This year, our world has seen many monumental changes—one in the vaping industry is known as PMTA (or premarket tobacco product application). But what does that mean? It’s a new regulation that will cause certain e-liquids and vapes to be taken off the market, while others will receive FDA approval. As a consumer, you’ll notice that this application process will change the products stocked at vape shops for years to come.
For many vapers, PMTA is at the top of their minds. This is a new requirement for vaping products, which specifies that they must be proven as adequate to protect public health. It applies to e-juices as well as vaping devices and separate components, including atomizers and drip tips. To identify illegal e-liquid, we need to review why they’re illegal. That involves reviewing the legislation rolled out by the FDA:
PMTA took effect on September 9, 2020. The deadline was pushed back numerous times over four years; the last extension was due to delays caused by COVID-19. This new law requires all vape businesses to submit applications for their products to the FDA; if they fail to do so, those products will be taken off the market. There are four main points that a product needs to demonstrate for the application to be successfully approved, and an e-liquid to be deemed legal:
● The first is if the product is determined to pose substantial risks to its users, or has benefits. This also applies to nonusers, like those who would be subject to second-hand smoke.
● Secondly, the FDA considers if those who use the product are more likely or less likely to cease the usage of tobacco products. Since many vapers use their devices to stop smoking and reduce harm, this is meant to assess the efficacy of e-liquids in this pursuit.
● Next, it’s measured according to whether people who don’t use tobacco products are more likely to do so if the product or device in question was on the market. This is to prevent new users from starting using nicotine if they had not previously—essentially, it aims to see whether vaping devices act as a “gateway” to smoking tobacco.
● Finally, the FDA looks at the process used to manufacture the vape or e-liquid; it includes the facilities, controls, and methods used when creating the product. These considerations, among others, are weighed heavily when the FDA makes their decision to accept or deny a PMTA.
Due to the costs associated with obtaining a PMTA, it threatens to put many small vape organization s out of business. The owner of a Winnipeg vape shop wrote that it will be tough for many companies to weather this storm. It’s estimated that the cost of s ubmitting an application for a single product is between $117,000 and $466,000. Now imagine how that cost grows when a brand has a range of products, all with varying levels of nicotine and flavor combinations—it’s simply not feasible. It puts bigger businesses at a serious advantage since they have the resources to gather documentation and evidence, while smaller ones won’t be able to afford to submit a single PMTA.
Products on the market before 2007 are considered to be grandfathered in and can be legally sold without an application. The issue is that e-liquid products and vaping devices didn’t exist at this point. A few things that companies need to include with their PMTA are scientific research, usage patterns, packaging appeal, and potential for misuse.
While companies are waiting for their applications to be approved, their products can remain on the market for up to a year. The time that it takes for a product to be reviewed, accepted, and approved varies; it can be under a year, or upwards of three.
https://vapepmta.com/So, what kinds of liquids are legal, and which ones aren’t? The determinant is whether their application has been approved. If you’re curious about the application status of your favorite brands, visit Vape PMTA—this website shows which products are verified to be FDA-approved.
You want your vaping experience to be a safe and legal one. Regardless of your opinion on the FDA’s new regulatory process, a PMTA determines whether a vaping product (e-liquid, device, or separate component) can legally be sold in a retail store. Ask your vape shop if their products are FDA-approved if you’re looking for legal products.
Norm Bour started VapeMentors in 2013 and since then has consulted in every sector of the Vape and CBD space worldwide. He is a renown author, speaker and trainer.