired for products that were introduced from 2007-2010).

But of course my question was never asked nor answered during the last 20 minutes of the webinar (when they were doing Q & A).

 

[hoogie76]

Interesting to watch. My interpretation of the scope they were talking about was that they can delay, request additional info or deny applications for whatever reason they feel like based on the fact that they do not have to follow any specific guidance docs and can change the rules as they see fit.

The other one that got my attention was that even the slightest modification of an existing product made it a new product, requiring a new product application with some substantial testing and documentation requirements.

hoog

 

[Placebo Effect]

I asked 3 questions -- none were asked.

The big take away from this webinar is that if the FDA passed its deeming regulation, and even if they moved the cut-off date for new products up a couple years, it could easily find ways to deny applications.

 

[Placebo Effect]

Artist rendering of the FDA receiving our questions