Judge Announces PMTA Deadline Extension Until September 9th 2020
In the midst of the ongoing coronavirus pandemic, a federal judge in Maryland has agreed to grant a 120 day extension to the deadline for pre-market tobacco applications. This gives the vaping industry a tiny bit of breathing room, but ultimately there is good reason for the delay and many vaping companies would have struggled to meet the deadline in the wake of the pandemic otherwise.
Extending the Deadline
The decision was made by US District Judge Paul W. Grimm, who issued a one-page ruling that essentially amends the deadline for PMTA submission to September 9th, 2020. The reasoning behind the decision is that many of the labs and research organizations that companies and regulators were depending on to conduct clinical trials and other testing have closed down in the wake of the coronavirus pandemic.
The PMTA process is lengthy and requires a lot of documentation, including the results of testing conducted on the products in question, and so without this in place it will be difficult if not impossible for manufacturers to complete the process.
Another factor is the restrictions on the FDA themselves as a result of the pandemic, as they wrote in a letter to the Fourth Circuit:
“While the FDA has taken steps to enable work to be performed remotely as much as possible, the agency anticipates that it will take additional time for a remote workforce to receive and process applications and conduct scientific review of those applications.”
The Industry Taking Action on the FDA Deadline
The pandemic has also had impacts on the industry. Some factories abroad that manufacture vaping products have had to close, and industry groups actually requested a 180 day extension to the deadline as a result of these problems. The FDA received a total of 15 letters about the problems as a result of the pandemic, representing thousands of companies from across the industry. However, the FDA didn’t agree that such a long extension was justified, but they did acknowledge the points raised by the industry and agree to the shorter extension.
However, there are also broader complaints from the industry. After the lung injury epidemic last year, many public health groups in the US aimed to speed up the FDA’s regulatory process and bring vaping products under their regulation sooner. This epidemic was found to be nothing to do with traditional vaping products, but the groups were still successful in speeding the process along. Vaping industry groups are currently fighting these new deadlines in the Fourth and Sixth Circuit courts.
The Future is Uncertain, But Black Note is Ready
Even before the coronavirus pandemic, the vaping industry was facing a lot of uncertainty as a result of the FDA’s regulations. The requirements for a PMTA are stringent and many smaller businesses won’t be able to survive, and this is all made harder because it’s unclear how the FDA will approach any applications that are made. The COVID-19 pandemic is really just a latest set-back for the industry, making it even more difficult to gather the required information and make the submission on time.
The 120 day extension should help to make up for the lost time, but ultimately businesses will remain in roughly the same situation as they were in before. Black Note was ready to submit for the original deadline, and so nothing changes for us either: whatever date ends up being the deadline, we will submit our PMTA and we fully intend to remain in business. The industry won’t be the same afterwards, but you can rest assured we’re here for the long haul.