PMTA Overview - What is PMTA?
In May 2016, the FDA passed a deeming rule stating that vape manufacturers would adopt the application process that current cigarette and smokeless tobacco manufacturers go through before releasing a product.
This application, the Pre-Market Tobacco Application (PMTA), is the process in which the FDA reviews products before they can be released and sold to the general public.
The application process gives the FDA the authority to approve or deny a product based on:
- Risks to the general public
- Benefits to the general public
- Manufacturing procedures
- If the proposed product prevents the use of current tobacco products
- If the proposed product might persuade non-tobacco users to try it
The application process is lengthy and, most importantly, expensive which has priced out many vape manufacturers already.
Who has to turn in PMTAs?
You might be asking who has to turn in Pre-Market Tobacco Applications. The answer, everyone manufacturing vape products currently or in the future.
At the time of the ruling, the FDA set a deadline for August 8, 2018 giving manufacturers 2 years to gather all supporting documents and submit their PMTAs 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 4 years, to August 8, 2022. Several organizations and pediatricians filed a lawsuit against the FDA due to outrage that products they deemed unsafe would remain on the market for four more years. 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
The two sides of the argument are as follows:
The 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 costs, and amount of paperwork applications required to submit.
The Plaintiffs wanted to roll back the extension, make all PMTAs due immediately, and remove all unapproved items from the market. The FDA wanted the extension to remain as is. Though the timeline would benefit the manufacturers it also benefited the FDA since they would need to review every application. The criteria to approve or deny products had not been tested yet and they were not sure it would work in practice. They wanted to prevent an industry collapse.
The judge ruled on the middle ground by reducing the extension by 2 years, May 12, 2020, citing both groups’ concerns as valid.
As the May 12 deadline approached a number of entities including Altria Group Inc. and tobacco association NATO, had asked the FDA to push the deadline back due to the complication caused by COVID-19 pandemic. Altria asked that the FDA seek an extension from a federal judge in Maryland, to coincide with the eight week social distancing period recommended by the CDC.
Deadline is effectively moved to September 9, 2020. Meanwhile, the FDA officials are encouraging applicants who are able to submit PMTAs earlier to do so as soon as possible. Additionally, they are asking companies with a large number of submissions to contact the agency in order to discuss their plans and method of submission.
How the PMTA Vape Ruling Affects Vapers
With the deadline approaching quickly for manufacturers, vapers will feel the effects.
Stocking Up and Selling Out
Much like toilet paper at the start of the COVID-19 pandemic, vapers are stocking up and sellers are selling out of popular vape products. It’s unknown what brands will submit their PMTAs and it’s even more unknown who will be approved. This has created the stockpile effect.
Brands Might Disappear
The PMTA process is long and expensive to file. Some brands do not have the research on hand to prove the safety of their products in the way that 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 these products on the shelves anymore.
*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
Even if a manufacturer submits an application, any of your favorite products could get discontinued by the FDA. The point of this application process is to ensure all products are relatively safe for the general public. 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.
Vape Packaging Changes
Part of the PMTA process requires changes to vape packaging. A large portion of the Plaintiff’s arguments involve how vape products get marketed towards the public. Packaging and marketing materials considered attractive to children could face rejection.
The Future of Vaping
From product to packaging, every detail will be under scrutiny during this application process. If one thing is for sure it’s that the vaping industry is going to be forever changed. All manufacturers' futures are up in the air.
Our best advice is to stock up on your favorite vape products now.