Category: Regulation

Staying Vigilant
STAYING VIGILANT
The effectiveness of the White House’s flavor ban remains to be seen, but it is time to adapt.
By Mike Huml
After months of speculation and anxiety, the Trump administration has finally released its final ruling on the fate of vaping. In a tepid compromise, refillable vapor products are to be left alone for the moment while closed pod systems will be restricted to tobacco and menthol flavors only.
While some in the vaping community are willing to take the win, others are hesitant to be optimistic. On one hand, many vapers hold a negative view of Juul, which accounts for a large portion of the vapor market. Juul sparked the popularity of the modern pod system and played a large role in building demand for nicotine salt e-liquid. On the other hand, the attributes that made the Juul popular among adults also found appeal among youth, and many believe that Juul’s availability, unassuming appearance and discreetness contributed to a surge in teen nicotine addiction.
The effectiveness of the White House’s decision remains to be seen, but one thing is certain: It’s time to adapt. Juul catches a lot of flak for many reasons. Juul Labs is partially owned by a major tobacco company, the Juul doesn’t offer any options for users to lower their nicotine strength (other than selling a 30 percent nicotine strength online) and many view the company’s marketing strategies as questionable. However, it’s important not to forget a time before the Juul.
Before pod systems, many e-cigarettes, including starter kits, required some instruction. Vaping required, at the very least, a passing interest in vapor technology. This alienated a large portion of smokers. Many tobacco users don’t give smoking a second thought. They stop by a gas station after work, pick up a pack of smokes and a lighter and they go on about their days. If any considered a switch to vaping, there were two options: disposables or proper vape starter kits.
While the learning curve to get into vaping wasn’t steep, the disposable option was much more appealing. Many disposables were and continue to be sold alongside analog cigarettes in convenience stores. So, the routine of buying cigarettes remained unchanged. Even though a large number of smokers tried to make the switch to vaping by using disposables, these products just didn’t satisfy in the same way that cigarettes could.
This poor experience turned many people off ofvaping since many smokers just don’t have the same interest in vaping as the hobbyist community. As such, one bad experience from a poor product, typically a disposable cigalike, cast a harsh shadow over the entire vapor industry. This all changed with Juul’s introduction to the market.
Juul offered a much better product that was convenient and satisfying. It was so popular that even mainstream vapor manufacturers tried to duplicate Juul’s success, leading to the boom in pod systems that’s been seen over the past several years. Unfortunately, this jump in quality and convenience also made vaping more accessible to minors, and while teen smoking is at an all-time low, vaping among youth has increased, according to the U.S. Centers for Disease Control and Prevention (CDC). This is where the idealist versus realist schism occurs.
Nobody wants teens to use nicotine, and while it’s not a good thing that kids are vaping, one side is pushing for the complete absence of nicotine use among youth while the other side views vaping as the lesser of two evils. However, for people who have never smoked, vaping can only increase the risk of health issues, even by a marginal amount, according to several studies. It’s difficult to determine how many vapers who have never smoked would have smoked had it not been for vaping. So, it almost becomes a philosophical question: For both youth and adults, should the end goal be to eliminate nicotine addiction completely or to accept that people will always seek out vices and to mitigate the associated risk as much as possible?
Some say this is the only true question as every issue will materialize two sides to the argument until the industry can agree on the true goal of vaping. As such, regulation and legislation will be nearly impossible to implement and enforce effectively while this issue remains so divisive. For now, the government seems to want to take the path of least resistance. It needs to show that it’s taking action after the bizarre lung injuries associated with black market THC cartridges, but it also can’t be seen crippling an entire industry in one fell swoop.
So, the ban on flavored pods is supposed to target youth in particular. The perception is that youth are attracted only to flavors, and by banning flavors in regard to the most popular vapor product among youth, the hope is that teen vaping will plummet. Only time will tell if this strategy will be effective. In all likelihood, kids will continue to vape whatever is easy to acquire, and a number of adult vapers will either seek alternatives or return to smoking. After all, underage vaping and drinking are also prohibited, but youth find a way.
What does this mean for vapor businesses? Well, it completely depends on the consumer. For stores that are more hobbyist focused, this ban may well mean absolutely nothing. These stores likely carry few, if any, closed pod systems, and certainly most don’t carry Juul. Other stores may focus more on attracting new vapers and primarily stock pod systems, starter kits and possibly a few mods or intermediate items, and this transition may prove to be more impactful.
Convenience stores may not want to deal with any of this and simply stop carrying vapor products altogether. The cumulative result of this flavor ban will likely be a net negative for vaping and public health. The selection of products just became smaller, which means there will be people who can’t find the product that kept them from smoking. Youth who developed an addiction or dependence on nicotine will now either have to stop vaping (unlikely), find another vapor product that’s easy to acquire or switch to smoking combustible cigarettes to satisfy their cravings, which would be ironically disappointing.
All hope is not lost. As a result of the closed system flavor ban, there is an obvious workaround: Make refillable pods an option. There is nothing stopping Juul or any other manufacturer from simply introducing a refillable pod and offering e-liquid as a separate purchase.
Of course, this adds an extra step of complexity to the vaping process, but this wouldn’t alienate nearly as many adult vapers compared to how many would need to find different options completely if these companies don’t adapt and start offering refillable pods. Business owners should keep their collective ears to the ground and take notice of any pod system manufacturers that start offering conversion kits or even new products. Alternatively, instead of, or in addition to, waiting for new refillable options from the current manufacturers, store owners can start stocking any of the myriad refillable pods that are already available.
In the short term, those who adapt to this change will be the most successful, and it shouldn’t be viewed as the “vapocalypse” just yet. The industry still must contend with the U.S. Food and Drug Administration’s upcoming premarket tobacco product application deadline (May 12) and possibly even more regulation. When this closed system flavor ban fails, smoking rates rise and the teen vaping “epidemic” continues, will regulators reconsider their approach to vaping regulation or double down and start banning more flavor-atomizer combinations? Only time will tell. For now, stay informed, stay vigilant and adapt.

February 18, 2020
No More Mr. Nice Guy
The FDA and CDC often seem to act absurd in their regulations and explanations of vapor products.
By George Gay
Have you heard the joke about the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the smoker looking to switch to vaping? No? Don’t worry; it’s probably just as well. It isn’t very funny, especially if you’re a smoker. In fact, it’s more of a shaggy dog story than a joke, so it goes on and on for so long—3 1/2 years and counting—that you need a pooper-scooper and a good supply of bags to clean up the mess created.
The FDA and the CDC have for a long time made a dog’s breakfast of vaping in the U.S. and, in recent times, have acted in a manner that comes close to being absurd as was well illustrated during the second half of last year when the CDC went off half-cocked over the lung disease affair, which has been well covered in these pages previously.
But most of the running has been made by the FDA through its Center for Tobacco Products, and it got off to a great and well-trailed start in 2020. On Jan. 2, it issued a release titled, “FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.” The release was subtitled with a threat, or, as some would see it, a promise: “Companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions.”
The headings reflect the rambling, repetitive nature of the release—1,700 words of what should have been a mea culpa but what was made to look like a bold move by an agency on top of its game. The subtitled threat is repeated more or less verbatim for the second sentence as if the companies referred to had been flagrantly breaking the law.
It is not until the sixth paragraph, about halfway through the release, that the reader learns that all of the electronic nicotine-delivery systems (ENDS) currently on the U.S. market are unauthorized for sale there—and that they are unauthorized because the FDA has used its discretion to allow them to be marketed without authorization.
In fairness to the FDA, the owners of these products could have sought authorization by putting their products through the agency’s premarket tobacco product application (PMTA) process, but it would have been unreasonable to expect them to go through such an involved and expensive procedure while the discretionary principle was being applied.
As most of the readers of this magazine will already know, the FDA’s Jan. 2 release marked the end of the FDA’s discretionary approach and the start of a “no more Mr. Nice Guy” stance. Or some such. There will still be some discretion but not in the case of certain products. The FDA said it was “focusing on the following groups of products that do not have premarket authorization:

Any flavored, cartridge-based ENDS product (other than a tobacco-[flavored] or menthol-flavored ENDS product);

All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and

Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.”
Of course, the above could take in every product but was widely interpreted as meaning that the sorts of flavored e-liquids used with open systems would not be the subject of the 30-day enforcement meted out to the cartridge-style products, provided that e-liquid manufacturers took stringent steps to ensure that their products weren’t getting into the hands of those who had not yet reached adulthood, which I think Congress was poised to set at 57 years of age by the time this story was published. But the FDA is set to prioritize its enforcement policies against all ENDS products for which manufacturers have not submitted a PMTA by May 12 this year.
This latest farrago is based on the idea that young people, who should not be vaping, prefer cartridge systems to open systems whereas the opposite is true in the case of adult smokers looking to quit their habit using electronic cigarettes. But, clearly, the scene is set for a quick crackdown on open systems because, following the logic of the FDA, young people, strung out on nicotine and deprived of their fruit-flavored and mint-flavored cartridges, will be driven slavishly into the arms of the open systems. Although, I need to add a caveat here because the question must arise as to whether young people would prefer menthol in a cartridge or mint in an open system. Tricky.
At this point, there is probably a need to explain something to people not used to FDA speak. Most people, I think, probably carry around in their heads rough distinctions between such terms as children, kids, adolescents, students, young people and minors, though they might be pushed to articulate them. But the FDA applies no such distinctions. The heading of the release uses the word “children,” but the first sentence alone refers to youth, children and kids. Sad person that I am, I counted 42 instances of the use of “youth,” “children,” “kids,” “minors” and “students”—that’s one instance every 40 words.
Of course, the FDA is right in a way. People in the U.S. up to one day short of their 21st birthdays have been declared by Congress as children, or kids, or youth, who, though able to marry, drive and fight for their country, are unable, under legislation signed into law at the end of last year, to obtain tobacco products legally.
This is in a country that allows what I would call children to work in tobacco fields (but won’t buy tobacco from countries in Africa that do likewise), that protects the rights of people to bear arms against students and that is seemingly indifferent to its subclass of young people who go to bed malnourished at the end of every day.
But never mind all that. The FDA is busying itself fighting the good fight—protecting the better-off young people from the tyranny of cartridge-type ENDS products—though with the exception of those running menthol and tobacco flavors. It has long interested me that authorities around the world are keen to protect individuals from things they can control for themselves, such as the consumption of tobacco, alcohol and fatty foods, but don’t like to get involved in those things that individuals have little or no control over, such as pollution, poverty, an incoming avian influenza and munitions.
The FDA’s release, which to my mind contains a number of questionable claims, opens by saying, “Amid the epidemic levels of youth use of e-cigarettes …” The idea of an epidemic has been dismissed by many commentators, and I simply don’t believe it, partly because it is an idea that the FDA and others, with the aid of a gullible media, seem overly keen in planting in the minds of people. The word epidemic appears in the first line of each of the first three paragraphs of the FDA’s release.
But its release is not convincing on the subject. It says that the 2019 National Youth Tobacco Survey (NYTS) results on e-cigarette use show that more than 5 million U.S. middle school and high school students are current e-cigarette users, which it defines as those having used such products within the last 30 days (presumably even just once), with a majority reporting cartridge-based products as their usual brand.
“The NYTS survey, which is conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, also shows that of current youth e-cigarette users in 2019, approximately 1.6 million were using the product frequently (use on 20 days or more in a 30-day period), with nearly 1 million using e-cigarettes daily,” the release said in part.
Where do these figures fit with the addiction of young people that the FDA wrings its hands about throughout its release? I mean, using an e-cigarette once or twice in 30 days hardly demonstrates addiction, and, I would suggest, even using a device 20 times in 30 days is not addiction. Okay, you might argue that people admitting below-daily use are just trainee addicts. But this would be trying to have your cake and eat it too.
We are told that just one dose of nicotine can cause addiction, so our e-cigarette trainees would be hooked from day one, and that would mean that a single survey count of less-than-daily users would surely throw up a very low number—not the 4 million implied here.
Is this an epidemic? Is it enough to justify taking fruit-flavored cartridge-type products off the market when they are probably the preferred choice of many young adult consumers who have quit smoking, who do not want to return to smoking and who find open systems difficult to use? Of course, the FDA says that companies can apply to have their flavored cartridge products authorized, but if the past is a predictor of the future, the young adults who use them will be muttering incoherently in old folks’ homes, and Congress will have raised the age of consent to 104 before that comes to fruition.

There is another thing that worries me about the rush to ban flavors that the FDA says appeal to “kids.” Even if one takes what the FDA says at face value, surely the fact that “kids” prefer fruit and mint flavors to tobacco and menthol flavors does not mean that these people vape because of the availability of fruit and mint flavors. There could well be something else at work here. The FDA seems to be in danger of addressing the symptoms, not the cause of its self-styled epidemic.
At least some of the big tobacco manufacturers reportedly welcomed the FDA’s announcement, claiming that it brought clarity to the situation. But they would, wouldn’t they? The complexities and the costs associated with making PMTAs is going to put off most of the competition, leaving the field clear for the major tobacco companies.
But this was to be expected because the FDA seems to favor tobacco-containing products—lit or heated (but not oral, of course)—over other types of products, especially ENDS, as was demonstrated recently by the PMTAs granted to Philip Morris International’s IQOS heated-tobacco device and to 22nd Century’s low-nicotine combustible cigarettes Moonlight and Moonlight Menthol.
But I guess the FDA’s preference for playing with fire simply reflects a wider picture where little effort is made to stop people smoking and, in fact, encouragement, in the form of decriminalization, is given to people to take up smoking marijuana. Perhaps the thinking is that if somebody is going to draw toxic fumes into their lungs, it’s best that they are properly toxic, along the lines of the air in major cities.
Now don’t get me wrong. I am happy for people, properly—that means truthfully—informed, to smoke tobacco or any other legal substance as long as they don’t interfere unduly with the lives of others. But a society that takes a laissez faire attitude to tobacco and marijuana while coming down hard on vaping seems to be a society that has lost its sense of direction.
Of course, as is stated above, the FDA tries to explain this away with talk of a youth epidemic, but this is nonsense. The only epidemic in evidence is that concerning the moral panic among adults, who are so worked up about vaping among young people that, without FDA-approved antidepressants and opioids, they would probably be tipped over the edge.
Having said all this, I have to admit to having some considerable sympathy for the FDA. When it was launched into the murky waters of tobacco in 2009, the FDA, like the Titanic before it, was seen as unsinkable, built as it was on the steely structures of solid science. And it well might have sailed on effectively but for the fact that it cannot set its own course, which is at the mercy of politicians with one eye on the media and the next round of elections, and of special interest organizations ranging from libertarian groups that would have discounted cigarettes sold at school canteens and liberticides who want total control of people’s lives, especially those bits where they try to have fun.
Somehow, and I have no idea what processes would be necessary to achieve this, the FDA needs to be set free so that it can follow the science, cushioned by common sense but unencumbered by the stifling interference and bureaucracy under which it now seems to operate. But it especially shouldn’t be at the beck and call of lunatic groups complaining about such things as “kids” being put at risk because gummy bears, having escaped from e-liquids, are freely defecating in the woods.
George Gay
George Gay is Vapor Voice’s European editor, but his territory spans the globe.
Based in London, George has covered the vapor and tobacco industries since 1982.
George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Vapor Voice’s readers.
February 18, 2020
Forward Progress
Blackbriar Regulatory Services has its sights set on getting its clients’ products through the PMTA process.
By Timothy S. Donahue
In less than 90 days, the landscape of the vapor industry is expected to change dramatically. Any electronic nicotine-delivery system (ENDS) product without a premarket tobacco product application (PMTA) submitted to the U.S. Food and Drug Administration (FDA) by May 12 must be removed from the market. The PMTA process is arduous and expensive, meaning many manufacturers will choose to go out of business rather than spend the time and money to submit the required data.
Companies have been very reserved about sharing how they are approaching the PMTA process. Luckily, Blackbriar Regulatory Services (BRS), a contract manufacturing company that specializes in FDA compliance consulting and laboratory services, agreed to sit down with Vapor Voice to explain its approach to navigating the sophisticated regulatory regime.
Typically, when dealing with the requirements of a government agency, nothing is guaranteed. This is especially true concerning vapor products since no ENDS product has received a marketing authorization from the FDA. Only two tobacco products, General snus and IQOS (a heat-not-burn device), have ever received a PMTA.
“No e-liquid has made it through the PMTA process before. We provide significant assurances to companies that their applications will be accepted,” said Ramesh Srinivasan, vice president for scientific services at BRS. “For certain products, we also will provide assurances that their applications will be successful at making it to the filing stage. Of course, we cannot guarantee that the application will be approved. This is because once an application is being reviewed, that is entirely at the discretion of the FDA.”
There are three steps to the PMTA process before a company receives a marketing order. First, a company must get their application accepted. The acceptance review confirms that basic elements are included for an application to be accepted, according to the FDA. After acceptance, the FDA will decide whether the PMTA application should go through a “filing” review process where the decision on whether to submit the application for full review will be made.
The full review process is a “multidisciplinary approach to determine if the new product can receive an order for commercial marketing,” according to the FDA. The FDA may also refer an application to the Tobacco Products Scientific Advisory Committee (TPSAC) based upon the FDA’s own initiative or upon request of the applicant during the review process.
Srinivasan says that while BRS has never submitted a PMTA before, the company is a sister company of Avail Vapor, a chain with 99 brick-and-mortar stores (see “The Great Divide,” page ?), and has been working on collecting data and designing protocols for the PMTA process for more than three years.
“Now, it’s a deep dive and [an] in-depth, precise look. We know what needs to be done, and we’re hiring the right kinds of people to accomplish all of our goals,” Srinivasan explains. “We have not submitted any PMTA yet because we were waiting for the final guidance [from the FDA]. Now that the final guidance has been published, our goal is to send all the PMTAs we are working on to the regulatory agency between April 15 and May 11. We are writing many additional contracts for other products that stretch into the last quarter of 2020. The pipeline is really growing.”
Working the procedure
Currently, BRS is preparing to submit more than 30 PMTAs for several e-liquid brands and Avail brands that BRS manufactures and several more for hardware manufacturers. BRS offers the full complement of services needed to successfully navigate the PMTA process using its proprietary road map, according to Srinivasan. BRS has partnered with multiple contract research organizations (CROs) in order to provide additional support.
“There are certain things that we do and things that we contract out,” says Srinivasan. “For instance, we have the ability to conduct harmful and potentially harmful constituents (HPHCs) testing on e-liquids. That is something we do internally, which helps to control cost. We have an ISO 17025 certified lab. However, for some tests, we go outside our organization because the amount of work that needs to be done is significant.”
Broadly speaking, there are eight key steps to completing the PMTA process, according to Srinivasan. The first step is to ensure that a manufacturer’s device manufacturing and quality control (DMQC) and/or e-liquid manufacturing and quality control (EMQC) process is robust. Manufacturers need to demonstrate that their processes and controls are based on ISO/ICH/GMP principles. Manufacturing facilities are audited by the FDA on a periodic basis, often unannounced. “You are only as good as your last audit,” says Srinivasan.
BRS highly recommends that its clients take advantage of the FDA’s Tobacco Product Master File (TPMF) process to submit confidential and repetitive information to the agency as a second step, according to Srinivasan. Often, manufacturers have intellectual property on their manufacturing process, trade secrets on their formulations and other proprietary information. “A good way to tackle this problem is to create and publish a suitable TPMF [and then] obtain a TPMF number that can then be cited throughout the PMTA application,” says Srinivasan. “TPMFs are an innovative tool that can be used to submit thousands of pages of information at one time, but [are] repeatedly referred to in multiple PMTA applications.”
The third step involves evaluating e-liquids and device hardware to make sure the products meet the FDA’s Center for Tobacco Product’s (CTP) statutory mandate to only authorize products that provide a net population health benefit—including both users and nonusers of tobacco products—thus meeting the “appropriate for the protection of the public health (APPH)” standard, according to the FDA.
“Our strategy parallels the pharmaceutical industry approach to drug approvals. They have been doing this for decades. We will collect the necessary data and conclude if products meet the APPH standard. If yes, we will move forward in the process” Srinivasan says. “A key component in this step is analytical testing. There are requirements related to HPHCs, in-vitro toxicology, extractables and leachables and so on and so forth.”
Step four relates to what vapor hardware will be used to conduct e-liquid testing. Srinivasan says it doesn’t make sense to use a device that isn’t going through the PMTA process as well. A device should also carry an Underwriters Laboratories (UL) certification because the FDA will most likely require one. “UL, technically, is not something that is mandatory, but it is extremely useful in demonstrating to the FDA that your device is safe from the standpoint of the components, including the battery,” says Srinivasan.
The fifth step is one of the more complicated processes. At least one clinical study is needed for the PMTA process. After September 2019, it became clear that the FDA would require clinicals after reviewing the proposed rule. The “proposed rule” details requirements on pharmacology data/pharmacokinetics, abuse liability assessments and biomarkers of exposure. “This kind of information does not exist for e-liquids. So, we put together a very cost-effective clinical study, and this is essentially a large phase of our work,” explains Srinivasan. “We spent considerable development efforts to determine the tolerances, out-of-control [limits] and out-of-spec limits.”
The sixth step involves the stability/shelf life determination process. A company must provide answers to questions such as shelf life. Srinivasan says there is a precise technique that the pharmaceutical industry follows to prove that.
“You don’t just put a product on the shelf and wait. It is much more elaborate than that,” Srinivasan said. “You have to take into consideration the amount of time the product will be stored in the store [and] in the warehouse. Then we must test the product at periodic intervals and observe the trend on harmful constituents to put all of this together. For a lot of what the FDA has provided guidance for, they have not actually specified out-of-control limits and out-of-spec limits on contaminants that are generated during the stability testing phase. Fortunately, we have devised protocols that lead to the determination of those limits.”

Perceived behavior
In step seven, there are several important perception and behavior studies needed for the PMTA. There are two, however, that may be the most vital in meeting the APPH standard necessary to get a marketing order, according to Srinivasan.
“Looking at this from a very high level, an applicant has to prove the following two things: One, what are you doing to market your products only to adult smokers? You must prove that you are not marketing your product to teenagers. [And] two, how does your product help adult smokers switch from cigarettes to your device or to your e-liquid?” Srinivasan says. “Then you have to address a lot of issues surrounding what happens if people switch from cigarettes to e-liquids. Do they remain with e-liquids, or do they transfer from here to being completely out of both, or do they become bimodal (both vapor and combustible product) users?”
A company is going to have to show the FDA that it is not marketing to children. The FDA has also said that it “could” delve into a company’s marketing and social media presence to search for any past indiscretions. “I work with a lot of clients who have no idea that they should not be doing the things they are doing. We point out to them that this is not like any other product,” Srinivasan says. “You also must remember that the FDA can look back at all social media posts, even if they have been deleted.”
If a company has made mistakes in its marketing, or even if a website was hacked and illegal posts were made by a hacker, a company must address these situations head-on, according to Srinivasan. The client must prove to the FDA that it hasn’t done these things, or if it did, why it did them. “If they have done something questionable, they need to explain what they are doing now to correct their mistakes,” he says. “The FDA is going to ask: What have you done to make sure this doesn’t happen again?”
Don’t blame the distributor either, says Srinivasan. A manufacturer must put stringent contracts and procedures in place so a distributor is not selling an illegal product or products to those underage. Srinivasan says he expects that the FDA is also going to want to know the age group of people who are buying a company’s products.
When it comes to the cost of a full PMTA approval, Srinivasan says it’s going to be an expensive process—at least until some e-liquids and hardware get approved. “There is no skinny PMTA. At the same time, we don’t need to prepare an $80 million dollar application, but there [are] still a lot of data sets needed. The overall strategy and road map that we have is very strong,” says Srinivasan. “When we price out a PMTA, the number is pretty much fixed because we know all the steps. We know the pricing for all the intricate details, and we come up with a finite number and a finite timeline.”
Another major reason why a company would want to do their PMTA with BRS, according to Srinivasan, is that BRS has a long-standing relationship with several of the major hardware manufacturers in China. “We help an e-liquid company partner with device companies. For instance, in a clinical study, you need both e-liquids and a device. So, if you do not have access to device manufacturers and you go and try to do a clinical study, you are just relying on the clinical CRO to devise a protocol and hoping that that’s the right one,” says Srinivasan. “Our value proposition on [the] PMTA is a significant differentiator; it is unique and strong at reducing risks for the client relying on us.”
The eighth and final step is the most vital, according to Srinivasan. It has two important pieces. The first is the length. He expects a BRS PMTA submission to be about 30,000 pages. Comparatively, the PMTAs approved so far are much higher in page count (Philip Morris’ IQOS, for example, was over 1 million pages). Srinivasan says the reason BRS wants to be concise is that the published version of the PMTA (the actual document sent to the FDA) needs to guide the agency through the narrative of why a product should be approved.
“This is where the PMTA is made or it’s broken. You have to tell the narrative about how you have tied all the pieces together—a very convincing story as to why your product is safe and one that helps cigarette smokers switch from cigarettes to your product and why it will not go and be a factor in youth uptake. It needs to be a data-driven, convincing and precise story,” Srinivasan says. “The PMTA must flow in an explanatory way, supported by science, with a conclusion on why this product is a benefit for public health. This is also a time-consuming and expensive piece of the puzzle.”

Sidebar
The Great Divide
Avail Vapor, one of the largest e-liquid manufacturers in the U.S., recently divided its operations into three separate entities. The company made the decision to separate its services to streamline its processes and to help its clients navigate the complicated premarket tobacco product application (PMTA) process required by the U.S. Food and Drug Administration (FDA).
“Evolving our corporate structure supports our continuing growth across the multiple segments of our portfolio from vaping, manufacturing, distribution [and] regulatory services to future markets,” said James Xu, former CEO of Avail Vapor, now chairman of the three entities. “Due to the increasing importance of our regulatory consulting division at a time when FDA compliance is paramount, we want to drive even greater focus to that area and also support the individual needs of our customers and clients.”
The three companies are:

Avail Vapor (the retail arm with 99 stores located in 12 states and online)

Blackbriar Regulatory Services (oversees all contract manufacturing, FDA compliance consulting and laboratory services)

Blackship Technologies (promotes research and development services)
BRS recently announced it has entered into agreements with Charlie’s Chalk Dust to manufacture a range of its nicotine products and take the lead in submitting a number of those products for the FDA’s PMTA process by the May 2020 deadline.
“We are honored that Charlie’s Chalk Dust has added its name to the growing list of companies that trust us to help them move forward in a maturing industry,” said Russ Rogers, CEO of Blackbriar Regulatory Services. “Under Avail, we partnered with Charlie’s for several years to help the company deliver the highest quality products to this market, and we are very happy to see that they remain so strongly committed to continuing their success working with Blackbriar as vape industry leaders start to add regulatory compliance to their list of critical strategies.” – VV staff
Timothy S. Donahue
Timothy S. Donahue is the co-founder and managing editor of Vapor Voice.
Timothy spends much of his time on the road, attending conferences and interviewing industry representatives.
His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
February 18, 2020
The Good Fight
Vape store owners lobby, protest and prepare as the FDA’s May PMTA deadline looms large.
By Maria Verven
It’s a battle to protect vapers’ right to vape. A battle for their livelihoods. A battle they have no intention of backing down from.
Vape store owners all across the U.S. are getting ready for the fight of their lives when, on May 12, 2020, the U.S. Food and Drug Administration (FDA) intends to start enforcing its new policies against e-cigarette retailers that have not received a marketing authorization.
The FDA’s set of enforcement priorities include any flavored cartridge-based electronic nicotine-delivery systems (ENDS) as well as any products—both open and closed systems—for which the manufacturer has not submitted a premarket tobacco product application (PMTA). Plus, any ENDS products targeted or marketed to minors or manufacturers that failed to take adequate measures to prevent access to minors will also be targeted.
Fortunately, the FDA is exempting tobacco-flavored and menthol-flavored ENDS products from its proposed enforcement priorities based on the fact that these flavors hold less appeal to youth.
However, in all the above cases, the FDA promises to take legal action, including against the thousands of retailers—mostly small business owners—that sell ENDS products. It’s estimated that independent vape shops account for about one-third of all e-cigarette product sales.
While the vast majority of vape shops sell refillable open system vapor devices and e-liquids, the owners nevertheless have grave concerns when it comes to the FDA’s new enforcement policies.
Vapor Voice spoke with three vape shop owners about the impending May 12, 2020, deadline—David Higginbotham, owner of HiggyCigs in Lilburn, Georgia, and president of the Georgia Smoke Free Association; James Jarvis, owner of Vapor Station and president of the Ohio Vapor Association; and Marc Slis, owner of 906 Vapor in Houghton, Michigan, and co-founder of the Michigan Vape Shop Owners Association.
How have you been preparing for the May 12, 2020, deadline?
Higginbotham: I have been working hard with local and national groups to fight this deadline, but at the same time, I am also looking for work in my previous career. My wife is planning to hold down the fort while I fund our business with outside income.
Jarvis: We have been hyper-focused on what our business will be like in the post-May 2020 world. If we get no relief or reform from [the] FDA, we will be forced to close three of our four remaining locations; we will continue to operate from that location until they physically shut us down. My wife has started online accounting classes, and more than likely, I will have to take a job in my previous field. I worry about our 16 employees who will be left with no other option but to start over or go on unemployment.
Slis: First off, I’m in this fight to win. We are on the side of right, science, truth and health. Call me naive, an optimist or foolish, but I believe if everyone pulls together, this industry and community can and will win this fight.
I must confess that until September 2019, I solely concentrated on learning how to help my customers quit smoking and figuring out how to run a retail business. I wasn’t involved or even aware of the community and industry at large. I just ran my shop, educated my customers and spent all my free time in the woods hunting and fishing. My bad, as it turned out.
How will the FDA’s new enforcement priorities affect your businesses?
Higginbotham: It will put me out of business completely. The cost of a PMTA is more than I make in a year or even two years. The PMTA process is designed to shut down small businesses, which is precisely what it will do.
Jarvis: If the FDA’s priority is truly prefilled flavored pods, it may not have much effect on our stores since we only sell Leap Vapor pods and disposables. Since the FDA’s announcement, we offered our current flavored pod users a 15 percent discount to switch to an open system and e-liquids. We also offer a 15 percent discount to smokers who surrender their cigarettes and start vaping in the hope that we can convert rather than lose them back to cigarettes or the black market. Keeping vapers from going back to smoking and giving smokers the most successful option to stopping smoking is our highest priority.
Slis: My sales have been suffering for a good year due to the mounting negative press and misinformation, the federal T21 [Tobacco 21] rule and recent enforcement priorities on flavored closed systems. Because I concentrate on creating ex-smokers, the majority of my customers transition off of smoking and eventually off of vaping. I’ve always said the second-best day with my customers is the day they come in and announce they’re done with both smoking and vaping.
My customers bring in their friends, family and coworkers, so I’ve never needed to advertise. But with the coordinated misinformation campaign by tobacco and pharma-funded “public health” groups, HHS [Health and Human Services], [the] CDC [the U.S. Centers for Disease Control and Prevention],
FDA and a complicit media, I began to see [fewer and fewer] new customers while our old customers continued to transition off of vaping.
During the last six months of 2019, my sales dropped by an estimated 60 percent after e-cigs were blamed for the lung illness outbreak and the announcement of the [Michigan] governor’s flavor ban and allegations that we were targeting and addicting kids.
In December, just as sales were rebounding to about 80 percent compared to December last year, T21 was responsible for another overnight 20 percent drop, making it impossible for me to continue to employ my one long-time employee, Alec, whom I had employed for the last five [years] after purchasing 906 Vapor. Alec was the young man who introduced me to e-cigarettes six years ago and singlehandedly saved my life after the government and the medical [and] public health communities failed for 30 years.
The single worst day of my life was having to let go [of] the man who saved my life, but the alternative was closing for good. My customers are my friends and neighbors, and I will do anything to keep them from having to go back to smoking or rely on a black market.
The most recent flavored closed pod ban has not impacted my sales at all. We never carried pre-filled closed systems at 906 Vapor with the exception of a few disposables. I’ve phased them out completely in favor of an inexpensive open system.
I am also compiling a list of pre-Aug. 8, [2016,] products still on the market if we are forced back to them. Otherwise, I am expending every effort to defeat that deadline, as I believe we all should be doing.
Have you been involved in the battle to fight for the vaper’s rights?
Higginbotham: I have indeed. As president of the Georgia Smoke Free Association, we have been involved in hearings with Georgia legislators over the past few months. In February, I will join a group of vape business owners in approaching those same lawmakers to show them how big an issue vaping is to the local economy and health of Georgians. On the national end, we are members of the Vapor Technology Association (VTA) and have joined them on Capitol Hill to address our legislators in Washington, [D.C.]
Jarvis: Since becoming president of the Ohio Vapor Trade Association, I have been heavily involved in defeating anti-vaping legislation in Ohio. However, last October, we were hit with both a statewide T21 and a vapor wholesale tax, which forced us to close one of our stores. On the day the tax went into effect, we held a rally, attended by 650 people, at the Ohio Statehouse to voice our frustrations with the new laws.
I have also been a speaker at several Vapor Technology Association (VTA) national conferences and was awarded [the] VTA’s 2018 Advocate of the Year. I attended many meetings in Ohio and Washington, D.C., including as a guest speaker at the United Vapor Alliance last November. Since then, I have traveled to Hershey, Pennsylvania; West Palm Beach, Florida; Lexington, Kentucky; Battle Creek, Michigan; and Toledo, Ohio to help lead protests at President Trump’s rallies.
Slis: Everything changed that early morning in September when I read The Washington Post story an hour after it broke. I got out of bed at 1 a.m., made a pot of coffee and compiled the phone numbers for my state representative, senator and governor. I spent the rest of the night learning about their political careers and the Michigan political landscape until morning, when I began calling them.
Since that moment, I have been fighting nonstop with little regard to anything else in my life.
My first call that fateful morning was to my state representative. I was the very first to call his office at 7:30 a.m. He answered the phone himself, which surprised me. I also made the first call to my state senator’s office (he also answered himself) and the first call to the governor’s office. My state representative called me back a few days later to inform me of a state House Oversight Committee hearing on vaping scheduled the next week and encouraged me to testify. While I’m terrified of public speaking, I summoned up the courage to speak, and surprisingly, the video of my testimony went viral on Redditt and YouTube.
Hundreds of media requests resulted from that initial testimony, including NPR and a live broadcast from my vape shop on Fox News. On behalf of the Defend Michigan Right Coalition, I then sued the governor, the state and the Department of Health and Human Services, testifying before the Michigan House Regulatory Reform Committee, which resulted in a preliminary injunction granting a temporary open-ended halt to the Michigan flavor ban. The governor appealed to both the state appellate and supreme courts, which declined to hear the case. Three separate motions filed by the state in all three courts to overturn the injunction were denied. The case is currently stuck in the Michigan appellate court.
A couple of other shop owners and I founded the Michigan Vape Shop Owners in late October, which is now becoming the Michigan chapter of the VTA. Completely self-funded, we’ve retained both an attorney, a lobbying firm and a media team to handle media requests and counter misinformation with actual science and statistics. We’ve been actively lobbying in our state capitol to properly regulate the Michigan vaping industry and organizing protests at President Trump’s rallies, garnering both national and international attention.
We held a lobby day when we met with as many state representatives as possible as well as a meet-and-greet with our U.S. congressman and two of my customers, when I made sure that vaping was the first topic we discussed.
I’ve been extremely active on social media to influence policymakers and the media but also to motivate others to be active and vocal, which will be crucial over the next few months. Twitter is the platform we need to be on, where we can directly engage lawmakers, policymakers, the public and media. I’ve done a podcast with Lindsey Stroud from the Heartland Institute, a few live shows with the Smoke-Free Radio Network, a very informative and dynamic group of advocates—I especially recommend the Monday 20!—a vaping documentary with the Economist Media Group and a program with the Japanese TV station NHK.
While I’ve been pretty active and have gotten a lot of attention over the past six months, I need to point out that I’m just a regular guy and a nobody. I just saw the need for my community and industry to be heard. I wasn’t comfortable or confident, wasn’t sure what to say or do, but I just jumped in, started speaking up and getting active on social media. I’m still terribly uncomfortable with all of it, but it needs to be done to save this amazing community and technology, so I do whatever I’m asked—whatever I can. I urge the business owners in every state to do the same! If I can do it, anyone can.
I urge all vapers to join Consumer Advocates for Smoke Free Alternatives (CASAA), the Smoke-Free Alternatives Trade Association (SFATA) and the American Vaping Association (AVA)—the organizations that represent consumers. And ask your vape shops if they’ve joined the VTA and/or any state vaping trade organization that’s active in the fight.
Ask what they’re doing to fight for your right to vape and be smoke-free, and support those shops as well as the hardware and liquid manufacturers that are active. Get on Twitter, follow other activists, media and lawmakers, and especially the tobacco control and scientific/medical folks that support tobacco harm reduction and vaping.
Whatever you do, don’t give your money to shops and manufacturers that are simply taking your money and refusing to fight. Make the power you hold as a consumer or a business owner work for you and help save vaping.

Maria Verven
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
February 18, 2020
US FDA Seeks Input From Public to Prevent Repeat of EVALI Event
Today, the U.S. Food and Drug Administration opened a docket to obtain data and information related to the use of vaping products that are associated with e-cigarette, or vaping, product use-associated lung injury (EVALI).
This request for information responds to direction from Congress to gather information from the public that could help identify and evaluate additional steps the FDA could take to address the recent lung injuries associated with the use of vaping products and to help prevent similar occurrences in the future, FDA Commissioner Stephen Hahn stated in a release.
“Our investigation has brought to the forefront the serious risks of using illicit, black market products. As part of our efforts to mitigate and prevent a potential future outbreak of vaping injuries, we are asking the public for input on additional steps the FDA can take to inform our regulatory work and address the illegal modification of these products.”
The FDA is seeking unpublished data or information related to the use of vaping products that are associated with recent lung injuries including information on specific chemicals, compounds, ingredients or combinations of ingredients that when inhaled or aerosolized, may be associated with EVALI symptoms, as well as product design and potential ways to prevent consumers from modifying or adding substances to these products that are not intended by the manufacturers.
Starting Feb. 18, 2020, you may submit responses to this RFI to Federal Register docket FDA-2020-N-0597 on regulations.gov. Comments should be submitted by April 20, 2020.
February 14, 2020
Maryland First US State to Ban Flavored Disposable Vapor Products
Maryland will become the first state to ban the flavored disposable e-cigarettes that are exempt under U.S. President Trump’s federal flavor ban. Tobacco and menthol flavors are excluded from Maryland’s measure.
Trump’s flavor ban went into effect last week, removing flavored pod products from the market, but it exempts single-use disposable products as well as open tank systems.
“I will not stand idly by letting kids get addicted to nicotine and hurt by these unregulated products that are marketed directly towards them,” Maryland Comptroller Peter Franchot said in a statement.
Franchot’s office sent a notice to the state’s tobacco retailers and wholesalers, warning that they will be disciplined if caught selling flavored disposable products.
February 12, 2020
Pennsylvania Joins Growing List of States Suing Juul Labs for Youth Use
Pennsylvania has joined a growing list of states suing leading e-cigarette maker Juul Labs, whose sleek vape pens and cartridges in fruit, dessert and candy flavors have been blamed for contributing to a sharp rise in e-cigarette use among teenagers and adolescents, according to an article in The Philadelphia Enquirer.
The lawsuit, filed Monday by Pennsylvania Attorney General Josh Shapiro, alleges that Juul misled consumers about the health risks and addictive power of its nicotine vaping pods and improperly marketed the products to youth, the article states.
The lawsuit seeks a state-wide ban on all of Juul’s products — including tobacco-flavored ones. If the court does not grant a full ban, the state wants to restrict sales to ban all of Juul’s flavored, menthol and high-nicotine vaping products except for those that are tobacco flavored, according to the article.
The U.S. Food and Drug Administration this month forbade the sale of flavored vaping pods nationwide. Over the last two years, Juul has phased out sales of flavored pods, except for those with menthol and tobacco flavors.
February 10, 2020
Flavored E-liquids are Back on Store Shelves in Washington State
On February 7, flavored e-liquid and other vapor products returned to store shelves in the U.S. state of Washington. The state’s lawmakers amended the ban on vaping last week. During the four-month period the flavor ban was in effect numerous local vape shops suffered financially.
Flavored vape products were one of the High Beast Vape shop’s biggest seller. When they were forced to take them off shelves in October, they say they had to turn down more than 40 customers per day, according to an article on klewtv.com.
“We had a lot of customer that came into ask and we had to answer; we can’t sell it and it’s not on the shelves anymore,” Lakhvir Sohal said.
Owner of High Beast, Lakhvir Sohal says she is relieved that flavored vapes returned to the shelves. When Governor Jay Inslee implemented the state-wide ban, businesses were impacted.
“It has changed,” Sohal said. “A lot our sales have gone down a lot like more than 50 to 60% off of regular sales every day.”
Some vape shops had to give their flavored products to stores in Idaho.
While Sohal says she took down more than 500 flavored vape bottles from her shelves. Each bottle ranging from $10 to $30.
“The taxes itself cost $4000 but the products I can’t really estimate it because it was a lot,” Lakhvir said.
Since the ban is removed, she will be able to sell the products she already bought. However, the products are making their way back with another restriction of the new age law, which changes the tobacco buying age from 18 to 21 years old, according to the article.
“We check ID of each customer especially that they’re under 50 and anyone we feel like we must check ID on,” Sohal said.
February 10, 2020
Health Canada Investigating Ad for Possible Breach of Vaping Rules
Health Canada and its Quebec counterpart are investigating a vaping ad by Imperial Tobacco to see if it violates advertising laws, reports CBC.
The ad warns of “an epidemic of disinformation” and “hypocrisy” surrounding vaping.
The Tobacco and Vaping Products Act states that it is illegal to “promote a vaping product, including by means of the packaging, by comparing the health effects arising from the use of the product or from its emissions with those arising from the use of a tobacco product or from its emissions.”
Imperial’s “Facts not Fear” website appears to violate that section of the law on the home page and at least seven times on the three pages accessible from the main site, according to Health Canada.
“Everything we do, from our point of view, is legal,” said Eric Gagnon, head of corporate and regulatory affairs for Imperial. “We’ll never do anything illegal. I can assure you that the advertisement, the campaign ahead of publishing looked at every detail, and we consider the advertisement to be legal.”
Imperial appears to have made slight changes to the website recently, removing references to its Vype vapor device.
“Inspectors are currently reviewing the ad and the associated websites,” the federal health minister’s office said.
February 10, 2020
Vapor CEOs Face Lawmakers’ Questions on Role in Youth Vaping
It was like a flashback to 1994. In early February, The House Energy and Commerce oversight and investigations subcommittee grilled the CEOs of Juul Labs, Reynolds American and NJOY, as well as the presidents of Logic Technology Development and Fontem US. It was reminiscent of when, in 1994, the CEOs from seven major tobacco companies testified before Congress about the marketing tactics for tobacco products. The tension in the rooms was also similar.
For more than two hours, lawmakers on the House Energy and Commerce Subcommittee on Oversight and Investigations asked questions ranging from marketing strategies to how to curb youth usage of these products. K.C. Crostwaite, CEO for Juul Labs, expressed his understanding of the serious need for companies to combat the uptick in youth use.
“I fully recognize that the opportunity for the millions of adult smokers who still use combustible cigarettes to have an alternative is at risk if we don’t address this issue,” K.C. Crosthwaite, Juul’s CEO, said. “We are focused on combating underage access because I know it puts it all at risk if we don’t make progress here.”
Legislators also wanted to understand the possible health effects vaping products pose to consumers and the role each company sees itself as playing in the ongoing effort to curb the nation’s uptick of youth use. Antoine Blonde, president of Fontem, said the company had a detailed youth access prevention program and maintained efforts to safeguard its products from youth.
“Fontem uses industry-standard online age-gating and age-verification mechanisms to prevent youth access to its products online,” Blonde said. “For example, for all purchases through our website, Fontem relies on industry-standard age-verification technology that compares a potential purchaser’s information against records of trusted data sources to verify the age of the purchaser.”
Blonde said Fontem recognizes that there “may be” bad actors in the marketplace who attempt to purchase bulk quantity of its products through e-commerce web sites in order to re-sell them (a practice often called strawman sales. “Fontem has always had policies in place to monitor for strawman sales and further is implementing a strict 4-Stage standard to monitor site access for any potential strawman purchases on its online platform,” Blonde explained. “This standard will track registered adult consumers’ monthly order frequency of pods from its online platform and will flag potential strawman sales.”
The companies are said to represent nearly 97 percent of the $19.3 billion U.S. e-cigarette market, according to Rep. Diana DeGette, chairwoman of the subcommittee. That data only includes convenience store sales, and many industry insiders say the figure is grossly inaccurate. Vape shop sales are not included in Nielsen data DeGette is citing.
“While consumers remain in the dark of the possible health consequences, these companies are making billions of dollars as they lure a new generation of young people into a lifetime of nicotine addiction,” DeGette, the chair of the oversight panel conducting the hearing, wrote in a press release.
February 5, 2020