PMTA deadline extensions: Vaping’s long and sorted history with the FDA
Earlier this week, the U.S. Food and Drug Administration (FDA) was granted a deadline extension by the federal courts for the vaping industry’s Pre-Market Tobacco Applications (PMTA) process. The four-month extension moves forward the previous deadline of May 12 to a new date of September 9, 2020.
Manufacturers of all kinds of vapor products must submit an application for each product that they would like to continue selling, including separately bottled e-liquids, pre-filled vapor cartridges, and even the vape technology itself like coils and cartomizers. If a PMTA application is not submitted by the September deadline, then all retailers - including online vape shops – must immediately pull these products from the marketplace.
Some vapers may be wondering, “Haven’t we heard this before?” Indeed, the federal government has revised the PMTA deadline on multiple occasions since its initial introduction during the release of the FDA deeming regulations of 2016. Sometimes they FDA moves it forward. Sometimes they move it back. On one occasion, the FDA under the direction of the former Commissioner Scott Gottlieb even extended the deadline forward by a full five years.
Vaping industry keeps fighting for a streamlined PMTA process
Just last week, the FDA rejected a request by Rep Raja Krishnamoorthi (D-IL) to temporarily ban the sales of all vapor products nationwide during the coronavirus pandemic. In a letter sent to FDA Commissioner Stephen Hahn on April 1, the congressman said that the sales of electronic vapes hampers public health.
Partially influencing Krishnamoorthi’s decision to write the controversial letter were several recent news reports claiming that the FDA believed that both smokers and vapers are at a higher risk of contracting the virus. However, in an April 15 interview with Bloomberg News, FDA officials contradicted this assertion by stating that “no evidence” exists which proves that vaping increases the risks of contracting COVID-19. Regarding smoking, however, the FDA’s stance remains firm.
"E-cigarette use can expose the lungs to toxic chemicals, but whether those exposures increase the risk of COVID-19 is not known," FDA spokeswoman Alison Hunt said. “Cigarette smoking causes heart and lung diseases, suppresses the immune system, and increases the risk of respiratory infections…People who smoke cigarettes may be at increased risk from Covid-19 and may have worse outcomes from Covid-19.”
As a longtime anti-vaping supporter, Krishnamoorthi was also likely irked by yet another PMTA extension issued by the FDA. Per the original FDA deeming regulations of 2016, the original PMTA submission date was August 8, 2018. It was moved to November 8, 2018, shortly thereafter because the FDA soon realized that the agency did not yet have the internal infrastructure to process potentially hundreds of thousands of applications in a timely manner.
Once Donald Trump was elected to office, it took some time to locate a new chief of the FDA. Dr. Scott Gottlieb was eventually appointed in July 2017, and another deadline extension was put into place. Gottlieb pushed it back to August 8. 2022 – a full five years. This caught the attention of democrats and certain anti-vaping activist groups who suspected the FDA might be trying to kick the proverbial PMTA can down the legislative road.
Related Article: Vaping cheers as Gottlieb extends FDA e-cig regulations to 2022
Perhaps in an effort to demonstrate good faith, Gottlieb’s FDA soon announced in March 2019 that the latest five-year extension would be moved backwards by 12-months to August 8, 2021. But the move failed to sway the opinions of anti-vapers.
In a 2019 lawsuit filed against the FDA by the American Academy of Pediatrics, U.S. District Court Judge Paul W. Grimm imposed “a ten-month deadline for submissions and a one-year deadline for approval.” The new date, which was revised again on Tuesday, was set for May 12, 2020.
Will the new September PMTA deadline revision be the last?
To make matters even more confusing, the new September 9 deadline just happens to fall within a few weeks of the 2020 election, which could cause an uncomfortable situation for the president. On September 11, 2019, President Trump made the surprise announcement during a White House press conference to ban flavored vaping completely.
Cheered on by the First Lady, Mr. Trump probably thought that he was doing a good thing and would be rewarded mightily by the American People. After all, the “vaping related” lung disorder called EVALI by the FDA had just appeared on the scene, and the mainstream media was going bonkers.
The vaping community was also going crazy, but in a completely different way. Vapers already knew that conventional nicotine-based e-liquids could not possibly cause a “vaping related” respiratory disorder. If it were possible, the disorder would have appeared years ago.
So, vapers fought back. They petitioned the White House, started the hashtag #WaVapeWeVote trending on social media, and quickly changed the president’s mind.
Will vapers be just as successful next fall? Can the vaping community use its political leverage to influence the president to either extend the PMTA deadline yet again or to eliminate the entire application process altogether?
(Images courtesy of Shutterstock)