You’re learning about the ever-growing vaping market. A market that is worth billions, yes- with a B- of dollars per year. For many people, PMTA is important when they are trying to decide if they want to open up a vape shop or not. For others, PMTA is something they want to understand before investing in a vape product or e-juice line. And, for others, a natural curiosity about the market is the reason they seek out information on the subject. Regardless of the reason, understanding the legalities of PMTA is vital.
So, what exactly is a Premarket Tobacco Product Application? According to its definition, PMTA, as it is referred to, is an application that must be reviewed and approved by the Food and Drug Administration before a new tobacco product can be legally marketed in the United States. This is important because vaping is considered a tobacco product. It is used by many cigarette and cigar smokers who are looking to quit or cut down on the amount of nicotine they use daily. Others use it simply because vaping is more appealing and convenient.
PMTA is the application that allows vaping manufactures and vape stores to exist. It is a formal application for businesses that afford the FDA to regulate vaping products and how these products are sold and to deem these products as safe, unsafe, or in need of a health label. There is a history behind this type of application. Basically, if a vaping manufacturer existed before 2007, they have been grandfathered into the marketplace and there is no need to go through a PMTA application or regulation. However, there were almost NO vaping companies in the USA or outside of the USA during this time frame. Thus, almost every vaping manufacture has to present a PMTA application for review. And, if you have products that can be separated, let us say atomizer components that can be inserted and removed from a shell casing, each component needs a separate PMTA. And yes, each and every PMTA license is a separate fee.
But what about different e-juice flavors created by the same manufacturer? Yes, each flavor and each nicotine (or lack thereof) level will require a separate PMTA application and a separate fee. Now, if you are a vapor then this information should make you feel good. Why? Well, part of the separate fee is an insurance, so to speak, that the product being presented by a vape manufacturer actually is what it says it is. If Company A presents an e-juice application for a brownie flavored juice, you know the FDA through the PMTA application is going to require samples of that specific product for further testing. That sample testing should mirror what the label claims to be contained in the e-juice. And, the health effects need to be mirrored as well.
The PMTA application is almost like applying to be a prescription manufacturer. The FDA wants to know the exact usage of the product. What modifications may and may not be used or made. Usage patterns need to be well defined and a statement on what can happen should a custom abuse or misuse the product has to be submitted. There is no fly-by-night setting up shop for vaping products in the United States unless someone or some company is skipping licensing, which can lead to very dangerous outcomes.
There has been some legal back and forth in the market as the cost of the PMTA applications and the deadlines for applications was due in early September 2020 after an already set extension. And because of the cost and the application process, in the United States some vaping business are expected to shut down and lead to hundreds of thousands of people being unemployed. This same sentiment is being echoed around the globe if the vaping manufacturer does business with customers in The United States. But, the vaping industry will pivot and survive. There is too much of a demand for the application process to scare the industry. It may be expensive and it may be a hassle to submit all of the information and samples, but there is no way forward when it comes to dodging or getting around the PMTA process. And, truth be told, people should know what is in their vape products.
The main part of the application is to protect the public’s interest in health. And while this process is fairly new – with existing vape manufacturers having to have already submitted applications by September 9th, 2020 for existing products being sold in the US, the current law mandates that the FDA define the scientific characteristics for each product application submitted. The FDA has to seek out and prove the science being submitted during the application process, which is tedious. And all applicants must prove to the federal government that their products have a scientific benefit appropriate for protecting the public from smoking-related diseases. Yes, a benefit and how it helps protect from smoking-related diseases. Now, this is a controversial point because traditional cigarettes have been grandfathered in under the same law and they come with a health warning, yet they are still for sale and there is no legal limit as to how many packs or cartons one can buy.
PMTAs can be submitted online or by mail to the FDA but this application shouldn’t be rushed. When you visit the FDA’s website for the application, everything is spelled out in great detail and if the application is missing one small component, well- it will lead to an automatic denial letter and probably further scrutiny if the application is later submitted. After submitting an application, the FDA will respond with a request for a formal, yet voluntary, meeting with the vaping manufacturer.
One of the many challenges with an PMTA application is the planning for marketing the product for sale. The FDA’s website states, “Requires applicants to establish and maintain records and make reports that FDA requires as necessary to determine or facilitate a determination of whether there may be grounds to withdraw or temporarily suspend a marketing granted order.” The language is very vague and the definition of the marketing granted order isn’t too clear. This is where I’d advise legal help, if possible when setting up a PMTA application.
Now, there is an Ombudsman who will act as an advocate for any application and manufacturer complaints but given the application flood that has been received by the FDA last month, obtaining help right away isn’t too inspiring and the FDA’s online resources are really limited in language. Most information is open for interpretation.
The PMTA process is new. It will cause frustration but eventually, all the kinks will be worked out and the process should become easier to navigate. There is still consumer demand for vaping and the price of an application or all the sampling and requirements that pair alongside the PMTA application shouldn’t discourage a vaping manufacturer from selling in the US. Sure, it can be frustrating at times but that doesn’t mean the opportunity for success in the US market will cease to exist.
Lastly, the pricing of PMTA will eventually change to help manufactures adhere to requirements and not sell unsafe products on the black market. According to the FDA’s website, “ the FDA has estimated the average cost for each premarket review pathway for newly regulated tobacco products to be:
- an SE exemption report = around $1,500
- an SE report = anywhere from around $3,500 to around $22,700
- a premarket tobacco application (PMTA) = in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000), not in the millions of dollars described by some others”
PMTA is here to stay. There is no way of getting around the application process of the fees. Instead, understanding what it is and what it will cost is the best way to play offense and still make a profit within the marketplace.
The only other point of concern for PMTA applications is for vape shops who are mixing products. Typically, vape shops don’t have a lot of start-up capital and funds are limited but the FDA has defined the rule that vape shops could be subjected to completing PMTA applications if the vape shop mixes, prepares, or combines liquid nicotine and other components of tobacco products meet the definition of a “tobacco product manufacturer” under the law. If they do, the vape shop will therefore subject to the same legal requirements as all other tobacco product manufacturers.
If you want to learn more about the PMTA, the FDA offers a FAQ section which may be accessed by clicking here: https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/commonly-asked-questions-about-center-tobacco-products#:~:text=an%20SE%20report%20%3D%20anywhere%20from,dollars%20described%20by%20some%20others