National – FDA Citizen’s Petition – PMTA Delay

by Leon Georgoulias August 29, 2020

Support a Citizen’s Petition to FDA for delaying the PMTA deadline for certain small vapor manufacturers!

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

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/