According to FDA regulations, all nicotine-based electronic atomization products must follow FDA's regulatory pathways and submit PMTA before September 9, 2020 in order to continue to be placed on the market. However, due to the impact of the epidemic, a group of small and medium e-cigarette manufacturers and trade organizations have requested the FDA to request the Federal Court to approve the postponement of the September 9 PMTA deadline for 180 days.
Azim Chowdhury of the Washington DC law firm Keller Heckman made the request yesterday in the form of a "citizen petition." It includes statements provided by 20 individuals from the companies and organizations behind the petition.
In the new request, petitioners in the e-cigarette industry said that the FDA’s reasons for the previous delay still apply.
Laboratory test delay
Environmental assessment delay
Supplier response delay
Travel restrictions
Employee health issues
In addition, small e-cigarette manufacturers are now facing the challenges they faced in April. As the epidemic forced many e-cigarette companies to shut down for a long time, the revenue used to prepare for PMTA decreased.
"Since the outbreak of COVID-19, the revenues of small manufacturers have fallen sharply (for example, between 20%-60%), and stores are closed, which limits the financial resources available for the PMTA process. In order to survive every day, these companies therefore They have to reduce their expenditure on testing, consulting, legal advice and scientific experts." The petition said.
Unlike tobacco companies, small e-cigarette companies do not get a reliable source of income from cigarette sales to fund their vapor product marketing applications to the FDA.
The petitioner wrote: “If the FDA does not seek further extensions due to COVID-19, these small businesses may be forced to close down and must fire thousands of employees immediately after the deadline expires.” In addition, relying on Open Electronics Adult smokers who smoke to get rid of the more dangerous combustible cigarettes will no longer be able to use these products.
As more and more evidence shows that former smokers have begun to use cigarettes that currently have restrictions on vaping products (for example, the fragrance ban), they must give these small businesses enough time to assemble and submit a complete PMTA.
Vapesourcing Opinion:
Due to the impact of COVID-19, many companies have suffered losses of varying degrees. Hope the FDA can allow to extend PMTA to help them through this difficult period.
