Hall Analytical is offering a virtual seminar on Feb. 11, 5-6 pm GMT about the U.S. Food and Drug Administration’s premarket tobacco product application process.
E-liquid and device manufacturers will have an opportunity to take part in a live Q&A session with subject matter experts.
Panelists include David Lawson, CEO, Inter Scientific; Patricia Kovacevic, founder and principal, Regulation Strategy; and Sally McGuigan, principal scientist, Hall Analytical
This session is limited to the first 50 registrants, and therefore places will be offered on a first come, first served basis.
Broughton Nicotine Services has published a summary of the U.S. Food and Drug Administration’s rule for the premarket review of new tobacco products.
Released on Jan. 19, the FDA’s final rule makes amendments and recommendations to the previous rule and helps ensure that PMTAs contain sufficient information for the agency to determine whether a marketing granted order should be issued for a new tobacco product.
The purpose of the rule is to improve the efficiency of the submission and review of PMTAs as well as providing applicants with a better understanding of the information a PMTA must contain.
Amongst other topics, the rule addresses:
The submitting of detailed information regarding the physical aspects of the new tobacco product and full reports of information regarding investigations that may show the health risks of the new tobacco product.
Whether the product presents the same or different risks compared to other tobacco products. The FDA requires the submission of these health risk investigations to ensure it understands the full scope of what is known about the potential health risks of a new tobacco product.
Electronic submission of the PMTA.
Post-market reporting requirements for applicants that receive marketing granted orders.
Retention of records requirements for PMTAs
Procedures by which the FDA reviews a PMTA
Broughton Nicotine Services summarized the 516-page recommendations and requirements report into a digestible guide, which is available for download here.
The U.S. Food and Drug Administration on Jan. 20 finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. PMTA and SE are two of the pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.
Stephen Hahn
“The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products. The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act,” said FDA Commissioner Stephen M. Hahn.
Mitch Zeller
“These final rules, together with our commitment to ongoing enforcement action against e-cigarettes and other tobacco products that illegally target youth, will help us continue to protect the public from the dangers of tobacco-related disease and death,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency as we ensure that tobacco products are put through an appropriate series of regulatory gates so that products can be marketed only if they meet the standards under the law.”
Both of these final rules are effective 30 days after publication in the Federal Register.
More information about the two foundational rules is available on the FDA website.
The U.S. Food and Drug Administration (FDA) has sent its first set of warnings letters to manufacturers of electronic nicotine delivery devices (ENDS) that did not submit premarket tobacco product applications (PMTA) by the Sept. 9 deadline.
On Jan. 15, the agency issued warning letters to 10 firms who manufacture and operate websites selling ENDS products, specifically e-liquids, advising them that selling these products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S.
Per court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by the FDA on the application.
The FDA plans to post a list of products for which the agency has received applications; however, before making such a list available, the FDA is verifying certain information about these products so that publication of a list complies with federal disclosure laws.
Stephen Hahn
“The premarket application process ensures that new tobacco products, including many already on the market, will undergo a robust scientific evaluation by the FDA,” said FDA Commissioner Stephen M. Hahn in a statement. “Scientific review of new products is a critical part of how we carry out our mission to protect the public—especially kids—from the harms associated with tobacco use. In addition to the important premarket scientific review, prioritizing enforcement against those who violate the law by selling unauthorized products is how we help protect public health.”
The 10 firms receiving warning letters are Little House Vapes; Castle Rock Vapor; Dropsmoke; Perfection Vapes; CLS Trading; Session Supply Co.; Coastal E-Liquid Laboratory/GC Vapors; Dr. Crimmy; CMM Capital LLC; and E-Cig Barn.
Mitch Zeller
“These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations,” said Mitch Zeller, director of FDA’s Center for Tobacco Products. “We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law.”
The FDA has requested responses from each firm within 15 working days of receiving the letter detailing how each company intends to address the agency’s concerns.
Regulation, taxation and fighting bad science is all on the agenda for the tobacco and vapor industries over the next 12 months.
By VV staff
During the final session of the Global Tobacco & Nicotine Forum (GTNF), the future of the vapor industry was put on center stage. The panel of experts suggested that regulation, taxation and confronting misinformation are going to be the major challenges that the tobacco and vapor industries battle over the next 12 months.
In the U.S., the premarket tobacco product application (PMTA) process is going to be a major legal and regulatory focus, according to Stacy Ehrlich, partner at Kleinfeld Kaplan & Becker LLP. She said that while companies need to file PMTAs or standard equivalency (SE) reports, it is unknown how the U.S. Food and Drug Administration (FDA) will review these new products and enforce its rules.
“How wide will the FDA enforcement be over these products? Another regulatory key issue over the coming 12 months will be flavors in vapor and cigar products at all levels of government,” she said. “Flavors may increase initiation in youth … but they may also help move adults to lower risk products.”
So far, the only action toward flavors by the FDA has been to remove all flavors except tobacco flavors for closed pod systems. The absence of federal rulemaking has motivated some local and state entities to enact their own flavor bans.
“What are unintended consequences of flavor ban?” Ehrlich asked. “A push towards the black market—push people back to smoking? What are the long-term impacts on public health? These are significant regulatory issues to watch in the coming year.”
The fight against misinformation will also be a major issue. David O’Reilly, director of scientific research for British American Tobacco, told attendees that the industry is still suffering from the effects of the e-cigarette or vaping product use-associated lung injury (EVALI) that began in mid-2019. That crisis was later found to be caused by vitamin E acetate in black market THC products and not any nicotine-based vapor products.
“What the pandemic might do, and the jury is still out on this, but it has brought science and evidence into everyone’s lives,” said O’Reilly. “There is an opportunity for this industry to use that science to promote harm reduction and bring this information to consumers and make them more savvy, and maybe they will look at the different products and brands [and move to a less-harmful product].”
Another effect on the industry caused by the pandemic may be on packaging. Omar Rahmanadi, CEO of BMJ, said that before the pandemic, there was a pressure through social media and from political groups to lessen the use of single-use plastics. The pandemic, however, has caused a major increase in the use of such plastics because of the massive need for gloves and masks.
When the pandemic ends, there could be a major pushback toward removing single-use plastics from the market completely, Rahmanadi speculated. “It’s only a matter of time before the vapor and tobacco industries are pressured to use less single-use plastics,” he said.
Sally Satel, resident scholar at the American Enterprise Institute and psychiatry lecturer at Yale University, said that for any innovation or regulation to be implemented properly, the industry needs “a massive public reckoning of the truth” about the advantages of switching to vaping from combustible cigarettes. For example, there has been a move toward negative science and studies in recent months, she says.
The World Health Organization (WHO) endorsed a vaping study centered on heart disease that was later retracted. The study, which appeared in the Journal of the American Heart Association (JAHA), was written by Dharma Bhatta and Stanton Glantz of the University of California, San Francisco, and concluded that “Someday and everyday e‐cigarette use are associated with increased risk of having had a myocardial infarction, adjusted for combustible cigarette smoking.”
Another study from Rutgers University found that 80 percent of doctors wrongly believe nicotine causes cancer. It also took the Centers for Disease Control months to clarify that EVALI was caused by black market THC vapor products. “This paints a fairly grim picture of what we are up against,” said Satel. “And all of this while allowing cigarette sales to go undisturbed while putting barriers on devices that are a great benefit to public health.”
Whatever the challenges facing the tobacco and vapor industries, answers are out there, according to David Sweanor, adjunct professor of law at the University of Ottawa. He said several countries have lessened restrictions on next-generation tobacco products in recent years, and that has had a ripple effect in the tobacco industry. Cigarette sales have slumped.
“We have seen what happens in other countries when we see a slight lessening of restrictions on these [next-generation] products like we have seen in Japan … Norway, Iceland, Sweden. These aren’t places that are actively trying to see how rapidly ending smoking is happening; it was just the effect of lessening restrictions,” explains Sweanor.
“What would happen if any jurisdiction in the world wanted to see how rapidly they could get rid of cigarettes? … Good policy is contagious. It would be very hard to resist if we saw something like that happen on a major scale to end smoking. Any country that gets that right—backs new technology—could save hundreds of millions of lives and possibly even create a new technology sector for its economy.”
Photo Credit: Peggy und Marco Lachman / Photo Illustration by Mike McDonald
By Maria Verven
Char Owen and Amanda Wheeler knew the enormous uphill battle other vape business owners would face when pulling together their premarket tobacco product applications (PMTA) for the U.S. Food and Drug Administration (FDA). After all, the PMTA process—which the FDA has foisted on thousands of small business owners—had been built for billion-dollar tobacco manufacturers. Every flavor in every nicotine level—even the smallest differences—needed its own PMTA, and each PMTA cost hundreds of thousands of dollars.
Add it all up, and some manufacturers had to submit PMTAs for more than 2,000 products. The costs will be astronomical—estimated in the hundreds of millions. Aside from the costs, there’s another huge hurdle: Very few vape business owners have information technology experts or paid scientists on staff—the kind of expertise necessary to submit the extensive paperwork required by a PMTA.
And what about the help for small businesses that the FDA promised? It never arrived. So Owen and Wheeler stepped up to help their colleagues. After downloading the complete list of manufacturers from the FDA site, they called each and every one to announce their new group, simply called PMTA Sharing.
Ultimately, the group grew to 1,700 members, including vape businesses all across the country as well as several suppliers that offered to pitch in to help business owners through the PMTA process. The group’s services are completely free; the only fee members pay is for environmental assessments or cover letters and forms created by industry attorneys. Thus far, the PMTA Sharing group has helped more than 200 businesses submit PMTAs for 1.7 million products. But Owen and Wheeler didn’t stop there.
They’re now starting a new nonprofit trade association called American Vapor Manufacturers (AVM) to help small businesses meet the FDA’s onerous scientific testing requirements (see sidebar).
Here’s their story.
Vapor Voice: Tell me more about your vapor businesses. How have your businesses fared over the years?
Owen: I own two brick-and-mortar vapor shops as well as a very small wholesale line. We started in 2013 as a labor of love dedicated to my father whom I lost from lung cancer in 2001. I’ve since gained more friends in my little town of Seguin, Texas, than I can count. We all have one common goal—keep people away from combustible tobacco.
We lost some sales due to the EVALI (e-cigarette or vaping product use-associated lung injury) scare, but thankfully most did not return to smoking, and those who did are slowly returning to vaping. Our retail lobby had to close during the shutdowns in Texas, but I fought extremely hard and was able to at least keep curbside service available. So while we lost a bit of sales, we didn’t have to close. We are grateful, as many others were not so lucky.
Wheeler: I own Jvapes E-liquid, founded in 2011, headquartered in Prescott, Arizona, with stores in Arizona, Colorado and Oklahoma. We also sell online at www.jvapes.com and wholesale at www.wholesalejvapes.com.
Both my husband and I are former smokers who quit with vaping. At the time, vapor products were not widely available in our local community. We started out with a tiny 400-square-foot store, but the response to vapor products was so positive, our business quickly grew into what it is today.
With the exception of late 2019 and misinformation surrounding EVALI, our business has fared very well over the years as people have seen for themselves the effectiveness and positive change from vaping. Our target audience are cigarette smokers, age 49 on average, who have not been able to quit by other means. We learned during our PMTA data collection that 83 percent of our customers have quit smoking entirely.
Have you been involved in vape advocacy?
Owen: I have been involved with advocacy in Texas for the last three years through SFATA [the Smoke Free Alternatives Trade Association] and have also been involved with federal advocacy. I am a member of SFATA, USVA [U.S. Vaping Association], a monthly supporter of CASAA [Consumer Advocates for Smoke-Free Alternatives Association] and am now the vice president of our new company, AVM.
Wheeler: I am the president of Rocky Mountain Smoke Free Alliance, our Colorado trade association. I’m also executive director of the Arizona Smoke Free Business Alliance where I’ve worked on everything from vapor taxes to flavor and public vaping bans to licensing. Prior to starting AVM, I was involved in federal advocacy for PMTA reform where we spent over a year lobbying Health and Human Services [HHS] to have small business PMTA applications accepted.
When and why did you start the PMTA Sharing group?
Owen: I was in the process of doing my own PMTAs. As a 20-year computer engineer, I had an extensive history in document replication and information technology, so I knew I could create the documents I needed. But I also knew that most small businesses did not have the same ability. Most could not even use Microsoft Excel.
I started the PMTA Sharing group on Feb. 17, 2020—a significant date for me because it was my son’s birthday. I lost my son in 2013 just a few weeks before we opened our first brick-and-mortar store. I tried many times to help him quit cigarettes but was never successful.
So after filing our own PMTAs, we created applications for other businesses to create and file their documents and then held Excel training classes. We even did computer support when their machines were unable run the applications, implemented a Microsoft OneDrive for data collaboration, and created training videos and step-by-step instructions.
Amanda Wheeler
Wheeler: I began advocating for a streamlined PMTA process for small businesses. I knew that my business as well as my state’s group members and most independent vapor manufacturers would not have the financial resources to complete the full PMTA process. Without significant changes to the process, only large corporations would survive PMTA regulations.
Does the work keep you up at night?
Owen: Helping the group submit PMTAs was a monumental undertaking, requiring 14[-hour] to 16-hour workdays most of the time. It has taken a toll on both my physical and mental health.
We put as much effort as was needed to make sure no one would be left behind. We’ve received tons of feedback [see testimonials] and gratefulness for our group. They now have hope that their small businesses can continue to help people who have quit and those who want to quit smoking.
It’s an amazing feeling when you’re walking in your town and someone who has smoked for 30-plus years recognizes you and gives you a hug because they can finally live a life away from combustibles. We all feel that same joy with each and every person who puts down cigarettes.
I remember one lady who called me to thank me, explaining that if it wasn’t for our group, she would have no means to support herself and her two-year-old daughter. Of course that makes me happy, but also very angry that the FDA put her in that situation and treated her as if she was a big tobacco business with all the resources necessary to meet their requirements.
Char Owen
The FDA has publicly acknowledged that the costs associated with the PMTA process may be challenging to small businesses and that many would go out of business. That is not how our government is supposed to operate.
What else do people in the vapor industry need to know that would help and motivate them?
Owen: We are optimistic that we will complete this process through sheer determination. While we don’t expect help from the FDA, the HHS has been willing and open to listen to our challenges.
We hope to move the group through to the testing phase and move the membership to the AVM. We have accomplished the monumental task of completing the first part of the process. It will be difficult, but we will move as many small businesses through the entire process as soon as we possibly can.
Our colleagues in the vapor industry need to know that we will not stop fighting for them. We understand what they are facing better than anyone. We are them. There is no one better to fight for small manufacturing than small manufacturers. Our hearts are fully invested in this industry.
Wheeler: I am optimistic. We have a very solid plan and approach, and we have the right scientific, legal and lobbying expertise to get the job done. Many passionate and dedicated individuals are on the AVM board, guiding our organization in the best interests of small businesses.
We are unified and moving together toward the same goal, and I believe we have a recipe for success.
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
The U.S. Food and Drug Administration’s (FDA) dreaded deadline for its premarket tobacco product application (PMTA) has come and gone after multiple delays. With all that’s happened this year, it may have gone unnoticed for many. Rest assured that the process of submitting a PMTA has been long and tedious for manufacturers and vendors alike, and they have been working hard to ensure that reduced-risk products remain available for as long as possible.
Many companies have been working tirelessly to submit their applications, but the process is fairly opaque and uncertain. The filing of the PMTA does not ensure FDA acceptance, and each product must be filed separately. Currently, it is largely unknown which specific products have been submitted for FDA approval.
What is known, however, is which companies intend to submit or have already submitted a PMTA and how far along they are in the process. Keep in mind that being further along in the approval process is not necessarily an indicator of success. No vapor company at the time of this writing has received FDA approval for any product, and the length of time each submission will remain within the approval process is unknown. With so many unknowns, it can be difficult to predict which products will be legal to carry, if any. By looking at which companies are taking part in the PMTA process along with their histories, one can make reasonable assumptions as to which direction the vapor industry will begin to sway.
First, the bad news. Given that each PMTA is only valid for one “distinct new tobacco product,” and that even the smallest difference in the design of a product could warrant an entirely new SKU, it’s only reasonable to assume that there will be massive consolidation of vapor products. Products that are too similar will need to reconcile, either by being discontinued or redesigned. Even identical products with different colors, flavors, resistances or nicotine strengths could be considered separate SKUs, with each requiring its own PMTA, which has proven to be prohibitively expensive.
The massively varied choices that vapers have in products is undoubtedly going to shrink, but by what degree? A mod is considered one SKU, and an atomizer or tank is considered another. If the mod requires separate batteries, those are also considered an SKU, which requires FDA approval. Said batteries require a charger; that’s another SKU. If the mod and the atomizer come as a kit, that would yield yet another SKU. If the atomizer has three coil options of different resistances, that could require three separate PMTA applications. Clearly, this can spiral out of control quickly, so it’s expected that companies will need to streamline their product offerings.
Two parallel philosophies have been playing out over the past several years. One is to throw everything at the wall and see what sticks. Several companies have been releasing an overwhelming number of products in quick succession to try to get a better feel for what works and what does not. PMTAs are expensive, and many companies have adopted the “measure twice, cut once,” mentality. The past 10 years or so have allowed the industry to innovate, unimpeded by government regulation. This innovation naturally plateaued to a point where vapers have enjoyed a few years of refinement.
The technology seen today is not much different from the technology introduced three years ago. The difference is that today’s products have gone through a process of refinement due to the growing population of vapers providing feedback with both their voices and their wallets. It’s been a completely free market up until this point, and while manufacturers have been steadily improving their products, now is the time to lock in the best of the best and commit to the long term by submitting PMTA applications.
The other philosophy is to streamline the product offering, and this can be seen with the popularity of proprietary systems. For example, 510 devices have pretty much stagnated in popularity while pod systems have seen a boom. If a 510 device is compatible with a thousand 510 atomizers, and vice versa, that’s an impossible number of PMTAs, and without an example of a product that has undergone the process, it would be a huge gamble to try to sell the FDA on a device that is compatible with products outside the applicant’s ecosystem.
The prospect of a device such as a 510-compatible atomizer, which is ripe for facilitating the rise of black market mods, could invalidate the PMTA process on that prospect alone. Not only would the applicant be taking a larger risk by submitting a PMTA for a 510 device, but he would also be complicit in the assumed knowledge that he won’t see a return on that PMTA investment if the end user chooses to go outside said applicant’s ecosystem for complementary products. In short, manufacturer X isn’t going to shell out hundreds of thousands of dollars to submit a PMTA for a 510 mod if vaper Y is just going to turn around and buy an atomizer off the black market.
The most likely scenario is that each company is going to submit PMTAs for a line of products that keep the customer within their ecosystem. Whether that’s one type of product or several remains to be seen, but it only makes sense for any company to want to see the highest return on investment possible. Additionally, this is only the first round of PMTAs, and no product has made it successfully through the process.
It’s unlikely that any applicant has already submitted more than a few products for approval. Even with FDA guidance, the industry is figuratively a canary in a coal mine. Until there is a solid example of a product successfully navigating the PMTA process, companies are likely to be conservative in how many products are submitted for approval. Those that do will likely be product types that have proven to be the most profitable and simple.
Pod systems are the most likely products to have already been submitted, along with e-liquids. They’re the most popular products in today’s market and are the easiest to consolidate. There are many pod systems out there, perhaps too many, but for good reason. They appeal to the widest market and ensure that consumers remain within the ecosystem as they keep coming back for replacement coils and pods.
Pod systems are also the most resistant pieces of hardware when it comes to a black market, therefore mitigating any risk for a PMTA rejection based on that premise. Many companies have released multiple pod systems over the years and by now have a good idea of which designs are the best. In terms of hardware, expect to see a pod system as the first “FDA-approved” vapor product.
As for specific companies to keep an eye out for, look at the largest companies. Smok, Innokin, Vaporesso, Juul—these manufacturers have been preparing for the PMTA deadline for years and have already submitted applications. In fact, almost all the big names in the vapor industry have submitted applications, including Uwell, HorizonTech, Sigelei, Suorin and others. Currently no PMTA has been approved, but none have been rejected either. These companies have the most resources, motivation and resolve to see this process through to the end.
E-liquid, however, is a completely different animal. It takes much more to create vapor hardware than it does to create e-liquid, and that means that smaller companies have also been submitting PMTAs for e-liquid. Unfortunately, much more consolidation will likely also be occurring. Remember, if only one flavor is available in four nicotine strengths and three bottle sizes, that’s potentially 12 PMTAs for “one” e-liquid. So even though more e-liquid companies are submitting PMTAs than hardware manufacturers, each e-liquid manufacturer will likely have to consolidate much more than a hardware manufacturer. This is also heavily reliant on how the FDA receives the PMTA. Many e-liquid manufacturers have submitted one PMTA for multiple flavors, but the success of this method remains to be seen, and the FDA’s own language is ambiguous:
“A manufacturer could submit one premarket application for multiple tobacco products with a single, combined cover letter and table of contents for each product. However, when [the] FDA receives a premarket submission that covers multiple, distinct new tobacco products, we intend to consider information on each product as a separate, individual PMTA …. [The] FDA considers each ENDS product with a differing flavoring variant or nicotine strength to be a different product.
So will each different nicotine strength of each bottle size require a separate PMTA, or can they be combined? It’s unclear, but some manufacturers such as AMV Holdings are confident that multiple SKUs can be covered by a single PMTA successfully. In a Sept. 9 press release, AMV writes, “AMV has filed an additional 104 PMTA submissions accounting for over 5,000 SKUs.”
However, even if multiple SKUs can be approved by the FDA under a single PMTA, consolidation will still occur, and only the most popular flavors, strengths and sizes will be submitted, at least initially. Given the popularity of pod systems, many manufacturers will likely submit a PMTA for e-liquids that use nicotine salts for a high concentration of the stimulant. Non-nicotine e-liquid is also likely to be among the first wave of submissions as well as one that is medium-strength. The reason being is that if a vaper prefers a nicotine strength of 3 mg, then unofficially the user can mix a higher strength with the non-nicotine e-liquid to achieve the desired strength.
Several well-known e-liquid companies have submitted applications, including Humble Juice Co., Suicide Bunny, Charlie’s Chalk Dust and Beard Vape Co. While the more popular flavors may or may not have been submitted, there are several things that can be expected. First, tobacco and menthol flavors will likely be among the first flavors to receive approval, followed by basic fruit flavors.
Like with nicotine strengths, flavors can be mixed by the end user, and by keeping it simple, mixing becomes much easier. Strawberry mixed with banana is much easier than apple-peach-mango mixed with blueberry mint. Depending on how the FDA treats bottle sizes, those may be consolidated to one size as well. Thirty milliliters is far and away the most popular size bottle for e-liquid, so expect that to become the standard.
As the top level of the vapor industry consolidates its products, so too must the ground level. Doing so in a similar way to manufacturers is the most pragmatic approach. If and when products begin receiving FDA approval, look for three “levels” of products—beginner, intermediate and advanced—with minimal variation for each.
At first, all three levels may be pod systems with varying degrees of advanced features, such as variable wattage, temperature control, etc. Beginner devices like disposables and pod systems, such as the Caliburn G from Uwell (see “Building on Success,” page xx), should take priority because even if they are mostly targeted at new and beginning vapers, advanced users can find value in those products as well.
Intermediate-level products can begin to include features such as variable wattage and a larger battery capacity or e-liquid capacity. These are generally features that are requested by beginners who have had time to use a lower level product and find themselves wanting for more. Perhaps it’s more vapor or just not needing to charge the battery quite as much. Each customer base can vary, but those moving to intermediate devices want “more but better.”
Advanced products are much the same but with generally higher power capabilities, e-liquid capacities, etc. The advanced user will generally know what they are looking for. In the current state of the industry, advanced devices generally include rebuildable atomizers as well, but these are likely not going to be a priority outside of niche markets. There’s a good chance that the first products brought through the PMTA process will be on the simple side, and rebuildables could require a separate PMTA for each type of wire and wick in order to be usable.
The mods most commonly used with rebuildables also tend to have removable batteries, of which there are multiple brands that could, again, each require a PMTA submission. There are quite a few “moving parts,” so to speak, when it comes to advanced vapor devices, and until the industry has a more complete knowledge of how to submit a successful PMTA, the more complicated vapor products will likely be left by the wayside.
The most important thing going forward is to simplify, reduce redundant products and provide a clear advancement pathway for new users. There is massive value in being a one-stop shop for new customers to discover vaping and keep coming back as they progress at their own pace. This may prove much easier throughout the PMTA process as a store owner may very well to be able to pick one manufacturer and stick to it since currently, many products are already similar between companies. Consolidation may also serve to clarify and simplify the development of a product line within a store, making it easier for stores and customers alike.
The PMTA process is grueling and stressful for the entire industry. Although choices may soon become very limited, rest assured that the most reputable names in the business will continue to make their products available. Consolidation is inevitable, but one way or another the burden of choice is about to become much lighter, for better or for worse.
U.S. Senator Dick Durbin urged the U.S. Food and Drug Administration (FDA) to strongly enforce its own regulations “to protect kids from addictive e-cigarettes” by publishing a list of products that submitted premarket tobacco product applications (PMTAs). The Illinois senator wants to remove products that did not submit PMTAs from store shelves.
“After years of delayed regulatory oversight, which fueled the explosion in youth e-cigarette use, FDA finally required e-cigarette PMTAs to be submitted for review on September 9. It has now been more than one month, and the agency has yet to publish a comprehensive list of products that submitted applications,” according to a press release.
Durbin said he was concerned that the delay to publish the list of products that have submitted applications will allow products that remain out of compliance and illegally on the market to proliferate.
“In order to protect public health and uphold the duty to enforce against products on the market that are out of compliance, I urge FDA to immediately publish a comprehensive product listing of all relevant e-cigarette applications received by FDA. While I appreciate the sheer volume of applications submitted to FDA, and the agency’s intention to prioritize review of those with the greatest market share and public health impact, we know from recent years that youth shift patterns of e-cigarette use based upon what products are available to them,” Durbin wrote in a letter to FDA Commissioner Dr. Stephen Hahn.
Vapor and e-cigarette products can remain on the market while the FDA determines whether to approve or reject PMTA applications. The agency has up to one year to make these determinations.
The ‘Davids’ of the vapor industry prepare for war.
By Maria Verven
In many ways, Gerri and James Jarvis are the epitome of the Davids who are up against the Goliaths of the vapor industry.
Now that the U.S. Food and Drug Administration’s (FDA) premarket tobacco product application (PMTA) deadline of Sept. 9 has come and gone, the wait is on to see which products—and which Davids—will survive.
The PMTA battle plan
Gerri and James own Jarvis Vaping Supply, a wholesale vaping supply store, as well as four retail stores called Vapor Station in and around Columbus, Ohio. James is also president of the Ohio Vapor Trade Association, and both Gerri and James are avid advocates of the vapor industry.
The Jarvis’ first got into the industry after watching the growth of Westside Vapor, which was started by their friend, Jason Gang.
“My passion for the industry came from the loss of my grandmother when I was 16 due to smoking-related issues,” James said. “I saw how successful vapor was for Jason in his goal of quitting smoking. It really made me want to help others do the same thing.”
The Jarvis’ business was going gangbusters until media reports of e-cigarette or vaping product use-associated lung injury (EVALI). Now known to have been caused by the addition of vitamin E acetate, a product that isn’t used in any store-bought e-liquids, EVALI scared many customers away from vaping.
Vapor Station experienced a devastating 50 percent loss in sales from EVALI reports, and then Covid-19 hit, causing another major loss as stores had to close during the early months of the pandemic. “Unfortunately, during the pandemic, several people went back to smoking since cigarettes were so easy to get,” James said.
While James continued to run the business, Gerri worked day and night over six months to fill out PMTAs for 998 products (SKUs). In the end, she dumped roughly 3 million pages off at the FDA.
With just the help of a Facebook group called PMTA Sharing, Gerri was able to climb the PMTA mountain without any help from firms experienced in submitting PMTAs. The Jarvis’ were among 1,600 vapor company representatives who joined this and other private groups to help them navigate the PMTA process.
“With Covid-19 hitting right in the thick of the PMTA process, money was so tight that we needed to be careful with spending. Thanks to the help of the Facebook group, we were confident that we could turn something in to the FDA,” Gerri said.
But that wasn’t enough. She then went on to help her friend Jason Gang of Westside Vapor as well as several other small companies negotiate the PMTA process, including Dripology, Vapor Generation, KL Labs and E Cig Cafe. Gerri said Westside Vapor’s PMTAs for its 1,800 products totaled over 6 million pages.
The waiting game begins
Now the wait begins. Encouraged by the successful FDA acceptance achieved by business colleagues at ECIG Charleston and Bad Drip, the Jarvis’ have high hopes for their PMTAs. All had used processes shared in the PMTA Sharing Facebook group.
They are also realistic, knowing that the FDA has received a flood of applications. The Jarvis’ are one of many e-liquid manufacturers and small vape shops that make their own e-liquids in dozens, if not hundreds, of flavors and in a variety of nicotine strengths and volumes. And each of these distinct products in every flavor and nicotine strength requires a separate PMTA.
The FDA publicly acknowledged that the market for vapor products is extremely large—“several orders of magnitude greater than anything the agency has experienced … The likelihood of [the] FDA reviewing all of these applications during the one-year review period is low.”
We asked Gerri to give us a glimpse inside the process of pulling together PMTAs for nearly 1,000 products. Here’s what she shared with Vapor Voice:
When did you start pulling together all the information you needed to complete the PMTAs?
As an industry, we’ve been working on this since August 2016, but we started really getting the paperwork together in March of 2020. I guess it took deadlines from the FDA to really hit us to get to the point of pulling together the PMTAs.
We currently offer 998 SKUs, or products. We provided information on and requested PMTA approval on every one of our products.
Please tell me all about the PMTA process: How long did it take? What sort of information did you provide?
I started working in March 2020 and worked pretty close to nonstop from July to September. The Facebook PMTA Sharing group helped me run the studies and programs to gather the needed data, such as underage studies, customer surveys and PMTA review literature.
In our customer survey of around 5,000 customers, we learned that 90 percent used flavors—and most preferred the fruit flavors. If those flavors go away, the majority—76 percent—said they would go to the black market or back to smoking. We have the weirdest industry in the world: Our business model is to get people to switch to vaping from smoking and then reduce their level of nicotine and eventually [get] off of vaping all together.
Why did you decide to do it on your own? How confident did you feel about the process?
With Covid-19 hitting right in the thick of the PMTA process, money was so tight that we needed to be careful with spending. Thanks to the help of the Facebook group, we were confident that we could do the initial submissions ourselves.
Please share what you can about the expense of pulling together the PMTAs.
For the preliminary review, we had to pay for programs such as the Environmental Assessment Generator and Cover Letter Generator and other environmental assessments. If the FDA accepts our initial applications, we will then move into the substantial review phase for the product testing analysis and safety information. The FDA has only accredited six labs, and the expenses are exorbitant: Each SKU could cost us anywhere from $84,000 to $480,000, depending on which lab we use.
That’s why we’re working to try to get some kind of reform through Congress by reaching out to our senators and congressional leaders and explaining that these costs will kill small businesses—all but about 5 percent of the industry. The costs are blowing their minds. If we can pass some type of reform, there are labs right here in Ohio that can do the testing for a whole lot less.
Please share your emotions during this process: Were you ever frustrated? Were you worried about what should or should not be included? Were you worried it might not pass or pay off in the long run?
During all the hours we were putting together the PMTA, there was always that thought in the back of our minds that all this work could be for naught. We had no clue if what we were putting together was going to be enough to get us to the next level of the process or not.
We were very stressed with all the work on the PMTAs while also running the day-to-day operation of our shops. We had very late nights when our systems stopped working and the generators were running slow. And to top it off, the FDA brought out a new system just nine days before the submission deadline.
What’s the status of your PMTA?
We are still waiting on the news. We know people who used the same process who were accepted, which gives us hope for our PMTAs. We were told we might have to wait up to 180 days to hear back from the FDA. There is no real timeframe established. We just have to sit and wait for the FDA to contact us. But we are encouraged by the fact that three or four companies in the PMTA sharing group have received acceptance letters.
I understand you’ve helped other companies navigate the PMTA process.
I helped our friend Jason Gang pull together the files to run the programs for the cover letters, description sheets and environmental assessments. I would stay up for hours making sure the files were correct.
And I completely fixed one company’s FURLS (files with product information that must be submitted to the FDA) so they could complete the filing. We spent hours on the phone and Facebook Live, helping walk them through the process.
What are your takeaways? What would you do the same? What would you do differently?
I learned that a lot of the process is repetitive. I would spend the same time helping others get to the finish goal. I would have started earlier and kept better records, such as more proof of the dates [that] our products went on the market.
How is business going now? Do you have any predictions for the future of your business?
Business online and at our vape shops has been terribly slow with Covid-19. We are hopeful that with all of our teamwork, this community of small independent businesses will grow stronger.
We need everyone to see the unrealistic, onerous and prohibitively expensive process we were thrust into and how hard we are working to save our technology for consumers, our employees and our businesses.
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
Following the PMTA deadline, vape shops are unsure what vapor products are legal to sell in the U.S.
By Timothy S. Donahue
On Sept. 10, vape shop owners in the United States faced a dilemma. Numerous hardware and e-liquid manufacturers in the electronic nicotine-delivery system (ENDS) industry were required to pull their products from store shelves. Any product for which the manufacturer failed to file a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA) by Sept. 9 is now illegal to market in the U.S.
Tim Scarborough, general manager for Tennessee Vapor Factory, with several stores in Tennessee, said that after talking with distributors, he removed thousands of dollars in product from his store shelves. “It was a straight-up loss. We estimate it to be probably upwards of $10,000,” he said. “We haven’t gotten final figures, but it was [a] large sum.”
As for ordering new products, Scarborough says that many manufacturers and distributors have lists of products for which they have filed PMTAs. Those are the products Scarborough’s shop is trying to keep in stock. “It’s getting harder. We are having to do research to figure out if some of these products filed as well,” he says. “The selection, variety of product, is really minimal right now. We don’t even know for sure the FDA is going to approve a product. I think that, in the long run, this will push people back toward cigarettes.”
During the Global Tobacco & Nicotine Forum (GTNF) held virtually in September, a representative of a large vapor industry distributor told Vapor Voice that his retailers had no way of knowing exactly what products are legal, so they have been selling off the product currently on shelves but have been weary of ordering new product. The distributor did not want to be named due to fears of potential FDA reprisal.
“I’ve had retailers call and say they have lost 50 percent of their juice wall because of the companies they know didn’t file PMTAs. Shop owners have been asking for a letter of acceptance and maybe even a list with all the SKUs for the files we have submitted,” he said. “Retailers don’t want to incur fines for selling illegal products, but how can we even as a distributor know if a company has filed a PMTA? How many products have even been filed? I saw something the other day where the FDA was expecting 2 million PMTAs. A vape shop in Texas had 333 submissions. Beard e-liquids had 72. We submitted 105, but its more than that if you break it down into the different flavors and nicotine strengths. If we broke down our submission like that, it’s about 7,000 PMTAs. It’s really hard to know what exactly the FDA is doing.”
Many manufacturers and retailers have closed their businesses due to the cost of submitting a PMTA and the uncertainty surrounding the industry. NicVape, BlueDot Vapor and Stash E-liquids did not submit PMTAs, for example. A note on Illinois-based e-liquid manufacturer Level Up Vapor’s website reads only, “Closed; We are no longer accepting orders.” In a letter to its customers, VapeWild, explained it would not be submitting PMTAs and was shutting down. The company had been in business for six years and was a favorite of vapers worldwide.
“The PMTA deadline is finally upon us … It’s been a long road, and we did our best, but in the end, we just aren’t able to pull it off,” VapeWild wrote. “These are crazy times we’re living in, and they just keep getting crazier,” the letter states. “Our sincerest hope, though, is that we have somehow made a difference in the world for the better.”
Only a small number of the thousands of vapor companies in the U.S. have announced that they filed PMTAs by the deadline. Complicating matters, most of those companies have not released what devices or e-liquid flavors they have filed. So far, based on Reddit posts, press releases and media reports, just over 100 companies stated they have filed a PMTA or had the intent to file before the deadline. Just over 50 companies announced they had filed an application before the deadline. Even fewer revealed that the PMTA had been accepted by the regulatory agency. All the major tobacco companies in the U.S. have a PMTA currently accepted, filed and under review for a vapor product.
Credit: Smoque Vapor
Once an application is sent to the FDA, manufacturers are permitted to sell their products for a year unless the agency acts. So far, Philip Morris’ heated-tobacco device IQOS and Swedish Match’s General snus are the only two tobacco brands to have survived the PMTA process.
And the process does not end with marketing authorization. After receiving a PMTA, a company must continue to conduct postmarket surveillance and studies to determine the impact the orders have on consumer perception, behavior and health and to enable the FDA to review the accuracy of the determinations upon which the orders were based. These postmarket requirements also include a rigorous toxicity study using computer models to help predict potential adverse effects in users, according to the FDA. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the products does not have unintended consequences for youth use.
In July, the director of the FDA’s Center for Tobacco Products, Mitch Zeller, said the agency would prioritize policing vapor products aimed at youth. However, the Covid-19 pandemic has put vape shop inspections on hold, according to Zeller, adding that no date has been announced for when in-person inspections would begin again.
“All the entities that we have contracts with have state level for activities like compliance checks and vape shop inspections,” Zeller said in July. “With that stop-work order, we’ve temporarily postponed all in-person inspections of tobacco retail establishments, but we continue to do all of our monitoring and surveillance and websites and publications and social media because we can do that remotely and have always done that, if you will, remotely from offices.”
Speaking at the virtual GTNF in September, Alex Clark, CEO of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA), said there is a lot of uncertainty right now not just in what types of products will get acceptance letters but also how quickly the FDA will be able to bolster enforcement. This, at a minimum, gives retailers a little leeway. If regulators can’t inspect stores, then retailers can still sell products if the FDA hasn’t previously stated that a product is illegal.
“Because there is this lag in enforcement, there [are] still [illegal] products on store shelves,” said Clark. “[The regulatory environment in the U.S.] is bad … we are concerned that [the U.S. is] exporting our bad policy ideas and our bad science and bad campaigns. In New York, for example, bad science … helped change people’s minds and vote to advance the flavor ban language.”
In a press note on Aug. 31, Zeller wrote that the FDA plans to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline and that were on the market as of Aug. 8, 2016 (it had not been released as of this writing). “However, before doing so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only certain types of product information from applications can be lawfully disclosed,” Zeller wrote.
This has left retailers in limbo. Shop owners don’t know if a product they are selling could make them a criminal. Zeller stated that the agency knows of more than 400 million deemed products. To date, the FDA has received applications for around 2,000 products, he said, adding that the agency has processed 40 percent of those. Zeller did not specify how many of those applications were for vapor products. Zeller acknowledged that the FDA was unlikely to be able to review that many applications in the year timeline set for their review.
“Even if applications are submitted for only a portion of those products, the likelihood of [the] FDA reviewing all of these applications during the one-year review period is low given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the agency has experienced,” Zeller wrote. “Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality, we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020, within the year.” The FDA has not announced how many products filed PMTAs.
Zeller also stated that the agency was willing to work with manufacturers. The FDA has said it could allow some smaller manufacturers to submit a “deficient” PMTA and keep marketing products until the necessary data is collected. He said the FDA would accept several justifications for such applications, such as the Covid-19 pandemic and a limited amount of lab space for testing. “Although we expect high quality and complete applications to come in by Sept. 9, if we do find deficiencies, it is likely [the] FDA will issue a deficiency letter with a 90-day deadline for companies to respond,” Zeller wrote.
Orion Saith, with Smoque Vapours Electronic Cigarettes in Chicago, says that her store had already destroyed most of their disposable products because of Chicago’s ban on flavored vapor products. The company is still selling mix-in flavors for e-liquids and has its own line of e-juices as well. “We haven’t taken any juices off the shelves yet. We have our own juice line, and those PMTAs were submitted to the FDA, so we are doing OK for now,” said Saith.
Finding hardware, however, has been extremely challenging. Saith says that knowing what products are legal to sell while PMTA submissions go through the process is getting more difficult by the day. “It is very difficult. We have been getting whatever we can that is still in stock from wholesalers who say that the devices are legal,” she said. “It involves a lot of trust. We have been asking to see submission letters from the FDA too. What’s concerning is that as some of these large major brands leave shelves, the consumers are the ones who suffer. If you can’t get a quality device, you probably end up going back to cigarettes. That’s just a horrible thing to force on someone.”
Credit: Thorn Yang
The FDA has been sending notices to companies selling illegal products. In late April, the FDA issued 10 warning letters to retailers and manufacturers who were selling, manufacturing or importing unauthorized ENDS products that “were clearly targeting use, or likely to promote the use, of these products by young people.” The agency sent three more notices on Sept. 9, the same day PMTAs were due. Zeller said the agency will continue to send warnings.
“All told, since our compliance and enforcement program began in 2010, we have completed over 1.2 million retailer inspections. This has resulted in over 97,000 warning letters, over 11,000 of which were for illegal products,” said Zeller. Many experts predicted the vapor industry would come to end after the PMTA deadline. For now, at least, it will continue.
