FDA Webinar

[salemgold]

I did not see this posted elsewhere here yet.

 

[YoursTruli]

I wonder if they would mind if you posted this in the general area big deeming thread
Deeming Regulations have been released!!!!
so many people never come to this area

 

[salemgold]

I wonder if they would mind if you posted this in the general area big deeming thread
Deeming Regulations have been released!!!!
so many people never come to this area

I normally do drop stuff off there. I will

 

[Pamawoman]

If it's another propaganda piece. I JUST CAN'T!!! They make me so freaking mad!!!

 

[Kent C]

Thanks for posting, Salem.

14:40... "products that are on the market on Aug 8 will be continued to be marketed by manufactures up to three years WHILE the manufacturers submit their PMTA to the FDA....."

My take is that if the manufacturers do not intend to submit PMTAs for their products to the FDA - as in, don't have the finances to do so, then those products can't be sold.

18:00 no nic = tobacco product if intended to be used for human consumption.
Same for component or part....

 

[YoursTruli]

Actually @Pamawoman it is well worth the watch this is coming direct from the FDA people including enforcement

 

[YoursTruli]

@Kent C I listened to that part several times I wish we could get the actual dialogue because it sounded like she said after or as of 8-8-16 you can continue to sell your eliquid if you file a PMTA at that time until such time the PMTA is accepted or denighed

ETA not that part go to 15:37 Swati the enforcement lady right after the part you said

 

[Pamawoman]

I'll maybe probably try tomorrow to watch it.

 

[Kent C]

If it's another propaganda piece. I JUST CAN'T!!! They make me so freaking mad!!!

Unfortunately, this ISN'T a propaganda piece. This is reality. It's still going to make you freaking mad. :- )

 

[Kent C]

@Kent C I listened to that part several times I wish we could get the actual dialogue because it sounded like she said after or as of 8-8-16 you can continue to sell your eliquid if you file a PMTA at that time until such time the PMTA is accepted or denighed

ETA not that part go to 15:37 Swati the enforcement lady right after the part you said

Yes. "IF" which is why I capitalized "WHILE" (above) and the enforcement (not saying how widespread this will be) but I'm guessing if the SWAT team from the FDA comes into a B&M and asks for copies of the applications that they have submitted for the products they are selling, and they don't have any evidence that they have submitted PMTAs, then they might very well be shut down.

 

[zoiDman]

Dozens of questions about Free Samples, 2 Question about Age Verification for Online Sales.

One answer was... "Yes"
The other answer (the 2nd to Last Question in this Webinar, 1:07:43) was... "Yes, it has to be a Photo ID."

 

[Cool_Breeze]

Unfortunately, this ISN'T a propaganda piece. This is reality. It's still going to make you freaking mad. :- )

...a reality that may be tested in the court system for its veracity.

 

[Kent C]

@29:42 - if you DIY as long as it's for personal use - no problem. Sell it = problem. 31:46

 

[YoursTruli]

OK Swati said:
"A newly marketed tobacco product which means it was not on the market as of Feb 2007, which is the statutory date, you are considered new and if you are manufacturing a new tobacco product as of the effective date of the rule, August 8, 2016, then you would be required to submit an application for premarket authorization within the compliance period provided by the agency in the regulation and once you have submitted the application you receive an addition period of time also provided in the regulation to continue to market your product while FDA reviews your application"

so I am taking from this they do not have 2 years to file if they plan on continuing to sell?

 

[Kent C]

33:18 - online selling verification for age requirements.

 

[YoursTruli]

(BTW I did the cc thing and seriously it makes it easier to follow when you can read it too)

 

[r77r7r]

It's gonna be a really long summer...

 

[Kent C]

OK Swati said:
"A newly marketed tobacco product which means it was not on the market as of Feb 2007, which is the statutory date, you are considered new and if you are manufacturing a new tobacco product as of the effective date of the rule, August 8, 2016, then you would be required to submit an application for premarket authorization within the compliance period provided by the agency in the regulation and once you have submitted the application you receive an addition period of time also provided in the regulation to continue to market your product while FDA reviews your application"

so I am taking from this they do not have 2 years to file if they plan on continuing to sell?

That's my understanding. If the vendor has not submitted PMTA, they can't sell. That's what the 90 days period until Aug 8th is for, although considering what is necessary for a PMTA, that really isn't enough time either. I'd say the enforcement crew may not be sent out until after the year end, but that's just a guess. Store 'checks' will be made for B&M as well as online vendors as of Aug 8. 42:35

 

[YoursTruli]

@zoiDman right toward the beginning at 9:50 she says
Online retailers must comply with the same requirement as brick and motor retailers must comply with once the deeming rule takes effect

 

[zoiDman]

@zoiDman right toward the beginning at 9:50 she says
Online retailers must comply with the same requirement as brick and motor retailers must comply with once the deeming rule takes effect

Yeah... It sure sounds like Online Retailers are going to need a Photo ID on file.