National – FDA Citizen’s Petition – PMTA Delay
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.
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