Tag: news

  • FDA Denies Marketing Orders for 55,000 Vapor Products

    FDA Denies Marketing Orders for 55,000 Vapor Products

    The U.S. Food and Drug Administration issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products today. In a press release, the regulatory agency determined that the premarket tobacco product applications (PMTAs) for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence they appropriately protect public health.

    The products from JD Nova Group, Great American Vapes and Vapor Salon subject to this action are non-tobacco-flavored ENDS and that include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal. The FDA states the products didn’t provide enough benefit to adult smokers sufficient to overcome the public health threat posed by the “well-documented, alarming levels” of youth use of such products.

    Credit: Stan Cuic

    “Congress gave the FDA the authority to regulate tobacco products to protect the public from the harmful effects of tobacco use through science-based regulation,” said acting FDA Commissioner Janet Woodcock. “Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”

    According to the TMA/Vapor Voice PMTA Tracker, Vapor Salon submitted 327 flavors in four sizes and 12 nicotine strengths covering approximately 47,108 submissions. Great American Vapes was also captured by the TMA/Vapor Voice PMTA Tracker with 150 flavors, including the Dr. Cola flavor mentioned in the CTP’s MDO release.

    The FDA’s review of new tobacco products before they can be legally marketed ensures that they meet the standard Congress set in the law to protect the public health, according to the agency. The agency noted that “the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study.” The FDA stated that there is the possibility that other types of evidence may exists that could be adequate if sufficiently robust and reliable. However, because the evidence was absent in these applications, the FDA issued MDOs.

    The agency will continue to review other PMTAs for non-tobacco flavored ENDS to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth. If the applications contain evidence of this type, the FDA will conduct further in‐depth scientific evaluation as to whether the evidence satisfies that statutory standard for authorization. But in the absence of this evidence, the agency intends to issue an MDO.

    The FDA has received applications from over 500 companies covering more than 6.5 million tobacco products. The agency refused to file more than 4.5 million applications from the JD Nova Group. Although the agency has issued other negative actions for some applications, this is the first set of MDOs the FDA has issued for applications that have reached the substantive scientific review portion of premarket review.

    According to the release, the products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement. The MDOs announced today do not include all ENDS products for which the companies submitted applications. Applications for the rest of the products remain under consideration.

    Credit: FDA

    “Flavored ENDS products are extremely popular among youth, with over 80 percent of e-cigarette users between ages 12 through 17 using one of these products. Companies who want to continue to market their flavored ENDS products must have robust and reliable evidence showing that their products’ potential benefit for adult smokers outweighs the significant known risk to youth,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of the public health.’ If this evidence is lacking or not sufficient, the FDA intends to issue a marketing denial order, which requires the product to be taken off or not introduced to market.”

    The agency also stated that the scientific review of menthol ENDS, as compared to other non-tobacco-flavored ENDS products, raises “unique considerations.” While menthol-flavored ENDS are not included in the these current FDA decisions, the regulatory agency stated that its reviews will “similarly examine whether the evidence in the application demonstrates a benefit to existing adult users that outweighs the known youth use” of ENDS products.

    The American Lung Association commented via Twitter that it stands “firmly with the science that no flavored tobacco products are appropriate for the protection of public health, and all should be removed.”

    Greg Conley, president of the advocacy group American Vaping Association, said the three companies targeted by FDA had minimal market share and chastised the agency for going after “low-hanging fruit.” Conley also stated via Twitter that its not a foregone conclusion that all or most pending flavored e-liquid applications will be rejected before the agency’s Sept. 9th deadline. He  stated that how the FDA will handle products from manufacturers that submitted requests for extensions and have attempted to supplement their PMTAs are still unknown.

    “The FDA never intended to fairly regulate open-system vape products. From the 2014 draft release of the agency’s Deeming Rule until today, the Center for Tobacco Products has looked forward to the moment it would eliminate the ‘wild west’ of the independent industry,” stated Conley.

    Scott Gottlieb, who served as FDA commissioner during the Trump administration, blamed e-cigarette manufacturers for their predicament, saying “many companies had ample time, and the benefit of guidances that we issued, to provide a path toward compliance, so they could demonstrate their value as tools that could help current smokers quit combustible tobacco. Many of them chose to fight the laws Congress enacted, and the FDA, and they didn’t invest in demonstrating the public health benefits that they asserted.”

    The FDA has until Sept. 9, 2020 to make a decision on the remaining estimated 2.5 million PMTAs.

  • Illinois Passes 2 Laws to Prevent Youth Access

    Illinois Passes 2 Laws to Prevent Youth Access

    The state of Illinois passed two new laws this week aimed at making it harder for minors to access vaping products. The first law (Senate Bill 512) prohibits the use of cartoon characters, video game characters, and popular children’s media from advertisements for e-cigarettes. It also makes it harder to buy vaping products online. Buyers will now have to use a credit card or check in the buyer’s name.

    Credit: Sharafmaksumov

    The second law (Senate Bill 555) amends the Substance Use Disorder Act to include vape shops. Adding vape shops allows the Illinois Department of Human Services to do compliance checks on the sale of e-cigarettes according to the minimum purchasing age of 21, according to B100. The legislation also allows underage individuals to test retailer’s compliance under the supervision of law enforcement as a part of a compliance check without violating tobacco laws.

    You must be 21 in Illinois to buy e-cigarettes. Illinois Governor J.B. Pritzker signed the two bills into law on Tuesday. Both Senate Bills 512 and 555 will go into effect on January 1, 2022.

    “This legislation will make our communities healthier places to live, and most importantly, will save lives. I’m proud that Illinois is taking yet another step toward protecting the health and safety of our young residents from tobacco and e-cigarettes and I want to thank Attorney General Raoul, our partners in the General Assembly, as well as the advocates and organizations for their work to make these laws possible,” Pritzker said in a statement.

  • Snowplus Taking Steps Towards Middle East Expansion

    Snowplus Taking Steps Towards Middle East Expansion

    The Middle East is a fast-growing market for vapor products. According to Mordor Intelligence, a market research firm, the Middle East and Africa vapor market is forecast to reach $485 million by 2025 with a growth rate of 9.74 percent during the forecast period (2021-2026). In a press release, vapor manufacturer Snowplus announced it is taking its first steps towards expanding into the Middle East market by attending the World Vape Show 2021 (WVS) in Dubai from Sept.19-21.

    Snowplus Alien X

    “Snowplus has seen a remarkable growth increase of 350 percent since late 2019 despite being faced with numerous challenges during the Covid-19 [pandemic] and is now looking towards more growth opportunities in the Middle East,” the release states. “The vaping company has secured lucrative partnerships with leading companies in their local market of China as well as regional offices around the world. These partnerships were made possible thanks to Snowplus’ quality products, the reliable support the company offers their partners, and strategic long-term investments.”

    The WVS is the first international vaping industry trade show to be held in the United Arab Emirate’s (UAE). Organizers say the show promises to attract some of the world’s most prominent vaping brands. Snowplus will be unveiling its latest device line: the Alien Series (Alien Air and Alien X). “The Alien lineup sits at the intersection of cutting-edge technology and unique, sophisticated design,” the release states. “Visitors will be able to catch a glimpse of the future of vaping through the Alien devices displayed at the Snowplus booth.”

    Snowplus also produces the Snowplus Pro, Snowplus Lite and Snowplus Go, as well as a series of flavored pods. Snowplus co-founder and head of overseas markets, Derek Li, said the company is excited for Middle East vapers to experience Snowplus’ products first hand. “We believe the Middle East market will be important for us and we’re ready to invest in creating partnerships to make it happen,” Li said.

  • England: Number of Young Smokers Up During Lockdown

    England: Number of Young Smokers Up During Lockdown

    Photo: marjan4782

    The number of young adults who smoke in England rose by about a quarter in the first lockdown, reports The Guardian, citing new research from University College London (UCL) and the University of Sheffield said. At the same time, the number of people who quit smoking nearly doubled across all groups.

    “The first lockdown was unprecedented in the way it changed people’s day-to-day lives. We found that many smokers took this opportunity to stop smoking, which is fantastic,” said Sarah Jackson, the lead author and a principal research fellow at UCL.

    “However, the first lockdown was also a period of great stress for many people, and we saw rates of smoking and risky drinking increase among groups hardest hit by the pandemic.”

    While the widespread belief that smoking and drinking relieved stress could be a factor in the apparent increased prevalence among people aged 18 to 34 years, the researchers pointed out that their data did not indicate what the causes may be.

    Doug Mutter

    Doug Mutter, director at U.K. vaping specialist VPZ, warned that the country is now in danger of missing its 2030 smoke free targets.

    “Smoking statistics are continuing to rise as the pandemic has triggered an increase in smoking rates and the public health problem has been compounded by funding cuts for NHS stop smoking services and local support groups,” he said.

    “There has been a lack of funding and joined up strategy to tackle smoking and we are now sleep-walking into another public health crisis with a new generation of smokers being consigned to an early death or serious disease.

    Mutter pointed to a new report from Royal College of Physicians Tobacco Advisory Group, which backs vaping as an effective treatment for tobacco dependency and recommends that it should be included and encouraged in all treatment pathways.

    A VPZ consumer survey from September 2020 found that among the 14,000 smokers served:

    • 25 percent of people said they were unable to buy their vaping products because of store closures.
    • 26 percent of smokers said they has increased the number of cigarettes they smoked during lockdown
    • 65 percent of people claimed they received no advice during lockdown of the best ways to quit smoking, through either NHS or online resources.
    • 58 percent of people said they did not feel healthier coming out of the initial lockdown.
    • 45 percent of people said their mental health was affected during the lockdown.
  • Video: Vaping’s Harm Reduction Potential

    Video: Vaping’s Harm Reduction Potential

    Considerable evidence suggests that e-cigarettes are an effective smoking cessation tool for adults in the United States, where hundreds of thousands of people die of smoking-related illness each year.

    Kenneth Warner, dean emeritus and the Avedis Donabedian Distinguished University Professor Emeritus at the University of Michigan’s School of Public Health, says, however, that the potential of vaping to increase smoking cessation has been largely overshadowed by media coverage and policies that focus on the potential risk vaping represents for teens.

    Warner and 14 other past presidents of the Society for Research on Nicotine and Tobacco co-authored an article that argues that the media, legislators and the general public have developed a negative view of e-cigarettes because of the heavy emphasis public health organizations have placed on protecting kids from vaping while ignoring the potentially substantial benefits of e-cigarettes in helping adults quit smoking. The article is published online in the American Journal of Public Health.

    In an interview with Michigan News of the University of Michigan, Warner discusses why the group, all of whom have presided over the top tobacco research society in the world, decided to take on this issue.

    What prompted this group to write this article?

    In my 45 years in the field of tobacco control research, I’ve never seen an issue that is as divisive as this one, and maybe none that is as important to public health. We have a large group within public health who are very much opposed to vaping because they see it as imposing huge risks on kids. On the other end of the spectrum, we see a number of researchers and members of the vaping community who believe that vaping is a great tool for helping people to quit smoking and that it is far less hazardous than smoking. These polar opposite views have created much of the contention within the tobacco control community.  

    Our goal in this paper is to try to inject some sense of balance, to get public health organizations, the media and legislators to recognize that their appropriate but singular desire to keep e-cigarettes out of the hands of kids may actually be harming public health. Policies oriented exclusively toward protecting kids may be responsible for more adults smoking than would be if we had policies that also emphasized helping adults to quit with vaping, and frankly, if we had honest characterizations of the risks of vaping.

    Exaggerations of the risk have led a majority of Americans, including a majority of smokers, to the erroneous belief that vaping is as dangerous as, or more dangerous than, smoking. The National Academies of Science, Engineering and Medicine has determined that vaping is likely substantially less dangerous.

    What do you want people to take away from the AJPH article?

    We call for a rebalancing of society’s consideration of vaping and specifically for more attention being paid to its potential to increase smoking cessation. We should continue working to decrease young people’s use of e-cigarettes—of all nicotine products, for that matter—but we must increase our focus on adult smokers.

    In the article, my colleagues and I express concern that we have forgotten about the adults who are going to die as a consequence of smoking. We lose 480,000 Americans every year as a result of smoking. Understandably and justifiably, all Americans were enormously concerned by the toll of Covid-19 this past year. Consider that we have a Covid-level disaster created by smoking every year, year after year after year.

    How would you characterize the risks associated with e-cigarettes? What are the potential benefits of vaping for adult smokers?

    Vaping is clearly not risk-free, but it is also substantially less dangerous than cigarette smoking. Inhaling combusted tobacco smoke, which includes over 7,000 chemicals, is what causes the disease and death associated with tobacco use.

    Multiple types of evidence, identified in our article, demonstrate that vaping can increase smoking cessation. The highly respected Cochrane Review has concluded that it is likely that vaping is more effective than FDA-approved nicotine-replacement products like gum and patches. The CDC has also found that more smokers use e-cigarettes than other aids in attempts to quit smoking—and with a higher self-reported success rate.

    Still, the public is largely unaware of the potential vaping has to aid in smoking cessation. As I mentioned previously, a majority of adults, including a majority of smokers, believe that vaping is as dangerous as, or more dangerous than, cigarette smoking. This misunderstanding has actually worsened over time. That reflects, in part, the media’s coverage of vaping.

    A recent study cited in our article found that 70 percent of U.S. news coverage on vaping mentioned vaping’s risks to kids while only 37 percent noted the potential benefits for adult smokers. As such, it’s likely that fewer smokers are trying e-cigarettes as a method of quitting smoking than would be the case if they were accurately informed about its potential to help them quit and its smaller health risk compared to smoking. That means fewer people are quitting smoking.

    Put simply, research shows that the potential benefits of vaping for adult smokers are substantial. Those benefits are not being fully realized in today’s environment of misinformation and a singular focus on the welfare of kids, to the detriment of the health of adults who smoke. 

    What is known about the risks of youth e-cigarette use?

    Vaping does have risks for kids, including the potential of addicting some to nicotine. But in our article, we point to evidence that the percentage of kids being addicted to nicotine by vaping is much smaller than popularly believed.

    We also note that while prospective studies have found that vaping by kids who had never smoked increases their risk of trying cigarettes 6–24 months later, much of this may be explained by what is called “common liability,” meaning that kids who try e-cigarettes are more prone to risk-taking than are kids who don’t vape, so the former may be more likely to try cigarettes anyway, even if e-cigarettes had never existed.

    Further—and very importantly—even if there is an increased risk, doing the math indicates that this factor would increase overall smoking initiation by kids by only a very small amount. However, even that seems unlikely since we’ve seen smoking rates fall among young people (both adolescents and young adults) at unprecedented rates precisely during the period of vaping’s ascendancy. That certainly is not consistent with the idea that vaping increases smoking.

    Why has e-cigarette use in adults not been a focus in policy or the media?

    First, the concern for young people’s welfare is a compelling one, and the rapid increase in youth vaping in 2018 and 2019 understandably created a great deal of anxiety. The focus on youth drowned out attention to the welfare of adults who smoke. Youth vaping decreased significantly in 2020. We will have to monitor future years’ trends closely.

    Second, I think a lot of people may believe that the problem of smoking is pretty much resolved. I’m referring mainly to the higher education, upper socioeconomic status population. They don’t smoke, their friends and colleagues don’t smoke, there’s no smoking in their workplaces, and there’s no smoking in the restaurants and bars that they frequent. They don’t see smoking and thus may believe the problem has largely been solved.

    And yet one out of seven adult Americans is a smoker today. When we take a look at who’s smoking, it’s the underprivileged members of our society, those who don’t have a voice in politics. African Americans as a group, although they don’t smoke more, have higher rates of smoking-produced disease and death than do [white individuals]. There are groups like low socioeconomic populations, people with mental health problems and the LGBTQ community that all have higher than average smoking rates.

    My fear, frankly, is that many nonsmokers are ignoring smokers because they may not care that much about them. There is a very large life expectancy differential between the rich and the poor in the United States, and perhaps the single most important behavior-related variable is differences in smoking. The data show that low-income, low-education populations smoke at much higher rates than the high-income population, and they die at much younger ages. If we could reduce smoking among these often marginalized populations, we might be able to reduce the gap in life expectancy. This is fundamentally a matter of social justice.

    What are some policy changes that might help achieve a more balanced approach to e-cigarettes?

    Currently, we have very unbalanced policies that are directed exclusively at trying to reduce youth vaping. Two of the most prominent are eliminating or seriously restricting flavors in e-cigarettes and trying to equalize the taxation of e-cigarettes and cigarettes. Both of these policies can have adverse consequences for adult smokers. Adult smokers like flavors just like kids do, and in fact, they tend to like the same flavors.

    Banning flavors would eliminate adult smokers’ access to the flavored e-cigarettes that they prefer in attempts to quit smoking. So that’s a real concern. We propose restricting the sale of e-cigarettes to adult-only establishments, such as vape shops. This is a compromise—flavors are a significant attraction to vaping for kids, and our recommended policy would not eliminate flavors; at the same time, the policy would restrict access for adults, thereby creating an inconvenience for them. But this policy would strongly limit youth access to flavored e-cigarettes while allowing adults to get the flavored e-cigarettes they want to aid in their attempts to quit smoking.

    We also suggest a substantial increase in excise taxes on cigarettes and other combusted tobacco products, and a much more modest tax on e-cigarettes. This is the opposite of what is happening now, with states imposing “equalizing” taxes on e-cigarettes without raising taxes on cigarettes. Significantly raising the tax on cigarettes will discourage both adults and kids from smoking. A big differential in price between very expensive cigarettes and less expensive e-cigarettes creates an incentive for adults who don’t quit smoking to switch to e-cigarettes. For kids, a modest tax on e-cigarettes will discourage them from vaping because they’re the most price-sensitive group when it comes to nicotine and tobacco products.

  • Study Debunks Link Between Heart Attacks and Vaping

    Study Debunks Link Between Heart Attacks and Vaping

    Vaping products are not associated with increased heart attack incidence among people without a history of smoking combustible cigarettes, according to a new study. Published in the American Journal of Preventive Medicine, researchers also concluded that three previous studies claiming a link between e-cigarettes and heart disease wrongly included those who previously smoked cigarettes or were using both vaping and combustible products. One paper even included participants who had heart attacks before they had ever vaped.

    “Previous researchers confused their own models’ assumptions that these risks were independent with the idea that their analyses validated the presence of independent risks,” the researchers wrote. “There is no reliable evidence that e-cigarette use is associated with ever having had a myocardial infarction among never smokers.”

    Authored by Michael Siegel, a community health sciences professor at Boston University, and University of California, Berkeley, business professor Clayton Critcher, analyzed data from 175,546 respondents to the annual National Health Interview Survey from 2014 to 2019. They found that daily e-cigarette use was only associated with higher heart attack incidence among people who were also currently smoking combustible cigarettes (duel users)—and that there was no evidence at all for increased risk among vapers who had never smoked combustible cigarettes.

    Credit: NDABCREATIVITY

    The researchers state that the initial study had drawn its conclusions about a perceived cause (vaping) and effect (heart attack) without factoring in a key variable (smoking). Critcher and Siegel acknowledge that a more thorough analysis of previous research would have noted that e-cigarettes are relatively new, limiting the ability to assess long-term health effects and make comparisons with combustible tobacco smoking, in an article with Filter. However, the findings of previous research that e-cigarette use in of itself causes heart attacks is fundamentally flawed.

    A 2018 study, also published in the American Journal of Preventive Medicine, claimed that daily vapers increased their odds of heart attack. However, the study only included participants who used both e-cigarettes and combustible cigarettes—none who used e-cigarettes alone. Suspicious of that methodology, a different group of researchers published a reply, arguing the importance of examining the purported link among people who had never smoked combustible cigarettes. Authors of the original study then published a reply to that reply, arguing that such a distinction wasn’t necessary.

    In the meantime, two (one, two) other papers were published based on the original paper’s claims, lending further harmful legitimacy to the idea of a link between e-cigs and heart attacks, according to Kevin Garcia writing for Filter.

    The second of those two papers was coauthored by the former prominent tobacco harm reduction opponent Stanton Glantz. It was retracted in 2020 for basing its claim that vaping caused heart attacks on evidence that included heart attacks from before the participants had even started vaping. Three weeks after the American Heart Association’s journal retracted the vaping study, academics and health experts began pushing for another influential peer-reviewed medical journal to retract another Glantz study.

  • Industry Experts Look Back on the PMTA Process

    Industry Experts Look Back on the PMTA Process

    Credit: Pressmaster

    As the FDA’s deadline to approve marketing applications nears, industry experts look back on the submission process.

    By Chris Howard and Rich Hill

    It’s been nearly a year since many of us filed premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration for new tobacco products, so now seems like a perfect time to reflect on what we took away from the experience. Below you will find a Top-10 list of learnings from the front line.

    1. Everyone (and no one) is an expert.

    From day one, we worked with dozens of consultants, researchers, similarly situated companies, regulators, outside counsel and other stakeholders. Which groups provided the most insight?

    Answer: It certainly wasn’t the ones who claimed to definitively know everything about a particular facet of the PMTA. Rather, we felt most confident when working with those who acknowledged the inherent uncertainty in the process. The ability to speak candidly with these individuals enabled us to collaborate to best achieve our goals of meeting FDA expectations. We learned the least from those who “guaranteed” us security or made promises about what the FDA needs/wants.

    2. The FDA is not the enemy.

    Believe it or not, the agency isn’t out to get you. The Center for Tobacco Products (CTP) is not maliciously trying to ensure that all applications for new tobacco products are denied. Despite what you read from frustrated vapers on Twitter, the team at the CTP is doing what they are required to do—assessing whether new tobacco products are appropriate for the protection of public health.

    Yes, it is expensive and requires a lot of work to meet this standard, but collaborating with the FDA is a much better approach to achieving this goal compared to taking an adversarial posture. If a combustible cigarette can receive a market order, then there is clearly a path for modern oral products and electronic cigarettes to do the same.

    3. Money talks. 

    Unfortunately, not too many shortcuts are acceptable when it comes to a PMTA, so as a result, the entire process is expensive. While you can reduce your spend by seeking discounts, collaborating with others, etc., the fact remains that you will need to make a substantial investment in this work.

    Throughout the process, we sought the best deals without sacrificing quality and looked for ways to reduce costs wherever we could, but we still spent a significant sum for our product applications. The greatest potential PMTA cost savings really begins with what products you intend to put through the process. Doing a full, scientifically sound PMTA for 1,000 stockkeeping units (SKUs) is not realistic. Make hard choices about your products in the beginning and pare your list down—this will generate your greatest cost savings.

    4. Not all labs are created equal. 

    This may seem obvious, but just because a lab is certified, has a slick website and talks a good game doesn’t mean they have the scientific rigor or physical capacity to complete your project. Many labs jumped into the “PMTA testing game”—but the solid labs delivered on time and provided scientifically sound methods and results. How do you choose a solid partner?

    Answer: Seek out laboratories that have a reputation working with your products. They don’t have to be the biggest, but they need to be experienced with the testing you are seeking. Audit them with external consultants. Do they have sufficient equipment and personnel to handle the throughput you need to finish on time (especially with competing client demands)? Ultimately, you get what you pay for. You can go to the cheapest labs, but there is no guarantee that you will get results on time or on target.

    5. No kids allowed.

    This goes without saying, but vapor products are obviously for adults only. We are all aware of the concerns regarding youth usage of vapor products, and you can be sure that the FDA places a priority on this topic. Take the time to describe the practices you employ to deter youth usage of your products.

    Don’t try to guess the minimum you need to do to achieve the goal. Rather, show the FDA that you are willing to spare no expense when it comes to this issue. We drafted company marketing standards and have shared them industrywide to encourage others to adopt the same.

    6. The perfect is the enemy of the good.

    A premarket tobacco application for a handful of SKUs can consist of tens of thousands of pages. Given this, we can confidently say that forgetting to indent a paragraph is not going to be determinative in whether the FDA ultimately decides to grant you a market order.

    Details obviously matter, but prioritize conveying your message(s) clearly by prioritizing substance over form. A misplaced semicolon isn’t going; to make the difference.

    7. Tell your story.

    Which story matters the most? Is it what you read this morning online about Juul and kids?

    Answer: No, the FDA isn’t evaluating your application based on what others in the industry are doing. Your application is the opportunity to tell the story of why your products are appropriate for the protection of public health. Don’t be consumed by details about what is going on with other products.

    8. From here to there 

    Finding a publishing partner that can handle your application is critical. Not all electronic publishers do large-scale projects. Many publishers want more time for loading and checking your application than you realistically can afford. Some publishers work with 20–30K pages exclusively (which doesn’t work as most PMTAs far exceed that page count).

    Clearly communicate your timelines and ensure that your publisher’s project management teams can meet expectations. Because it’s the final step in the submission process, publication is naturally a bit of a scramble—which makes it prone to errors. Develop a dedicated quality control process so that you can confirm that your publisher submitted your complete application.

    9. It’s not over until it’s over.

    You will undoubtedly feel a sense of relief following the submission of your application, but we caution you to keep your eye on the prize. The FDA will inevitably have questions about your products in the form of a deficiency letter, so you need to stay focused on responding with the detail required.

    These questions will come with deadlines, so do not wait until the last minute to prepare your response. Nothing would be worse than fumbling the ball at the goal line.

    10. Uncertainty is the only certainty.

    Anyone working in the vapor industry during the past five years knows exactly what I am talking about. The PMTA process is effectively in its infancy and, as such, several variables are subject to change. Is this a reason to give up on harm reduction and your individual goal of securing a market order?

    Answer: No. Embrace the changes as they arrive and do your part to help the FDA develop a clear path forward for your future applications. This evolving regulatory environment provides an opportunity for you to help shape changes. Those who back away won’t have this luxury.

    Chris Howard is the vice president, general counsel and chief compliance officer of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands. Rich Hill serves as regulatory compliance director for E-Alternative Solutions.

  • Smok Parent, IVP Technology, Considering Hong Kong IPO

    Smok Parent, IVP Technology, Considering Hong Kong IPO

    Smok is one the most well-known and respected hardware manufacturers in the vaping industry. Now, Shenzhen IVPS Technology, the firm behind the brand Smok, is considering an initial public offering to raise at least $500 million in Hong Kong as soon as next year, people with knowledge of the matter said.

    According to a Bloomberg report, the company is working with a consultant in preparation for a potential share sale, said sources who asked not to be identified as the information is private. The offering could raise between $500 million and $1 billion. Deliberations are at an early stage and details of the potential offering such as timing and size may change, the people said. IVPS didn’t immediately respond to requests for comment.

    Smoore International Holding’s stock (HK: 6969), parent to the Vaporesso, FEELM and CCELL brands, grew by nearly 150 percent on its opening day of trading on the Hong Kong Exchange. However, after China’s Ministry of Industry and Information Technology proposed a draft regulation in March that would apply the same rules for the conventional tobacco industry to the e-cigarette sector, shares of several Chinese e-cigarette companies plunged and Smoore shares are down about 40 percent this year.

    While rising regulatory scrutiny of the vaping industry could impact investor appetite for listings in the sector, according to the article. IVPS could be less affected because it makes the device rather than the e-cigarette liquid, one of the sources said. However, Smoore also produces hardware and shares still fell after the Chinese government’s regulatory announcement.

  • RLX Revenue Growth Slows Amid Regulatory Uncertainty

    RLX Revenue Growth Slows Amid Regulatory Uncertainty

    Photo: RLX Technology

    RLX Technology revenue slowed in the second quarter of 2020 amid uncertainty about the regulatory environment in China.

    Net revenues were RMB2.54 billion ($393.6 million), representing an increase of 6 percent from RMB2.4 billion in the first quarter of 2021. The improvement was due primarily to an increase in net revenues from sales to offline distributors, which was mainly attributable to the expansion of the company’s distribution and retail network.

    The company believes that the slowdown in quarterly sequential revenue growth was due primarily to external factors, including negative publicity on the vapor industry in the latter half of the second quarter, coupled with the fact that the draft new rules for vapor products announced by China on March 22, 2021, have not been formally confirmed and no new implementation details had been revealed, which had an adverse impact on sales.

    The company is also target of a lawsuit by investors who claim RLX Technology overstated its financials and misrepresented potential regulatory risks when it filed the paperwork for its initial public offering in the U.S.

    Gross margin was 45.1 percent compared to 46 percent in the first quarter of 2021.

    “In the second quarter of 2021, our business continued to develop as we increased our efforts to further improve underage protection and product safety,” said Ying (Kate) Wang, co-founder, chairperson of the board of directors and CEO of RLX Technology, in a statement. “With our strategic focus on technology investment and brand building, we strive to make RELX a trusted brand for adult smokers with state-of-the-art products, industry-leading technologies and scientific advances. Going forward, we will further enhance investments in scientific research, strengthen our distribution and retail network, and improve our supply chain and production capabilities to create more value for our users and shareholders alike.”

    RLX hosted an earnings conference call on Aug. 20, 2021. A live and archived webcast of the conference call is available on the company’s investor relations website. A replay of the conference call will be accessible until Aug. 27, 2021.

  • VPR Brands Reports ‘Turnaround’ in Second Quarter

    VPR Brands Reports ‘Turnaround’ in Second Quarter

    Photo: snowing12

    VPR Brands, a supplier of vaporizers, reported revenues of $1.7 million for the second quarter of 2021, up from $1.2 million in the comparable 2020 quarter.

    The increase was a result of the Covid-19 pandemic, which hampered sales significantly in 2020 and increased direct on-line sales in 2021.

    Operating expenses for the three months ended June 30, 2021, were $457,895, compared to $372,652 for the three months ended June 30, 2020. The increase in expenses is primarily due to increased sales activity in 2021.

    Revenue for the six months ended June 30, 2021, was $2.96 million, compared with $1.8 million in the second quarter of 2020.

    Operating expenses for the six months ended June 30, 2021, were $995,798, compared to $849,476 for the six months ended June 30, 2020. The increase in expenses is primarily due to increased sales activity in 2021.

    Net income for the six months ended June 30, 2021, was $163,135 compared to a net loss of $471,944 for the six months ended June 30, 2020.

    Net income for the three months ended June 30, 2021, was $264,786 compared to a net loss of $50,354 for the three months ended June 30, 2020.

    “The company has finally put the pandemic and other extenuating circumstances behind us and is back on track,” said Kevin Frija, CEO of VPR Brands, in a statement. “The numbers, which show a tremendous turnaround from last year, speak for themselves as our team is focused on maintaining not only steady growth but most importantly profitability.”