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V T A AND VAPOR STOCKROOM FILE LAWSUIT AGAINST FDA

lordmage

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to quote "Plaintiffs are taking action to require FDA to publish and complete the long-promised “foundational rules” describing the specific requirements for PMTAs. In addition, Plaintiffs are asking the court to enjoin FDA from enforcing the May 2020 PMTA deadline or taking enforcement action against companies that do not have a PMTA on file until a reasonable period of time after the actual foundational rules are finalized."

it is a procedural thing they want a the FDA to finalize its rules and publish them and to stop changing them to fit there agenda. in addition to seeking an injunction on the early PMTA date after those rules are published

and quote "The stark facts set forth in the Complaint are that, even with unlimited resources, there are not enough labs, there are not enough subjects, and there are not enough hours in the day to properly conduct the scientific inquiries that FDA only just laid out on June 11, 2019, by the May 2020 deadline. "

and again "FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful. The Agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedure Act. Grossly accelerating the deadlines and then repeatedly changing the already onerous requirements is unacceptable under any regulatory regime, but this is especially true for vapor products when FDA itself warns that ‘it is likely that there would be a mass market exit of ENDS products’ that 'could adversely affect the public health,’" said Tony Abboud, Executive Director of the Vapor Technology Association."

finally " The case number is not yet assigned but a link to the filing can be found here."

in short the FDA short of admits that it will cause a complete shift of the vaping market to some other less then legal form.


the fact remains a lot of my slowtech shipments have slowed down a lot more for me what used to go thur flushing ics now routes to a slower case by case ics then back adds about 4 days to the shipments and 3 places for seizure. so i think it is very possible that the FDA have already placed cuffs on the market and are just waiting for the hammer to drop. yes i have some nic and flavorings will not be stopped and i went rda , rta but what i see this hurting the most are the new converts that will either be stuck with a less the effective pmta approved costly device via a heat not burn see iqos or some other closed system akin to juuls where there goal is not to help your reduce your dependence on nic but to make you go back to approved easier alternatives such as smoking.
 

The Cromwell

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to quote "Plaintiffs are taking action to require FDA to publish and complete the long-promised “foundational rules” describing the specific requirements for PMTAs. In addition, Plaintiffs are asking the court to enjoin FDA from enforcing the May 2020 PMTA deadline or taking enforcement action against companies that do not have a PMTA on file until a reasonable period of time after the actual foundational rules are finalized."

it is a procedural thing they want a the FDA to finalize its rules and publish them and to stop changing them to fit there agenda. in addition to seeking an injunction on the early PMTA date after those rules are published

and quote "The stark facts set forth in the Complaint are that, even with unlimited resources, there are not enough labs, there are not enough subjects, and there are not enough hours in the day to properly conduct the scientific inquiries that FDA only just laid out on June 11, 2019, by the May 2020 deadline. "

and again "FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful. The Agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedure Act. Grossly accelerating the deadlines and then repeatedly changing the already onerous requirements is unacceptable under any regulatory regime, but this is especially true for vapor products when FDA itself warns that ‘it is likely that there would be a mass market exit of ENDS products’ that 'could adversely affect the public health,’" said Tony Abboud, Executive Director of the Vapor Technology Association."

finally " The case number is not yet assigned but a link to the filing can be found here."

in short the FDA short of admits that it will cause a complete shift of the vaping market to some other less then legal form.


the fact remains a lot of my slowtech shipments have slowed down a lot more for me what used to go thur flushing ics now routes to a slower case by case ics then back adds about 4 days to the shipments and 3 places for seizure. so i think it is very possible that the FDA have already placed cuffs on the market and are just waiting for the hammer to drop. yes i have some nic and flavorings will not be stopped and i went rda , rta but what i see this hurting the most are the new converts that will either be stuck with a less the effective pmta approved costly device via a heat not burn see iqos or some other closed system akin to juuls where there goal is not to help your reduce your dependence on nic but to make you go back to approved easier alternatives such as smoking.

I cannot disagree with your comments.
However I expect the FDA to rollover any reasonable arguments just like they always have.
 
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