Nicotine
The US Food and Drug Administration (FDA) has requested an extension to the Premarket Tobacco Product Application (PMTA) deadline due to the global Coronavirus outbreak.
What have the FDA requested?
The FDA have filed a motion with the US District Court for the District of Maryland, requesting a 120-day extension of the PMTA deadline for many e-cigarettes, cigars and other tobacco products.
As the current deadline is May 12, 2020 this extension, if granted, would move the deadline to September 9, 2020.
The FDA stance
FDA state that they are seeking this extension solely due to the highly unusual circumstances caused by the Coronavirus outbreak.
The letter submitted to the court details why they feel this extension is necessary, not least due to the May 12 deadline posing a public health risk to those who are unable to comply with the deadline through telework. Furthermore, they point out that as a result of the outbreak, many laboratories and contract organizations have shut down or suspended in-person work indefinitely*.
FDA remain aware of the importance of ensuring certain deemed products undergo premarket review to safeguard public health and are committed to implementing and enforcing premarket requirements.
Recommendations for ENDS manufacturers
FDA still strongly recommend that manufacturers of Electronic Nicotine Delivery Systems (ENDS) products submit applications as soon as possible. Also, companies planning to submit applications for a large number of products are advised to contact FDA to discuss their plans and method of submission.
Implications of a deadline change
If a 120-day extension is granted by the court, ENDS manufacturers can expect the following:
- FDA intends to revise its enforcement priorities guidance published in January 2020 to be consistent with the new deadline.
- FDA intends to provide companies that submit timely submissions with continued enforcement discretion for a period of up to one year from the date an application was submitted (up to Sept 9, 2021 if the extension is granted) unless negative action is taken by FDA during that time.
Note: Until a court decision is made, the May 12, 2020 deadline is in effect.
PMTA partners to support your ENDS business
Broughton offer a team of scientific and regulatory experts to manage the full PMTA process on your behalf. We’ll generate and compile the data you require, consult with the FDA, and submit your PMTA. Book a meeting with us today to discuss your requirements.
*Broughton has taken the necessary Government guidance to protect the health and safety of our employees, customers and partners. We continue to operate fully and thank you for your continued loyalty and support during these challenging times.
