Category: Regulation

  • All Hands on Deck

    All Hands on Deck

    The new deadline for premarket tobacco product applications presents a major stress test for the vapor industry.

    By Timothy S. Donahue

    The clock just started ticking a lot faster. On July 11, a U.S. District Court in Maryland slashed the time available for vapor companies to submit the paperwork required to keep their products on the market. Previously set for Aug. 8, 2022, the deadline to deliver premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) is now May 12, 2020—less than 10 months from now.

    Due to the cost and complexity of preparing PMTAs, only the most determined players will have their applications ready in time. Completing a PMTA requires numerous tests and trials consuming tens of thousands of pages of data. It also requires submitting a plethora of information on how companies handle everything from consumer complaints to employee training. Vapor companies are required to submit harmful and potentially harmful constituents (HPHCs) studies, consumer perception studies, environmental assessment studies and more. The list is seemingly unending.

    As a result, experts say there will likely be fewer e-liquid flavors on the market in the future. There will be less hardware too. Businesses will close, and industry consolidation is nearly guaranteed. “Each manufacturer in this industry must make the decision to pursue this enormous and difficult endeavor or face a future of non-engagement domestically,” says Kristofer Manabat, chief strategy officer of USA Vape Lab, one of the largest e-liquid manufacturers in the U.S.

    SUGGESTED DIRECTION

    The industry is now scrambling to get the data necessary to complete the PMTA process. The FDA released its finalized PMTA guidance for the vapor industry nearly one month before the court ruling. The final guidance is very similar to the FDA’s draft guidance released in mid-2016, and acting FDA Commissioner Ned Sharpless says that responsible manufacturers “certainly don’t need to wait 10 months” to act.

    “We’ve outlined our recommendations for what the FDA expects to be included in e-cigarette premarket applications and have provided a number of other resources to aid [the] industry in their submissions for other products and assist the agency in fulfilling its public health mandate,” Sharpless said. “We encourage [the] industry to use these resources now as a guide for their submissions to the agency.”

    Importantly, while the final guidance continues to note that nonclinical studies alone generally would not support a marketing authorization, it also says that long-term clinical studies generally would not be required, according to Agustin Rodriguez, an attorney with Troutman-Sanders, a law firm with 12 offices across the U.S. that specializes in the vapor and tobacco industries.

    “The final guidance provides additional recommendations regarding battery safety, including testing certificates for any voluntary electrical standards,” he says. “The final guidance also provides new recommendations for [the] testing of harmful and potentially harmful constituents. Some HPHCs were removed from the original draft guidance and some were added, and [the] FDA also decreased the recommended number of replicates for testing.”

    Derek A. Beauchamp, senior technical director for analytical sciences at Avomeen Analytical Services in Ann Abor, Michigan, USA, notes that the 2016 guidance did not include a list of chemicals required for HPHC testing. The final guidance lists 34 chemicals plus “other,” most of which can be found on the Hoffman list, a list of hazardous smoke components used by the tobacco industry to simplify testing.

    “A lot of the 34 chemicals chosen by the FDA were out there on the Hoffman list,” says Beauchamp. “These known carcinogens would be the most important for vapor testing. I would say a focus should be placed on testing for heavy metals, nitrosamines, diacetyl …. Attention should be placed on the ‘other’ known irritants or chemicals requirement too. You must test for any chemical if you know or believe that the chemical might be present.”

    Beauchamp says that Avomeen started developing a methodology for appropriate analysis in 2016 when the draft guidance was released. “With the new guidance, we are updating our methods and going through a revalidation in terms of what is required for analytical testing,” he says. “The new FDA guidance is going to ensure that e-liquids are as safe as possible in terms of harmful constituents when the liquid is aerosolized.”

    Currently, the FDA requires a PMTA for each individual flavor, which is costly and expensive, especially for smaller companies. It should be noted that a single PMTA may include multiple products with a single cover letter and table of contents; however, the FDA will “consider each product as a separate, individual PMTA.” Beauchamp hopes there will be options down the road to reduce the cost and time required. “Maybe if a company tests flavors A, B and C, then maybe D doesn’t need to be tested,” he says.

    CROSSING THE BRIDGE

    Two other options to minimize testing costs are bridging and tobacco product master files (TPMFs). “Bridging allows applicants to reference information that is already known for a particular product with the appropriate justification—i.e., why the data used are applicable to the new tobacco product,” says Neelam Gill, a regulatory attorney with Troutman-Sanders. “In other words, when justified, the bridging approach uses a body of information to extrapolate safety and health data in cases where these specific data do not exist. The key is providing adequate rationale and justification to support bridging to existing data for, say, an earlier generation tobacco product or similar tobacco products.”

    Bridging generally allows a company to test a lesser amount of a similar product, although in some cases, a bridging study may be needed. Bridging to existing data and bridging studies are two separate concepts. According to Beauchamp, bridging studies can be valuable because the FDA considers different nicotine strengths and different flavor variants as different tobacco products, each requiring its own PMTA.

    “Imagine a company has a strawberry e-liquid in 10 different nicotine strengths,” he says. “What bridging will allow you to do is test a low-end nicotine strength, a high-end [nicotine strength] and a midpoint … and if you get passing data in all three, the FDA will allow you to make the assumption that everything in between the high, mid and low points would all pass. All individual flavors will require this and will be filed as separate PMTAs.”

    Bridging may also help with hardware submissions. Since the FDA doesn’t specify wattage or temperature conditions, requiring only a “reasonable” range, Beauchamp says that if a company tests some low-end temperature settings, some mid-range temperature settings and some high-end temperature settings, a company should be able to use that as a bridging study for a device. “That should cover it,” he says. “Also, in my opinion, if there is a way to over-increase the wattage, then maybe do some testing there too because if the consumer can do it … people will modify devices. You just want to cover your bases,” he says.

    While there is a significant rationale to bridging, the science should be sound, according to Manabat, especially when realizing how bridging studies can impact other required studies, such as consumer use and perception studies. “The consumption behaviors in 3 mg nicotine and 12 mg [nicotine] are different. There is also a certain amount of nicotine [that] a consumer will use, and that could change with the addition of flavors,” he explains. “This is partially why the PMTA is so complicated. The mechanical application and the oral application …. HPHC bridging could be a crucial factor …. It’s complicated, but we are focusing on creating methodology to be sure we comply with all requirements.”

    TPMFs are another vehicle to save money in the PMTA process. Unfortunately, these won’t be available to reference until at least some products survive the PMTA process and receive approval, according to experts. The TPMF is a submission to the FDA that allows a company to submit its trade secret or confidential commercial information to the FDA without disclosing that information to another downstream manufacturer that would need the information as part of its PMTA, says Bryan Haynes, a partner at Troutman-Sanders.

    “For example, a supplier that sells a certain ENDS component can grant a right of reference to its already-submitted TPMF to the multiple manufacturers that use this supplier,” says Haynes. “The applicant relying on this information to support its submission does not have access to the proprietary information. This approach simplifies the premarket process by helping applicants benefit from increased efficiencies and reduced costs because applicants can simply use the reference information in TPMFs rather than developing the information on their own. Importantly, [the] FDA does not typically review a TPMF in isolation and only reviews it in context of the PMTA or other regulatory submission that references the TPMF.”

    HOLD THE LINE

    There is a lot of information required for the PMTA. There are consumer perception studies, an environmental assessment study, methods for how a company will handle consumer product returns, managerial oversight and how a company will train its employees to conform with FDA guidelines.

    Consumer perception studies assess how consumers perceive product harms as well as consumer interest in (and intentions to use) the product. “[The] FDA expects applicants to describe consumer perceptions among current ENDS users, other tobacco users, and nonusers for appeal and use intentions based on labeling and actual use of flavors,” explains Rodriguez.

    There is no mention of synthetic nicotine in the guidelines, and Beauchamp believes that topic “is still to be seen and could be an issue down the road.” Zero nicotine is addressed and would not be regulated by the FDA unless the consumer is “reasonably expected” to add nicotine. This means that a closed system might avoid FDA regulation in that scenario, according to Beauchamp. “Based on what I know about the FDA, the closed system would be the only way. An open system is prone to adulteration—but then again, I can’t say definitively. It’s a gray area.”

    The Environmental Assessment Study is another requirement that could pose complications. The FDA isn’t clear on its requirements, but secondhand and thirdhand vapor studies are probably going to be required, according to experts. “It would fall onto a toxicologist and may be based on what an analytical lab does with air quality testing,” says Beauchamp.

    Because the final ENDS guidance is essentially unchanged from the draft, companies that have taken measures consistent with the draft guidance will generally be in compliance, according to Beauchamp. However, he says that if a company is just now getting started in this process and is looking for help in submitting its PMTA application, that company should “go with somebody that has experience with the FDA. There are parts that are challenging and parts that are routine practice. The FDA guidelines are just that: guidelines.”

    Haynes adds that although the ENDS guidance provides valuable information, it is important to note that the guidance provides only nonbinding recommendations. “We recommend that applicants develop scientific testing programs appropriate for their products in order to meet the statutory standard of whether marketing the products is ‘appropriate for the protection of public health.’”

    The PMTA process is going to consume much of the vapor industry’s energies over the next months. Getting products approved is essential because, without it, jobs and lives will be lost, according to Manabat—jobs as a result of failing businesses and lives as a result of vapers reverting to combustible cigarettes.

    “Companies conducting responsible, forward-thinking business have the best chance to survive. The fact of the matter is that a significant amount of this endeavor is trailblazing. It’s a difficult and nebulous path because no one in the vapor industry has done it before. There has never been a greater time in our industry for a need of consilience of effort and a unification of industry movement.”

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • Strongly Recommend

    During a recent PMTA seminar/webinar, industry experts say submitting a PMTA will seem overwhelming, but it’s not impossible.

    By Timothy S. Donahue

    It’s going to be a challenge to get it in on time. It’s going to be even more challenging to get electronic nicotine-delivery system (ENDS) products approved. During a Vapor Voice and TMA joint seminar/webinar held in August, “Finding Direction: Navigating the PMTAs,” in Richmond, Virginia, USA, industry experts discussed the challenges and possible solutions to submitting premarket tobacco product applications (PMTA) to the U.S. Food and Drug Administration (FDA).

    Companies will need guidance, according to the panel of eight experts representing the legal, clinical, scientific, nicotine and hardware industries. “You can expect to always be seeking the advice of experts,” a panelist said. “They will provide you options, but ultimately the company will have to make the decisions.” The experts recognized that, currently, there is still a level of uncertainty in the industry on whether any products will be approved. The panel reminded the audience that while the FDA guidance is just a suggestion, the protocols laid out are strongly recommended, and the FDA does not charge a fee for submitting a PMTA.

    The process can get overwhelming, they agreed. “However, ultimately, what the FDA wants you to do is to demonstrate that you know your ENDS products,” one panelist suggested. “Your goal is to be able to show that you know and understand what you are selling/producing and that you will always be able to provide further information about your product.” The experts also stated that companies should have a dedicated team or individual in charge of the PMTA process. “You are not going to be successful if you have a part-time person doing this,” one speaker noted.

    One of the first issues discussed was the standard set forth by the FDA’s final guidance for vapor and e-cigarette products and the requirement that ENDS must be “appropriate for the protection of public health.” This is under the “Public Health Considerations for ENDS Products” section of the final guidance. Companies must be able to demonstrate that their products are no riskier than the products currently on the market. Companies submitting PMTAs must consider the impact of their product on both users and nonusers, according to the panel. “The most sensitive issue facing vapor products is probably youth use,” a speaker said. “This will be a challenge in light of the recent uptick in youth use.”

    Whenever a company is working with the FDA, it is advisable to attempt to look at things from the FDA’s perspective. Many speakers had firsthand experience working with the FDA and agreed this is a viable outlook. “There is the potential for nonusers to use vapor products,” a speaker said. “This can be a difficult thing to overcome …. I think, for the FDA, you must put forward a case that the product is directed toward current smokers and not nonsmokers.”

    The statute is extremely broadly worded, an expert noted, adding that it would have been beneficial if the agency issued regulations around the regulatory review process, and even though it said it would, it has not. It’s also important to remember that regulations would be binding while the guidance just offers suggestions, albeit highly recommended suggestions. “It certainly represents what the agency thinks,” a speaker said. “There have been two products to gain FDA approval, but no vapor products have yet to be approved. However, looking at the PMTAs for General snus and IQOS, a heat-not-burn device, will give the vapor industry clues about what the FDA expects in a PMTA submission.”

    CONSIDERING THE CONTENT

    The second section of the seminar/webinar centered on science. The scientific data a company submits must be solid. “The FDA is not going to be looking for an opinion; the FDA wants data to prove [any statements] about your products,” a speaker explained.

    The panel also agreed that studies must be conducted in a valid manner that is generally accepted by the scientific community. The scientific evidence must be based on a unified standard—a methodology that everyone can adopt. It was also recommended to consult the FDA for advice. “If there [are] any questions about whether a study would meet the FDA’s expectations, you need to vet them through a meeting with the FDA. The worst that could happen is if you spend a lot of time and money on a study and discover that it doesn’t meet their expectations for whatever reason,” a speaker said. “You may not get a definitive yes or no, but you will get powerful clues as to whether you are on the right track.”

    The experts also said that companies should be submitting data from a comparison product, and that product should be a combustible cigarette. Any applicant would be foolish not to look at comparative products when considering the public health standard, one speaker said. “An applicant needs to look at who they are marketing their product to, who is buying the product and how are they using it,” a speaker explained. “How is your product being used in the real world? What product do you hope to displace? I think those are the most relevant comparators.”

    There are several different types of studies that the FDA will expect. The panel said that it is important to remember that while the FDA allows for a single PMTA that covers multiple products, with a combined cover letter and table of contents, the FDA will consider the information included for each product as separate PMTAs. “It is imperative that you clearly identify what content pertains to each distinct product,” according to the FDA. “For example, [the] FDA considers each ENDS product with a differing flavor variant and/or nicotine strength to be a different product.”

    The experts agreed that it is critical for companies to be honest and forthright in their PMTA submissions to the FDA. In their submissions, companies will have to explain several aspects of their product from company protocols, management and employee training, consumer complaints, product returns and other standards. For example, companies must explain their packaging and how it will influence the product. There must also be shelf life studies, and all packaging must be child resistant. This data can be used for all products, such as e-liquids, that will require a PMTA submission, according to the speakers.

    Some of these studies will be very general. For example, when it comes to required nicotine warning labels, the FDA has laid out what the mandatory warnings are, and companies should have warnings on labeling appropriate for their products. Many of these studies can be bridged, which will help lower costs by using one study across many products, according to the experts. Bridging can also be used within a study across multiple products such as nicotine content (see “All Hands on Deck”). When talking about bridging, “bridging to existing data” and “bridging studies” are two separate concepts, an expert explained after the conference. “These are very different concepts, and both are very important,” he said.

    SUBMITTING WITH CONFIDENCE

    The FDA is careful about not putting itself into a corner, according to one expert. “The FDA is never going to say, ‘You need to do X, Y and Z and you will get a marketing authorization,’” he said. “They will not be so definitive. They will always give themselves wiggle room.” This is another major reason why a company considering submitting a PMTA should seek professional guidance.

    During the final section of the seminar/webinar, the panelists discussed content formatting and any advice they can give companies moving forward. “It helps the relationship with [the] FDA that your PMTA is formatted in a way the FDA is used to,” a speaker said. Another expert said that their company has a guidance document that explains how a document should be put together. “There are a lot of little details …. You want things to be presented consistently so the reader doesn’t get tripped up on locating documents all types of different ways,” the speaker said. “There is a very detailed consideration centered around file naming. It has to be a flat file structure; there can be no folder structure. It is one long list of files from top to bottom.”

    Consistency is also key, according to the panelists. Companies should not use different formats in their submissions. “[Often], the data is there but the FDA can’t find it,” a panelist said. “It is always better if you have a simple system.” Giving the FDA the ability to find the necessary information is critical, and the experts agreed that forcing the FDA to “hunt” for information is only going to complicate the process. “Remember this is an electronic submission,” another panelist noted. “My advice is to do whatever makes the most sense for you because the FDA will likely come back the other way …. There has to be a logical and rational [direction in] how you group your data.”

    Having a strategy is also important, according to the experts. Companies must have a system in place where they can easily pull data and help the FDA with any questions or concerns about a specific section of a PMTA submission, one panelist noted. “If you don’t have a strategy in place, you are already on a risky path,” she said. “It’s time to put your money down and play your cards.” Another panelist explained that it’s all about minimizing risk and increasing the chances of success. “Take your time, and listen to people you trust,” he said. “There is no set-in-stone rule.”

    The PMTA is due May 12, 2020, according to the FDA. The experts agreed that if a company is going to submit a PMTA for an ENDS product, it shouldn’t be a “half-hearted” effort. The entire industry is hampered by this new deadline, including the FDA. “There will be very few companies that will have a ready-to-go-as-intended submission by May,” a speaker explained. “It is the FDA’s view that applications have to be complete on submission. The due date and that statement are at odds with each other.”

    Lastly, companies should remember that they will have to continue to submit data to the FDA even after a PMTA is approved. The FDA requires ongoing data submissions—this is not a once complete and approved, it’s finished process. “There will be additional costs, and once a product is approved … you will have an annual requirement to provide the FDA with more information,” a speaker said. “Those [studies] will go on in perpetuity until the FDA rescinds the order … and don’t forget, if a company doesn’t follow through with FDA expectations and requirements, the PMTA can be taken away.” Nothing in the ENDS industry is guaranteed, especially the approval of a PMTA. Like one speaker reminded the audience, “The rules are heavily skewed in favor of the government.”

    Joyetech advertisement
    VAPOR VOICE AND TMA TEAM UP TO SERVE THE INDUSTRY

    When the District Court of Maryland recently ordered the U.S. Food and Drug Administration (FDA) to move the premarket tobacco product application (PMTA) deadline forward to May 12, 2020, it sent the vapor industry scrambling.

    The new deadline is more than two years ahead of the Aug. 8, 2022 PTMA deadline that was established in 2017 when former FDA Commissioner Scott Gottlieb took over his position—but the burden of compliance is equally daunting.

    Vapor companies must carry out expensive and time-consuming studies to demonstrate that their products are “appropriate for the protection of public health”—a considerable hurdle, especially given that the FDA guidance has at times raised more questions than answers.

    With only nine months remaining, the pressure to get it right is high. Those who fail to meet the FDA’s strict guidelines will have to remove their products from the market and may even be forced out of business.

    To help vapor companies navigate the process, Vapor Voice and TMA organized a one-day workshop in Richmond, Virginia, USA, on Aug. 22. Examining the FDA guidance document chapter by chapter, experts in vapor hardware, clinical testing, data collection and regulation shared their knowledge to help participants make sense of the requirements.

    The respective strengths of Vapor Voice and TMA ensured a productive conference. Catering to distributors, manufacturers, retailers and wholesalers, Vapor Voice is a leading source of information on vapor industry regulation, legislation, product development and science.

    TMA was established in 1915 to provide unbiased information at a time of policy and industry uncertainty and to act as a convener of forums to address pressing issues. Catering exclusively to the tobacco industry at first, the association has in recent years expanded its scope to cover new nicotine products as well.

    TMA’s membership includes manufacturers, retailers, suppliers and service providers.

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • Unintended Consequences

    Unintended Consequences

    A new study suggests anti-vaping measures may achieve the opposite of their objectives.

    By Marina A. Murphy

    Regulation is supposed to encourage good behavior for the public good. But sometimes it just doesn’t. Sometimes it has the opposite effect. Like naughty children, if you tell us we should do one thing, we will just go ahead and do the opposite.

    There have been a number of studies showing that when it comes to vaping, it’s no different. According to a study from the Yale School of Public Health, U.S. states that banned e-cigarette sales to minors in a bid, presumably, to drive these youngsters toward a nicotine-free lifestyle instead drove an increase in smoking in 12-year-olds to 17-year-olds. A Cornell study showed that increasing the vaping age had the effect of increasing smoking in youth—but then it really shouldn’t be surprising that if you make access to something difficult, people will turn to something else. Now a new study from Duke University suggests that misguided regulations on e-cigarettes could not only potentially negatively impact the group they were developed to protect but others as well.

    This latest study suggests that the effect of restricting access and availability of e-cigarettes in an effort to discourage youth vaping could have the unintended consequence of driving existing vapers back to smoking. Clive Bates, a well-known advocate of tobacco harm reduction, argues that not proactively assessing the potential unintended consequences of misguided regulations is professional negligence. And if this negligence leads to harm, “then it is a form of corporate manslaughter,” he says.

    “The youth card is often played to justify dubious policies,” says Martin Cullip, chairman of the New Nicotine Alliance, a consumer advocacy group in the U.K. “So often, we see suggestions like banning e-cigarette flavors to discourage youth use—that is, of course, except the flavors traditionally associated with smoking (tobacco and menthol), the very activity we are supposedly trying to discourage. How does that make sense at all?” he asks.

    Indeed, the results of the Duke University study revealed that almost one-fifth of respondents said that if e-cigarette flavors were to be restricted to tobacco and menthol, they would likely not use e-cigarettes as much, and they would smoke more conventional cigarettes. “Effectively, you would be throwing adult vapers under the bus,” Cullip says.

    The Duke University researchers used on online survey to ask 240 participants aged 18 to 29 to predict their use of two products—e-cigarettes and traditional tobacco cigarettes, which they already used—in response to hypothetical regulations to limit e-cigarette flavors, limit the customizability of e-cigarettes or eliminate the nicotine in e-cigarettes.

    About 47 percent said if regulations eliminated nicotine in e-cigarettes, they wouldn’t use e-cigarettes as much and would increase their use of traditional cigarettes. About 22 percent said if regulations limited the customizability of devices, such as features allowing users to adjust nicotine dose or vapor temperature, they would use e-cigarettes less and smoke more tobacco cigarettes.

    “The FDA now has regulatory authority over all tobacco products, including e-cigarettes, and we know that some communities have taken action to ban flavored e-cigarette products,” said Lauren Pacek, the study’s lead author and an assistant professor in psychiatry and behavioral sciences at Duke University. “We wanted to take a first pass at seeing what users’ anticipated responses to new regulations might be,” she said. “Our findings suggest that while some regulations, such as banning certain flavors to limit appeal to adolescents, might improve outcomes for those young users, the new regulations might have unintended consequences with other portions of the population.”

    But this study is small, and we are talking hypotheticals—that is, asking people what they might do in certain circumstances. “True,” says Cullip, “but the authors themselves have said that this study was not designed to predict behavior. They also say, however, that their data highlights the importance, when considering changes to e-cigarettes, of considering the downstream effects of new regulations on other users. And lest we forget, it was data from studies based on hypotheticals that were used to justify bringing in plain packaging,” he adds.

    Picture of Marina A. Murphy

    Marina A. Murphy

    Marina A. Murphy is a scientific communications and engagement expert with more than 20 years of experience, including 10 years in the tobacco sector.

  • Joining Forces

    Joining Forces

    A new EU legislative term calls for a strong vaping association willing to fight for the industry.

    By Holger Knappenschneider

    A new political cycle has kicked off in Brussels, Belgium, with attention increasingly focused on the vapor products sector. With legislative threats once again on the horizon, some in the industry have banded together in the EU’s administrative capital to tell the public health story around vapor products.

    The European Parliament vote that saw Ursula von der Leyen appointed as the new president of the European Commission was too close for comfort. Only nine votes separated her victory from a need for the EU member states to go back to the drawing board.

    Such a narrow margin shows the fragile nature of the new Parliament’s majority. The two traditional parties—the Socialists and the European People’s Party—can no longer command a majority between them. Smaller parties, such as Renew Europe, the Greens and a nationalist group led by Italy’s Deputy Prime Minister Matteo Salvini, will play a much stronger role in future agreements.

    It is against this backdrop that we could see the next iteration of the Tobacco Products Directive (TPD) as well as new rules on tobacco excise taxes.

    A medical doctor by training, von der Leyen is expected to put a strong emphasis on health in the upcoming term and has already promised a “European plan to fight cancer” to assist member states in improving cancer control and care. Smoking is, of course, a leading cause of cancer, and the logical response would be for the commission to follow Britain’s lead in encouraging the proliferation of reduced-risk alternatives among smokers.

    THE PRESIDENT’S IN-TRAY

    Last year, the European Commission quietly announced that it would review the market for electronic cigarettes via its Scientific Committee on Health, Environment and Emerging Risks weeks after that same committee named vaping in its top ten emerging health threats for Europe.

    In parallel, the commission convened a working group of member states to review the implementation of the TPD. Known as Joint Action on Tobacco Control, the group’s job will be to sift through the information provided to EU member states in their TPD notifications and look for trends.

    A separate group on TPD enforcement convened in Copenhagen, Denmark, earlier this year, with presentations from regulators across Europe discussing issues such as child resistance, short-filled e-liquids and the use of cannabidiol. The event was attended by Katja Bromen, deputy head of the commission’s tobacco control unit. In their downtime, delegates took a canal tour and had a late-night dinner at a local pizza parlor.

    We are expecting a report from the commission on the functioning of the current Tobacco Excise Directive any day now. The last three years have seen two public consultations and one report on the subject—and vapor products have featured heavily in all of them. Almost half of EU member states have some form of excise duties imposed on vapor products—although the data shows that consumers find ways around the resulting higher prices—either through parallel imports or short-fill e-liquids.

    WHAT HAPPENS NEXT

    After the summer break, new commissioners will be appointed to run the Departments for Tax and Public Health. Once the identities of these people are known, the full commission will adopt a work program (expected in November or December) from which we will get a clearer picture of what else is to come before the end of this term in 2024.

    Based on what is known so far, we might see proposals for a revised Tobacco Excise Duties Directive and TPD with a strong focus on e-cigarettes. At a push, the new commission might aim to have these key files concluded before the end of the term in 2024, which does not give the industry a lot of time for planning and strategy development.

    The fragmented nature of the new Parliament will make it harder for the commission to deliver concrete pieces of legislation, but it makes working with the political system harder for the private sector too.

    In anticipation of future developments, several industry representatives came together and formed a pan-European independent vaping alliance: The Independent European Vape Alliance (IEVA).

    IEVA is a Brussels-based trade association that wants to unite and represent the vapor sector to promote robust, proportionate and evidence-based regulation for vapor products. The association seeks to ensure that smokers have accurate information about vaping and the harm reduction potential; that the debate around vaping differentiates between vaping and smoking; and that regulation and taxation of vapor products is sensible and takes account of the public health opportunity vaping presents.

    “The association gives a strong, singular voice to the [vapor] industry, representing their interests independently from the tobacco sector,” said Dustin Dahlmann, president of IEVA, during a recent roundtable with industry representatives. “One of the main objectives of the association is to ensure that local and community regulations are suited to [vapor]products by obtaining a maximum level playing field in terms of legislation.”

    Past experience confirms the importance of a unified approach toward the European Parliament, Commission and Council. More than half of the Members of European Parliament have never served in the chamber—a higher turnover rate than we have previously seen. As a result, policy makers have yet to understand the difference between vaping and smoking, and it is essential that the correct information is conveyed to avoid misunderstandings and legislative proposals based on inaccurate information. By joining forces across Europe, the industry’s arguments can carry more weight, increasing its credibility with policy makers.

    Holger Knappenschneider

    Holger Knappenschneider serves as secretary general for the Independent European Vaping Alliance. He can be reached at hk@eurovape.eu.

  • Black Tuesday

    Black Tuesday

    A Maryland judge has ruled that vapor and e-cigarette manufacturers must submit premarket tobacco product applications by May 2020.

    Things can change quickly in the vapor industry. By Tuesday, May 12, 2020, all manufacturers of the life-saving products must submit premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) or remove those products from the market. The FDA then has one year to approve or deny those submissions.

    On July 11, Judge Paul Grimm of the U.S. District Court for Maryland ruled in a lawsuit filed by anti-tobacco groups that the regulatory agency had exceeded its authority in allowing electronic nicotine-delivery systems (ENDS) to remain on the market until 2022 before companies applied for regulatory approval.

    “Given the uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the overstated effects that a shorter deadline may have on manufacturers, the industry’s recalcitrance, the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health emergency, I find that a deadline is necessary,” Grimm wrote. “I will impose a ten-month deadline for submissions and a one-year deadline for approval as the FDA suggested.”

    Attorneys for the plaintiffs asked the court to rule that applications for marketing orders be filed within 120 days of issuance of the “court’s order, and products for which applications have not been filed within this period shall be subject to FDA enforcement actions.” The plaintiffs also asked that “products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while [the] FDA considers the application.”

    The defendants stated that the four-month deadline was not feasible, and Grimm agreed, writing that the “10-month deadline for applications would be more reasonable than the four-month deadline, allowing sufficient time for application submissions that present the information that the FDA needs to assess the e-cigarette products” while not delaying longer than required.

    Grimm ordered the following, which was filed on July 12, 2019:

    • The FDA shall require that, for new tobacco products on the market as of the Aug. 8, 2016 effective date of the deeming rule (“new products”), applications for marketing orders must be filed within 10 months of the date of this memorandum opinion and order.
    • New products for which applications have not been filed within this period shall be subject to FDA enforcement actions in the FDA’s discretion.
    • New products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while the FDA considers the application.
    • The FDA shall have the ability to exempt new products from filing requirements for good cause on a case-by-case basis.

    Companies are claiming that the shear cost of the PMTA will force numerous businesses to close (see “All Hands on Deck”). Some companies have estimated a single PMTA to cost millions of dollars, if not tens of millions of dollars. The FDA estimates that a PMTA should cost companies somewhere “in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000)—not in the millions of dollars described by some others.”

    The agency also states that over time, as manufacturers become more experienced and relevant research develops, “the FDA expects many efficiencies to lower the average costs of premarket review. For example, we expect that manufacturers’ costs will be dramatically lowered by the bundling of applications for similar products, by reliance on tobacco product master files and by [the] bridging of data from one product to another.”

  • Beyond the Event Horizon

    Beyond the Event Horizon

    To better understand the U.S. premarket tobacco product application process, turn to astrophysics.

    By George Gay

    Like many people, I was fascinated earlier this year to see the first-ever image indicating the presence of a black hole—one in the Messier 87 galaxy, 55 million light years from Earth. Since it is not possible to “see” a black hole, the image was of its event horizon where all known physical laws collapse and where stuff pops into and out of reality. One of the most illuminating comments I read about the image was provided by The Guardian’s science correspondent, Hannah Devlin, who wrote, “At the event horizon, light is bent in a perfect loop around the black hole, meaning if you stood there, you would be able to see the back of your own head.”

    Obtaining the image required a huge effort, but I wonder if the scientists involved didn’t miss a trick. Couldn’t they have looked closer to home if they wanted to study a region where stuff pops into and out of reality? During a presentation on the U.S. vapor industry at the electronic nicotine-delivery systems (ENDS) conference in London, U.K., in June, I definitely formed the idea that timelines were dropping into and out of reality across some sort of event horizon, and, by the end of it, I’m sure that I got at least a glimpse of the back of my own head. This sense of confusion wasn’t caused by the presentation, which was good, but by the time warping effects of the U.S. Food and Drug Administration’s (FDA) shuffling of deadlines for the submission of premarket tobacco product applications (PMTAs) by ENDS product manufacturers, largely in response to external pressures.

    At the time of the presentation, the deadline issue was before the District Court in Maryland, but, on July 11, that court ordered the FDA to require that manufacturers of ENDS products (and certain other products) file PMTAs within 10 months of the order (by May 12, 2020) for any products placed on the market on or before Aug. 8, 2016, the date after which no new products have been allowed to launch without a PMTA but after which many have, presumably because we have been operating on that event horizon.

    The story behind the court case and the order is beyond the scope of this piece, but the situation, as it stands, seems to be that because of the enormous costs—millions of dollars per product variant, as I understand it—involved in submitting PMTAs, the time necessary to do so and the limited time available to do so, the U.S. market for ENDS products could be reduced in fairly short order to IQOS (the only ENDS product—officially a cigarette, I believe, as far as the FDA is concerned but one characterized as a legally undefined noncombustible cigarette—to have been granted a PMTA), devices supplied by companies willing to run the gauntlet of the law until such time as they are closed down, and, eventually, a handful of yet-to-be-launched products belonging to companies with bottomless pockets.

    Although the deadline for the submission of PMTAs was once set by the FDA as 2022, and though the granting of PMTAs has proved to be a painfully slow process, in responding to the court order, the FDA seemed not to be too bothered about the task ahead. In a 1,100-word statement (mostly given over to anguished cries about having to protect young people from vaping), acting FDA Commissioner Norman Sharpless’ only suggestions that time might be short appeared when he said the FDA stood ready to accelerate the review of e-cigarettes and other new tobacco products and when he added that manufacturers didn’t need to wait 10 months to act. Of course, some manufacturers will have already made moves toward preparing PMTAs, and the court order allows products to remain on the market for up to a year while the FDA considers those PMTAs. The main reason the FDA is probably not alarmed at the situation, though, is because it knows that the cost of preparing a PMTA is way beyond the reach of most companies.

    REGULATORY GUIDANCE

    Meanwhile, back at the event horizon, the FDA was said to issue policy and regulatory guidance documents in relation to such things as PMTAs that, if I have this correctly, are not binding but are binding, though not necessarily enforced. Another presentation on how to keep products in the U.S. market had it that a guidance document was not legally binding, but complying with it was a really good idea unless you had a brilliant alternative way of staying on the right side of the regulatory issue for which the guidance was issued, which seemed like another way of saying that they were and were not binding. Otherwise, staying in the U.S. market, which was said to offer significant growth opportunities, meant rationalizing your product portfolio, having a plan and an awful lot of spending money, and moving expeditiously. Presumably, even more expeditiously following the court order.

    It is illuminating that while tobacco products—deemed, presumably during a meeting held at some event horizon, to include ENDS—were made the responsibility of the FDA so that their control could be governed by the application of science, that governance seems to have slipped—inevitably, I would suggest—largely into the hands of politicians, nongovernmental organizations, pressure groups and the courts.

    Let’s not forget the parents concerned about the use of ENDS products by young people—part of what conference delegates learned was the “kiddification” of the U.S. The conference was told that pressure by parents was causing some head teachers to close school bathrooms, presumably to prevent the youngsters from using such facilities for vaping.

    My goodness. Once you learn about such alternative realities, you know you’re looking at the back of your own head. I mean, where are these youngsters doing the things that bathrooms are provided for? Holding on will cause more physical damage—on what the FDA would refer to as an individual level—than any amount of vaping, while not holding on and not using the bathroom facilities will lead—on a population level—to a mighty unpleasant and unhygienic state of affairs.

    Meanwhile, on this side of the event horizon, the conference was given a briefing about the activities of the e-cigarette unit of the U.K.’s Medicines and Healthcare products Regulatory Agency, including those necessary to prepare for a post-Brexit U.K. The agency is responsible for operating the national product notification system under the EU’s Tobacco Products Directive (TPD), publishing a list of notified products, operating an adverse reactions system and reviewing safety reports of products in use. In addition, the unit provides systems for intelligence gathering, online market surveillance and product removal in collaboration with e-cigarette stakeholders.

    There are reportedly 39,000 products accepted for U.K. supply and more than 55,000 products notified for the U.K. via the EU Common Entry Gate, an IT tool designed to ensure uniform reporting. The unit has reportedly received 59 adverse reaction (yellow card) reports detailing 170 adverse reactions and 11 referrals relating to the safety and quality of products. In addition, it has received about 100 referrals from enforcement agencies while, in 2018–2019, it disseminated more than 500 intelligence referrals to external agencies. As a result of collaboration with enforcement agencies, more than 700 unnotified product listings have been removed from the online marketplace since December 2018.

    CONVERGENCE OF REGULATIONS

    Looking at the bigger picture, another presentation included a world map that showed where bans are in force on nicotine-containing electronic cigarettes—a map that seemed to indicate that countries of the southern hemisphere are keener on such bans than those of the northern hemisphere. Whether this phenomenon has something to do with the trade winds, I don’t know, but it is no surprise that regulatory burdens in respect of these products are seen as being greater in countries of the southern hemisphere than in those of the northern hemisphere, though in this case, with the inclusion of regulations that stop short of bans, the south/north division is less marked. Apparently, the worldwide trend is away from bans but toward more regulation and more restrictions, with countries around the world gradually becoming more similar in their regulatory approach to ENDS products.

    Of course, the idea that regulations comprise a burden has meaning only if those regulations are unnecessarily restrictive and if they are adhered to by those operating within the marketplace. In the U.S., the law that has banned the launch of new-to-the-market and updated ENDS products without a PMTA since Aug. 8, 2016 seems to have been widely ignored. And in the EU, the TPD provision that limits nicotine-containing e-liquid refills to 10 mL is being circumvented by “short-fills,” which basically provide consumers with a way of mixing their own higher quantity liquids, conveniently and accurately, without busting the ban on the sale of nicotine-containing e-liquids above 10 mL. Apparently, short-fills account for more than half of the sales of refills in the top three EU markets—the U.K., Germany and France—taken together. They can have consequences for taxation in those countries where tax is applied to e-liquids.

    Quite what you make of such a circumvention or of the illicit products launched in the U.S. will be down to your view on law and order. There seemed to be a current of opinion at the conference that because not enough official action was being taken against offenders, the advantage was falling to irresponsible operators. This view is all well and good, and as long as those who hold it abide by all the laws of their countries, they may reasonably pat themselves on the back for being such upstanding citizens. But if, for instance, they regularly drive at speeds that exceed the legal limits and park where they shouldn’t, they are simply hypocrites.

    My view is that while everybody should abide by the law, it has to be expected that some won’t when, for instance, those laws are, in the case of the 10 mL e-liquid limit, simply silly and, in the case of the PMTA requirement, seemingly unnecessarily loaded in favor of one group (big companies) over another (small companies).

    Some regulations are seen as not being burdensome but rather as essential, but those tend to be the kind that help to ensure certain standards are adhered to—that products available to the consumer are of a certain quality. Looked at from one point of view, this is important because the vapor industry is controversial, and it shouldn’t hand its opponents ammunition. The same can be said of the cannabidiol industry, which, as is becoming increasingly common at such events, also got a look-in at the conference. Looked at from another direction, the imposition of inappropriate standards could be anti-competitive and anti-innovative, so it is vital that those involved in deciding on standards are representative of a broad spectrum of interests.

    STANDARDS

    One presentation had it that standards aim to facilitate international trade and protect consumers. It is, of course, important to protect consumers from overly risky products, but what about protecting them from a reduction in innovative products that might be caused by the sort of internationalization that has encouraged huge consolidation in the tobacco industry? You must ask yourself whether the tobacco consumer has been well served in those tobacco markets that have been reduced to the products offered by just a few major manufacturers, all with basically the same outlook. Encouraging international trade in vapor products might be the last thing that is needed. Certainly, it cannot be taken as a given that it is a good thing, and it certainly raises to new heights the importance of getting the balance right of those involved in determining standards.

    Of course, when standards are being developed, an eye must be kept on whether they would be measurable in a meaningful way. Once standards have been agreed on, repeatable methods of measuring whether those standards are being adhered to have to be developed. It was useful that the conference included a presentation on the part that the Cooperation Centre for Scientific Research Relative to Tobacco (Coresta) is playing in this field, which apparently includes work that other organizations are unlikely to do. Coresta has the advantage of being made up of a wide range of organizations with expertise from different sectors and of having a track record of supporting—though not being involved in—the development of international standards.

    The importance of testing regimes was also underlined by presentations on safety and toxicology aspects of e-liquids, an introduction to extractable and leachable testing of ENDS devices, and the uniformity measurement of aerosol delivery in tobacco-heating products.

    On a more prosaic level, the conference was given a rundown of what is generally seen as the U.K.’s vaping dichotomy, whereby the public health community has a positive approach to vaping but that positivity is not fully reflected in public beliefs and actions. Different presentations had it that the vaping prevalence in the U.K. has been stable since 2015, that 26 percent of people in the U.K. believe that vaping is as harmful or more harmful than smoking, and that 40 percent of smokers have not tried vaping. While smoking prevalence is at a record low, 15 percent of the adult population, or 7.4 million people, are said to smoke while 11 percent of mothers are still smoking at the end of their pregnancies.

    However, a presentation by a healthcare professional shed some light on this situation and suggested that there really was no mystery here. Part of the problem is that while those at the top of the healthcare pole have accepted the positive role that vaping can have in encouraging people not to smoke, that message is not necessarily reaching those below. There is, in other words, a gap between healthcare policy and practice caused in part by a mismatch between national health goals and funding for those goals. This has resulted in a lack of knowledge among healthcare professionals at the sharp end.

    There are also the well-known hurdles of a media ready to relay vaping scare stories, no matter how slender their links are to reality, and lazy private and public sectors that hitch vaping bans onto public smoking bans without, it would seem, the slightest regard for the fact that these are very different activities. In other words, having returned to the event horizon, they seem to be content just to stare at the backs of their own heads.

    The conference, which was held at the Amba Hotel Marble Arch in London from June 4–6, 2019, was staged by Smithers Rapra.

    Picture of George Gay

    George Gay

  • Setting Standards

    Setting Standards

    China starts regulating the vapor hardware and liquids sold in its domestic market.

    By Josh Church

    One could easily argue that China is the birthplace of e-cigarettes. For well over a decade, Chinese companies have been manufacturing, distributing, exporting and selling vapor products at a large scale. While most of these goods produced over the last 10 years have been exported for sale into international markets, some products remained at home. During this period, China has maintained a steady growth in the number of its domestic e-cigarette users and remained in the presence of vapor retail channels.

    Anyone who has had the opportunity to attend the IECIE trade show that occurs annually in Shenzhen, China, has had the opportunity to observe this growth. The event is now one of the largest vapor and e-cigarette expos in the world. In years past, much of the trade show attendance consisted of international companies and buyers, with little to no attendance of local domestic Chinese e-cigarette users.

    This has shifted drastically in the past two years. The event now mirrors the size and scope of the events that took place in or around 2016 throughout the United States. Thousands of Chinese vapers now flood the attendance lines in hopes of getting a look at the newest and hottest products of the year. With this huge uptick in usage of vapor products by the Chinese people, the question arises as to how these products get to market and who oversees them.

    For anyone who has visited China, it is made apparent the minute you step foot in the country that the smoking culture is prevalent and widespread. China’s regulators have long developed ways to regulate and authorize traditional tobacco products.

    China’s tobacco industry is run by a state-owned monopoly. At the head of this structure is the Ministry of Industry and Information Technology. The ministry is responsible for maintaining and enforcing the tobacco monopoly. Under the ministry, two divisions covering tobacco products exist, the first being the State Tobacco Monopoly Administration (STMA). The STMA is the government agency responsible for all tobacco regulations.

    The second division is the China National Tobacco Corporation (CNTC). The CNTC is the state-owned manufacturer of tobacco products and is currently the largest producer of combustible cigarettes in the world. Split between these two divisions is the responsibility to regulate and operate a market that accounts for more than 40 percent of the world’s total consumption of traditional combustible cigarettes.

    With such a prevalence of tobacco use by the Chinese people, you would expect that the regulations may be less stringent than what we see in other global markets, especially when it comes to advertising tobacco products. This is not the case.

    The regulations on where products can and cannot be advertised are well-established and observed. These restrictions cover traditional methods such as print, radio or television ads. Even outdoor banners or billboards featuring tobacco products are required to go through a long preapproval process. With these strict regulations in place, the Chinese tobacco brands have had to comply and become creative with how they market their products.

    Over the past decade, China has also seen a social push to ban smoking in certain places, namely hospitals and doctors’ offices but also restaurants and bars in some of the larger, more international cities. Until recently, vapor and e-cigarette manufacturers, as well as users, were unburdened by such restrictions.

    This situation has changed. Until recently, e-cigarettes and vapor products were outside the umbrella of STMA regulations and had little participation from CNTC. Currently, discussions are taking place within the government agencies in regard to how the Chinese e-cigarette market will be regulated and who will be in control of the regulations. What will industry taxation consist of, and what kind of cooperation can be forged between the CNTC and the private Chinese e-cigarette manufacturing companies? What does this mean for the budding industry, and how does it play out for the Chinese e-cigarette user?

    Recently published draft standards for the e-cigarette industry point to a new era of regulation for the Chinese e-vapor product manufacturers and their consumers. The current Chinese national e-cigarette standard specifies the terms and definitions, technical requirements, testing methodology (for devices, e-liquids and vapor emissions) as well as the requirements for packaging, labeling, user instructions and transportation. This impacts all e-cigarette and vapor products intended for domestic sales.

    These standards borrow heavily from what we have seen in the EU with the Tobacco Products Directive, or TPD, as well as safety features that overlap with the UL 8139 battery safety standard for electronic nicotine-delivery system devices. The standard is broken down into sections covering the aforementioned items and gives clarity on limits and requirements for each.

    For the aspects of the devices themselves, many of the standards are common to most consumer electronic products and include Chinese standards such as the GB31241, which is a widely used standard for products containing a lithium ion battery cell. There are some uncommon requirements that cover such things as sealing and leak prevention for atomizers as well as a visual volume marking on the side of all tanks or pods. This harkens to the first product exported widely by China in the early 2010s. The requirement that really sets this standard apart from others is the limitation of output power or wattage to 40 watts at the atomizer connection.

    Moving into e-liquid packaging, we see some similarity to the EU TPD with a nicotine threshold of 20 mg per mL of nicotine in the final e-liquid solution and no more than 200 mg of nicotine in a childproof/tamper-evident refill container. Also listed are limitations on identified toxicants and the prohibition of certain additives. Again, we see some Chinese national standards referenced, including GB14881, which covers the liquid production.

    The standard then moves into testing methods. These methods cover key items such as automatic shut-off verification, numerous drop test requirements, EMC radio disturbance, temperature limitations and chemical analysis of components that touch the mouth or contain e-liquid. Basic requirements are listed in the packaging section of the standard, mentioning packaging quality as well as limitations on design and materials to prevent contamination of the final goods.

    Labeling requirements are more in-depth, covering not only the packaging but also the labeling required on the device or e-liquid container. Most of these requirements are congruent with regulations throughout the EU and U.S., and they include things such as the listing of manufacturers’ information, date of manufacturing, storage conditions and graphical warning requirements. Finally, the standard outlines the necessary material that must be published in the instructional manuals. Both e-liquids and vapor devices are required to include an instruction manual consisting of an inspection certificate and manufacture information.

    Devices also require diagrams indicating key functions, refilling methods, service and cleaning procedures. Devices and e-liquids must also include instructions for proper waste disposal. Overall, the Chinese e-cigarette standard is in line with what we have seen globally. It will be interesting to watch how this standard is ratified and enforced once regulations are put in place. Professionals across the country seem to agree that this will happen sometime between October and the end of 2019.

    These initial standards are just the beginning of a long process to create regulations for a new and dynamic industry. Many questions are still unanswered. Will the vapor manufacturers be forced to abide by the same marketing restrictions as the traditional tobacco companies? Will the taxation scheme push them into the same channels as traditional tobacco? Will Chinese health officials recognize vapor products as a safer alternative to combustible cigarettes? What does the future landscape look like for a vaper in China? Will they be lumped in with cigarette smokers and banned from using their devices in the same places?

    These questions can only be answered with a high level of speculation. As has been the case in many other countries, only time will tell what the future holds for China’s e-cigarette industry.

    Picture of Josh Church

    Josh Church

    Josh Church is the chief regulatory and compliance officer of JWEI Group, the largest vapor industry manufacturer in the world.

  • Turning 21

    Turning 21

    As retailers and government entities in the U.S. raise the age to purchase vapor products to 21, some doubt the measure’s effectiveness.

    By Timothy S. Donahue

    Hawaii was the first. Now, 14 additional U.S. states, including Arkansas, California, Delaware, Illinois, Maine, Maryland, Massachusetts, New Jersey, Oregon, Texas, Utah, Vermont, Virginia and Washington, have raised the minimum age to purchase vapor and tobacco products from 18 to 21.

    At least 470 localities, including New York City; Chicago; San Antonio; Boston; Cleveland; Minneapolis; Kansas City, Kansas; and Kansas City, Missouri, as well as Washington, D.C., have raised the minimum tobacco and vapor product purchase age to 21, according to the Campaign for Tobacco-Free Kids. Some of the vicinities are in states that subsequently enacted statewide ordinances. Soon, the U.S. government may also raise the legal age to purchase tobacco from 18 to 21 nationwide.

    The biggest surprise came in early May, when Walmart, the world’s largest retailer, announced that beginning July 1, it would raise the minimum age to purchase tobacco products, including electronic nicotine-delivery systems (ENDS), to 21 at its 5,000 Walmart and Sam’s Club stores. The company stated that it is also phasing out the sale of fruit-flavored and dessert-flavored ENDS products and e-liquids.

    The announcement came in response to a letter from then-U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb that threatened to fine a dozen retailers, including Walmart, Walgreens, Kroger, Rite Aid and Family Dollar, for illegally selling tobacco products to youth under the age of 18.

    In its letter to Walmart, the regulatory agency stated that it found 17 percent of Walmart stores had sold vapor and tobacco products to minors since 2010 (by comparison, 7-Eleven had a violation rate of 25 percent, compared with 41 percent at Marathon Petroleum, according to the FDA).

    “This violative history is disturbing and cannot possibly come as a surprise to corporate leadership. In addition to issuing a warning letter, civil money penalty or no-tobacco sale order, as applicable, to violating retailers, [the] FDA also makes retailer compliance check results publicly available in a searchable database that can be accessed by any member of the public, including by the corporate management of retailers themselves,” the FDA letter states. “These illegal sales must stop.”

    Walmart does not agree with the FDA’s calculations. “Since 2010, the FDA has conducted approximately 12,800 retailer compliance checks involving minors at Walmart stores and Sam’s Club locations. Over that period, Walmart and Sam’s Club passed 93 percent and 99 percent, respectively, of those checks,” wrote Walmart’s senior vice president and U.S. chief ethics and compliance officer, John Scudder, in response to the FDA’s accusations.

    “Most recently, in 2018, Walmart stores passed 94 percent of the more than 2,400 FDA checks, and Sam’s Club passed 100 percent of its 15 FDA checks. While we are not satisfied with falling short of our company-wide goal of 100 percent compliance, those compliance rates nonetheless are significantly higher than the rates referenced in Dr. Gottlieb’s April 5 letter—and, in our view, more fairly and accurately portray our performance.”

    Other retailers have also raised the minimum purchase age to 21 in their stores, including Walgreens and Rite Aid. The FDA called Walgreens one of the top violators among pharmacies that sell tobacco, with 22 percent of locations failing FDA inspections. Rite Aid announced it would remove e-cigarettes and vapor products chain-wide. The tobacco company Altria and e-cigarette manufacturer Juul Labs are also supporting an age increase in vapor product purchases.

    On the federal level, as of May 21, there were two bills in the U.S. Senate aimed at raising the purchase age to 21 for vapor and tobacco products. Senator Todd Young of Indiana is among four authors who were the first to introduce legislation centered on raising the age to purchase tobacco products in this legislative session. Young claims it’s the most attainable and noteworthy thing Congress can do to lower healthcare costs and save lives. He says that, according to the U.S. Centers for Disease Control and Prevention (CDC), smoking-related illnesses cost the U.S. $300 billion a year. Senators Mitt Romney, Brian Schatz and Dick Durbin, along with Young, authored the Tobacco to 21 Act.

    On May 20, Senate Majority Leader Mitch McConnell said he supports raising the age and introduced his own bill, which was co-authored by Senator Tim Kaine. Young says his proposal is a clean bill with no exemptions, and he says McConnell should have just signed on to that version. Young says he has “hopes and confidence” his bill will become law.

    McConnell says his bill will also save lives. “In recognition of tobacco’s history in our states and aware of the threat that all tobacco products pose now and for future generations, we introduced legislation to raise the national age of purchase to 21,” he stated in a press release. “We’ve heard from countless parents who have seen the youth vaping crisis firsthand, and together Senator Kaine and I are addressing this public health crisis head-on. By making it more difficult for tobacco products to end up in the hands of middle school and high school students, we can protect our children and give them the opportunity to grow and develop into healthy adults.”

    THE OTHER SIDE

    Despite this trend, some vape shop owners are unsure whether they should raise the minimum purchase age in their shops to 21. Several of the vape shops contacted asked not to be included in this story because the issue is so devisive. However, numerous owners said off the record that they don’t see raising the age as the answer to the problem of youth use, pointing to the experience of the alcohol industry.

    Sam Salaymeh, president and CEO of North America for AMV Holdings, which owns Madvapes, Alohma, Maxx and Select-A-Vapor stores, supports eliminating youth access but says that raising the purchase age may be less effective than some believe. “It hasn’t made a difference with alcohol,” he says. “We have a serious problem with teen binge drinking in the U.S.”

    Alcohol is the most commonly used and abused drug among youth in the United States, according to the CDC. Its website states that while drinking by persons under the age of 21 is illegal, people aged 12 to 20 years drink 11 percent of all alcohol consumed in the U.S., and more than 90 percent of this alcohol is consumed during sessions of binge drinking.

    In 2016, the National Survey on Drug Use and Health reported that 19 percent of those between the ages of 12 and 20 drink alcohol, and 12 percent reported binge drinking in the past 30 days. In 2017, the “Monitoring the Future” survey reported that 8 percent of eighth graders and 33 percent of 12th graders had consumed alcohol during the past 30 days, and 2 percent of eighth graders and 19 percent of 12th graders had binge drank during the past 30 days. The 10–19 age group makes up 13 percent of the U.S. population, according to 2017 census data.

    Until a law raising the minimum age for purchasing tobacco from 18 to 21 is passed federally, there are a plethora of issues with raising the purchase age in just one specific state or city. For example, Kansas City, Kansas, raised the age to 21 while neighboring communities retained the age minimum of 18. This is an issue with neighboring states as well.

    If an 18-year-old in North Carolina buys legal vapor products and they then travel to Virginia, they are breaking the law in Virginia by being in possession of a product that was legal where it was purchased. Also, store owners cannot prevent someone of legal age from purchasing a product and giving it to a minor.

    Research has shown that youth often have their older friends and classmates purchase vapor and other tobacco products for them. According to numerous studies, increasing the purchase age for vapor and other tobacco products to 21 would reduce the probability of a high school student being able to legally purchase these products for other students and/or their underage friends.

    Retailers are also concerned that a higher minimum age may push people toward unsavory sources. “What is even worse is that what is happening in the vapor industry is increasing the size of the black market too,” Salaymeh says. “Teens will go to the black market to get the products they want.”

    There are simpler arguments as well. One example is that there just isn’t any justification for raising the age to buy vapor and other tobacco products, according to Ramesh Ponnuru, a researcher with the American Enterprise Institute, a public policy think tank.

    The main argument for the U.S. senators pushing their Tobacco 21 agenda “is that most tobacco users take up their habit before age 21 and that making them wait will improve their health,” says Ponnuru. “The senators write that ‘if the current rates of smoking continue, the CDC projects 5.6 million of today’s youth will eventually die from preventable smoking-related illnesses.’”

    That projection is based on combustible cigarettes not e-cigarettes; legal restrictions cannot be justified on the latter, says Ponnuru. “But in either case, the question remains: Why not let adults decide for themselves what risks to take? And if we’re not going to let 20-year-olds take the health risk of smoking, why should we let people one year older?” he asks.

    Some states have exemptions for military personnel in their Tobacco 21 laws. That’s also one of the main differences between the two bills in the U.S. Senate. Salaymeh says that raising the age for military personnel doesn’t make sense. “If you are old enough to join the military, you should be old enough to make the decision to use nicotine,” he says. “It’s not that I don’t agree with the military exemption; it’s that the exemption should be for everyone over the age of 18, including the military.”

    McConnell stated that a military exemption in Young’s bill was one of the deciding factors in drafting his own legislation. “On further reflection, I decided the military carve-out made no sense,” McConnell said.

    Not all U.S. states support raising the age to 21 either. Nebraska, for example, will require its residents to be 19 years old in order to vape nicotine legally after a bill, introduced by Senator Dan Quick of Grand Island, Nebraska, was passed unanimously on May 24. The restrictions take effect Jan. 1. The higher age limit doesn’t apply to vapor products that do not contain any nicotine.

    Salaymeh says he believes that we need to have proper regulation that limits youth access in ways that work. “As a company, we have spent a large amount of funds to develop software to prevent underage sales. A customer must have a legal, valid ID scanned in order to make a purchase in all our stores, and we comply with all local and state laws for purchase age. We have extensive employee training procedures. We have a zero tolerance policy,” he says. “We also limit the number of pods a single person can purchase. These are effective measures in preventing youth access.”

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • Certified Concern

    Certified Concern

    Chinese manufacturers say UL certification proves that their vapor hardware is safe.

    By Timothy S. Donahue

    It’s a positive for the vapor industry. However, it’s also meaningless in the U.S., the world’s largest vapor market. Numerous vapor hardware manufacturers have produced Underwriters Laboratory (UL)-certified devices, but under current regulatory guidelines in the U.S., the safer products are often not allowed to be marketed. The exception to the rule is if the certified device had been marketed before Aug. 8, 2016, the cutoff date for new vapor products set by the U.S. Food and Drug Administration (FDA).

    Several major Chinese manufacturers, including Aspire, Innokin, Joyetech, KangerTech, SmokTech and Vaporesso, have or will soon have UL-certified devices that were on the market before the FDA deadline; however, the hardware was certified after the deadline, and manufacturers have shied away from adding the UL logo because that could be construed by the FDA as altering the device. While the EU has allowed vapor products to innovate, the FDA has not permitted any new devices to be marketed in the U.S. since the Aug. 8, 2016, cutoff date. Vapor Voice recently visited with some of China’s leading vapor manufacturers in Shenzhen to discuss their efforts to get UL certified.

    Joyetech has been an innovator in adopting UL standards. It was the first organization to receive a UL 8139 certification for its eGo AIO device, according to UL. Joshua Church, chief compliance officer of Joyetech, said that the UL standards are an important element to quality standards in the vapor industry. “UL compliance isn’t easy. It has taken a lot of time, money and effort to push products through the certification process,” he says. “Joyetech has been a leader in helping create and confirm these guidelines. Joyetech has its own ISO-certified labs and reinvests 50 percent of its profits back into R&D. Joyetech has its own UL-certified testing lab (or witness test data lab).”

    Through UL’s witness test data program, tests may be conducted at customer or third-party test facilities under the supervision of UL personnel. Currently, Joyetech is the only manufacturer in China other than UL with a witness test lab. SmokTech’s lab, however, is nearly complete.

    Welfer Ou, CEO of SmokTech, says his company’s products are used by more than 80 million vapers around the world, and choosing to get products UL certified was just a way to show customers that SmokTech is dedicated to making industry-changing innovations under the highest standards of safety and quality.

    “We had our Novo pod system UL certified very quickly after the UL guidelines were confirmed,” says Ou. “We have spent a lot of time and money in equipment to be able to complete the required testing under UL standards. The FDA has stated that a PMTA [premarket tobacco product application] recommendation could involve UL 8139 certification, and we are working on having all of our models receive UL certification.”

    George Xia, co-founder and vice president of Innokin, says consumer safety and producing quality products are a part of Innokin’s ethos. However, the vapor market is changing very fast, and competition is getting fiercer. Xia says he sees having devices UL certified as a way for a company to set itself above the competition.

    “The Kroma-A and Zenith kit were the world’s first variable output mod certified UL 8139,” says Xia. “It is one of the best-selling mods internationally. We have been paving our own trail in R&D, and Innokin will continue to work closely with UL on the certification of existing and future devices. We are committed to constantly improving our manufacturing and quality control [QC] standards that are already some of the best in the industry. Innokin devices are always focusing on safety and durability. It has become a part of our core culture, and our customers enjoy these qualities.”

    A global safety consulting and certification company, UL collaborates with a diverse array of stakeholders to create standards that generate level playing fields to help develop new pathways for innovation. The organization’s UL 8139 guidelines evaluate the safety of the electrical, heating, battery and charging systems while also addressing fire safety concerns raised by North American fire officials. The new UL standard has been published with the acceptance of the American National Standard Institute and Canada Standards.

    UL 8139 requirements include determining if lithium cells are operating within safety windows, assessing the battery management system for both regular use and likely misuse, and evaluating compatibility among interconnected systems. The UL 8139 requirements also consider wide environmental parameters and conditions, tests for reasonably expected mechanical stress in use/misuse and requires devices to direct venting away from the inhaler.

    UL 8139 standards were written specifically for electronic nicotine-delivery systems (ENDS) and are part of the larger UL 1642 standard that covers a wide array of lithium-ion products. To qualify for UL 8139, the battery cells must be internalized, meaning that the standard 18650 e-cigarette battery can never be certified or listed under the UL standard if it’s changeable or not inside a battery pack. However, it can receive a UL “Recognized Component Mark” or “RU.” This quality mark can be applied to components that are affiliated with a UL-listed product.

    Currently, KangerTech does not have a UL-certified device. This will change soon, however, according to Danny Zhu, founder and chairman of KangerTech. “We are working on getting some of our products UL certified,” he says. “It isn’t about being first; it is about doing things the right way the first time. We are also now actively working on breakthrough technology that focuses on some common issues such as leakage. In a few months, KangerTech will have new products that will address the concerns of the consumer. This will improve the customer experience. That is most important to KangerTech. This technology will be applied to both open and closed systems and will, for the first time in the industry, combine the battery and cartomizer to make the system work better.”

    Eve Wang, the director of sales and marketing for Vaporesso, said that UL is certifying e-cigarettes to enhance consumer safety, and that’s one of the same goals Vaporesso has. “At Vaporesso, we have a real drive to give people a vaping lifestyle that is not only safe but up to our high standards,” she says. “First and foremost, we built up a panel of experts to study and understand the requirements of the UL certification. Then, we had the team look at our existing product portfolio to ascertain that we definitely shared the same vision. Even with our early stage products, like the Tarot Nano, we had the same mindset. We sent out the device to UL for testing, and based on the feedback we received, we made small adjustments to obtain our certificate successfully. The Tarot Nano is one of our earliest and most popular devices, released in early 2016.”

    Tony Lau, president of Aspire, says that battery quality is a major factor in achieving UL certification. In order to guarantee the quality of batteries in Aspire products, Lau opened his own battery factory. “Yes, we are continuing to put products through the UL 8139 certification process,” says Lau. “We will also send materials from our battery factory and other suppliers to a third-party testing facility to test the quality of materials and [see] if it meets our standards. The third-party is a global standards company. Every batch is tested for quality, size … if it is OK from a production standpoint. This is critical to maintaining high QC standards.”

    Because the FDA doesn’t allow new vapor products on the market that have been introduced after its deadline, many companies are selling their improved products in other markets, such as Asia and Europe. Vaporesso states that the FDA’s rules don’t prevent the company from innovating. “We are constantly striving for new ways to bring safer, more advanced devices to the entire market, not just the U.S.,” said Wang. “So, by continuing to work closely with the FDA and making sure our premarket tobacco product application certificates are processed as smoothly as possible, we hope to be able to make all of our new innovations available for everyone as quickly as possible.”

    Ou says that SmokTech’s quality control is internally controlled to maintain a high level of success. The company places a major focus on the R&D process, which needs to be strong and consistent from the single sample to mass production. “We want to be able to control the high quality expected in a Smok product,” he said. “Our biggest advantage is quality control. If the quality is bad, people can only trust you the first time. We want to be trusted repeatedly. We want to be a global brand, not just a Chinese brand.”

    Wang adds that Smoore (Vaporesso’s parent company) is also putting its pod system, the Renova Zero, through the UL certification process, and more existing products with the UL certification will be released soon. “We will make UL certifications standard for our future products by making it our R&D standard,” she says.

    Church said he couldn’t be more pleased with how Chinese manufacturers have embraced UL certification. “The UL standards are a way for a company to prove that their products meet a high level of safety and quality,” he says. “This isn’t just saying, ‘Oh, our products are safe.’ This is proving our products are safe.”

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • Better Options

    Better Options

    In the struggle against underage vaping, restricting access to flavored e-cigarettes should be the last resort.

    By Chris Howard

    Put yourself in the shoes of a smoker who is trying to quit. You’ve tried various quit-smoking products, such as nicotine patches, gums and prescription medications. None have worked. Your friend tells you how vaping with flavors works, so you decide to give e-cigarettes a try.

    You stop at a convenience store, seeking a vapor product that meets your needs. Surprisingly, the flavors that seemed so appealing are nowhere to be found. You never liked menthol, and tobacco reminds you of the cigarettes you hope to avoid. Like many smokers, you’re anxious about leaving cigarettes behind and your ability to quit. This latest obstacle makes quitting seem impossible (again). What happens next? You buy another pack of cigarettes and promise to try again another day.

    The reality is that smokers don’t get to count on “another day.” Each cigarette increases the smoker’s risk of developing a smoking-related illness that will inevitably lead to a lower quality of life or worse—premature death.

    The vapor industry shares the U.S. Food and Drug Administration’s (FDA) goal of ensuring e-cigarettes are used only by adults. That said, the FDA should consider a variety of more reasonable options to curb youth access without jeopardizing e-cigarettes’ harm reduction potential.

    Codify marketing standards: Many adult-oriented industries employ voluntary codes of conduct to govern marketing practices. The FDA should seek consensus standards prohibiting marketing practices directed at youth. The Vapor Technology Association (VTA), which advances the interests of 800-plus manufacturers, wholesalers, small-business owners and entrepreneurs of the vapor industry, has already enacted such standards (see https://bit.ly/2Ozbfyn), which are mandatory for membership. Most, if not all, vapor companies would likely embrace objective, FDA-accepted parameters as reasonable ways to reduce youth e-cigarette access.

    Revamp enforcement scheme: Undoubtedly, the FDA is resource-constrained and overwhelmed by age-verification requirements for vapor products. That said, even if the FDA could act on every violation, the current scheme allows a retailer to sell tobacco products to a minor five times within a 36-month period before the FDA can stop them from selling tobacco for 30 days. Revamping the current enforcement policy to provide for stricter and more consistent penalties would enable the FDA to use agency resources more effectively and deter bad actors from breaking the law.

    Enhance restrictions for online purchases: Some online retailers are already implementing two-factor authentication and other measures to curb youth access to vapor products—measures rightly considered by the FDA. Such online purchase restrictions should continue to be developed, strengthened and exercised in order to eliminate youth access to vapor products.

    Work with schools: Nearly every anecdotal news report involves a teenage student’s exposure to e-cigarettes. Given that schools are also seeking tools to combat this issue, the FDA should work more closely with school districts to provide resources and training that helps teachers identify the signs of youth e-cigarette use and how to stop it. The FDA’s current “The Real Cost” campaign is the right approach to assist teachers and educate youth, but unfortunately the messaging is riddled with inaccuracies about health effects that could deter smokers of combustible cigarettes from switching to vapor products.

    Analyze the impact of higher minimum purchase age: Some states have increased the minimum purchase age for e-cigarettes to 21. The FDA should analyze purchase and use patterns in these states to assess any reduction in straw sales and youth usage rates resulting from increased purchase age requirements.

    The decisions the FDA makes affect millions of adults who rely on vapor products for harm reduction. Restricting the availability of flavors is a radical measure that places unnecessary obstacles for adults obtaining products of their choice. In many ways, the proposed restrictions may actually help combustible cigarettes.

    For these reasons, the FDA’s proposed flavor ban should be a last resort.

    Picture of Chris Howard

    Chris Howard

    Chris Howard is vice president, general counsel and chief compliance officer at E-Alternative Solutions.