Mitch Zeller, former director of the FDA’s Center for Tobacco
Products
The U.S. Food and Drug Administration (FDA) stated today that it still intends to prioritize enforcement against any electronic nicotine delivery system (ENDS) product that continues to be sold and for which the agency has not received a premarket submission as indicated in FDA’s enforcement priorities guidance.
“Now that the deadline has passed, and the submissions are with FDA, many may be wondering about the upcoming steps for both submitters and the Agency,” the agency wrote in today’s release. “As Mitch Zeller, CTP Director, stated in a recent perspective piece, FDA strives to be as transparent as possible with regards to the status of these submissions and plans to provide regular updates to the public over the course of the next year.”
The factors behind enforcing a device will include several factors, including the likelihood of youth use or initiation. The regulatory agency stated that it will make the best use of agency resources to enforce against any other deemed new tobacco product that does not have the required premarket authorization (PMTA).
in January of this year, the agency did not mention prioritizing open-systems. The three urgencies that earned a bullet-point were:
“Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
“All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
“Any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors.”
“New data, such as that from the 2020 National Youth Tobacco Survey (NYTS), will also inform the FDA’s enforcement and other actions, and flavored disposable ENDS will be an enforcement priority for the agency,” according to today’s agency release.
The 2020 NYTS showed a large decrease in youth vaping. On Sept. 10, the FDA announced that after two years of disturbing increases in youth e-cigarette use, the agency was “encouraged by the overall significant decline reported in 2020,” the FDA stated in a release. “This is good news; however, the FDA remains very concerned about the 3.6 million U.S. youth who currently use e-cigarettes and we acknowledge there is work that still needs to be done to curb youth use.”
Complicating matters, while the FDA has said that it plans to post a list of the deemed new tobacco products that were on the market in the U.S. as of Aug. 8, 2016, are still on the market now, and for which a premarket submission was made by Sept. 9, 2020, that list may not be available for many weeks or even months.
“Before making such a list available, FDA needs to ensure that publishing any such information complies with federal disclosure laws and regulations,” the FDA wrote. “For example, before FDA can include a specific product on this public list, the Agency may need to verify with companies, on a case-by-case basis, the current marketing status of a product and whether it was on the market as of Aug. 8, 2016.”
The regulatory challenges of the vapor market in the United States has not deterred a Chinese challenger from entering the world’s largest vaping market.
RELX, one of China’s largest e-cigarette companies, is seeking to submit its Premarket Tobacco Product Application to the U.S. Food and Drug Administration (FDA) by the end of 2021. Upon completion of a review process that will take no longer than 180 days, the FDA will take “action”, which could be marketing authorization, a request for more information, or denial, according to an article on techcrunch.com.
The vaping success story has requested a pre-submission meeting with the FDA and is expected to meet with the regulator in October, said Donald Graff, the two-year-old startup’s head of scientific affairs for North America, appearing in a video during a press event this week in Shenzhen.
Graff had a brief stint at Juuls Labs as its principal scientist after a 13-year streak at clinical research company Celerion where he oversaw tobacco studies. He’s now spearheading PMTA for RELX. Another scientist from Juul Labs, Xing Chengyue, who helped invent the nicotine salts critical to e-cigarettes, also joined in China’s vaping industry and founded her own startup Myst.
The PMTA is an extensive, meticulous, costly bureaucratic process for vaping products to establish that they are “appropriate for the protection of public health” before being marketed in the U.S. RELX, headquartered in the world’s e-cigarette manufacturing hub Shenzhen, has set up a team to work on the application process, including hiring third-party consulting services and clinical partners to generate data from tests that are necessary for the submission.
The high costs of PMTA keep many small players from entering the U.S., but RELX has the financial prowess to bear the expense — it estimates the entire process will cost it more than $20 million. A Nielsen survey RELX commissioned showed that the company had a nearly 70 percent share of China’s pod-style market as of April.
As the risks associated with e-cigarettes continue to draw attention from regulators around the world, Relx has ramped up its research investments to examine vaping’s impact on public health. At this week’s event, its chief executive Kate Wang, a rare female founder of a major tech company in China, and previously the general manager of Uber China, repeatedly highlighted “science” as a key focus at her startup.
Recently unveiled is the company’s Shenzhen-based bioscience lab, which is measuring the effects of RELX vapors through in vivo and in vitro tests, as well as conducting pre-clinical safety assessments.
Despite its ongoing efforts to prove the benefit of switching from smoking to vaping, RELX alongside its rivals faces regulatory uncertainties across various markets. The Trump administration banned flavored vape products last year (RELX plans to submit unflavored products for FDA review) and India banned e-cigarettes citing adverse health impacts on youth.
When asked how the startup plans to cope with changing policies, a RELX executive said at the event that “the company keeps a good relationship with regulators from various countries.”
“You can’t make conclusions on something that is still in the process,” said the executive, referring to the early stage of the vaping industry.
My Vape Order, parent to the Air Factory e-liquid brand, has announced its submission of a bundled premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA). The PMTA was for the company’s suite of 72 Air Factory flavors. The products include both freebase and salt nicotine formulations in a variety of nicotine strengths.
“Submission of the Air Factory PMTA marked the culmination of years of planning and hard work for the MVO team and our valued partners,” said MVO’s CEO Kyle Godfrey. “MVO is honored to be a leader in the vape industry, and is proud to provide consumers of tobacco and nicotine products a quality line of e-liquids that consumers can trust and enjoy.”
The PMTA submission was electronically filed with FDA on September 3, 2020. Included with the application were robust scientific data including independently-conducted toxicological risk assessments for the submitted products, as well as thorough research findings intended to establish the AIR FACTORY® products as appropriate for the protection of public health, according to a press release. T
The company’s PMTA filing coincides with the launch of redesigned product packaging for the Air Factory brand and the implementation of additional safeguards through the company’s B2B and B2C websites to further the company’s commitment to preventing youth exposure to tobacco and nicotine products.
The EAS Consulting Group is offering a webinar on how to prepare for premarket tobacco product application pre-approval inspections of manufacturing facilities by the U.S. Food and Drug Administration (FDA).
EAS Consulting Group’s senior director for dietary supplement and tobacco services, Tara Lin Couch, and LabStat’s Andrew Mooney will help participants understand the requirements.
The webinar is free of charge and will take place Sept. 15, 2020, at 11 a.m. Eastern time. Participants can register here.
On Nov. 9 2020, E-liquid manufacturer Purilum has entered into an exclusive, long-term supply agreement with E-Alternative Solutions (EAS), the manufacturer and supplier of Leap Vapor products.The Leap products containing e-liquids provided by Purilum have been on the market since prior to August 8, 2016, and are currently under review by the U.S. Food and Drug Administration (FDA).
Turning Point Brands (TPB) has submitted to the U.S. Food and Drug Administration (FDA) premarket tobacco product applications (PMTAs) for 250 products.
The PMTAs cover a broad assortment of products in the vapor category including multiple proprietary e-liquid offerings in varying nicotine strengths, technologies and sizes. They also include proprietary replacement parts and components of open system tank devices, along with a closed system e-cigarette.
According to TPB, the filings provide detailed scientific data to demonstrate that the products are “appropriate for the protection of public health,” as required by law.
The applications are supported by five pharmacokinetics studies, a likelihood-of-use study, and a patterns-of-use study, in addition to a toxicological review. Data throughout the applications underline that TPB products do not appeal to never users, youth or former users; that an extremely small percentage of users are never users, youth, or former users; that a significant majority of users have completely ceased use of combustible cigarettes; that a low percentage of users engage in dual or poly use; and that the products are substantially less harmful than combustible cigarettes and comparable to other products in the vapor category.
TPB has also provided a detailed marketing plan to illustrate how it will continue to prevent youth exposure to the products.
“We look forward to engaging with the FDA as it reviews our submissions,” said Larry Wexler, president and CEO of TPB.
Keller and Heckman has asked the U.S. Food and Drug Administration to postpone its Sept. 9 deadline for filing premarket tobacco applications (PMTAs) by six months because of the Covid-19 pandemic.
On behalf of a group of small vapor product manufacturers, retailers and trade associations, the law firm filed a citizen petition asking the FDA to postpone the PMTA due date until March 8, 2021.
Many of Keller and Heckman’s clients have experienced delays in preparing their applications because of the coronavirus. Without an extension, small vapor companies will either have to file incomplete PMTAs or forego submission altogether, according to Keller and Heckman. This would force them to layoff thousands of employees, close their doors permanently, and remove from the market less risky vapor products that addicted adult smokers rely on to move away from cigarettes, the law firm said.
The current PMTA deadline was set by a federal district court in Maryland as part of a lawsuit filed by anti-vaping groups challenging an earlier August 2022 deadline established by FDA through guidance issued in 2017.
The petition specifically asks FDA to request from the district court an extension on the court-imposed deadline that would apply only to small manufacturers that demonstrate to the agency that they have been working in good faith to complete PMTAs by the Sept. 9, 2020 cutoff and have otherwise taken steps to ensure that their products will not contribute to underage use.
Blackbriar Regulatory Services (BRS), a firm specializing in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market, is expanding.
The company announced today that it is growing its facility and services to meet increasing client demand. Immediate expansion efforts include adding cleanroom manufacturing space, increasing its analytical capabilities and expanding regulatory service offerings.
“With the [U.S. Food and Drug Administration’s (FDA) premarket tobacco product application (PMTA) deadline approaching within weeks for existing nicotine-based vaping products currently on the market, we are now seeing an increase in PMTA demand for new, innovative nicotine-based vaping products,” said Russ Rogers, CEO at BRS. “The FDA rightly worked with the industry to pause and take a look at the appropriateness of the products on the market, and those companies who understand how to make the highest-quality products are in a position to start working on applications for next generation technologies that should create dramatically improved user experiences and step-wise safety improvements.”
BRS was established to address challenges such as those that the PMTA process creates for manufacturers and brand holders. Its unique business model and capabilities provide numerous cost and speed advantages to clients who are looking for solutions to keep their products on the market in the United States, according to Rogers.
BRS is under contract to file more applications before the Sept. 9, 2020, deadline for several U.S. and international customers, and is now starting to prepare PMTA submissions for next generation nicotine-based vaping products for companies that are seeking to revitalize their product portfolio after the recent industry-wide focus on obtaining approval for legacy products.
Post Market Surveillance is an integral and mandatory commitment manufacturers must make to the FDA as part of their PMTA submission. BRS has also expanded its capabilities in this area to service clients both domestic and international to help them remain compliant in this regard, according to Rogers.
Authorities should create independent bodies to evaluate the science behind vapor—and base their policies upon the most credible evidence.
By George Gay
June 19, the Australian federal government announced a ban, from July 1, on the import of nicotine for vaping. The ban reportedly amounted to a de facto prohibition on vaping with nicotine because, while it provided for an exemption for imports made on the basis of a doctor’s prescription, the Australian Tobacco Harm Reduction Association (ATHRA) said that using such an exemption would have been complex, time-consuming and ultimately unworkable.
But temporary relief was granted when, on June 26, the government announced that it was suspending the implemen-tation of the ban while it conducted a review and consultation around the classification of nicotine. At the same time, how-ever, it said that a new version of the ban with a “streamlined” [but at the time unspecified] method for people to obtain prescriptions would be brought in from the start of next year.
There might be a good reason why the government is going to conduct this review when it has already decided to reintroduce a modified ban within six months, but it wasn’t immediately obvious to me what that reason might be. Having said that, perhaps there is no good reason. The government seems to have form in putting the cart before the horse.
According to ATHRA, the June 19 announcement of a ban was made before the publication of a report that was based on a scientific inquiry into vaping commissioned, at a cost of aud750,000 ($529,403), by the health minister last year.
I was reminded by all this of the nonsense song: “You put your left arm in / You take your left arm out / You do the hokey cokey / And you shake it all about.” I mean, even if you assume that vaping policy decisions in Australia are made on the basis of “two-up” and therefore might not always make a whole load of sense, that doesn’t explain the change that took place. Unless, that is, Australia is only partway through a best-of-three-throws series. In which case, before I get to the end of this piece, the policy might have changed again.
Despite, like the rest of us, being fully paid-up members of the club of sentient animals, Australian smokers and vapers may be allowed to import nicotine for vaping only if they have a prescription from their doctors, a certificate from their spiritual advisers and a letter signed by their mums. For goodness’ sake, these are adults who are allowed to buy and consume any amounts of cigarettes and alcohol, which are surely the two most toxic consumer products on the market.
I don’t want to trivialize what is a deathly important debate on vaping, but I find it difficult to take seriously such a rapid change of direction, even given that a week is a long time in politics. Of course, an argument can be made that the government acted responsibly in reacting to the opposition that quickly arose in respect of its June 19 nicotine ban—that it listened; that it had an open mind.
But it must be of concern that the government apparently didn’t listen before it made its announcement. And there has to be concern that the government might have suffered the same fate as many of those who attempt to maintain a completely open mind—that is, its brain fell out.
In fairness to the government, however, you have to say that the mess it got itself into was simply built on some fairly strong foundations already established by federal and state governments. For instance, as I understand things, even before the new ban was announced, nicotine for vaping was classified in Australia as a poison, and its import was illegal unless approved by the Therapeutic Goods Administration. Though, depending on the laws of individual states, nicotine could be bought over the internet provided it was for personal use. “You put your right arm in,” etc., etc .…
There are many arguments to be made against a ban on the import of nicotine for vaping, most of which will be familiar to the people who read this magazine, and those arguments are being well made in Australia by individuals, organizations such as ATHRA and politicians, even some within the ranks of the ruling coalition.
But one of the major problems for those opposing the ban is that it is irrational and, as has often been stated in the past, it is pretty well impossible to reason somebody out of a position that they didn’t reason themselves into.
And there could be significant negative consequences if the government persists with its policy of banning nicotine for vaping. Despite the best efforts of the World Health Organization (WHO) to ensure that smokers continue to smoke rather than switch to vaping, the smokers of Australia, who, unlike the WHO, don’t exist in a bubble that protects them from unauthorized ideas, know that vaping might be their best route to harm reduction. And some of them will continue, despite the ban, to try to remain on that harm reduction route by obtaining nicotine through whatever means possible.
This will inevitably create risks because some of that nico-tine will no doubt be produced in unlicensed premises and all of it will be mixed with other e-liquid ingredients by users with no training in such enterprises. Goodness me, to take another example, surely no government would encourage its untrained citizens to start producing their own alcohol?
And it seems obvious that the Australian government recognizes the risk of homebrewing e-liquids because, as part of its original ban, it set the penalty for infringements at aud220,000. The severity of the penalties set for laws reflect a number of things and, it seems to me, in some cases, one of those is the likelihood that people will break the law because it is unreasonable. And nothing could be more unreasonable than introducing a law that makes it more difficult for an individual to try to improve his or her own health.
URGENCY TO ACT
But there are many people better qualified than I am to make the case against the ban and who will be using the time to the end of this year to do so. I am interested in a more general question that arises out of the shambles that was the ban and its suspension—a question that pops up in other countries, that has global repercussions but that is less often addressed.
Why haven’t countries around the world and even the inter-national community arrived at a working consensus on vaping that leads us down a rational, clearly defined pathway with direction that can be adjusted as new information is received about the best way ahead? Why do we persist with performing the vaping “Hokey Cokey”? After all, you would imagine, I think, that this issue would be viewed by authorities around the world as a matter of the greatest urgency.
We are told by the WHO that tobacco consumption, largely in the form of cigarette smoking, comprises one of the biggest public health threats the world has ever faced, killing more than 8 million people a year worldwide. At the same time, it is indisputable that some cigarette smokers have used vaping to purge themselves of their tobacco smoking habit.
And, according to a timeline published by the Consumer Advocates for Smoke-Free Alternatives Association (CASAA), the idea of electronic cigarettes has been around for about 90 years, and the first commercial unit was pro-duced 17 years ago.
In other words, there is clearly a need for urgency here, and there has been time to act. But as can be seen from the Australian experience—and Australia is by no means alone in this—17 years on, many countries are still at the most basic of consultation stages; or, to put it in the Australian vernacular, we’re still running around like headless chooks when it comes to vaping.
FEAR OF THE NEW
Why is this the case? I don’t know the answer to that question, but there are a number of possibilities that occur, some, unfortunately, that tend toward the sorts of conspiracy theories that tell you Covid-19 is spread by 5G and that you would be better off forswearing a Covid-19 vaccine, should one be developed, and protecting yourself instead by sitting in a darkened room with a mixture of cow dung and honey on your head while listening to recordings of the narwhal daring us to be free.
Credit: Obi Onyeador
But much as I like a truly bonkers conspiracy theory, I think I need to keep this piece on a reasonably even keel and, the more I think about it, the more I tend to the view that the major problem the world has in embracing vaping is that it is different to what we are familiar with—good old smoking. In The Book of Nothing, John D. Burrow quotes Francis Cornford as saying, “Every public action, which is not customary, either is wrong or, if it is right, is a dangerous precedent. It follows that nothing should ever be done for the first time.”
Perhaps because it is not much into irony, the WHO seems to have taken seriously this reasoning in its approach to vaping. While acknowledging that much has been written about the potential of electronic cigarettes to help tobacco users quit, it says the evidence is inconclusive and goes on to advise against e-cigarette use.
OBJECTIVE EXAMINATION
Given the enormous differences between the constituents of tobacco smoke and those of e-cigarette vapor, and given the evidence that points to the ability of vaping to substitute for smoking for a significant number of smokers, the WHO’s position seems to take the precautionary principle to absurd heights. And one of the problems here is that the WHO exerts enormous influence over the health policies of many countries.
But there is no need for governments of the world to slavishly follow the WHO line. There is available to governments a huge amount of information on vaping from which they can make their own judgements and decisions. At the same time, however, there is a problem because while some of the information available is reasonable, some of it is questionable and some of it is unreasonable.
And since this information is being made available in a constant stream, there is probably little wonder that governments announce policies that within a week have to be suspended. To my way of thinking, what is needed, therefore, is for countries to establish taxpayer-funded bodies that are isolated from lobbyists and that are staffed with scientists who can examine objectively any scientific papers produced in respect of vaping and vapor devices.
Such bodies would examine all such papers and exclude any, no matter what side of the debate they supported, that did not meet the required standards of methodologies and results interpretation.
These bodies could then make precis for politicians of the papers that were found to advance the vaping debate. In this way, governments would be able to make decisions on the basis of facts, they would not be continually pulled this way and that by the latest bungled interpreta-tions of the results of biased research, and they would have no excuse for inserting their own biases.
Of course, some would complain that this would be an expensive exercise, but given what we are told are the extremely negative health, economic and social con-sequences of the continuing smoking epidemic/pandemic, such expenditure would surely be repaid many times over.
Others might complain that the U.S., for instance, already has the Food and Drug Administration (FDA) to oversee research in this way, and there is some truth in this. But the FDA also makes and enforces regulations, it interacts with those carrying out research and its decisions are subject to court challenges.
Credit: Vaporesso
The bodies I envisage would act sim-ply as filters that let through to regula-tory bodies only the research results that have passed close scientific scrutiny. They would perform peer reviews as part of a process that was properly funded and fit for purpose. They would not make policy recommendations and, importantly, their decisions would not be open to challenge, though the workings of these bodies would be subject to scrutiny by a suitable organization.
Surely it would be worthwhile putting in place such bodies so that, if vaping has the potential that many people believe it has to prevent a significant number of smoking-related deaths, that potential can be fully realized. And, of course, if it were found that that potential did not exist or could not be realized, it would allow us to move on. Such a process has got to be better than doing the “Hokey Cokey” on a loop. V
It seems the vapor industry has a future after all. Several large tobacco companies, such as Vuse, Blu, Logic and Juul, have already filed premarket tobacco product applications (PMTAs) for their vapor products with the U.S. Food and Drug Administration (FDA).
While several smaller companies have said they would file PMTAs, E-Alternative Solutions (EAS) is the only vapor manufacturer to announce that it has received both acceptance and filing letters from the FDA for its submitted vapor products.
EAS’ Leap and Leap Go brands will now move on to the substantive review stage of the PMTA process. During this phase, the FDA will decide whether the EAS products are “appropriate for the protection of public health.”
“This milestone represents an important step forward for EAS as we support our mission of producing high-quality vapor products that serve as an alternative to combustible cigarettes with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS. “FDA acceptance and filing letters are a testament to the strength and thoroughness of our applications, which we believe will meet [the] FDA’s requirements.”
Leap Vapor is a closed pod system designed for adult smokers. Leap Go is a line of disposable e-cigarettes. The Leap and Leap Go products can now stay on the market past the FDA’s PMTA deadline of Sept. 9. The products will be allowed to remain on the market for one year or until the FDA decides whether the products are a benefit to public health compared to combustible cigarettes.
When asked why EAS publicly announced its accep-tance and filing letters unlike some other companies, Chris Howard, vice president, general counsel and chief compliance officer at EAS, said that many vapor wholesalers and retailers remain uninformed about the potential status for many of the vapor products they are selling. EAS wants to be “open and honest” about the process.
“We’ve taken a different approach by providing informa-tion regarding the PMTA process and what it’s like to work with [the] FDA. This gives retailers an idea of what to look for, especially after Sept. 9,” says Howard. “A lot of retailers want to do the right thing. So, after Sept. 9, they don’t want to be doing something illegal. They definitely don’t want to be confused and unsure. We’re providing retailers with a tool to be certain that they are selling legally compliant products after the deadline.”
Howard said that, unfortunately, he does not see a scenario where the FDA will allow a sell-through period for products already on store shelves. The FDA is most likely going to demand that all products that have not submitted a PMTA be removed. However, the FDA may face challenges in policing the more than 152,000 convenience stores operating in the United States, according to the 2020 NACS/Nielsen Convenience Industry Store Count.
“We know [the FDA is] not staffed adequately to do that, and that’s unreasonable. So, in large part, [the] FDA relies on the people who want to be the good actors, to adhere to the regulations,” said Howard. “I think that most will—75 percent if I had to guess. A lot of them will immediately try to be compliant.”
Many retailers wonder if they will be responsible for the products that can no longer be sold or if distributors will buy back the products. While many distributors will not buy product back, Howard says that EAS has always offered its products with a 100 percent guarantee for the retailers.
“At EAS, we make it clear that our products are 100 percent guaranteed, and we do take product back. We’ve taken back all of the flavored pods that we had on the market and provided people with full refunds or credit in the form of other product,” he explains. “I personally believe that is the right thing to do, especially in an industry where the channel was burned multiple times by various vapor companies, and retailers got stuck with inventory that they couldn’t move. I think that some companies are aligned with my view on that, and they will take it back—but I wouldn’t say it’s the majority.”
RAPID RESPONSE
The FDA does not necessarily have a reputation for moving quickly. However, EAS received its acceptance and filing let-ters just over a week after submitting the application. Howard says that there isn’t necessarily a rational reason for why it was so fast. However, the FDA is committed to its timelines and is trying to move in an expedited manner.
“When you have something that’s organized and it comes in and makes it easy for them, then yes, you’re likely going to get the benefit of a quicker review. Now, I don’t know if that translates into a quicker substance review, or scientific review,” Howard said. “I believe one of [the FDA’s] goals is to clean up this space and get their arms around the problem. One of the ways to do that is to make sure you get those acceptance and filing letters out quickly. And you reject the ones just as quickly that aren’t adequate to meet the standard.”
Howard said that the EAS PMTAs for the Leap and Leap Go products together comprised 109,000 pages. EAS essentially filed two “buckets” of PMTA data with one being the Leap Go (which contained three SKUs) and the other the Leap (which contained 26 SKUs) for a total of 29 SKUs. The data contained more than 25 individual studies. The applications also contained several digital links to data.
“The Leap application had about 45,000 links, and the Leap Go had about 46,000. We covered every discipline. We did behavioral testing. We did an assessment of popula-tion risk. We did clinical studies. You might have heard of PK [pharmacokinetic] studies to see how the body reacts to the products. We did those to show that the products have a lower abuse liability potential relative to cigarettes,” says Howard. “We did all of the required HPHC work to con-firm that our exposures are a lot lower than the combustible cigarette. We did toxicity testing. We did a comprehensive analysis of every ingredient that’s in the products. We did chemistry testing. We evaluated the products for stability and shelf life, and that’s still ongoing for the next two years. We did an environmental assessment.”
Flavors in vapor products have been a controversial subject recently. When asked if EAS had submitted any flavors other than tobacco flavors for its PMTAs, Howard said the company approached the subject carefully and with much consideration of how flavors have been shown to help smok-ers make the decision to seek an alternative to cigarettes. He also acknowledged the open question as to whether flavors may contribute to youth experimentation but noted that companies like EAS, which prioritize compliance and limit-ing access and exposure to adults, are positioned to market flavored products responsibly moving forward.
“For the Leap pods, we currently only sell tobacco and menthol, which were submitted. We also submitted all the flavors we had to remove from the market back in February. There were a handful,” said Howard. “For the Leap Go, which are disposables and flavors are permitted, we submit-ted a mango flavor as well as tobacco and mint. You have to make decisions when you’re spending millions of dollars trying to create some efficiencies, and this was one of the ways we tried to be prudent. It’s not to say that we wouldn’t file more Leap Go flavors later, but if you look at our rela-tive business model, the Leap is a more dominant product, so we had a heavy focus on its PMTA submission.”
Jacopo D’Alessandris
Howard said he could not share the total cost for the PMTA process; however, it was in the tens of millions of dollars for all 29 SKUs combined.
WAITING FOR ANSWERS
Howard says the letters are straightforward. They state that EAS’ application has been accepted and filed, respectively, and the applications are ready to move on to the next stage. This is the stage where the FDA may want a tour of the com-pany’s manufacturing facilities. “I could see this happening,” explains Howard.
The process is now completely in the hands of the FDA, according to Howard. There could also be several different types of situations that present themselves before the FDA issues either a marketing authorization or denies the applica-tion. Howard said the acceptance and filing letters do provide some clarification, but it is still a “wait and see” process.
“I think the next step should be that, if they’re going to do it, they’re going to ask for samples. I believe that is what really starts the 12-month timeline. We haven’t been asked for samples yet. We’ve immediately engaged to make sure we have the samples ready, even the flavored pods, which are not currently on the market,” said Howard. “Now, they’re going to have their hands full come Sept. 9; I’m sure they’re going to get a lot of applications, and that might slow things down.”
Chris Howard
The FDA may also need additional information, accord-ing to Howard. The agency may request additional details regarding studies EAS has already provided, for example. It’s also possible that EAS may have to complete additional stud-ies to be able to answer a specific question.
“What I like to think is going to happen in that stage is a give-and-take and sort of a collaboration about what’s reason-able because, at the end of the day, these products are clearly appropriate for the protection of public health as compared to cigarettes,” Howard said. “Then you have this engagement, and that’s consistent with what [the] FDA has said, and then you’re on your way. Additionally, if you do get a request for additional information, that technically stops the clock, so that could extend your 12-month window. After the FDA receives any additional information it may require, the next phase is receiving the marketing authorization.”
If EAS receives a PMTA, the next step for the company to consider is whether it wants to file for a modified-risk tobacco product (MRTP) application. The only products to have ever received an MRTP are snus products and Philip Morris’ IQOS heat-not-burn device. Howard says that EAS may consider going through the process, but he questions the value of an MRTP.
“We now know it isn’t just some black box that nobody gets. I mean, it’s clearly possible. But we have to wait and see how this vapor category shakes out and whether or not an MRTP claim—whether it’s reduced harm or exposure—does that really add value in the eyes of the consumer?” Howard asks. “I don’t know the answer; so it’s a wait-and-see kind of decision.”
To grant a PMTA, the FDA will have to determine a product is “appropriate for the protection of public health.” It can be interpreted that a tobacco product receiving a PMTA is less risky than a combustible cigarette. However, a company can make that claim only after receiving an MRTP. Even if granted, MRTP claims will still be limited. IQOS, for example, received an MRTP but can only make reduced expo-sure claims. The company cannot make a reduced-risk claim.
“The MRTP is also super expensive. That’s many more millions of dollars on top of what we’ve already spent for the PMTA. We’re looking into the opportunity, but we haven’t decided,” says Howard. As far as advice for companies still preparing their PMTAs, Howard says to remain diligent.
The Covid-19 pandemic has only made collecting the data more complicated. This may lead many companies to be nervous about submitting an incomplete application. Howard says he believes that companies must be open and honest with the regulatory agency.
“If you’re in a position where you can’t do it all, you focus on the statutory requirements and making sure that those are robust and complete. And then areas where you do have gaps, you very clearly explain why you have a gap and what you’re going to do to fix it and when you’re going to be done. Don’t try to do a shortcut version,” says Howard. “I think [the] FDA will be understanding and receptive and ultimately work with you to make sure that all the data is complete. I mean, they don’t want to kick you out for not having finished your human factors testing. However, if you submit without an environmental assessment, they’re going to kick it out.”
After the Sept. 9 deadline, Howard says he expects to see the industry become more streamlined. He says that there’s a strong possibility that numerous companies will go out of business. However, there will still be a sufficient amount of options at retail.
“I think that there’ll probably be multiple variations of e-liquid, so it won’t be as many selections as there are today, but there will be open system options. I think because the products contribute so much to harm reduction that it’s not in [the] FDA’s best interest, or anyone’s best interest, for the cat-egory to be gone,” he says. “So anytime I hear someone say, ‘Oh, the vapor category is going to be gone,’ I completely disagree.” V
Avail Vapor announced today that it has received its first premarket tobacco product application (PMTA) acceptance letter from the U.S. Food and Drug Administration (FDA) for its e-liquid nicotine products. While the company would not say what flavors or how many flavors, it was confirmed that the mixed-berry flavored Mardi Gras was a submitted flavor.
Blackbriar Regulatory Services led the regulatory process for Avail’s submission. The application now moves to the substantive scientific review where the FDA will determine if Avail has scientifically proven that its nicotine vaping products are appropriate for the protection of public health.
This is one of numerous applications that Avail plans to file prior to the September 9, 2020 deadline which will provide a wide-ranging flavor portfolio to meet the needs of adults seeking alternative choices to combustible tobacco products, according to James Xu, chairman of Avail.
James Xu
“We started mapping out our regulatory framework and PMTAs in 2015, before nicotine vaping products became subject to the FDA’s tobacco authority,” said Xu. “We couldn’t be more pleased that the years of hard work, investment and dedication have gotten us to this point. Our end goal is to seek an FDA marketing order which would allow us to continue to keep our products on the market for those adult smokers looking for alternatives to traditional tobacco products.”
In order for nicotine vaping products to remain on the market after the FDA’s September 9, 2020 PMTA submission deadline, companies must submit a viable PMTA with the intent of seeking an FDA marketing order. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health.
