Count One:
ENDS can apply for SE once a product has been approved via PMTA. FDA does not have the authority to change the grandfather date, as it was set by Congress.
Count Two:
The two year period is not a deadline to file, it is a deadline to file before products must be removed from market. Manufacturers can apply for PMTA after the compliance period, they will simply not be able to market their unapproved product in the meantime.
Also, the PMTA process was set forth by Congress, the FDA is simply upholding the standard for new
tobacco products to ensure benefit to public health.
Count Three:
Regulate, not ban, if ENDS are better for public health the manufacturer should be able to provide sufficient data to support this.
Count Four:
I got nothing.
Count Five:
Again, if ENDS are lower risk products, they should be able to provide suffcient evidence of public health benefit, which would then open them up to MRTP marketing.
Count Six:
As
tobacco product components affect the tobacco product's performance, composition, constituents, or characteristics they pose significant public health questions of their own, therefore the agency deems their regulation necessary to the benefit of public health.
Count Seven:
The Agency expects the adverse impact of the regulations to be mitigated by industry consolidation and conversion from manufacturing to retail, though some market exit is unavoidable, it is necessary for the benefit of the public health.
Count Eight:
The Agency feels the benefit of protecting future generations from the harms of tobacco use outweigh any potential costs to the tobacco industry.
