Author: Staff Writer

Fighting for Survival

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.
December 28, 2020
Trump Signs Bill Restricting Vapor Shipments by USPS

Photo: Tobacco Reporter archive
U.S. President Donald Trump signed a $2.3 trillion coronavirus relief and government funding bill into law Sunday night, averting a government shutdown that was set to begin on Tuesday.
Initially, Trump had refused to sign the legislation, calling on Congress to increase stimulus payments from $600 to $2,000 and to get rid of “wasteful and unnecessary items.” The president signaled in a statement Sunday night that he signed the coronavirus relief bill only after securing a commitment for the Senate to consider legislation to increase stimulus checks.
For the nicotine industry, the bill is significant because it contains a provision prohibiting prohibits the U.S. Postal Service from delivering e-cigarettes.
It also subjects e-cigarettes to other rules that currently govern online cigarette sales. Among other things, online retailers will be required to use private shipping services that collect an adult signature at the point of delivery, collect all applicable local and state taxes, and send each taxing state’s tax administrator a list of all transactions with customers in their state.
Critics said the legislation would place a considerable burden on vapor companies. Increasing cost and paperwork.
The new rules could go into effect as soon as 120 days.
December 28, 2020
Internet Covid-19 ‘Vape’ Vaccine Picture is Hoax
A photo purportedly showing a 510-threaded e-liquid tank for delivering Pfizer’s Covid-19 vaccine is talking the internet by storm. The photo and product are a hoax. It was widely shared humorously as early as Dec. 19, however, recently some social media users have reported the meme as true.
The photo being shared shows a package containing a cartridge that would be used in an electronic cigarette and inhaled as a vapor (here). It carries Pfizer-style branding and is described as a “single dose” vaccine cartridge. There are signs the label was printed as a joke; the box describes Pfizer as “makers of ‘the boner pill’”.
While most shares of the image appear to recognise that the product is not real, it nonetheless generated confusion for some, according to Reuters. A string of social media users shared the image with captions such as “Could this be fake?”, “Can you escape the RESET?” and “Why’s the Pfizer vaccine made in China?”, the latter comment being in response to text on the fake package reading “MADE IN CHINA”.
The real vaccine is being made using Pfizer and BioNTech’s combined manufacturing network in Germany, Belgium and the United States, the story states. Reuters contacted Pfizer who confirmed by email the vaporiser cartridge was fake. The real Pfizer vaccine is injected into the upper arm and given as two doses 21 days apart.
December 27, 2020
Outlook: Vapor’s Future in Mexico and Latin America

Credit : Omni Matryx
Misinformation continues to be the greatest challenge to normalizing vapor products in Latin America.
By VV staff
Vapor products didn’t begin to take hold in Latin America until 2009. They took the region by surprise. Everyone, including regulators and tobacco industry controllers, were “caught with their pants down,” according to Roberto Sussman, senior researcher and lecturer at the National University of Mexico and founder and director of Pro-Vapeo.
“The reaction was pure panic,” he says. “Tobacco controllers immediately wanted to prohibit the devices. The WHO [World Health Organization] was also afraid of them. In Mexico, tobacco controllers and a lot of physicians pressed a regulatory agency called COFEPRIS to ban them outright.”
In 2012, Mexican officials banned the marketing of e-cigarettes. However, Mexico’s tobacco laws were designed to ban candy cigarettes, not regulate a market disruptor, according to Sussman. In 2015, the Supreme Court in Mexico ruled that the ban on marketing was unconstitutional. Now, Mexico, along with many other Latin American countries, has what is referred to by Sussman as “a tolerated nonregulation,” where regulators, tobacco control and other public bodies have become the “visceral opposition and [purveyors of] nasty misinformation campaigns.” The regulators started to take the same approach as the WHO, explains Sussman.
“These are nongovernmental organizations (NGOs) sponsored by Bloomberg Philanthropies and associated charities like the Campaign for Tobacco-Free Kids, acting in synergy with small but influential groups of health professionals clustered in the tobacco control sections of government public health institutions. But at the same time, despite all this, the usage of the devices became socially accepted,” he explains. “It was tolerated even in many indoor spaces. Vaping started to boom. In Mexico, we estimate that we have 1.5 million vapors.”
Speaking during the Global Tobacco & Nicotine Forum (GTNF), Sussman told attendees that Mexico also has its own small, self-regulating vapor industry that produces e-liquids. Like many other countries, Latin America gets its hardware from China. While rules are fluid from country to country, Sussman says vaping was still helping people quit combustible cigarettes. This meant vaping itself was not a big concern for most authorities.
In the last five years, the vapor industry in Latin America has changed, says Sussman. E-cigarettes are illegal in Brazil, Mexico, Argentina and Uruguay. These are the countries with the strictest rules against vaping. Vapor products are legal [with heavy restrictions] in Costa Rica, Guatemala, Columbia, Paraguay, Ecuador, Chile and Panama. Regulators, however, still did not see regulation as a priority in any of these countries. “The products were in a sort of nonregulation grey area,” Sussman says. “Regulators had better things to do and a lot of other things going on.”
Then, two events further changed the course of the vapor industry, especially in the region’s largest market, Mexico. First, says Sussman, the Mexican people elected Andrés Manuel López Obrador, and his MORENA party is now in control of both houses of congress. Mexico had not seen this degree of centralization of political powers since 1997.
“One of the most powerful officials in the government of López Obrador is Dr. Hugo López-Gatell. He’s an epidemiologist, and he has strong links with the Pan American Health Organization and with Bloomberg Philanthropies. He’s also the health minister. And at the same time, together with this appointment, was a massive increase of lobbing activity by Bloomberg Philanthropies in the whole region,” says Sussman. “This [is] how Bloomberg works in our countries. First, they set up NGOs that they use as lobbing machines. This lobbing is done through the WHO or the Pan American Health Organization. Now, health ministries and government, they get grants from Bloomberg, but they will never say [that].”
Second, the U.S. Centers for Disease Control and Prevention (CDC) announced they had reason to believe a dangerous, newly identified lung disease was linked to vaping. The acronym EVALI (e-cigarette or vaping product use-associated lung injury) was born.
“The use of EVALI to spread fear on nicotine vaping in Mexico and in Latin America was particularly crude, dishonest and more intense than in other places. Up to this day, all officials of the health ministry in Mexico are still blam[ing] nicotine vaping,” says Sussman. “And when you try to engage them, they say, ‘No, no, no. That’s it. Full stop. End of discussion.’ That’s it.” EVALI has since been found to be caused by illegal THC vape pens, not nicotine-based e-cigarettes. Sussman says no one has told Latin America.
The misinformation surrounding e-cigarettes and their role in EVALI persist. Earlier this year, Mexico’s president signed legislature prohibiting the importation, manufacture and distribution of all noncombustible products tobacco products, including heat-not-burn products. “Their justification was that we need to protect Mexican youth from EVALI. Given the proximity of the U.S., this epidemic can come to Mexico any time,” says Sussman. “Pure fear-mongering and they’ve refused all debate.”
Sussman says the true objective of prohibition is to prevent the tobacco industry from introducing noncombustible tobacco products. Regulators and anti-vaping groups also want to destroy the existing distribution network of vape shops and the emerging local e-cigarette industry. “Like all regulations surrounding vaping products, this is failing because vaping still operates in Latin America and in Mexico not exactly through black markets, but through the informal sector,” explains Sussman. “And it is very widespread. Nevertheless, the WHO will praise the Mexican government for implementing this ban.”
Then came the Covid-19 pandemic. Now these same groups have begun to blame the spread of Covid-19 on vaping products, even though there is no record of any vaper being hospitalized or progressing to severe stages of the disease or death. Even combustible smokers are underrepresented, according to several studies.
Now, according to Sussman, more regulations and more enforcement is on the horizon. This time, The Union, a global scientific organization that says it is working to improve “health for people in low- and middle-income countries” (LMICs) is stepping into the fray. Sussman says the group plan for vapor regulations is a “pernicious technocratic fantasy that is completely detached from the realities of smokers and health institutions” in Latin American countries. The Union’s plan is simple: total prohibition.
The Union justifies outright prohibition with arguments allegedly based on the need to comply with the tobacco control policy advice of the WHO’s Framework Convention for Tobacco Control (FCTC), an international treaty on tobacco regulation sponsored by the WHO, which has been signed by more than 180 countries, including most LMICs. At first glance, these arguments might look reasonable, but a closer look reveals that they are real recipes for disaster, says Sussman.
The presidential decree that bans imports in Mexico is a first step toward implementing The Union’s agenda. The informal “no-regulation” environment which has served vapers and the vaping industry in Latin America—and LMICs around the world—is very different from the environment in high income countries like the United States, Canada, and most European countries, according to The Union.
“Regulating a novel technology can be difficult and expensive for LMIC governments which are strained in resources. However, what The Union is not considering is that the cost of enforcing prohibitions and bans will far exceed the money that is saved by avoiding public regulation,” Sussman told GTNF attendees. “Besides the social cost, black market criminality, lack of consumer protection, but most importantly, given the opacity of government spending in our countries, it is extremely unlikely that the money that will be saved on not doing regulation will be redirected to tobacco control efforts. That’s a fantasy. It’s not going to happen.”
Sussman says officials at The Union are concerned that Latin America does not have the ability to regulate vapor products properly so they should be banned. “[They think] we are going to be so sloppy in regulating that we shouldn’t be regulating. That’s a colonialist argument. The natives need the white men to step in and run their lives,” says Sussman. “But most importantly, The Union is glossing over the loopholes of prohibition. The loopholes of prohibition can and will be exploited by black marketeers, [cigarette] smokers and criminals.”
Prohibition is much more costly than regulation in terms of public resources: it needs to be enforced and policed, and it deprives governments of much-needed tax revenues, says Sussman. “The cost balance in the regulation vs prohibition debate cannot be based only on tobacco control objectives as defined by the FCTC,” he says. “It must also factor in the whole range of adverse effects of prohibitions: black markets, criminality, lack of quality control, and increased underage usage.”
Currently, in Mexico, the health ministries, led by government officials, are continuing to try to implement The Union’s plan. However, there is some opposition beyond vapor industry businesses and vapor advocacy groups, according to Sussman. It’s from inside the Mexican government. “These officials want to regulate because regulation will bring tax revenues. And regulation, it’s better. It’s always better,” says Sussman. “Cigarettes are toxic. Misinformation about e-cigarettes is damaging to public health. Vaping bans belong in the trash can. Things need to change. Otherwise, people will just go back to smoking.”
December 26, 2020
Predicting the PMTA

Credit: Andikatalinmueller
By Mike Huml
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.
December 26, 2020
Sullum: U.S. Congress Misguided on E-Cigarette Rules
Buried in the enormous spending/COVID-19 relief package that Congress approved this week is a bill that imposes new restrictions on the distribution of all vaping equipment, parts, and supplies, including a ban on mailing them. The provision illustrates not only how utterly irrelevant legislation can be slipped into unread, must-pass bills but also how Congress warps reality through legal fictions and uses save-the-children rhetoric to justify restricting adults’ choices, writes Jason Sullum in an opinion piece for Reason, a libertarian think tank.
Jacob Sullum / Credit: Reason
Title VI of the 2021 Consolidated Appropriations Act, which appears on page 5,136 of the 5,593-page bill, is called the Preventing Online Sales of E-Cigarettes to Children Act. The bill was introduced last April by Sen. Dianne Feinstein (D–Calif.), joined by seven original cosponsors: six Democrats plus Sen. John Cornyn (R–Texas). It includes two changes aimed at complicating and obstructing online sales of vapes and e-liquid.
Feinstein’s bill amends the Jenkins Act of 1949, which requires that vendors who sell cigarettes to customers in other states register with the tax administrators in those states and notify them of all such sales so they can collect the taxes that the buyers are officially obligated to pay. In 2002, the General Accounting Office (now the Government Accountability Office) found that online cigarette sellers routinely flouted the Jenkins Act and that the federal government had done virtually nothing to enforce it. Nine years later, Congress amended the law, beefing up its reporting requirements and extending it to cover roll-your-own tobacco.
The Feinstein bill further expands the Jenkins Act, redefining cigarette to include “electronic nicotine delivery systems,” which are not cigarettes. It also counterintuitively defines electronic nicotine delivery system to include products that do not deliver nicotine: “any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device” (emphasis added). That category includes e-cigarettes, e-hookahs, e-cigars, electronic pipes, vape pens, and refillable vaporizers, plus “any component, liquid, part, or accessory” used with those devices, whether shipped together with them or sold separately.
In other words, every product related to vaping, whether of nicotine, THC, CBD, lavender, or anything else, will now be subject to the Jenkins Act’s burdensome requirements. According to Feinstein, a bottle of e-liquid is a cigarette; so is a bottle of herbal essential oil if you plan to vape it. A coil or pod cartridge for a nicotine vaporizer is now also a cigarette; so is a vaporizer designed for THC or CBD oil.
Feinstein’s bill also requires the U.S. Postal Service to “clarify” that the ban on mailing cigarettes covers all of those products, which are not actually cigarettes and may not even have anything to do with nicotine. The new ban, disingenuously presented as a clarification of the existing ban, will take effect within 120 days of the law’s passage.
These reality-defying redefinitions ostensibly are aimed at preventing the sale of e-cigarettes to anyone younger than 21, the minimum age set by federal law. “Buying e-cigarettes online is one of the easiest ways for children and teens to get their hands on these harmful products,” Feinstein said when she introduced the bill. But the new burdens and restrictions go far beyond what is necessary to enforce the minimum purchase age. Requiring robust age verification for orders or an adult signature for deliveries, for example, would prevent sales to consumers younger than 21 without the expensive disruptions this law will cause.
“While there is no shortage of talk in Congress about the importance of small businesses and social distancing, the decision to shove this ban in the middle of a pandemic relief package reveals how hollow that rhetoric is,” says Gregory Conley, president of the American Vaping Association, an advocacy group that supports vaping as a harm-reducing alternative to smoking. “Many Americans at risk of COVID-19 complications have been staying home and ordering their supplies online, but Congress just decided they should either pay much more for shipping or go to a retail store that may not stock the product they use to stay off deadly cigarettes.”
Conley notes that shipping vaping products to minors is already illegal, and “the Food and Drug Administration has repeatedly enforced this law against bad actors in the industry.” While law-abiding vendors for years have been using the postal service’s ID-at-delivery option to comply with the age limit, “this will no longer be permitted.”
In short, a bill presented as a commonsensical effort to enforce the minimum purchase age is actually an assault on the vaping industry and its adult customers. “If the increase in shipping costs wasn’t enough, the bill also imposes huge paperwork burdens on small retailers, and backs it up with threats of imprisonment for even innocent mistakes,” Conley notes. “This is not a law designed to regulate the mail-order sale of vaping products to adults; it’s an attempt to eliminate it.”
Thanks to Feinstein’s sweeping and arbitrary definition of electronic nicotine delivery systems, the impact extends far beyond nicotine vaping. On its face, the law requires companies that sell cannabis vaping devices to comply with the Jenkins Act. It also prohibits them from mailing their products to customers. Although that is already arguably prohibited by federal law, the issue hinges on whether vaping equipment sold without any reference to cannabis nevertheless qualifies as “drug paraphernalia.” As written, the Feinstein bill also imposes these burdens on federally legal products such as CBD oil and herbal extracts used for aromatherapy.
“This could have a significant effect on cannabis vaping products, even if the intent is clearly to curb nicotine products,” Aaron Smith, CEO of the National Cannabis Industry Association, told Marijuana Moment. “We’re making sure that Congress and the incoming administration understand that it would be a misguided waste of resources to apply this to the already heavily regulated cannabis industry. In the long run, it’s important that cannabis is descheduled so it can be appropriately regulated at the federal level, clearing up ambiguities like this.”
Jacob Sullum is a senior editor at Reason.
December 26, 2020
Bidi Stick Fastest Growing Closed System

Photo: Kaival Brands
Bidi Vapor’s Bidi Stick has become the fastest-growing closed system vaping product in the U.S., the company announced.

Based on Goldman Sachs’ recent equity research report on the Nielsen data for total nicotine volumes, the Bidi Stick is now the second-largest disposable electronic nicotine-delivery system (ENDS) offering based on retail sales for the last 52-week period.

The Bidi Stick increased its absolute-dollar market share of the disposable ENDS market share from 7.4 percent during the 52-week period ending on Oct. 27, 2020, to 24.2 percent of retail sales during the 52-week period ending on Nov. 28, 2020.

According to the Goldman report, total dollar sales growth has surged to 1,845 percent to lead the category for the 12-week period ended Nov. 28, 2020.

“The Bidi Stick is an electronic nicotine-delivery system designed for current adult smokers and is manufactured and marketed with sustainability and socially responsible practices in mind,” said company founder and CEO Niraj Patel.

“We even incentivize our customers to recycle with a one-of-a-kind rewards program. We are also hyper-vigilant in making sure the Bidi Stick does not get into the hands of young people but only those adult smokers over 21 looking for alternatives to cigarettes.”
December 24, 2020
Change of the Guard

What might the new U.S. President’s administration have in store for the vapor industry?
By Patricia Kovacevic
At the time of writing, the results of the U.S. elections are still contested by the presidential incumbent, a Republican, via various vote recount requests and litigation; however, it is a virtual certainty that the U.S. will have a new president, representing the Democratic Party, as of Jan. 20, 2021.
The heads of departments, including the head of the Department of Health and Human Services (HHS), are appointed by the president, subject to confirmation by the Senate, and typically change with the administration. In turn, the Food and Drug Administration (FDA), which is the agency within the HHS with primary jurisdiction over tobacco products (including electronic nicotine-delivery systems, or ENDS) as well as drugs, foods and other products, will be led in the new administration by a new commissioner.
Given the Covid-19 crisis, the new president will be under immense pressure to appoint a new FDA commissioner immediately. Interestingly and somewhat surprisingly, a former FDA commissioner, David Kessler, was recently named co-chair of the new administration’s Covid-19 task force, although Kessler resigned his commissioner role in November 1996 amid controversy for overbilling his travel expenses during his tenure.
Also during Kessler’s tenure, the FDA attempted to regulate tobacco products as “delivery devices for the drug nicotine” to bring tobacco products under FDA jurisdiction. Tobacco companies challenged the rules all the way to the Supreme Court and won (FDA v. Brown and Williamson Tobacco Corp.). The Supreme Court ruled that “Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products. Such authority is inconsistent with the intent that Congress has expressed in the FDCA’s [Food, Drug and Cosmetic Act] overall regulatory scheme and in the tobacco-specific legislation that it has enacted subsequent to the FDCA. In light of this clear intent, the FDA’s assertion of jurisdiction is impermissible.”
Kessler’s wish to see tobacco regulated by the FDA was eventually granted by Congress in June 2009 through the bipartisan passage of the Family Smoking Prevention and Tobacco Control Act. While some speculate that Kessler may be on the short list for HHS commissioner, it is likely that the administration will bring forward new faces. Still, Kessler’s life-long anti-tobacco stance and past working relationship with the current head of the Center for Tobacco Products might give an indication of the increased scrutiny of the tobacco sector in the years to come.
Patricia Kovacevic
The ENDS industry status quo, from a legislation point of view, while far from ideal, is by now familiar to the ENDS industry. The recent premarket tobacco product application (PMTA) filing deadline has come and gone, and, as expected, we have not seen a flurry of warning letters post-September 2020 ordering certain vapor manufacturers to stop selling their products because they did not submit a PMTA.
The FDA is, however, expected to start enforcing this legislation sooner or later. For any dramatic change to occur, the governing legislation, the Food, Drug and Cosmetic Act, would have to be amended, which is not likely to be top of the list for the upcoming Congress given the priorities the new administration announced during the election campaign. Still, the House of Representatives, one of the chambers of the U.S. legislature, remains dominated by the Democrats, the same party whose representatives initiated several tobacco-related bills and called for confrontational hearings on vapor products. The most recent one, in February 2020, was relatively tame compared with the tone of the July 2019 Juul hearing and even with the June 2014 Senate hearing.
Senate races in Georgia will require runoff elections on Jan. 5, 2021. If Democrats gain both Senate seats in Georgia in January, there would be a 50-50 tie in the Senate, and the vice president would have the tie-breaking vote in case the Senate is deadlocked on a piece of legislation. When the House, Senate and White House are controlled by the same party, the chances of the current administration to pass laws in support of its agenda are greatly increased, though divisions exist within each party, and surprises always happen. Furthermore, 34 out of the 100 Senate seats are up for regular election in two years as well as all 435 House seats; these will be a trying two years for Americans in an economic crisis, and the public sentiment can swing in the other direction. Thus, the new president may have only two years, if even that long, to pass a flurry of laws, and there may be more urgent matters than revisiting the Tobacco Control Act, which, for better or for worse, has worked so far.
The FDA already has broad powers to expand requirements and restrictions involving ENDS products, including the authority to impose product standards through notice-and-comment rulemaking. Ingredient caps and bans are among the standards the FDA has the authority to promulgate via regulation.
The latest unified agenda of regulatory and deregulatory actions
As of spring 2020, active regulatory actions include four potential future regulatory actions by the FDA, rolled over from previous agendas, with no clear deadline for publication of a proposed rule:
Requirements for Tobacco Product Manufacturing Practice (colloquially referred to as “Good Manufacturing Practices”)
Tobacco Product Standard for Characterizing Flavors in Cigars (follow-up to the 2018 Advance Notice of Proposed Rulemaking); this is unlikely to move into the final rule stage on account of recent courtroom successes by the cigar industry.
Modified-risk tobacco product applications; this future proposed rule would establish content and format requirements to ensure that modified-risk tobacco product applications contain sufficient information for the FDA to determine whether it should permit the marketing of a modified-risk tobacco product. Additionally, the proposed rule would set forth the basic procedures for modified-risk tobacco product application review and require applicants receiving authorization to market a modified-risk tobacco product to establish and maintain records, conduct post-market surveillance and studies, and submit annual reports to the FDA.
Premarket tobacco product applications and recordkeeping requirements, a 2019 proposed rule, which would have as a next step at some point in the future, likely in 2020, a final rule.
Notably, ingredient bans and nicotine caps are not on the regulatory agenda. A first step toward an ingredient ban would likely be an Advance Notice of Proposed Rulemaking (ANPRM), although the FDA can in theory skip this step and move directly to a proposed rule, open a docket for comment, collect comments and consider whether it has sufficient information to finalize the rule. Given the complexity of the issue and the current research focusing on flavor ingredients in ENDS, if the FDA determines that an exploration of a flavor ban is desirable, the FDA will probably go through the ANPRM step.
One would have to wonder, though, why engage in rulemaking when the FDA already reviews all relevant information about every ENDS product on the U.S. market, present and future, through the PMTA process—thus allowing the agency to make a case-by-case determination—and the FDA will no doubt pay considerable attention to certain flavored products. In the author’s personal opinion, the PMTA process is the FDA’s preferred avenue to make decisions on individual products rather than issuing rules on product categories, which can also be challenged—and the current Supreme Court might entertain challenges to the FDA’s behavior if it came to it down the road.
Meanwhile, the majority of states by number still lean conservative, which likely means fewer developments in taxation, some scrutiny of ENDS but not necessary priority placed on shrinking the lawful ENDS market as there is no immediately quantifiable health benefit from doing so, and many potential harms. Of note are the California litigation and the potential referendum in California to overturn SB 793 (the flavor ban legislation). By the time this you read this article, we should know whether the bill opponents succeeded at collecting the necessary signatures to place the referendum on the November 2022 California elections ballot and suspend the application of the California flavor ban until then and pending the referendum’s outcome.
The question we must also ask, given the political, public health and economic crisis context is whether ENDS are a threat to anyone and why any administration would, at this juncture, prioritize overregulating a harm reduction asset over the important, systemic changes Americans expect from the administration and drastically mitigating the Covid impact. The industry is likely to consolidate and survive.
A global legal and compliance nicotine industry expert, Patricia I. Kovacevic has experience that includes general counsel and chief compliance officer roles at Nicopure Labs as well as leading senior legal and regulatory positions at Philip Morris International and Lorillard. Kovacevic served on the board of directors of the Vapor Technology Association and on the advisory board of the Global Tobacco & Nicotine Forum. She is the founder of RegulationStrategy, a global legal and compliance FDA-regulated industry consultancy.
December 23, 2020
Trump Sends Back Bill With U.S. Post Office Ban on ENDS
President Donald Trump has sent back to Congress a Covid-19 relief bill that included language to ban the U.S. Post Office (USPO) from mailing vapor products.Trump had the authority to use a line item veto on the provision and still pass the larger bill, however, he sent the bill back to Congress in its entirety saying he would not sign the proposal without $2,000 individual payments to taxpayers.
Congress banned all electronic nicotine delivery system (ENDS) products from being mailed by the USPS on Monday. The rule change was lumped into the Covid-19/ omnibus budget bill passed yesterday. The proposal, collectively called the Consolidated Appropriations Act, 2021.
The updated provision redefines the word “cigarette” under the Prevent All Cigarette Trafficking Act (PACT Act), which is part of the federal Jenkins Act, to include ENDS products.
By including ENDS products within the PACT Act, manufacturers and retailers will be banned from shipping vaping products to consumers using the USPS within the next 120 days. All orders of vaping products will be required to ship using an alternate (and considerably more expensive) service that verifies the recipient of a package is at least 21 years old.
Beginning 90 days after enactment, all online retailers also will be required to file monthly reports with native, state and local governments disclosing the identity, address and product received for all customers, as well as remit any excise taxes owed.
Many vaping industry advocates are angered by the text of the proposal because legislators used an expansive definition of what qualifies as an “electronic nicotine delivery system” that seems to include products that may not contain nicotine. The term “means any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device,” the legislation states.
Greg Conley, president of the American Vaping Association, said that despite the inclusion of the word “nicotine,” the definition used in the bill is so broad that it appears to capture vaping liquids containing CBD and standalone devices intended for vaping THC or other substances.
“The sponsors of this legislation repeatedly refused to consider common sense amendments that would have protected youth, while also not needlessly shutting down small businesses. Thanks to their intransigence, the language included in the omnibus is so sloppily drafted that it will also ban the USPS from shipping CBD liquids intended to be vaporized, as well as devices intended for use with THC or other non-nicotine substances,” said Conley. “There are still 36 million American adults smoking combustible cigarettes and over 400,000 will die from smoking-related illnesses this year alone. The American people should start questioning why their government is so intent on making it harder for adults to quit smoking.”
According to its website, UPS prohibits the shipment of all cigarettes and little cigars to consumers, regardless of destination state. Other tobacco product shipments must be made using the “UPS Delivery Confirmation Adult Signature Required service, requiring the signature of an adult 21 years of age or older upon delivery.”
December 23, 2020
Study: E-Cigs Aid Cessation Only in Clinical Settings

Photo: Vchalup | Dreamstime
In the form of mass-marketed consumer products, e-cigarettes do not help smokers quit cigarettes, according to a new study published Dec. 22, 2020, in the American Journal of Public Health by researchers from the University of California San Francisco.
The authors examined both observational studies, which question people “in the wild” without specific guidance to quit, and clinical trials, in which smokers trying to quit were given free cigarettes under medical supervision.
While e-cigarettes led to more quitting than some other therapies in clinical trial settings, the authors noted no such effect in observational studies.
Richard Wang
“It’s important to recognize that in clinical trials, when certain e-cigarette devices are treated more like medicine, there may actually be an effect on quitting smoking,” said study leader Richard Wang.
“But that needs to be balanced against the risks of using these devices. Also, only seven e-cigarette devices were studied in the clinical trials. Whether the effect observed with these seven devices is the same or different than that of the thousands of different e-cigarette products available for sale is unknown.”
The 2009 Family Smoking Prevention and Tobacco Control Act charges the U.S. Food and Drug Administration (FDA) with allowing e-cigarettes on the market only when manufacturers can prove their tobacco-based products are “appropriate for the protection of public health.” The FDA is currently evaluating thousands of applications to sell e-cigarettes.
“If e-cigarette consumer product use is not associated with more smoking cessation, there is no population-level health benefit for allowing them to be marketed to adults who smoke, regardless of the relative harm of e-cigarettes compared with conventional cigarettes,” said Wang.
“Moreover, to the extent that people who smoke simply add e-cigarettes to their cigarette smoking—becoming so-called dual users—their risk of heart disease, lung disease, and cancer could increase compared with smoking alone.”
December 23, 2020