Under a Court order, the FDA (Food & Drug Administration) is allowed to extend applicant submissions for up to a year, allowing those with complete applications permission to sell.
US sellers of vape products are obligated to submit an FDA premarket PTMA application if they plan on selling hardware, flavors or, nicotine-based products to consumers. Lawmakers encouraged the FDA to ban flavors unless there was proven evidence that flavors helped adults quit smoking and didn't encourage youth to use flavors.
The recent ban of flavors was a push after the growth of youth began abusing flavors and e-cigarettes. Early nicotine addiction and lung injury were thought to be a result of vaping big brand products like JUUL, but further research has extended fault to teens vaping unregulated vaping products.
If you are a vaping company with lots of products fret not, you’ll be clear to sell as long as your application meets the deadline or you haven’t had your application denied. The real truth of the matter is that the FDA is overwhelmed by applications with no real plans to swim through them until 2021.
The large influx of applications is in part due to many new vape shops creating flavors. In the vaping world, there are many big brands and smaller shops that create their selections of e-liquids, there are hundreds of flavors, each needing its own application if it is offered in different nicotine strengths.
The application process can become pricey for smaller businesses with lots of products because they have less money and too many products that they have to apply, while the bigger companies get by because they have fewer products and more money to spend. The flavor ban against JUUL works out in their favor because they now only have two flavors that they have to apply for verses hundreds.
Earlier this year, the sale of flavored cartridges and pods was banned by the Trump administration unless they were for refillable tanks deeming the sale of certain products okay for devices labeled as pricey and conspicuous to teens.
The extension of the FDA application gives cushion to smaller vape shops for a little while longer. Yet the FDA still needs to access products to ensure the protection of public health, meaning that before banning, the FDA will consider the possibility of flavors keeping people away from the harmful effects of cigarettes vs. the effects of the flavors hooking young nicotine users.
Since the effects of vaping nicotine-based products over a period of time are still relatively unknown, the FDA suggests that applicants include scientific studies to show if there are harmful health effects within their vaping products.
After the scandal with JUUL labs, the vape giants have been scrambling to maintain a good face in an effort to not have all of their flavors banned. Since then, JUUL has been able to produce studies to support that their products are less harmful than cigarettes, while some smaller shops struggle to find evidence, relying on published research to prove that their product is safe.
The FDA regulations are a double-edged sword that in turn could do more harm than good by driving smaller vape shops out of business and in turn cause more traction for the illegal black market, but for now, vape shops are safe, at least until 2021.
