Courts Granted 120-Day Extension of PMTA Filing Deadline
On April 22, 2020, the courts granted FDA a 120-day extension of the May 12 deadline for premarket tobacco application (PMTA) filings, solely due to the Coronavirus (COVID-19) pandemic, which drastically impaired the ability of manufacturers of e-cigarettes, e-liquids, vape, and ENDS products to submit applications for premarket review by the original May 12, 2020 deadline.
What the Court Order Means for ENDS Companies & PMTA Submissions
The PMTA Deadline is Extended to September 2020
PMTA submissions are now required to be filed by September 9, 2020.
Other Aspects of the Original Court Order Stand
FDA may continue to exercise enforcement discretion for companies that submit timely applications. Unless a negative action is taken by FDA on a submitted application, companies that submit timely PMTAs may generally continue to market their products without being subject to FDA enforcement actions. The timeline for this enforcement discretion is within 1 year from the deadline (up to September 9, 2021).
The September 2020 PMTA Deadline is due to COVID-19
COVID-19 is impacting all FDA-regulated industries, which include tobacco and ENDS products. FDA received more than a dozen requests for PMTA extensions from the ENDS and tobacco industry, as well as numerous other communications expressing concerns about the inability to meet the original May 2020 deadline due to unforeseen impacts of COVID-19, including:
- Preventions or disruptions to in-person laboratory work and clinical studies;
- Preventions or disruptions to necessary international travel; and
- Shuttering of manufacturing facilities abroad
Of more the more than one dozen requests FDA received for PMTA extension deadlines, public health concerns were mentioned repeatedly. It is FDA’s position that public health is better protected by not having firms compromise employees’ health or take actions risking the spread of COVID-19 by trying to meet the previous May 12 filing deadline.
FDA’s Resources are Reallocated to COVID-19 Pandemic Efforts
A number of FDA’s Center for Tobacco Products personnel have been deployed to work on COVID-19 pandemic issues for the US Public Health Service, which has resulted in fewer staff to process submissions. The Agency is also expecting more personnel to be deployed to COVID-19 pandemic efforts, and for the length of time they are working on COVID-19-related assignments to be extended.
September 2020 PMTA Deadlines are in the Best Interest of Many
The September 9, 2020 PMTA submission deadline will better serve the public health by allowing e-liquid, ENDS, e-cigarette, and vape manufacturers to prepare for, and the Agency to conduct the thorough scientific review of data that is required. FDA strongly encourages applicants who are able to submit their applications to do so as soon as possible. Likewise, FDA encourages those that plan on submitting applications for a large number of products to contact the Agency as soon as possible to discuss their plans and method of submission.
Avomeen Helps ENDS Companies Comply with PMTA Regulatory Requirements & Filing Deadlines
Avomeen is an FDA-registered, GMP-compliant lab and we have years of experience supporting regulatory submissions and filings. We’re ready to assist our clients that serve the vaping industry comply with the FDA’s PMTA guidance for e-liquid products. Get in touch with us to see how we can help you meet the newly extended September 2020 deadline and to learn more about our role as a trusted partner for industry-leading ENDS companies.
Our expert blogger is Dr. Derek Beachamp, Avomeen’s Senior Technical Director of Analytical Sciences. He epitomizes the role of technical director, with expertise in both highly regulated and newly regulated industries and applications, such as nicotine and e-liquid analysis. Derek serves as Avomeen’s foremost expert in this space, and his knowledge has been showcased in trade publications and regulatory focused conferences.