The tobacco industry in the United States is heavily regulated by government bodies such as the Center for Tobacco Products and its parent agency, the Food and Drug Administration (FDA). Their responsibilities are to help ensure the general well-being and health of citizens by preventing tobacco companies from introducing potentially harmful products to the market.
Recently, the tobacco industry went through a big change with the introduction of new regulations which specifically impact new companies on the market, including those selling traditional tobacco alternatives, like vaporizers. Let’s explore everything you need to know about the new regulation called the Premarket Tobacco Application (PMTA), how it affects both tobacco companies and consumers, and the future repercussions of this process on the tobacco industry as a whole.
Use the links below to navigate the guide:
- What is PMTA?
- The Premarket Tobacco Application Process
- PMTA Regulations and How They Affect the Industry
- What to Know About FDA Regulations in The Future
What is PMTA?
As the name implies, a PMTA is an application submitted to the CTP by a company intending to sell a new tobacco product. Under the Family Smoking Prevention & Tobacco Control Act, before a product can be legally marketed and sold in the U.S., the government body must first accept and approve a PMTA. The application deadline for this new process was September 9, 2020.
Any company introducing a new tobacco product or making a modification to an existing tobacco product after February of 2007 is required to complete this process. Products manufactured before this date, like some traditional cigarette brands, are grandfathered in via a simpler process, the substantial equivalence (SE) report. However, since newer forms of tobacco consumption, like vaping, weren’t didn’t exist 13 years ago, newer companies don’t have that same luxury.
The point of the new process is to demonstrate that a certain product is “appropriate for the protection of the public health,” as laid out in Section 910 of the Federal Food, Drug and Cosmetics (FD&C) Act.
Is Vaping FDA Approved?
As of August 2016, vaping has been regulated by the FDA through the Electronic Nicotine Delivery System (ENDS) Act. That includes e-cigarettes, e-liquid, and all related products. In general, manufacturers must comply with a number of rules set forth, including proper labeling, youth-preventive measures, and advertising restrictions. The PMTA serves as a vehicle to analyze these efforts and allow FDA approval of new tobacco products.
Why are PMTAs Important?
The PMTA process is important for consumers and retailers, alike. The FDA considers a number of criteria in order to approve or reject a new tobacco product application, including (but not limited to):
- Risk versus benefit to the general population, for both users and non-users.
- The likelihood that such a product would cause current tobacco users to switch from the more harmful alternative.
- The likelihood of non-tobacco users using the product if it were available.
- Each element of the manufacturing process, from production to facilities to packaging.
For consumers, these criteria provide users with peace of mind knowing that they’re purchasing a product with a verified level of quality. Users can also trust that the product doesn’t have any unregulated, potentially harmful ingredients, something that has been an issue in the vaping industry. It’s also a way for the FDA to identify potentially less harmful tobacco alternatives that can be supplied to the public.
For companies, it means the right to legally market and sell your products at retail locations and online venues throughout the country. Both manufacturers and importers—sometimes referred to as distributors—are affected by the implications of the PMTA. For example, applications for each individual product will need to be filed, eating up limited internal resources. Vape companies are required to file an application for each flavor and its nicotine level, as well as any separate components like atomizers, cartomizers, tank systems, batteries, and beyond.
While there has been some level of confusion in the industry about the PMTA process and its deadlines, what is known is that the goal of the PMTA is to make the industry more regulated and more safe for consumers.
The Premarket Tobacco Application Process
One thing that is well known about the PMTA process is that it is tedious, but an essential part of providing the best end-product to the consumer. While future deadlines haven’t been announced, the industry as a whole is in a brand new era under the PMTA. Let’s take a look at the ins and outs of the application process for FDA approval of a new tobacco product.
What Do You Need For a PMTA?
To be considered for acceptance and approval of a PMTA, you must have:
- Published information, investigations, reports, or data that show the health risks of such tobacco products and their risk compared to other tobacco products.
- Comprehensive lists and an explanation of the components, ingredients, additives, properties, and principles of operation.
- Detailing of your methods of manufacturing, processing, packing, distribution, etc.
- A reference to an existing tobacco product standard, either relating to or justifying any deviation from such a standard.
- A sample of the new tobacco product and labeling.
You’ll also need to provide a few other key pieces of information to boost your application and make it more likely to be accepted and approved. The FDA-recommended outline below ensures that your application is as good as it can be. You will need:
- A cover letter and administrative information
- A table of contents
- A product description and manufacturing information
- Nonclinical information
- Clinical - product impact on individual health
- Clinical - product impact on population health
- The environmental Impact
And, of course, don’t forget about the costs associated with submitting a PMTA.
While cost differs from person to person and company to company, there are a number of factors that contribute to the amount you pay. For example, a brand new product will require more testing, third-party verified research, and other data gathering efforts to prove that the product is safe for public consumption. Not to mention the amount of time and manpower it takes to complete such a complex application process.
In other words, before a company even has a chance to get a product to market, they must have a substantial amount of capital to meet application requirements. This increased cost can be a barrier to entry for some vape companies. From the FDA’s Regulatory Impact Analysis (RIA), you can view some estimated costs associated with various premarket pathways:
The hundreds of thousands of dollars it costs for a PMTA submission is substantial, there’s no doubt about it. But, the FDA says it’s committed to lowering those costs over time as manufacturers gain experience and enhance research capabilities. Many of these efforts, like data sharing, are already getting kicked off.
There are other ways the FDA is trying to bring down costs so smaller businesses aren’t as affected by these regulatory measures:
- Sharing Tobacco Product Master Files (TPMF) by allowing applicants to use existing research on their applications, rather than having to develop their own. Find out more about TPMFs.
- Providing insight into the FDA’s current thinking of what the supplied information should be, as well as how they intend to review PMTAs, particularly as it pertains to ENDS products like vaporizers.
- Supplying guides, training videos, live webinars, and other resources in order to better understand rules and regulations.
However, regardless of the costs, this hasn’t stopped countless companies from jumping in and making submissions. In June of this year alone, 650 companies submitted their PMTAs because once the application is accepted and approved, their newest vapes, tinctures, cigarettes, hookahs, and other exciting tobacco products can finally be sold legally. Plus, they get the added marketing benefit of proudly declaring “PTMA Approved” on packaging, labels, and other brand materials.
How to Submit a PMTA
Once the new deadline is announced and you’re ready to submit a PMTA, there are two main ways to go about doing so: online and via mail. Follow the instructions below to submit your application.
Online PMTA Submission
Thanks to portals and software integration, it’s fairly simple to submit your PMTA through online means:
- Go to the FDA electronic submissions page.
- Get access to the CTP Portal by designating an Industry Account Manager from your organization. This person oversees account activity – learn more here.
- Access the “CTP Transmittal Form” template through the account’s eSubmitter software.
- Submit the application on the CTP Portal.
Mail-In Your PMTA
If you’d rather mail-in your PMTA, you can do that as well. However, note that the CTP is moving toward an electronic submission that allows them to deal with applications more prudently. Before mailing your PMTA, you may need to request and receive a waiver from the FDA.
- Mail submissions to the CTP's Document Control Center address:
Center for Tobacco Products – Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center
Building 71, Room G335
Silver Spring, MD 20993-002
What’s Next for PMTA Deadlines?
The history of premarket tobacco applications goes back to 2016, when the FDA introduced the process, giving companies two years (until August 2018) to make a submission. The slow grind of bureaucracy continued through to the end of 2019, proving ineffective as not a single e-cigarette company had submitted a PMTA. The initial deadline for applications was May 12, 2020.
Then, like many other events in 2020, the PMTA deadline was heavily affected when the COVID-19 pandemic crisis came to the U.S. As the May 12 date approached, the FDA was forced to delay after pushback from the industry amid unprecedented times.
Thus, the PMTA deadline was officially moved to September 9, 2020. Although companies could market non-approved products before thanks to the FDA’s “enforcement discretion” rule, it is now illegal to do so without a PMTA acceptance.
Is There an FDA PMTA Extension?
According to a status report filed with a U.S. District court, the FDA said that there will be no further extensions of the PMTA deadline in 2020. While this leaves some companies who want to market new products in the lurch, on the bright side, they can take time now to prepare their applications for when the next deadline is announced.
PMTA Review Process
The review process is lengthy, and can take a year or longer for the FDA to approve your application. Here are the process steps to ensure that your submission goes through smoothly:
- Pre-submission Meeting: A voluntary meeting between the FDA and applicant to discuss a PTMA submission.
- Acceptance Review: An initial administrative review of the product as it pertains to Section 910 of the FD&C Act.
- Filing Review: A scientific review that ensures the application contains all necessary data and research.
- Substantive Review: If the previous reviews are passed, the more in-depth FDA evaluation of all components of the application takes place. At this juncture, applicants may receive a deficiency letter, which informs them of any changes that need to take place within 180 days. They will also need to submit an environmental impact report.
- Acceptance or Rejection: Following the various reviews, a company receives a marketing order letter if the application has been accepted and approved.
- Postmarket Reporting: The company is required to establish and maintain records and reports required by the FDA to facilitate further approvals, withdrawals or suspensions of marketing orders.
What to do After You’ve Submitted a PMTA
Once you’ve completed the review process, is there anything left to do? After all, the FDA has one year to review products that were filed on time—and with the surge in applications, the review may take even longer.
One good step to take, if you haven’t done so yet, is to protect your legal interests. There are many law firms that represent tobacco companies and take on PMTA-related cases. They can help in case of disputes, extensions, and many other scenarios.
PMTA Regulations and How They Affect the Industry
Tobacco is one of the most heavily regulated industries in the United States, and the FDA has laid out a number of rules and requirements that companies must follow in order to operate. Unfortunately, these regulations can hamstring businesses and prevent them from successfully developing new, interesting product lines.
Problems With PMTA Regulations
The increasing desire for alternative tobacco products, like vaporizers, among the general public is undeniable, with 15,000 small and medium-sized vape companies popping up around the United States alone. With strict tobacco regulations from the FDA, however, these companies are facing an uphill battle against the government.
The unfortunate thing is that consumer sentiment is obviously trending toward a cleaner tobacco option, with recent studies showing vaporizing on the rise, and traditional smoking on the decline. Not only that, vaporizers, in addition to other newer offerings like tinctures, have been shown to be a positive tool for smoking cessation.
Another gigantic problem is the cost associated with the PMTA. When the FDA first introduced the PMTA process, there was a lot of miscommunication and confusion, including inaccurate media reporting that inflated application costs in millions of dollars. Although costs aren’t that high, they can still be quite extravagant for the average small to medium-sized businesses. And, when businesses can’t get off the ground, competition in the industry suffers, leading to fewer products like e-juices, devices, and hardware from a smaller variety of brands.
Many in the tobacco industry cried foul, claiming that the process was designed in such a way that allowed large manufacturers, that can afford the time and financial costs associated with PMTA, to take advantage, while leaving lesser-known brands fending for themselves. Because of that, the FDA has taken steps to reduce costs, but remain stubbornly high in the meantime.
Additionally, the law is the law, so companies must comply by proving to the FDA that their products have a scientific benefit appropriate for protecting the public from smoking-related diseases and mortality. The companies that can do so successfully are able to get their product to market and start selling at retail locations throughout the country.
PMTA Approved Products: Vape Company Statuses
As mentioned, hundreds of companies have submitted their PMTA and have either been rejected, accepted, or approved so far. If you’re looking for a list of PMTA-approved products, here are the statuses of the industry’s top brands.
Z Stick PMTA Status
Currently, Z Stick is one of the country’s only disposable vape companies to receive a PMTA filing and acceptance letter from the FDA.
JUUL PMTA Status
In August of this year, JUUL officially entered the FDA’s substantive review phase for the JUUL Device and JUULpods in “Virginia Tobacco” and “Menthol” flavors at 5% and 3% nicotine concentrations.
Geek Vape PMTA Status
According to their website, Geek Vape is working on their PMTAs for major products, including Aegis and other series.
Uwell PMTA Status
Uwell has submitted several applications to the FDA and “will submit more and more PMTAs for more products in the future.”
Vuse PMTA Status
Vuse announced that they submitted two new PMTAs seeking marketing orders for their Vuse Vibe and Vuse Ciro vapor products. The PMTAs include multiple flavor variants for each brand style.
Vaporesso PMTA Status
Vaporesso received a PMTA acceptance letter for its initial round of applications, just three days after submission.
SMOK PMTA Status
Just last month, SMOK informed customers that they have passed the second round of the PMTA review and moved to the final phase.
Avail PMTA Status
Avail’s Virginia-based vape company received the first PMTA acceptance for a flavored e-liquid, Berry Vapor Voice.
What to Know About PMTA in The Future
Overall, we’ve seen a general trend in the U.S. where traditional smoking has become less and less popular, but the demand for tobacco products overall has remained consistent. As such, there is a market to take advantage of for those companies that want to sell these new exciting tobacco products like vaporizers.
Whether you vape, manufacture, own a store, or are otherwise affiliated with tobacco, there are several things that may change in the industry throughout the upcoming years. Let’s explore some of the more noticeable impacts the PMTA and related FDA regulations have on the tobacco industry as a whole.
Shrinking Company Pool
As we’ve noted, the application process is complex, expensive, and time consuming, and some companies simply don’t have the adequate resources to cope. Fortunately, the FDA is taking steps to improve the “scientific” portion, through TPMFs. This means companies can voluntarily submit their research anonymously, allowing applicants access to existing information that they can use in their own application.
Because every item sold requires its own application—from flavors to nicotine percentages to vaporizer hardware to tinctures and beyond—companies will likely begin discontinuing certain products out of financial necessity. Of course, that doesn’t mean there aren’t plans to get them approved in the future, but for now, stock up on your favorites just in case. Additionally, because of the requirements to receive PMTA approval, new products may come to market that better comply with these regulations.
If you’re into vaping, you may have noticed changes to your favorite brands’ labels, perhaps with language around “PMTA”, the removal of flavors, colors, or other certain familiarities. This is a portion of the marketing requirement from the new regulations to encourage health-conscious labeling with warnings as well as fighting youth addiction.
Higher Standard of Available Products
While it is a pain for companies to go through and may stifle competition, the PMTA process does push tobacco companies to produce a higher standard of cigarettes, cigars, hookahs, edibles, vapes, and other electronic nicotine delivery systems. The point of this regulation is to put everything the company produces under careful scrutiny to ensure it’s safe for public consumption – which is ultimately a good thing.
Staying Ahead of an Evolving Tobacco Industry After PMTA
Overall, the PMTA process is a tedious, but necessary one, that can make or break the newest, coolest tobacco product. For those in the industry, it’s important to stay on top of regulations and future deadlines that may impact their ability to bring new products to market.
The tobacco industry has undergone a lot of changes over the past few years, and while innovation is absolutely crucial in keeping up with consumer demand, regulation is a necessary component to make sure these new products are safe for use. The PMTA is just one of the first regulations to help, and we can expect additional news and clarification around this application as the FDA further refines the process.
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And in 2020, we’re proud to announce that Z Stick’s PMTA application has been accepted by the FDA and is pending approval. In September, we received a filing letter that made us one of the only disposable vape companies on the market to have their PMTA accepted by the federal government, passing the filing stage and currently under the substantial review phase.
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