Since the start of the new year, it seems like FDA vape deadlines are popping up all over the place. These have already had an impact on vapers across the country, but they aren’t finished yet. With a new deadline approaching on May 12th for PMTA applications to be received by the FDA, the vaping market is set to change once again. While this isn’t always easy or practical for many vapers, there is some information you need to know so you can make sure you’re prepared for any changes and have time to do what you can to make sure your vaping goes uninterrupted.
Why So Many Changes Are Happening In 2020
If it seems like the industry is in regulatory flux this year, you’re absolutely right. Fresh on the heels of 2019, which saw a big push against Juul by anti-vaping activists, a large amount of attention directed at the youth vaping epidemic, and an explosion in respiratory illnesses attributed initially to vaping in general before eventually being linked primarily to illegal THC cartridges, 2020 began with a raise in the age to buy nicotine and tobacco products to 21 years of age at the federal level. While not specifically directed at vaping, it showed that this would be a year of change for vapers everywhere.
Goodbye Flavor Pods
The first of the FDA vape deadlines to pass this year was at the start of February when a new FDA enforcement initiative went into effect. This enforcement initiative sent shockwaves through the vaping community. This three-part guideline announced some distinct focuses for enforcement, that the FDA was cognizant of the fact that many adults were using vaping as a way to leave smoking behind, and that the FDA did not consider any electronic nicotine delivery system (ENDS) to be approved, thus any product was available to be marketed only at the FDA’s discretion.
The three enforcement priorities identified for this FDA vape deadline were:
- An effective ban on cartridge-based vaping systems other than in two approved flavors, tobacco and menthol. While Juul had already contracted its flavor selections in the face of scrutiny from state and federal regulators of their marketing practices, this enshrined it in federal guidelines across all manufacturers’ products.
- A directive that no product could be marketed toward youth or in a way that might promote youth vaping. Unfortunately, there wasn’t a lot of guidance issued to manufacturers, leaving it widely open to the FDA’s discretion. Since some of the heat directed toward Juul was based on its use of candy and fruit flavors, this provision will bear watching over time.
- Manufacturers were also saddled with the responsibility of ensuring their products would not fall into the hands of youth. Of the changes tied to FDA vape deadlines so far this year, this may be one of the most puzzling, as retailers and not manufacturers are most often involved at the point of sale with direct access to customers.
The intention behind this enforcement directive, of course, was primarily to address concerns about youth vaping. Whether or not it makes an appreciable difference remains to be seen, but it did have an immediate effect on the vape market. Customers who enjoyed Juul or other pre-filled pod devices were left with either choosing tobacco or menthol flavors or transitioning to other devices. To offer a similar vaping experience blending ease-of-use and convenience, the disposable vape market exploded. Both companies who were known for manufacturing Juul-compatible pods and liquid manufacturers seeking to enter the lucrative device niche have rushed to fill the vacuum left by pods’ exit.
The Next Big Deadline
May 12th, 2020, is the next of the FDA vape deadlines. This marks the date that Premarket Tobacco Applications (PMTA) are due in to the FDA for products that were on the market already on or before August 8th, 2016. Any products that were released after that date should have already been through or be in the process of the PMTA, and so should not be affected by this deadline.
The PMTA paperwork gives the FDA the information they need to review new (and in this case, existing) e-cigarette and vape products. Originally designed for cigarettes and smokeless tobacco, it was expanded by an FDA “deeming” rule to include the new and booming vape industry as of August 8, 2016, to begin providing a regulatory framework for new products, but for years it didn’t get very far. While the FDA was responsive to direct calls for guidance from manufacturers, finalized guidance was only recently issued, leading the governing body to postpone parts of their mandatory compliance FDA vape deadlines to 2021 and 2022.
This extended deadline prompted a lawsuit from anti-vaping groups in an attempt to force the PMTA rules to take immediate effect. In the ensuing trial, industry leaders argued they would need the full extension in order to comply with PMTA guidelines while the FDA argued that while a full extension may not be necessary, given the already 2-year timeframe that had passed during which manufacturers should have been working toward compliance and the deep pockets of major manufacturers, an immediate deadline would cause a rushed process that exposed the public to danger. In the end, the judge found a middle ground between the two proposed FDA vape deadlines and set a date of May 12th, 2020, approximately 9-months from the judgment.
So far, there’s no way to be sure how this deadline will affect the market. Manufacturers are aware and have been working diligently to get their paperwork in order for their PMTA filings. While the application process is underway, they are still allowed to market their products as normal. There are also resubmission and amendment procedures in place should they need to add to or otherwise modify their PMTA. Those who do not get their paperwork submitted in time for the FDA vape deadlines will see their products pulled from shelves, but it’s not clear what kind of timeframe the FDA will allow for products that need amendments, corrections, or resubmissions in order to be approved.
Stock Up And Stay Informed
As a consumer, your best bet to make sure you don’t run out of your favorite products is to make sure you have extra on hand prior to May 12th. That way if there are interruptions, you have time for the manufacturer to fix the situation or to find a new favorite for yourself. In the meantime, the Elevated Vaping blog will keep you up to date on the latest FDA vape deadlines and regulatory actions so you can protect your vaping rights.