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The American Electronic Cigarette Association sued FDA on PMTA's influence on small companies

The American Electronic Cigarette Association sued FDA on PMTA's influence on small companies

2022-11-10

New Consumer Report of Blue Cave, November 9th, according to foreign news reports, the US Electronic Cigarette Association (USVA) is suing the Food and Drug Administration (PMTA) application (PMTA) and the small pair of small to small Enterprise influence.


The USAVA lawsuit on behalf of the small enterprise said that the FDA failed to correctly consider the impact of seemingly impossible and expensive PMTA process on small enterprises.


USVA wrote in a statement: In the predetermined rules, the FDA statement seems to be able to fully rely on public data, or FDA itself was conducting 70 studies at the time. Finally, the FDA formulated a heavy PMTA rule that caused many people in the industry to go bankrupt. However, in fact, FDA claims that it will not have a significant impact on small enterprises.


The lawsuit requires relief for companies as members of USVA, including:


The final rule of PMTA violated the "Regulatory Flexibility Law";


Return PMTA's final rules to FDA;


It is forbidden to perform PMTA's final rules for any member of the USVA and take necessary and appropriate actions to correct their violations caused by any such actual or attempts to implement.


The lawsuit also criticized FDA priority manufacturers with the largest market share, which has sufficient funds in handling PMTA processes. Some larger companies have also been allowed to change their PMTA submission issues, and smaller companies with the same problem have received marketing rejection orders for these issues.


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