A public row over e-cigarettes has broken out between a powerful US House subcommittee and the Food and Drug Administration (FDA), which representatives have accused of failing to do its job at a time of crisis.
It follows the FDA’s rejection of a call by the House Subcommittee on Economic and Consumer Policy to remove all vaping products from the market “immediately” for the duration of the COVID-19 pandemic.
Mitch Zeller (pictured above, left), director of the FDA’s Center for Tobacco Products (CTP), told a subcommittee briefing session that the FDA had not even discussed the idea.
And he made it clear that the agency is currently reviewing available literature and studies to determine whether vaping is a risk factor for coronavirus.
Subcommittee chairman Raja Krishnamoorthi (pictured right) wrote to FDA commissioner Stephen Hahn at the beginning of April requesting the total clearing of the e-cigarette market.
FDA ‘not a leader’
“Allowing e-cigarettes to remain on the market during this period would harm children and adults throughout the country and exacerbate the coronavirus crisis in critical ways,” Krishnamoorthi wrote.
The subcommittee also called on Hahn to suspend all approvals of premarket tobacco product applications (PMTAs) – the deadline for which was recently extended to 9th September – to end sales of e-cigarettes “by prioritizing enforcement against them”.
Zeller, however, dismissed the option of temporarily withholding the PMTA process.
In an angry response, the House subcommittee warned that the FDA “may grant approval to sell e-cigarettes before it knows if they exacerbate coronavirus problems”.
Krishnamoorthi insisted: “FDA needs to be a leader in a crisis, and on vaping it is not.”
Staff redeployed elsewhere
He added: “Studies indicate that smokers and vapers suffer worse outcomes from coronavirus. Instead of temporarily suspending sales of e-cigarettes, FDA officials say they are studying the issue. This is another instance of Americans suffering while we wait for FDA to do its job.”
The subcommittee also accused the FDA of overstating its need to delay a previous court order that required the agency to accept PMTAs from e-cigarette makers by May 2020.
According to the subcommittee’s statement, FDA officials said some CTP staff had been redeployed to work for the US Public Health Service. This would include some of those staff who normally work in the CTP’s Office of Science, the division in charge of reviewing all premarket applications.
ECigIntelligence has confirmed from a reliable source that there are currently fewer FDA staff than usual to process PMTAs submitted by e-cigarette manufacturers.
Zeller told lawmakers the agency was conducting “aggressive hiring” to fill gaps in the various sections of the centre that deal with PMTA assessments.
What This Means: The determination of the FDA clashes with the strong demands from Democrat representative Krishnamoorthi, who has accused the agency of failing to take a leadership role on the current crisis.
It is yet to be seen if the powerful oversight committee at the House of Representatives will take further action against the FDA’s tobacco-alternatives policy after the agency chose not to carry out its demand to stop all e-cig sales.
– David Palacios ECigIntelligence staff