Citizen’s Petition requesting FDA Vapor PMTA delay

PMTA filing deadline is currently September 9, 2020

Click here to make your comment on the Citizen’s Petition!

On August 25, Keller and Heckman LLP filed a Citizen’s Petition with the FDA requesting that the PMTA filing deadline of September 9, 2020 be delayed by 180 days. This petition is requesting that FDA go back to the US District Court for the District of Maryland to request a deadline extension, which the court recently granted for small cigar manufacturers that are being negatively impacted by this coronavirus pandemic.

  • All interested parties are invited to comment on the Citizen’s Petition by filling out the form provided on this page and customizing your message.
  • If you are writing on behalf of a small, open-system manufacturing company, please follow the instructions here.

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.

It is vital that people who use vapor products make their voices heard! While this pandemic is obviously putting a strain on services for businesses, people who depend on safer nicotine alternatives in order to stay smoke-free are being even more challenged by the prospects of losing access to these products and feeling pressured to go back to smoking. Whether it’s by regulation or global disaster, removing vapor products from the market threatens to inflict irreversible harm to millions of people.

Thank you for taking action!
Alex Clark

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