On March 31, 2020, the U.S. Food and Drug Administration (FDA) filed a request with the courts to postpone the deadline for e-cigarette makers to prepare approval and testing justifications. The e-cigarette deadline postponement is motivated by complications arising from COVID-19. According to the FDA and Law360, the virus brought clinical testing to a screeching halt and dealt a crippling blow to e-cigarette supply chains.
In an email regarding the e-cigarette deadline postponement, the FDA requested that the Fourth Circuit allow the lower court handling the case to extend the established May 12 deadline by 120 days, setting the new compliance date to Sept. 9, 2020. The FDA has also made sure to explicitly state that the e-cigarette deadline postponement is in an effort to assist the struggling e-cigarette industry and is not in any way supportive of claims by the e-cigarette industry that their products may not be regulated by the FDA.
In their letter, the FDA presented their case as to why the e-cigarette deadline postponement is fair. One of the most compelling arguments presented by the FDA is that the laboratories and research organizations that were tasked with conducting clinical trials regarding e-cigarettes are unable to conduct that research. Whether because they are shutting down or refocussing their efforts, there is neither the time nor the manpower available to test the claims of e-cigarette manufacturers.
An additional issue lies with the FDA’s own capabilities. According to the e-cigarette deadline postponement letter, FDA staffers are being enlisted by the U.S. Public Health Service to help combat the COVID-19 pandemic. In that same letter, the FDA says “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 final argument the FDA presented concerns the supply chain of e-cigarette manufacturers. With COVID-19’s impact, factories across the world have shuttered temporarily or permanently, making the examination of facilities that manufacture vape products nearly impossible. Additionally, travel restrictions have limited FDA information excursions into nations such as Italy, China, Honduras, the Dominican Republic, Nicaragua and Mexico.
With these considerations, the FDA argues, it is perfectly reasonable to grant the e-cigarette deadline postponement in order to allow e-cigarette manufacturers to properly plead their case to the organizations.
By James Parker
James Parker is a news writer and fact-checker from Coral Springs, Florida. He majored in Communication and Media Studies at Stetson University, where he spent much of his time bringing the cutting edge of medical research to his peers’ attention. When he’s not writing, he enjoys rewatching “Almost Famous” or curling up with a good book.