In recent days that the PMTA deadline which had been issued by United States Food & Drug Administration (FDA) had been overruled by a judge of a federal court.
Following that news is the Vapor Technology Association has released its own response. The ruling by the judge forces the agency to give out a final directive on PMTA process before the agency was ready to do it. The federal court’s decision comes as a result of a push by the groups. It claims to advocate for public health.
One of the standout aspects of the VTA response, which is also an analysis, is the tone and perspective of being against what it sees as an overreach by the judge into the PMTA guideline matter. This opinion and spirit are shared by the FDA, who in their response to the ruling pointed out the negative effect the decision would have, especially on public health.
According to the FDA, first, the given deadline period of 120 days will cause more mass migration by users from the ENDS products. They are less harmful to more harmful tobacco products, especially the traditional combustible ones.
The adult smokers who had made the switch to the less harmful products will be forced to go back to the products they had left, a situation that the FDA feels should be avoided at all costs. The overall result the FDA says will be the mass withdrawal of ENDS products in the market.
Further, the FDA says the court should not be in the position to order the submission of pre-market applications by a specific date. Even in the situation where the court can do so, the FDA response advises against the setting of such date earlier than ten months since from the court’s ruling in any circumstances.
The agency believes such a decision should factor in a one-year period for the agency to review the applications while also maintaining its enforcement discretion.
Further analysis and distilling of the FDA’s response bring forth three definite conclusions. The FDA is not ready to provide the final guidance on the PMTA process. And the FDA’s position is to avoid any action that would get former smokers back to the smoking products.
And finally, the FDA is committed and seeks to get it right when it issues its final guidance. This message is the same the agency has been sending since the first time PTMA was extended to 2022.
According to VTA, the timeline going forward will be short but packed and eventful. From 13th June 2019, plaintiffs get five days to respond to the FDA’s response, which then paves the way for the court’s deliberation on the issue.
After the court’s ruling, the FDA will have 30 days in which to appeal the decision to the 4th Circuit Court of Appeals. The VTA believes that an appeal is what will be the most likely result of the process along with the FDA filing for a stay over the term of the appeal process.