The US Food and Drug Administration (FDA) has hinted that it might push back the deadline for e-cigarette PMTA applications, or offer flexibility to companies struggling to meet the May target while coping with the effects of the coronavirus outbreak.
As the situation currently stands, premarket tobacco applications (PMTAs) for vapour products must be submitted to the agency by 11th May if the products are to remain on sale after that date. They would then be allowed to remain on the market for a year while the FDA considered the applications, which must be accompanied by comprehensive supporting materials.
However, “the agency has received numerous inquiries from industry expressing concern about the impact of COVID-19 on the May deadline”, an FDA senior advisor told ECigIntelligence.
“We understand that COVID-19 is impacting all FDA-regulated industries, including tobacco product manufacturers, and…the FDA is currently engaged in internal discussions to determine how to best address this issue. Additionally, we encourage manufacturers who have concerns about meeting the deadline for any reason to contact the FDA directly.”
The court order last summer which set the 11th May deadline provided the FDA with “the ability to exempt New Products from [PMTA] filing requirements for good cause on a case-by-case basis”.
The FDA has already acted to ease regulatory requirements on some sectors – not only those directly involved in coronavirus testing or treatment, but also those impacted by the need for social distancing. For example, it has loosened rules on testing patients before they are provided with certain drugs, and on veterinarians’ use of telemedicine.
It has also said that on issues related to the pandemic, it plans to act quickly on issuing guidance documents without going through the usual comments process.
What This Means: Some relief for the industry seems likely, and in the current circumstances even vaping’s fiercest critics (in Washington and elsewhere) are unlikely to stir up much interest in opposing such a decision. The FDA must also be aware that enforcement would be difficult in the midst of the pandemic.
What remains to be seen is what form relief will take – for example, will the deadline simply be moved, or will bare-bones PMTA applications still be required by 11th May with fuller details to follow later?
Meanwhile, an attempt to challenge last summer’s court ruling has been under way in the Fourth Circuit appeals court in Richmond, Virginia, but may be rendered academic if the FDA acts anyway.
– Barnaby Page ECigIntelligence staff