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The vape industry in the US has recently been up in arms due to the new PMTA regulations being enforced by the Food and Drug Administration under the Tobacco Control Act of 2009.
In early 2020, there were fears of favorite vape brands being wiped out from the American market due to the “flavor ban” and the ongoing war on vaping. Not only is it seen as a threat to the vape industry, but also to vapers themselves.
But we must separate fact from fiction when it comes to Pre-market Tobacco Product Application regulations and be informed instead of hysterical. Despite the fears, this is not the death of vaping in America.
PMTA, or Premarket Tobacco Product Application, is something that all e-cigarette manufacturers must submit to the FDA in order to keep selling vaping products. It requires the companies to provide scientific data which shows their products are safe and appropriate for protection of public health.
It had been in the works since the Obama administration. Advisers of then-President Barack Obama were apprehensive about quickly implementing the new tobacco regulations as it may result in disaster for the burgeoning vape industry.
President Donald Trump had spoken against vaping and nicotine user rights during the height of last year’s “epidemic” of vaping-related lung illness. But despite that, his administration has extended the deadline for PMTA for as long as possible for current products in distribution.
New products must be registered and be authorized for every marketing component they may undergo. That includes adjustments in packaging, manufacturing processes, product design, and so on. The FDA also has the right to enforce discretion, letting them defer PMTA requirements for products already available on the market as of August 8, 2016.
This systemic grandfathering date does not assure legality of said products as introduction of new products will still require PMTA approval.
Preparing for premarket tobacco product application, as with most legal registrations, involves compiling the necessary documents.
The PMTA itself includes full reports of all published information showing the actual health risks of the tobacco products being
The FDA recommends a structured format of cover letter and administrative information, table of contents, summaries, product description and manufacturing, nonclinical information, clinical information of product impact on individual health and population health, and environmental impact.
You may submit your PMTA online through the FDA’s Center for Tobacco Products (CTA) portal or by mail to the CTP’s Document Control Center. Amendments may be submitted as well through these same procedures.
The review process involves a voluntary pre-submission meeting for initial screening, acceptance review to verify the qualification of the product, filing review for preliminary scientific review, substantive review to evaluate the scientific information in the application, action to come up with an order letter for either allowing marketing of the product or not, and post-market reporting to determine whether the product is indeed safe or should be withdrawn.
PMTA is being set as a foundation for establishing long-term vape businesses due to the incredibly high standards and complicated processes that vape products have to undergo. The rise of illicit vape products in recent years has necessitated this action to ensure public health and safety without permanently banning vaping in America.
Vaping has brought together people of all creeds, nationalities, ethnicities, and walks of life due to being an effective method of quitting conventional tobacco products. Therefore, banning vaping poses a significant threat to the vaping community, which only continues to grow over the years.
The establishment of PMTA is both a compromise and a way to further legitimize vaping as both an industry and a way of life.
PMTA will not end vaping in America. In fact, it’s far from it. The PMTA deadline is not when the vape industry ends. It’s merely one of the first steps in the fight against those who think they know better about people’s rights and health.
Vaping was created to give people hope with a viable alternative to smoking. Other countries like the United Kingdom have incorporated vaping into their healthcare system, using it as a means of harm reduction and addiction management. That can be possible for the US as well.
Instead of panicking, the best thing to do from here on is to join the movement to convince the whole world of vaping as an effective harm minimization method for quitting conventional tobacco. Every step towards that legitimization counts.
Only time will tell if PMTA is actually effective in eliminating illicit vape products from the market and making vaping safer for everyone. There may be more regulations in the future to curtail other vaping-related problems, like vaping among minors.
However, PMTA is a significant step towards making vaping much less of a taboo and more of a lifestyle choice that makes smoking obsolete. While it can make vape products more expensive due to the added costs of applications in terms of money, time, and energy, but