National – FDA Citizen’s Petition – PMTA Delay

A Citizen’s Petition has been filed with the FDA requesting that the agency seek a 180-day extension to the PMTA deadline for certain small, open-system manufacturers. The request is narrowly limited to companies that are already in the process of submitting a PMTA and are compliant with other FDA deadlines for regulating vapor products.

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:

  • Has less than 50 employees and/or 10MM in annual revenue;
  • Only manufactures open system products (e.g., e-liquids) and does not produce products used in cartridge- or pod-based products;
  • Has taken steps to prohibit access by and sales to underage consumers for brick-and-mortar stores and/or retail websites;
  • Will only market to adults and not rely on kid-friendly advertising (e.g., using age-gated social media accounts);
  • Is otherwise in compliance with TCA and Deeming Rule requirements (e.g., facility registration, product listings, etc.); and
  • Has already made progress in completing PMTAs prior to the September 9, 2020 deadline, but has been materially delayed in one or more tasks due to COVID-19.

U.S. Residents Can Use This Form to Submit Your Comment Automatically:

Note: We STRONGLY encourage you to customize this so the FDA’s system does not flag it as spam.

Read full article here.

CASSA – August 27, 2020.

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