Words say a lot. It’s especially true in the rule of law. When Congress approved the recent appropriations bill to keep the government running, lawmakers also passed the “Preventing Online Sales of E-Cigarettes to Children Act,” which prohibits the United States Post Office (USPS) from shipping vaping products.
Credit Anne Onyme
While the legislation was geared towards nicotine vaping products, the law is so broadly defined that hemp businesses must also prepare to comply, according to Patricia Kovacevic, founder and president of PK Regulatory Strategy. The legislation takes effect in late March – 90 days after its published in the Federal Register. The USPS then has 120 days to issue its rules.
Speaking during a Smoke-Free Alternatives Trade Association (SFATA) webinar, Kovacevic said that the legislation states that an electronic nicotine delivery system (ENDS) is defined as any device that “delivers nicotine, flavor, or any other substance to the user inhaling from the device.”
“It’s very broadly defined. It really is any other substance. So even if you inhale, I’m being ridiculous, the air [if inhaled from] a device is still covered,” she said. “So, unfortunately, it’s very broad. That’s actually what makes it worrisome. But that also could be its flaw. [The definition being too inclusive] could be an opportunity to challenge the rule.”
According to the legislation, anyone selling vaping products must:
Register with the U.S. Attorney General
Verify age of customers using a commercially available database
Use private shipping services that collect an adult signature at the point of delivery
If selling in states that tax vaping products, sellers must register with the federal government and with the tobacco tax administrators of the states
Collect all applicable local and state taxes, and affix any required tax stamps to the products sold
Send each taxing state’s tax administrator a list of all transactions with customers in their state, including the names and addresses of each customer sold to, and the quantities and type of each product sold
Maintain records for five years of any “delivery interrupted because the carrier or service determines or has reason to believe that the person ordering the delivery is in violation of the [PACT Act]”
Both UPS and FedEx have rules against shipping traditional cigarettes and say they will extend those rules to include ENDS products. Violators can receive up to three years in prison, face steep fines and potentially lose their business.
U.S. Customs and Border Protections (CBP) officers at Chicago O’Hare’s International Mail Branch seized 50,000 dragster Mountain Vape Pens on Tuesday. The shipment, originated from Hong Kong, and was destined for a residence in Alexandria, Kentucky.
Credit: CBP
The U.S. Food and Drug Administration (FDA) determined the shipment violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) as misbranded consumer goods being imported by an unauthorized agent, according to a press release. Tobacco products imported or offered for import into the United States must comply with all applicable U.S. laws. Read more about the FDA’s regulations governing e-cigarettes and other tobacco products.
The shipment was seized on January 19, and was mis-manifested as Lithium Ion Battereies, a common practice used by smugglers, CBP states. “CBP believed the shipment was intentionally improperly labeled in order to avoid detection,” the release states. “Additionally, CBP presumes the products are being sold without authorization. CBP continues to work diligently to stop non-legitimate products from entering the U.S.” The pens had an MSRP of $450,000.
“Our officers are dedicated to identifying and intercepting these types of shipments that could potentially harm our communities,” said Shane Campbell, Area Port Director-Chicago. “Customs and Border Protection’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers, and we will continue to work with our consumer safety partners to identify and seize unsafe and illicit goods.”
Last year the FDA announced an increased enforcement priority of electronic nicotine delivery systems, and issued detailed guidance to the industry of these new enforcement priorities that regulate the unauthorized importation of tobacco products.
CBP provides basic import information about admissibility requirements and the clearance process for e-commerce goods and encourages buyers to confirm that their purchases and the importation of those purchases comply with any state and federal import regulations.
CBP conducts operations at ports of entry throughout the United States, and regularly screens arriving international passengers and cargo for narcotics, weapons, and other restricted or prohibited products. CBP strives to serve as the premier law enforcement agency enhancing the Nation’s safety, security, and prosperity through collaboration, innovation, and integration.
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 Jones Labs announced it has received filing letters from the U.S. Food and Drug Administration (FDA) for both its premarket tobacco product application (PMTA) and its modified-risk tobacco product application (MRTP).
Credit: The Jones Labs
“The Jones product family is being evaluated for safety and efficacy as alternatives to combustible cigarettes and their comparable safety to smoking the Harmful or Potential Harmful Constituents (HPHCs) of combustible cigarettes,” a press release states. “As a leader of pre-August 8 [the FDA’s deadline for a product to be on the market to be eligible to remain on the market while going through the PMTA process] compliance, The Jones Labs registered with the FDA in July 2016 in preparation for Electronic Nicotine Delivery System regulations.”
The Jones Labs states that the potential of electronic drug-delivery systems remains at the core of its technology. “Due to our record of compliance with the Center for Tobacco Products (CTP), our products are eligible for enforcement discretion until our application process has been completed,” the release states.
The core technology of The Jones Labs submissions are based in “Buffered Aerosol Drug Delivery,” a review article published in the inaugural edition of the United Journal of Drug Development and Industrial Pharmacy. “The technology submitted for review is being further developed in parallel to address other cessation and medicine-assisted therapeutic needs in the market,” the review states. “With this unique drug-delivery platform technology they stand to disrupt the established order of all smoking and smokeless products, cannabis or tobacco.”
The Jones Labs offers universally compatible tobacco vapables as an alternative to smoking combustible cigarettes, the release states. “With multiple present and future product offerings similar to The Jones Pods (www.thejonespod.com), we are developing Rise, by The Jones (www.risebythejones.com), a state-of-the-art smoking cessation platform that utilizes the core technology for replacement and cessation therapies across the board.”
A new study suggests that vaping reduces inflammatory biomarkers when to compared to someone who smokes combustible cigarettes. “While vaping inflammatory biomarkers were elevated compared to nonusers, those differences were not statistically significant,” the study’s authors state.
“There was also no significant difference in the elevation of biomarkers between the exclusive smokers and dual smokers – the additive effect of e-cigarettes was low if present at all.”
The research, reported in the journal Circulation, used the U.S. For Disease Control and Prevention (CDC) and the U.S Food and Drug Administration’s (FDA) Population Assessment of Tobacco and Health (PATH) that has been released yearly since 2013.
The dataset is from this first cycle using data of participants’ smoking habits along with blood samples. The researchers looked specifically at metabolites, biomarkers, of inflammation and oxidative stress – the culprits felt to underlie tobacco’s harmful effects. In addition to the usual demographic data, there was specific information on the use or nonuse of tobacco, vaping, and cigarette smoking.
Results reflect findings for adults age 18 or older, where data on biomarkers and tobacco use were available, which was 7130 participants. This included 58.6 percent neither smoked nor used e-cigarettes (nonusers); 29.6 percent smoked exclusively; 1.9 percent vaped exclusively and 9.9 percent smoked and vaped (dual users).
“Exclusive and dual smokers had the highest inflammatory and oxidative stress biomarkers relative to nonusers,” the researchers note. “Exclusive vapers had ‘significantly lower levels’ except for C-reactive protein (than smokers).”
The research concluded that e-cigarettes appear to have little impact on inflammatory biomarkers, certainly not as great as smoking tobacco. This research “highlight(s) the importance of completely replacing cigarette smoking with e-cigarettes or quitting the use of both products for cigarette smokers to derive potential health benefits,” the report states.
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.
U.S. Customs and Border Protection (CBP) officers at the Dallas Fort Worth International Airport working in conjunction with agents from the U.S. Food and Drug Administration (FDA) have seized 33,681 units of e-cigarettes with a manufacturer’s suggested retail price of $719,453.
Credit: SFGate
In December 2020, CBP seized 42 separate shipments arriving from China destined to various Texas counties. The shipments included individual disposable flavored e-cigarette cartridges resembling the Puff Bar brand, including Puff XXL and Puff Flow.
As part of an ongoing joint operation with FDA, officers and agents were looking to intercept counterfeit or other violative e-cigarettes, including certain flavored e-cigarettes imported to the U.S. that did not meet the Federal Food, Drug, and Cosmetic Act requirements, as amended by the Family Smoking Prevention and Tobacco Control Act.
“Many counterfeit, unapproved or unauthorized products are likely produced in unregulated facilities with unverified ingredients posing a serious health concern to consumers. It is especially alarming when these types of counterfeit and unauthorized products find their way into the hands of children as studies indicate,” said CBP Port Director Timothy Lemaux in a statement. “We will continue to take every opportunity to work with our partners at the FDA to intercept and seize products that threaten U.S. consumers.”
Tobacco products including e-cigarettes imported or offered for import into the U.S. must comply with all applicable U.S. laws.
“The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “We are very concerned about how popular these products are with youth. This seizure makes clear to tobacco product manufacturers, retailers and importers that the FDA is keeping a close watch on the marketplace and will hold accountable those companies that violate tobacco laws and regulations.”
CBP’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers. In fiscal year 2020, CBP seized 93,590 units of e-cigarettes that did not meet U.S. federal regulations.
In July 2020, the FDA issued a warning letter to Cool Clouds Distribution (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization.
“Protecting American consumers from illicit and especially harmful tobacco products, such as counterfeit or flavored e-cigarettes, is of utmost importance to the FDA,” said Judy McMeekin, FDA associate commissioner for regulatory affairs. “We will continue to investigate and remove from the marketplace products that pose a particular danger to the public health.”
While the Puff Bar website appears to have recently stopped online sales and distribution in the U.S, it does not mean that the firm ceased distributing products to other retailers or selling products at brick and mortar retail stores, according to the FDA. The website’s store locators are still active, indicating that potential consumers can still search for products located for sale at retail stores.
VDX Distro announced today the launch of its e-liquid brand, Four Seasons Fine Tobacco. The brand was founded to give smokers a more authentic and pleasing replacement for traditional cigarettes, according to a press release.
Credit: Four Seasons
“Four Seasons’ e-liquids are designed to withstand flavor bans by being what they are and no more – pure, authentic tobacco flavors. Its flavors are all made from naturally extracted tobacco, with no artificial flavors, colors, additives, or sweeteners, giving consumers that pure tobacco taste,” the release states. “Each flavor is carefully crafted to emulate those of the most widely appreciated cigarette brands, resulting in a vaping experience that most closely resembles the mouth feel, throat hit, and taste.”
Four Seasons’ products have received an acceptance letter from the U.S. Food and Drug Administartion (FDA) for its premarket tobacco product application (PMTA) accepted, according to the release.
“At Four Seasons we seek to bring you a satisfying vaping experience that will give you the tools you need to make the switch away from combustible tobacco for good,” said Four Seasons CEO and Founder Ryan Chalmé. “Our mission from day one remains the same as it does today, helping adults discover an alternative to traditional tobacco.”
The FDA requires a product to have been on the market prior to Aug. 8, 2016 and have filed a PMTA in order to remain on the market after Sept. 9, 2020. There was no mention if Four Seasons was on the market prior to Aug. 8, 2016.
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.
