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In February 2020, flavored vape cartridges were officially restricted from production in an unprecedented move by the Food and Drug Administration (FDA). This decision came after an onslaught of underage e-cigarette use caused public concern. The decision may be a surprise to some, but it’s a part of a much longer timeline of vape-related FDA regulations.
Background on Pre-Market Tobacco Applications
In May 2016, the FDA passed a “deeming rule.” This deeming rule stated that vape manufacturers would adopt the application process that cigarette and smokeless tobacco manufacturers go through before releasing a product.
This application — the Pre-Market Tobacco Application (PMTA) — is part of a process in which the FDA reviews products before they can release them to the general public for sale. A PMTA vaping regulation like this relegates vapes to the “danger zone” where tobacco products are.
The point of this application is to give the FDA an opportunity to approve or deny a product based on:
- Risk and benefit to the general public
- If the proposed product prevents use of a current tobacco product
- If the proposed product might persuade non-tobacco users to try it
- Manufacturing procedures
It is a long and expensive process to gather all the necessary products that has priced out many vape manufacturers already.
Implementing the Pre-Market Tobacco Applications
If you’re wondering whether products already on the market need to file a PMTA application, they do. At the time of the ruling, the FDA set a deadline for August 8, 2018. That deadline gave manufacturers two years to gather all upporting documents and submit for all products released to the market after August 8, 2016.
In July of 2017, the FDA announced that they were extending the deadline by four years, to August 8, 2022. Several organizations and pediatricians, outraged that products they deemed unsafe would remain on the market for four more years, filed a lawsuit against the FDA. The group of plaintiffs included:
- American Academy of Pediatrics
- American Academy of Pediatrics (Maryland chapter)
- American Cancer Society Cancer Action Network
- American Heart Association
- American Lung Association
- Campaign for Tobacco-Free Kids
- Truth Initiative
Anti-vapers vs the Food and Drug Administration
The two sides of the argument are as follows:
- Plaintiffs argued that the FDA didn’t give them enough time to contest the PMTA extension, citing the Family Smoking Prevention and Tobacco Control Act.
- The FDA argued that the initial timeline was unreasonable given the lack of guidelines for approval, the manufacturer filing cost, and amount of paperwork applications require to submit.
The plaintiffs wanted to roll back the extension, make all PMTA applications due immediately, and remove all unapproved items from the market. The FDA wanted the extension to remain as it was. The FDA’s argument seems like it only benefits the industry, but they argued that the extension was helpful to the FDA itself, too.
They would need time to review every application before approving items for the marketplace. The criteria to approve or deny products were only real on paper. The FDA hasn't tested the criteria yet, so they don't know if they would work in practice. The plaintiff’s desires would have effectively neutered the industry. So to prevent an industry collapse, the judge ruled on a middle ground.
The judge reduced the extension by two years to May 11, 2020, citing both groups' concerns as valid.
How the PMTA Vaping Ruling Affects Vapers
The deadline is coming up quickly for manufacturers, and vapers will feel the effects of the new process. Changes will happen rapidly, so it’s important to know what to expect.
Your favorite brands might disappear
The PMTA application process is long and expensive to file. Some brands don’t have the research on hand to prove the safety of their products in the way the FDA is asking. If they can prove how similar they are to another product that is PMTA-approved, they could qualify for grandfathering. That is some manufacturers’ best chance at approval. If the brand doesn’t file an application, you won’t see those products on the shelves anymore.
Your favorite products may face discontinuation
o Even if a manufacturer submits an application, any of your favorite products could get discontinued by the FDA.The point of this is to ensure all products are “relatively” safe. With the anti-vaping organizations watching closely, the FDA is under a lot of pressure to critique products and their safety. Especially following the lawsuit, each decision will face scrutiny. Important criteria used for products released between August 8, 2016, and the deadline, May 11, 2020, include:
- Appropriate marketing plans: Packaging and marketing materials considered attractive to children could face rejection.
- Manufacturers can try to be grandfathered in: To do this, they need to either (A) prove that their product was released pre-deeming rule, (B) show examples of comparable products available pre-deeming rule, or (C) show examples of comparable products with a PMTA in the works.
You may see changes in packaging
This is a part of the marketing requirement for the PMTA. A large part of the plaintiff’s arguments involves how vape products get marketed to the public. Along with the banning of flavored vape juice flavors, marketing tactics that seem child-friendly won’t fare well.
The future of vaping
The packaging matters. The product matters. The component that holds the product matters. Every detail is under scrutiny during this application process.
If there’s one sure thing, it’s that the vaping industry will never be the same. The unprecedented lawsuit leaves all manufacturer futures in the air. If manufacturers had a PMTA plan, they surely had to throw it out with two years less to execute it. And even if companies file before the deadline, there’s no telling how long it will take for them to get an approval or denial on their application.
There is no concrete information about applications that get submitted after the deadline passes. If the applications are even accepted, they have to wait for every other manufacturer in the queue to await their product’s fate. A product that is available right now may not be available in a year due to the application’s processing deadlines.
It’s also not clear what happens to applications that don’t get the green light. Will they have time to refine the product? Is there an appeal process? Compared to what the cigarette manufacturer community went through, this situation is completely new. Some vape companies face ceasing production altogether simply due to the application costs.
The goal of PMTA vaping guidelines is to reduce minors' access to vaping products, but they may cause the vaping industry to disappear. Some people believe that dismantling the vaping industry is the goal.
This could prove detrimental to those who use vaping products to move away from cigarette use. Some believe that only vaping companies that manufacture cigarettes will survive, since they have a long history and deep financial pockets. We may be years away from a real answer.
Our best piece of advice is to stock up on your favorite vape products now. They may not be available for purchase forever.