FDA grants 4-month extension on PMTA deadline for vaping – just weeks before 2020 election
The U.S. Food and Drug Administration (FDA) will grant the vapor industry a four-month extension to the Pre-Market Tobacco Application (PMTA) process. The previous deadline of May 12 is now being pushed forward to September 9, 2020 – just a few weeks before the 2020 election.
Citing challenges to the approval process due to the “highly unusual circumstances” surrounding the coronavirus pandemic, FDA officials petitioned the courts for the extension on March 30. The process of acquiring an official court ruling took some time because two different courts needed to act on the FDA’s request.
The U.S. District Court for the District of Maryland ruled on April 3 that it would grant a 120-day extension pending approval from the higher courts. On Tuesday, the U.S. Circuit Court of Appeals issued its remand order overturning a previous decision that mandated the previous May 12 PMTA deadline. In a March press release, the FDA made the following statement regarding the need for a deadline extension.
‘FDA remains aware of the recent surge in youth use of e-cigarettes and the public health imperative that these and other deemed new tobacco products undergo premarket review. The Agency is committed to implementing and enforcing the premarket requirements in the law. The Agency strongly encourages applicants who are able, to submit applications as soon as possible. The Agency also encourages applicants who plan on submitting applications for a large number of products to contact the Agency to discuss their plans and method of submission.”
In its legal motion to the courts requesting the four-month extension, the FDA explained that the COVID-19 outbreak is creating numerous obstacles for both federal employees and manufacturers of vapor products who intended to file PMTA applications. Some of those impediments include the following.
- Many FDA employees are currently being reassigned to other departments to assist in the federal management and response to the coronavirus pandemic. Others are being forced to work from home to avoid virus contraction.
- Many research laboratories involved in compiling the necessary scientific documentation required for PMTA submissions are currently closed due to governors reclassifying them as non-essential businesses.
- Many vapor companies are also classified as non-essential. So, their employees are currently not in the office to complete the overly complex forms and documents.
- With the global supply chain essentially on lockdown, delays in product deliveries are now the new Norma and hamper companies abilities to navigate swiftly through the application process.
The PMTA deadline extension gives vape retailers another four months to submit their applications – one application per each product. If the PMTAs are not submitted by the new September 9 deadline, then retailers must pull the related products from store shelves immediately. Those companies that have submitted a PMTA can continue to sell their products for up to one year or until the FDA grants PMTA approval – whichever comes first.
All vapor products introduced to the market prior to November 8, 2016, will require a PMTA submission. This includes every type of vaping product imaginable, from e-liquids to cartomizers, vape mods, pre-filled cartridges, and even coils.
New PMTA deadline just weeks before 2020 election
The revised PMTA deadline just happens to fall weeks prior to the 2020 election. If the September 9 deadline stands, President Trump could face harsh pushback from within the vaping community – which might cause him to intervene in a last-ditch effort to save vaping along with his re-election campaign.
On September 11, 2019, the president unexpectedly announced during a White House press conference that he intended to ban the sales of flavored vapor products immediately and nationwide. He was apparently convinced by the First Lady after misguided reports began surfacing in mainstream media alleging that nicotine-based vaping was the cause of a mysterious outbreak of lung injuries occurring among teenagers illegally purchasing vapes.
Shortly thereafter, the respiratory disorder would be renamed EVALI (e-cigarette or vaping product use-associated lung injury) by the FDA. However, after several months of spreading misinformation, the agency would finally acknowledge in early 2020 that the disorder is actually caused by Black Market cartridges illegally laced with vitamin E acetate.
However, in the months between Trump’s initial announcement and the official acknowledgement by the FDA, the vaping community started publicly rebelling against the president. The hashtag #WeVapeWeVote began trending on social media, and the president would quickly change his mind – more or less. By the Christmas holiday, Mr. Trump ultimately decided to sign an executive order banning the sales of only pre-filled vapor cartridges like JUUL. The vaping community felt vindicated.
Will this happen again in the days leading up to the new PMTA deadline just as President Trump is trying to lock up his re-election? It could, but a great many things can happen between now and then.
(Images courtesy of Shutterstock)