PMTA Deadline Extended

PMTA Deadline Extended

Back in May 2016, the FDA announced a “deeming” rule stating that the PMTA guidelines would cover both the traditional market and the vape industry. This means that any vape product manufactured after August 8th, 2016 would need to file a PMTA so that the FDA can make sure the ingredients and everything used are safe. The PMTA would then be approved or declined for the sale of these products. When the deeming rule was implemented, a deadline for August 8th, 2018 was set for vape manufacturers to submit their PMTA’s. The next year (July 2017) the new FDA Commissioner, Scott Gottlieb, announced the deadline would be postponed until August 8th, 2022. The deadline was later set to May 12th, 2020 by District Judge Paul Grimm of the U.S. District Court for the District of Maryland. 


In March, NATO sent a letter to the FDA’s Center for Tobacco Products requesting that the PMTAs deadline be extended as there were concerns that the deadline would create an unnecessary burden on companies that sell essential products. “The main reason for the extension is the ongoing COVID-19 crisis,” Tom Briant, executive director for NATO said. “Given the enormous number of products that require [PMTA] submissions, retailers would be very hard-pressed to continue their critical workplace function of providing food, beverages, groceries, medications, and gasoline to the public while simultaneously attempting to comply with FDA tobacco regulations.”


Later that month on March 30th, the FDA filed a request to District Judge Paul Grimm that the PMTAs deadline be extended by 120 days due to disruptions caused by the coronavirus outbreak. The FDA received many inquiries from the tobacco industry expressing concern that they won’t be able to complete their PMTA’s by the May 12th deadline originally set due to interruptions at most stages of preparation, including employees needing to stay home to avoid becoming ill and overseas manufacturing facilities being shut down for the time being.


The vape industry got a win on April 22nd when District Judge Paul Grimm agreed to extend the deadline for the PMTA’s to September 9th, 2020 due to the coronavirus outbreak. This win comes after the House of Representatives Committee sent a letter to the FDA Commissioner, Stephen Hahn, requesting the FDA to immediately “clear the market” of all vaping products. The request was quickly shut down and the extension was granted.


Do you think 120 days is long enough for manufacturers to complete their PMTAs? Leave a comment with your thoughts below.

 

 

 

Resources:

Federal Judge Approves Delay of PMTA Deadline for Vapor Products. (2020). Retrieved 23 April 2020, from https://csnews.com/federal-judge-approves-delay-pmta-deadline-vapor-products 

 

Abcede, A. (2020). Judge Agrees to PMTA Deadline Extension. Retrieved 29 April 2020, from https://www.cspdailynews.com/tobacco/judge-agrees-pmta-deadline-extension 

 

FDA Rejects Subcommittee’s Call to Temporarily Remove E-Cigarettes Despite Potential Risks to Coronavirus Patients. (2020). Retrieved 29 April 2020, from https://oversight.house.gov/news/press-releases/fda-rejects-subcommittee-s-call-to-temporarily-remove-e-cigarettes-despite 

 

Rowland, M. (2020). Politicizing COVID-19: FDA denies Dems request for temporary vape ban. Retrieved 29 April 2020, from https://www.vapes.com/blogs/news/politicizing-covid-19-fda-denies-dems-request-for-temporary-vape-ban 

 

Abcede, A. (2020). NATO Asks for Delay on PMTA Deadline. Retrieved 29 April 2020, from https://www.cspdailynews.com/tobacco/nato-asks-delay-pmta-deadline 


Update on FDA Request to Extend PMTA Application Deadline - Swisher International, Inc. (2020). Retrieved 29 April 2020, from https://swisher.com/update-on-fda-request-to-extend-pmta-application-deadline-2/


7 comments


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    he FDA is allowing a drug that hasn’t been proven to be used for this virus! And they allow cigarettes on the market!


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  • Manuel R Guillen

    Look if they start to messing with the vaping industry again a lot of people are going to turn to the black market for the product that don’t pass pmta and we all seen what that leads to just let us vape in peace.


  • MIKE

    I HAVE VAPED FOR TWELVE YEARS. I SMOKED CIGARETTES FOR FIFTY SEVEN YEARS. I DO NOT WISH TO GO BACK TO CIGS. LEAVE THE VAPING ALONE AND GO AFTER THE CIGARETTES!


  • Tom C.

    120 is not reasonable! 2022 was!


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