The Vapor Technology Association (VTA) has been fighting to keep the vape industry alive.
The VTA has filed a lawsuit against the FDA and PMTA. Championing for the vape industry and those employed within it. And the people who continue to use vaping as a tobacco cessation method, and future users.
Pre Market Tobacco Application
PMTA is an application that will affect all in the vape industry. Vape Manufacturers must submit PMTA to market products legally in the US. Products such as vape juice or vape mods. Once submitted the FDA will have to review and approve. Sounds simple. But indecisiveness and changing deadlines are making this process difficult.
PMTA is nothing new to the vape industry. Pre Market Tobacco Application deadline has been looming over the industry for months. But the FDA has constantly changed the deadline date and requirements. Making it impossible for vape brands to submit an application.
The lawsuit by VTA aims to set the FDA straight. Requesting them to complete their decision. And to finish the rules and guidelines that will need to be followed for PMTA approval.
While guidance has been provided to the industry on the FDA's ideas on what the rules may need. The history of this program has many in the vape industry unsure of what to test. As what is needed to pass FDA approval is not 100% clear. It is typical that a draft rule is set up initially. Allowing all involved in the creation of the rules to provide input. Once the draft rule is complete a final rule is then submitted. This final rule is the bible of how vape companies should proceed with testing.
The FDA has stated that they will be publishing the rules. Including guidance documents, product standards, and good manufacturing practices. Yet the FDA has extended the dates because of the inability to define the rules.
VTA hopes the lawsuit will not only organize the FDA in a way. But also enforce them to follow the law. To allow ample amount of time for manufacturers to test and submit for PMTA. And to publish a final set of rules and guidelines for the industry and stakeholders to adhere to. Yet to this day. The vape industry awaits the FDAs move. As we have a deadline. But no rules, guidance, good manufacturing practice, or product standards to strictly follow. The FDA regulations meant to govern the entire industry. From vape device to e-liquid manufacturers.
Not allowing time for these companies is unfair.
What makes the requirements by the FDA unrealistic?
Time for testing and resources. Some of the testing requirements imposed on companies will not be possible. As some of the tests will take longer than the 10 months that the deadline currently stands at. Resources such as labs may not be able to take everyone in with the sudden influx of requests. A large amount of companies will need to take part in the processes within the 10-month window. As over three million vape related products will need to tested before submitting to the FDA. Testing then may be incomplete. And not finished in time. Specialized Labs will not have the resources to complete testing for all products.
Additionally. Some products requiring stability testing also poses a problem. As this type of testing study reports shelf life and can take one year plus thirty percent to complete. This time frame puts the results over the May 12, 2020 deadline.
Will the FDA accept partial tests if this is the case? As the FDA has stated that accelerated testing will not be accepted. And nothing has been stated by the FDA if this scenario occurs. Manufacturers of vape juice and mods will be scrambling to find an answer.
“FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful", said Tony Abboud, Executive Director of Vapor Technology Association.
The suit wants the FDA to follow the process as it is laid out in the law. To create a method in which all those in the vape industry can follow to continue operations. And to take part in alongside the FDA. Not as the news and media state.
Postponing the rules, not participating, or not being regulated is not the goal. And is not how manufacturers are thinking. In fact vape has been heavily regulated. Since August 2016 when the deeming regulation went into effect.
Yet.
The media are having a field day with this topic. Questions such as: "the vape industry seems to have known about their involvement with PMTA all along, why haven't they started?" have come up. An easy answer. If the rules were set that could be followed.
Getting approved is also costly for most manufacturers. The amount of money spent on getting approved may not make sense from a business standpoint. Why begin vape testing on something that may not need to get tested? Or why test for something that is not required in the final rules and guidelines?
Quick action on this suit is critical for vape businesses who are in limbo at the moment. VTA is hoping to expedite the process but that may still take some months. Currently what is being asked, is a preliminary injunction. A court order to the FDA to stop enforcement of the 10-month deadline.
The FDA has yet to appeal the suit, even so, the deadline set on May 12th, 2020 may not change.
What would you do if your favorite vape juice no longer existed? Comment below.
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