Broughton's Head of Regulatory Affairs, Lloyd Smart discusses Food and Drug Administration (FDA) final ruling for Premarket Tobacco Product Applications (PMTA) and what this means for Electronic...
Nicotine
Extension of the Premarket Tobacco Product Application (PMTA) deadline, requested by the US Food and Drug Administration (FDA) due to the global Coronavirus outbreak, has been agreed by the 4TH Circuit of Appeals.
What is the new deadline?
The FDA previously filed a motion with the US District Court for the District of Maryland requesting a 120-day extension to the previous May 12, 2020 PMTA deadline for many e-cigarettes, cigars and other tobacco products.
The 4TH Circuit of Appeals agreed to remand the case back to federal district judge Paul Grimm for the purpose of allowing the delay, effectively changing the PMTA deadline for ENDS to September 9, 2020.
*Update April 23, 2020* - The FDA’s Request for Extension of Premarket Review Submission Deadline is now complete, view the announcement here.
Tobacco and vaping manufacturers will now need to submit PMTAs by September to allow for a large number of their products to remain on the market during FDA review.
Why was the extension requested?
Those in the sector will be aware that this is not the first time the PMTA deadline has changed, with a number of deadline extensions having taken effect over recent years. Last July the deadline was actually brought forward to May 12, 2020 following the filing of a lawsuit by anti-tobacco groups.
When FDA requested this recent extension it stated that it was solely due to the implications of the Coronavirus emergency. They expressed concern about posing a public health risk to those unable to comply with the former deadline through telework and pointed out that many laboratories and contract research organizations have had to shut down due to the outbreak*.
What does this mean for ENDS manufacturers?
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 pre-market requirements. Therefore, despite this slight reprieve, ENDS manufacturers should still continue to progress with PMTA applications.
- FDA still strongly recommend that manufacturers of Electronic Nicotine Delivery Systems (ENDS) products submit applications as soon as possible.
- Companies planning to submit applications for a large number of products are advised to contact FDA to discuss their plans and method of submission.
- 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) unless negative action is taken by FDA during that time.
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.
