National – FDA Citizen’s Petition – PMTA Delay
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All interested parties are invited to comment on the Citizen’s Petition by using the form below or following the instructions on this page and customizing your message.
Small Manufacturers: Click Here for specific guidance for your comment.
If granted, the extension would move the deadline for small, open-system manufacturers to March 8, 2021. The request is predicated on a recent action taken by FDA in which small cigar manufacturers are being granted a similar extension due to complications and delays to completing PMTA’s associated with COVID-19.
Description of companies for which an extension is being requested:
Draft Comment Language You Can Use
Note: We STRONGLY encourage you to customize this so the FDA’s system does not flag it as spam.
I am writing in support of the Citizen’s Petition for Extension of Premarket Tobacco Product Application Filing Deadline from Keller and Heckman LLP (FDA-2020-P-1797-0001). It is vital that small manufacturers of open-system vapor products be afforded the necessary time and resources needed to submit acceptable premarket applications.
The FDA has already asked the court for a similar exemption for applications from certain combustible tobacco product manufacturers that are being delayed by COVID-19. It is logical that a similar accommodation is made for small manufacturers of demonstrably safer nicotine products. I rely on these products and the shops where they are sold in order to stay smoke-free. As the FDA has already acknowledged, sudden mass removal of these products will put me and millions of other people at risk of returning to smoking.
Click Here -
http://www.casaa.org/call-to-action/fda-citizens-petition-pmta-delay/