Winter is Coming!
Quotes from yesterdays FDA document
And OMG!!!!! Look at the PMTA test section beginning on page 150.
Quotes from yesterdays FDA document
We expect that asserting our authority over these tobacco products will enable us to propose further regulatory action in the future as appropriate
We note, however, that FDA is not banning any type of tobacco product, so we expect current classes
of products to be available under the final rule, although there may be some loss of product variety and price increases for some products.
Potential substitution towards black market or do-it-yourself products could affect the public health benefits of this final rule. We are unable to predict the likelihood or size of this effect.
It is likely that some manufacturers within each particular industry segment will be able to bear the burden of complying with the regulation and it is therefore highly unlikely that all entities or products within a ny segment would choose to exit.
We continue to assume a substantial amount of product consolidation and exit will occur as a result of regulation
we expect most vape shops that currently mix e- liquids will convert to a retail model
We do, however, forecast that most vape shops will cease to engage in mixing or
other manufacturing activities
At most, a handful of ENDS products may have been on the market as of February 15, 2007.
Therefore, nearly all ENDS products will be subject to premarket review
We expect a much larger share of ENDS products to exit rather than submit a
premarket application.
we expect that one percent of ENDS devices may be grandfathered. We also assume
54 percent of delivery systems and somewhere between 50 and 87.5 percent of e-liquids
will not submit a marketing application and will exit the market
we forecast that annual submissions for new products seeking marketing authorization will be between 5 and 10 percent of the number of products that will remain on themarket
Overall average cost per PMTA= $466,563
We do, however, expect there to be a substantial amount of product exit for certain product categories, such as ENDS
The ENDS market would be subject to the most severe disruption because flavors make up the majority of the market and there likely will not be any flavored grandfathered ENDS products.
And OMG!!!!! Look at the PMTA test section beginning on page 150.