FDA to host webinar at 2PM on April 10 on "Substantial Equivalence" applications, which the agency hasn't approved

[Bill Godshall]

The FDA will host April 10th at 2pm ET a webinar on Compliance Training for Small Business to discuss the Substantial Equivalence review process and "common deficiencies identified" during SE reviews:
www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/ucm220111.htm


Vapers and vendors are encouraged to watch this webinar, because the FDA "Substantial Equivalence" policy that now applies to cigarettes and smokeless tobacco products (i.e. don't approve ANY SE application, and instead demand even more information from all 5,000+ SE applicants) will apply to all e-cigarette products if the FDA approves the "deeming" regulation to apply Chapter IX of the FSPTCA to e-cigarettes.

 

[Paulette]

Thanks for that info Bill -- I think it will be most interesting!

 

[Bill Godshall]

Please note this FDA webinar starts in several minutes.

 

[Bill Godshall]

It would be helpful if the following questions are submitted to the FDA staff speaking at this webinar
"How many SE applications have been submitted to the FDA so far?"
"How many SE applications have been approved by the FDA so far?"

I need to leave the office in ten minutes, and won't be able to pose questions.

 

[Elnroth]

I'm having trouble accessing

 

[Elnroth]

Probably over already. Unfortunately I had class.

 

[Got-Ta-Go]

In my opinion, it was a non-event. Content mostly talked about issues with applications not being complete or with incomplete data. E-cigs were not mentioned.

The only thing that caught my attention were references to the requirements that tied tobacco products to the 2007 standards.