Tag: FDA

  • What a Waste

    What a Waste

    Disposable vapes help smokers to quit combustibles but are deadly for the environment.

    By Maria Verven

    Cigarettes used to be the most littered things in the world.

    Trillions of cigarette butts are thrown onto our streets, parks and beaches every year. The Ocean Conservancy estimates that cigarette butts account for 25 percent of the total number of garbage items collected—over twice as much as any other category. Worldwide, it’s estimated that 1.69 billion pounds of cigarette butts end up as waste each year.

    While some smokers may think their butts will eventually decompose, it actually takes decades for them to degrade. Cigarette filters aren’t made of innocuous cotton; they’re made of cellulose acetate and about 12,000 nonbiodegradable plastic-based fibers.

    The chemicals in a single cigarette butt can contaminate hundreds of gallons of water. They can also be dangerous, causing fatal fires that burn hundreds of acres every year.

    Things have changed dramatically in the last several years as many smokers have switched to vaping, thanks in large part to the convenience of disposable e-cigarettes.

    In fact, these handy-dandy devices appear to be taking over the industry since they’re the simplest and most accessible vaping devices on the market.

    But in the process, we created a whole new environmental hazard that, as of yet, has no easy solution.

    Popular among youth

    Among all the vaping devices on the market, none are more popular than disposable electronic nicotine-delivery systems (ENDS), particularly among young people.

    According to the 2021 National Youth Tobacco Survey, well over half (54 percent) of youth who reported using e-cigarettes had used disposables. The 2020 Population Assessment of Tobacco and Health Study corroborated this finding. It reported that 38 percent of young adults aged 18–24 versus 17 percent of older adults (over age 25) who had used any ENDS product in the past 30 days had used a disposable.

    At the May 2022 Vaper Expo U.K., nearly every vendor offered some variety of disposable device. Many were new to the market that were capitalizing on the trend—as well as renowned companies such as Innokin, which launched its new Aquios Bar disposable device in 10 different flavors.

    “Disposable vapes are certainly the hottest-selling item among smoke-free nicotine-delivery devices,” said Dimitris Agrafiotis, owner of Global eVapor Consulting, executive director of the Tennessee Smoke Free Association and brand ambassador and designer at Innokin Technology.

    Agrafiotis said disposable vapes attract individuals who make impulse buys at various points of sale as well as new users who enjoy the convenience of a product that doesn’t require any knowledge of coils or ohms. They can purchase disposables nearly anywhere where cigarettes are sold. They can simply tear open the package and start vaping, making disposables the perfect solution for beginners.

    “In my experience, vapers who quit smoking use disposable vapes part time as secondary devices when they don’t want to take their usual rig with them, such as at a nice dinner or in situations requiring them to be more discrete,” he said.

    The technology behind disposables has only continued to improve over the past several years. Most vape pens can now deliver around 400 puffs before they’re no longer viable—nearly twice as many puffs as a pack of cigarettes can deliver. Some vape pens with larger batteries can even deliver as much as 5,000 puffs.

    Another significant advance is the use of auto-draw switches that activate the device and heat the coil when the vaper inhales, delivering a smooth and seamless experience.

    And thanks to nicotine salts, disposables offer a smoother vaping experience. While the nicotine level in most disposables is limited to 5 mg, vapers can satisfy their nicotine cravings without a harsh throat hit or any interference in the flavor experience.

    Speaking of flavor, that’s another advantage disposables have over refillable vape devices. Manufacturers often add sweeteners to disposables to make the flavors pop without having to worry that the sweeteners will gunk up and ruin the device. The disposable will be tossed long before that happens.

    The range of flavors available from disposables is mind-blowing. As more and more manufacturers take advantage of the growth in this market, they entice vapers with interesting and often exotic flavor profiles, such as bergamot and carambola.

    While battery technology hasn’t necessarily improved dramatically, some brands have created larger internal or rechargeable batteries in their efforts to increase puff count. This is a step in the right direction to reduce battery waste.

    The environmental impact

    Even refillable and replaceable vape pens typically contain several metal, plastic and cotton elements, making them difficult to separate and recycle. Thus, they tend to end up as general household waste. Even the smaller replaceable coils and pods don’t often get recycled.

    But disposable e-cigarettes are way worse because the vaper disposes the entire device, which is composed of plastic and metal coils as well as a battery cell. While some brands and vape stores offer recycling programs for disposables, most vapers simply toss them into the trash.

    Millions of lithium-ion batteries, hard plastic and nicotine-contaminated pods are being disposed of in our landfills, creating a significant waste problem. Nicotine, including nicotine salt, is listed by the Environmental Protection Agency as an acute hazardous waste. When disposables leak battery acid and/or nicotine into the environment, they harm fish and wildlife in the process.

    The Food and Drug Administration is required under the National Environmental Policy Act to evaluate all major agency actions to determine if they will have a significant impact on the human environment. If the environmental assessment identifies significant environmental effects, the FDA will prepare an environmental impact statement to help make informed decisions on the relevant environmental consequences and alternatives available.

    In addition to assessing potential environmental impacts of new tobacco products during premarket review, the FDA has also posted information for consumers on proper disposal of e-cigarettes and e-liquid waste.

    “While we are excited that lots of people are not inhaling combustible tobacco, we should be concerned over the environmental sustainability and proper ethics in the sale of these products,” Agrafiotis said. “In its quest to market and sell millions of these products, the industry has failed to implement any type of consumer education or recycling initiative that would help alleviate the disaster,” he said.

    “The irony is that in most countries in Europe, plastic straws are banned—and yet these products continue to be dumped by the boatloads. I simply cannot see how governments will allow this to continue, especially in Europe, where environmental waste is such a huge issue,” Agrafiotis said.

    “With TPD 3 approaching and countries already discussing legislative measures, I believe the days are numbered for disposables—at least as we know them right now.”

    What’s the solution?

    The first and most obvious answer is to encourage consumers to use rechargeable devices.

    Consumers could also be encouraged to purchase refillable pod devices, vape pens with replaceable coils or even rebuildable tank atomizers, all of which are far more cost effective in the long run, not to mention more eco-friendly.

    The industry has yet to find ways to encourage and/or incentivize consumers to dispose of these devices in the right manner. When Agrafiotis tried offering a financial incentive for every disposable brought back to his store, there were very few takers.

    “The younger demographic that predominantly uses these products simply doesn’t seem to care,” he said. “At least the older demographic tends to quickly transition from disposables to open systems when they realize the daily costs and environmental impact.”

    Agrafiotis said he’s unaware of any other outlets for collecting and recycling disposable vapes. “At this point, there’s no budget or avenue for us to try and change the existing system. Incentives and/or drop-off points for hazardous waste should have started with the construction and sale of the first disposable vaping device ever made.”

    “The only thing I could do is break the plastic and remove the battery and bring it to a battery recycler, but I would still have to dispose the plastic and nicotine pod in the trash,” he said. “All brands would have to work together to start a viable recycling program, but unfortunately, I simply do not see this is possible.”

    Nevertheless, Agrafiotis said Innokin is striving to reduce environmental waste in its products. Innokin was the first company to start using fully recyclable packaging for its open vapor systems, made entirely of paper with absolutely no plastic, he said.

    The first disposable vaping device that can be disassembled and recycled, the Innokin Enviro uses materials with a lower carbon footprint—a reinforced paper shell—to replace the plastic shell found in most disposable vaping devices.

    “We believe disposable vapes should have less impact on the environment,” Agrafiotis said. “With more efficient manufacturing processes and recyclable designs, our goal is to continually optimize Enviro and make disposable vaping greener. We can only hope demand grows for this approach and more companies follow in the same green footsteps.”

    Clearly, the industry must act quickly to devise solutions before the products that help millions of smokers are carbon taxed or—even worse—removed completely from the market.

    “Most of all, I hope we see more people quit smoking and transition to vaping, regardless of the device they choose to help them. Any vaping devices that can help smokers around the world make the switch is worth pursuing,” Agrafiotis said.

    “Plastic casings and batteries simply should not go into our landfills after just one use,” he said. “More companies should be actively looking at sustainable solutions and proactively working with existing recycling companies to implement programs to keep these products out of our already overflowing landfills.”

    The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry. 

    MORE ON VAPING WASTE

    Garbage facts

    There is an estimated 44.7 million tons of e-waste generated around the world every year. That waste contains up to $65 billion worth of raw materials like gold, silver and platinum sent to a landfill. The amount of global e-waste is expected to increase by almost 17 percent to 52.2 million tons in 2021, or about 8 percent every year, according to Cleanaway Waste Management, an Australian waste management, industrial and environmental services company. 

    Vaping products contain lithium-ion batteries, a heating element and a circuit board. These components—which may include plastic and heavy metals—make disposing of e-cigarettes a considerable challenge because of the various types of chemicals and materials involved in their manufacturing. 

    The global disposable e-cigarettes market size is expected to be valued at $6.34 billion in 2022, according to Future Market Insights (FMI). The overall demand for disposable e-cigarettes is projected to grow at a CAGR of 11.2 percent between 2022 and 2032, totaling around $18.32 billion by 2032.  

    “Demand for non-tobacco products is expected to augment the growth of the disposable e-cigarettes market in the near future. It has been observed that older people prefer this product as it does not have any negative effect on health,” stated an FMI analyst. 

    There are no direct regulations for recycling or use of e-cigarettes, heated-tobacco products (HTPs) or the cellulose acetate filters in combustible cigarettes in the EU, U.S., China and Japan. There is some legislation that regulates the management of e-waste; however, these guidelines typically apply only to cell phones, computers and other large electronic products.

    According to the Global Overview of Recycling Programs for E-Cigarettes, Heated-Tobacco Products and Vaporizers Business for 2022 and Future Prospects of Electronic Devices and Consumables Development report by Research and Markets, large vaping industry players have several recycling programs and recycling targets for the near future: 

    • Philip Morris International established two hubs in Europe and Asia that inspect, process and separate materials from electronic devices for recycling. The effective recycling rate of IQOS devices increased from 30 percent in 2018 to 40 percent in 2020. The target recycling rate is 80 percent by 2025. 
    • BAT replaces plastic elements of vapor products with pulp-based alternatives. The share of recycled waste was 79–80 percent in 2019–2021. The target recycling rate is 95 percent by 2025. 
    • Japan Tobacco International launched a return scheme of used devices through the recycling boxes at shops. In 2020, 67 percent of produced waste was recycled. The target for waste reduction is 20 percent by 2030. 
    • Imperial Brands launched takeback recycling schemes for used vaping devices and pods. The recycling rate decreased from 69 percent in 2017 to 61 percent in 2021. The target recycling rate is 75 percent by 2030. 
    • Other vape companies (Dotmod, Shanlaan, Dovpo and Vinn) launch their own recycling programs by return schemes. Innokin works on battery utilization programs. 
    • FEELM, an atomization brand and an independent business unit of Smoore Technology Ltd., won the IF Design Award 2020 for its eco-friendly Disposable Paper E-cigarette. CCELL launched a new line of disposable vaporizers in 2021. 
    • Recycling companies Gaiaca and TerraCycle cooperate with vape manufacturers to provide services for collecting and recycling e-waste. Some vape producers cooperate directly with recycling companies; for example, RELX cooperates with China Siyan Foundation for Poverty Alleviation. 
    • The Bowman Company offers refill stations to fill empty vapor bottles/pods. It will help to reduce plastic usage for vapor bottle production in the future. 

    It is expected that the future of e-cigarette, HTP and vaporizer recycling will depend on producers’ product life cycle programs. Recycling decisions from large vaping companies to combat waste include using a combination of polylactic acid (PLA) and plastic or starch blend and plastic for the device body; using paper packaging; and making inner packaging consist of paper or paper and PLA. 

    A survey by Opinium on behalf of Material Focus, a not-for-profit established to help the U.K. meet its electrical reuse and recycling targets, found that 18 percent of 4,000 people surveyed in the U.K. had bought a vape device in the previous year, with 7 percent buying a single-use device.  

    The Opinium figures would suggest that about 168 million disposable vapes are being bought every year in the U.K. Two of the biggest brands in the country are Elf Bar and Geek Bar, which between them make up about 60 percent of the market. 

    More than half of people that buy single-use e-cigarettes dispose of them in a general trash bin compared to 33 percent on average for all types of vape, according to the research. While each vape contains just 0.15 g of lithium, the scale of the waste means that about 10 tons of metal is ending up in landfills. – VV staff

  • CTP Terms: ‘Grandfathered’ Becomes ‘Pre-existing’

    CTP Terms: ‘Grandfathered’ Becomes ‘Pre-existing’

    Photo: Olivier Le Moal

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has updated the term “grandfathered tobacco product” to “pre-existing tobacco product” to describe these products more appropriately.

    Additionally, the term “grandfathered,” when used to describe someone or something exempt from a new law or regulation has its roots in 19th century racist voting laws, according to the FDA.

    Like the grandfathered products before it, a pre-existing tobacco product is any tobacco product (including those products in test markets) that was commercially marketed in the United States as of Feb. 15, 2007.

    As was the case with submitting a grandfathered determination request, submitting a request to determine the pre-existing status of a tobacco product is voluntary and not required under the Federal Food, Drug and Cosmetic Act.

    According to the CTP, the terminology update requires no additional action by companies with pending grandfathered determination request.

  • Vapor Makers Prevail Over FDA in PMTA Denial Suit

    Vapor Makers Prevail Over FDA in PMTA Denial Suit

    Credit: Tanasin

    A split 11th Circuit on Tuesday told the U.S. Food and Drug Administration it shouldn’t have denied six e-cigarette companies’ premarket tobacco product applications (PTMAs) to sell flavored vaping products without first taking a look at their marketing and sales plans designed to minimize youth exposure and access.

    The U.S. Court of Appeals for the Eleventh Circuit granted petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications in a 2-1 decision. According to Chief Judge William Pryor, the agency didn’t assess “the companies’ marketing and sales-access-restriction plans designed to minimize youth exposure and access.”

    The court explicitly labeled the FDA’s decision-making as “arbitrary and capricious.” Prior legal decisions have determined that FDA action must consider all relevant factors in order to be legally justifiable. In the case of these vape manufacturers, the court ruled that the FDA had not performed such consideration.

    “These tobacco companies submitted survey information from their customers about smoking cessation, literature reviews, scientific studies about switching to e-cigarettes, smoking cessation, and the role of flavors, and details about its marketing and youth-access-prevention plans,” notes the court in its opinion. “For example, Diamond uses technology for its online sales that relies on public records to verify a purchaser’s age.”

    Vapor industry advocates welcomed the decision. Gregory Conley, director of legislative and external affairs at the American Vapor Manufacturers Association said that while court ruling does not order the FDA to grant PMTAs—and that the agency is likely to deny the applications in the future—the companies involved could end up in the queue for review in 2025, which keeps them in business.

    “Additionally, this leaves the door open for further litigation on these and other PMTAs,” Conley wrote on Twitter. “The FDA’s vague and undefined ‘appropriate for the protection of public health’ standard has long been open for attack. This is just the start.”

    The 11th Circuit decision follows revelations that forced the FDA to admit to not considering all evidence when issuing marketing denial orders (MDOs) to vape products made by Juul and Turning Point Brands. In the interests of public health, future FDA decision-making must engage with all available evidence, not just evidence that leads to their preferred outcomes.

    The court also recognized relevant distinctions between closed/cartridge systems and the e-liquids used in open systems. The court also found that the FDA’s refusal to review marketing plans was “error and not harmless” (disagreeing with Fifth and DC Circuits).

    All petitioners’ appeals were granted, denial orders vacated and remanded.

    In her dissent, Judge Robin Stacie Rosenbaum wrote that anyone who knows all the relevant facts of this lawsuit probably already knows how this case will eventually end.

    “The Majority faults the FDA for not considering the companies’ proposed restrictions on kids’ use. And to be sure, the FDA said that factor would be relevant,” stated Rosenbaum. “But even assuming that the FDA erred when it didn’t consider the Companies’ proposed marketing and access-restriction plans, the FDA’s framework for evaluating pre-market tobacco product applications leaves no room for doubt that the FDA will deny—in fact, under the Family Smoking Prevention and Tobacco Control Act, must deny—the applications on remand. To paraphrase the Borg, then, remand is futile.”

     

  • FDA Issues Guidance on Perception, Intention Studies

    FDA Issues Guidance on Perception, Intention Studies

    The U.S. Food and Drug Administration Today issued a final guidance on Guidance perception and intention studies.

    This guidance, “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies,” is intended to help applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product (MRTP) application, a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report).

    TPPI studies can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products, according to the FDA.

    These studies provide critical information during the review of product applications and this guidance provides recommendations on how to perform these studies.

    This final guidance addresses the following scientific issues for applicants to consider when designing and conducting TPPI studies to support tobacco product applications:

    • Developing study aims and hypotheses
    • Designing quantitative and qualitative studies
    • Selecting and adapting measures of study constructs
    • Determining study outcomes
    • Selecting and justifying study samples
    • Analyzing study results

    This guidance document is intended to provide clarity to applicants regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed as recommendations for consideration, unless specific regulatory or statutory requirements are cited.

  • EAS Offers an Inside Perspective to CTP Review

    EAS Offers an Inside Perspective to CTP Review

    By Chris Howard and Rich Hill

    Recently, U.S. Food and Drug Administration Commissioner Robert Califf announced an external evaluation of both the Human Foods Program and the Center for Tobacco Products (CTP). The FDA press release observed that “… even greater challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health. To that end, the review will push toward ‘organizational excellence.’”

    Califf is right—the CTP clearly requires assistance. The purpose of this article is to review how the CTP arrived in this untenable situation and to suggest areas of focus for the review of the CTP processes.

    How Did We Get Here?

    There is little doubt that the CTP is in an unenviable position. No matter which way the agency turns, it is impossible to please everyone. The anti-tobacco/vaping groups will never be satisfied until all tobacco products are gone—so realistic harm reduction propositions from the center will always be met with opposition. And when the CTP tries to develop policies with a focus on efficiency, many in the industry claim that they are “prohibitionist” and that they have no regard for harm reduction and/or the human and economic consequences of their decision-making.

    Recently, several court opinions and CTP actions have significantly contributed to the challenging environment for the CTP:

    • West Virginia v. EPA. While not directly related to the CTP, the West Virginia v. EPA Supreme Court decision has reopened the question as to whether discretion of regulatory agencies may become more limited in the future. The court seems poised to chip away at longstanding doctrines (or apply them more forcefully) to limit agency power and place policymaking back with the legislature.
    • Cigar Association of American v. FDA. More recently, in the Cigar Association of America v. FDA case, Judge Amit Mehta of the U.S. District Court for the District of Columbia examined whether the FDA’s decision not to exempt premium cigars from the Deeming Rule was arbitrary and capricious. The court ultimately found that the FDA ignored evidence in the rulemaking record—and ruled against the agency.
    • Juul v. FDA. Days later, the CTP found toxicological issues with Juul’s popular vapor products and issued marketing denial orders (MDOs) for those products. Not surprisingly, Juul immediately requested and received an emergency stay of the MDOs from the D.C. Circuit. Without missing a beat, the CTP promptly “… administratively stayed the marketing denial order. The agency [determined] that there are scientific issues unique to the Juul application that warrant additional review.” Several commentators questioned the CTP’s rationale for its decision to re-review Juul’s applications, and some have gone so far as to suggest that this quick reversal indicates a less than appropriate review of Juul’s data or worse—a lack of confidence in the CTP’s decision-making. Either way, the entire chain of events draws into question the CTP’s review process.
    • Finally, the CTP is still under pressure to complete decisions on premarket tobacco product applications (PMTAs) for those companies addressed in the Maryland court decision which, according to the CTP, will not be completed until next summer. Further compounding the CTP’s problems, the center continues “processing” approximately 1,000,000 synthetic nicotine PMTAs past the congressional deadline for marketing decisions on July 13, 2022. How the center will respond to this pressure is anyone’s guess. So far, it seems like the CTP continues to move at its own pace, following the Maryland court’s order to the best of its abilities.

    These external and internal factors point to one conclusion that cannot be ignored—the CTP appears to be struggling and needs something to change. With the above in mind, the following are a few areas ripe for external (and internal) review at the CTP.

    Credit: Fizkes

    Operational Changes

    Operationally, the CTP seems to have the resources (personnel and budget) to successfully regulate tobacco products. That said, certain policy choices and administrative actions (both self-inflicted and externally inflicted) appear to hamper the center’s ability to effectively manage the space. Importantly, effective regulation is hamstrung by the complexity of the U.S. tobacco regulatory scheme, a lack of clear standards for product testing and approval and a too opaque product application process.

    The most challenging operational issues come from the existing regulatory scheme, which is too complex for tobacco products. The Tobacco Control Act dictates the parameters/guardrails, but the CTP has latitude in how the process is implemented. The comprehensive PMTA guidance and robust final rule demand a scientific depth that goes too far. The question is: Is all of the delineated scientific data really necessary to determine that a product is appropriate for the protection of public health (APPH)?

    If comparing to combustible cigarettes, it would seem that most electronic nicotine-delivery product APPH determinations could be made based on chemistry alone. Piling on bench toxicology, human factors, pharmacokinetic and behavioral studies, it’s no wonder the review process takes so long.

    Standards are not clear. Without clear standards, the CTP and industry both are left constantly employing guesswork and conjecture to facilitate decision-making. While understandably there is no simple formula for APPH, clear expectations would be beneficial and efficient. By way of example, which device characteristics really need testing? What is the depth of stability testing necessary? What constitutes a sufficient PK [pharmacokinetic] study? While the initial meeting with the Office of Science is often useful to help answer questions like these, better defining product-specific standards and setting minimums would go a long way to streamlining the approval process.

    Transparency is lacking. While one can review the Technical Project Lead Reviews and some of the review standards memos that the CTP places on its website, few PMTA applicants have any idea what’s going on with their applications at any given time. Other than the initial pre-PMTA meeting and the sole deficiency letter, there is little that applicants know about the status (both administratively and substantively) of their applications. While more transparency about the status of applications would be welcome, more back and forth on issues in applications would benefit everyone—particularly the CTP. In the case of Juul, reports indicate that Juul provided thousands of pages of data related to the toxicological issue that the CTP raised in the MDOs. If the now outdated additional information requests were utilized by the CTP, Juul would have pointed out this data, and at least one issue could have been resolved well short of a trip to the courthouse.

    Credit: Oleg

    Policy Changes

    It goes without saying that U.S. government policy can be fickle to say the least. Setting and maintaining long-term policy is difficult—especially in light of changing administrations every few years. Despite this, overriding policy tenants as they relate to harm reduction can, and should, form the cornerstone of tobacco regulatory policy. If harm reduction is the priority, then regulators need to prioritize pathways for reduced-harm products to enter the market, incentivize innovation and focus on providing offramps to combustible cigarette smokers seeking to quit smoking.

    Harm reduction policy. During the tenure of former Commissioner Gottlieb at the FDA, many in the industry thought harm reduction would prevail and that all would recognize vapor products’ place at the opposite end of the continuum of risk from combustible cigarettes. Unfortunately, the significant uptick in youth experimentation with a few types of vapor products prodded the CTP into a tough position. Public health groups, dissatisfied with the CTP’s pace, forced the center into a corner via litigation.

    Assuming the goal of the Tobacco Control Act remains to reduce smoking-related morbidity and mortality, harm reduction strategies are central to achieving that goal. Importantly, harm reduction strategies should be palatable to all stakeholders. While the CTP has several initiatives moving forward, is there a plan for initiatives dedicated to moving smokers to safer alternatives? Efforts to move smokers to less risky alternatives do nothing when those less risky alternatives cannot succeed via the PMTA pathway. Current tobacco policy is remarkably dissimilar from the variety of strategies employed for other unsafe behaviors where harm reduction is embraced as the primary alternative. In areas such as drug use and sexually transmitted diseases, our society generally accepts reduced-harm efforts, but for tobacco, collectively we are still searching for that sweet spot.

    Given all the challenges that the CTP faces, working on harm reduction policies hand-in-glove with nongovernmental groups and industry probably does not seem like the best use of time. When the center was first formed, frequent scientific meetings were held on various issues (such as harmful and potentially harmful constituents). These have fallen off in recent years, likely in part due to Covid and also due to the onerous demands on the center. Prioritizing genuine and open conversations between the CTP, industry and tobacco control groups is critical to developing strong harm reduction policies. Holding scientific meetings (either through the CTP or the Tobacco Products Scientific Advisory Committee) on harm reduction plans and policies would add transparency and bring all ideas to the table.

    The FDA should not let the perfect be the enemy of the good when considering reduced-harm products. At present, PMTA reviews appear to be searching for the perfect. Reviews seem to focus on the smallest details that might pose a risk while ignoring a more generalized comparison to combustible products with 70 known carcinogens (and a track record of 480,000 deaths per year). APPH does not mean no risk—it means less risk than the deadliest consumer product ever invented, the combustible cigarette. Reconsidering how APPH is adjudged would be an excellent first step in combatting morbidity and mortality attributable to smoking.

    Investing in harm reduction must be incentivized. If one wants to develop a new product, the timeline is a hard stop. A year of product development, up to three years of PMTA testing (including two years of stability and time to plan, conduct and write up the studies) plus one year to three years of the CTP review before the possibility of a marketing order sounds like a pretty poor investment. The PMTA process must change to bring less risky products more rapidly to market.

    Society must not forget about smokers. Youth tobacco issues are important, but the 1,300 smokers dying each day are important too. A balanced harm reduction policy—controlling youth access and exposure while moving combustible cigarette smokers to quitting tobacco altogether or moving to a less risky product is necessary.

    Moving Forward

    Hopefully the external review will be a fruitful exercise—one that provides robust alternatives for the CTP to consider. The review, if rightly focused, will address foundational issues that will, in the end, lead tobacco regulation to a reasonable, reduced-harm world where smokers are given hope for a future.

     

    Chris Howard is vice president, general counsel and chief compliance officer at E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.

    Rich Hill is the compliance director and associate general counsel of E-Alternative Solutions.

  • A Survivor’s Story

    A Survivor’s Story

    Nathan (Nate) Coccimiglio

    An entrepreneur is using his business acumen to reinvent the convenience store experience.

    By Norm Bour

    The one thing we can all agree on is that the vape industry has been in a constant flux, peppered with an occasional crisis. The once “easy to operate,” unregulated business from a decade ago has morphed into a highly regulated (with more to come) struggle to stay ahead of the U.S. Food and Drug Administration and maintain their competitive position in a very crowded, ever-evolving market.

    “I think it’s easy to see where the market is going,” claimed Nathan (Nate) Coccimiglio, who has been in the business world for almost 15 years. “But besides having the vision, you need the guts to make a change and the capital to implement [that change].”

    Coccimiglio hasn’t always had the complete package, but as he just crested the age of 40, he has had his share of victories along with the inevitable defeats along the way. However, now, he feels as prepared to go forward as he’s ever been. He’s been a mainstay in the Salt Lake City business community and had a journey through nutritional supplements, enhancement pills and even owned a storage facility for precious metal and bullion.

    “I saw an opportunity in that space, so I took it and grew it into a multimillion-dollar company. I did the same thing with vapes when I ventured into that in 2012,” he said. “In 2007, my life took a serious detour when I got hit on my motorcycle on the interstate doing 80 mph. I was running an electrical contracting business and suddenly that all went out the window. I wasn’t able to do certain hard labor like I used to, and suddenly, I had to reinvent myself,” he shared. “That forced me into starting my own business.”

    ALT21

    Coccimiglio began with vitamin supplements and enhancement-type pills, which he started selling from his home and later expanded into a second location in Tucson, Arizona. That location got burglarized, and the entire inventory was stolen. Once again, he had to backtrack and dig in at his home office.

    Even after adversity, in less than two years, Coccimiglio generated over $5 million in annual sales, and he sold that business just a few years later.

    “I look back and wish I had kept that one,” Coccimiglio confided. “I was in my mid-twenties and didn’t know then what I know now. It taught me lots of lessons about what to sell, how to sell and what to stay away from.”

    The cash from the sale, along with his passion for metals and the business experience, gave him confidence to start a private vault company. He started storing and warehousing bullion in 2012. The company stored platinum, ore and worked with several mines in Utah storing hundreds of millions in metals.

    However, Coccimiglio was still intrigued with supplements and accessories and decided to open an e-liquid company called Tronic Vape. He also created a few other lesser known brands.

    “E-liquid was easy back then,” he laughed. “Just a simple 10 mL bottle filled with liquid, which we made with no restrictions or regulations at all. We also imported little e-cigs from overseas that I thought were the hottest things. Even though there was minimal regulation, we implemented our own and insured our products with Lloyds of London and had full liability coverage.”

    Coccimiglio continued to manufacture his e-liquids until 2018. Over the years, he private labeled for other companies as well. That was when he opened his first vape shop: Draper Vaper, in Draper, Utah.

    I visited that shop and can verify that it was over-the-top beautiful and a true testament to the possibilities of a high-end vape shop. He also opened a second location and phased out of private labeling to focus on his retail locations and to grow his wholesaling opportunities.

    Coccimiglio also offered his experience and knowledge with other shops in the area along with taking an ownership interest with a few that he believed could be successful. He also got involved with many of the vaping advocacy associations to help support the industry. He even served a stint as president of the Utah Smoke-Free Alternatives Trade Association.

    Coccimiglio has been challenged with many of his fellow vape entrepreneurs, who he says have closed minds and unwillingness to change.

    “When they say they are vape only and will stay that way, I just roll my eyes and walk away,”  he said. “If there is one thing I have learned from entrepreneurship, [it] is that you either adapt or die. I started saying that almost 10 years ago when I saw smoke shops carrying vape shop products.”

    He sees standalone vape shops as being a “thing of the past” and instead all-around “vice shops” will carry any and everything that people want.

    “We’re all playing in Big Tobacco’s sandbox,” he lamented. “It’s inevitable that they will control the vape industry over time. If every single one of our vape businesses banded together, we’d still be outmanned, outgunned and out financed.”

    Over the years, Coccimiglio has almost divested out of his vape businesses and is now evolving into his version of where the future is going.

    The key word is “almost” since he still has one shop left, which has added CBD, alternative products and adult novelties. He went back in time with his version of a “build-your-own” flavor station and offers flavors for his customers to create their own e-liquids.

    Coccimiglio believes that flavoring for e-liquids will universally be stopped through regulation. However, his new shop, Alt21, located in Murray, Utah, may be on to something. It also offers clothing, glass, kratom, e-juice and pretty much anything anyone would want.

    Coccimiglio also sees convenience stores taking over a larger share of these types of products. “For years, they’ve been looked down upon,” he said, “but c-store owners are pretty smart. They look down the road and many times band together to totally change the market.”

    Coccimiglio currently manufactures a product for them, Kush Kubes (a brand of Delta-9 and CBD-enhanced gummies) and sells them domestically as well as overseas.

    “We’re a manufacturer/distributor right now, and rather than taking new products to old markets, we’re trying to lay new ground and create new markets for our stuff. We see gas pumps coming out of the ground and c-stores looking totally different in the future. They have so much exposure and visibility right now; it’s up to us to find things for them to sell.

    “We want to sell less SKUs to more markets rather than load everyone up with a surplus of things they can’t sell. If you can’t recognize opportunity, then you’ll always miss it,” he said. “I don’t think I have a magic eye; it’s just a matter of who has the bigger pockets and how can we do business with them.”

    That is how a survivor thinks.

    Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com. 

  • VPR Brands Gets FDA Warning for Nicotine Gummies

    VPR Brands Gets FDA Warning for Nicotine Gummies

    The U.S. Food and Drug Administration on Aug. 18 issued a warning letter to VPR Brands (doing business as Krave Nic) for marketing illegal flavored nicotine gummies—the first warning letter for this type of product.

    According to the FDA, these types of gummies are of particular public concern because of their resemblance to kid-friendly food or candy products and the potential to cause severe nicotine toxicity or even death among young children.

    VPR Brands markets gummies that have 1 mg of nicotine each and are available in three flavors – Blueraz, Cherry Bomb and Pineapple. The packaging claims that the products contain tobacco-free nicotine. This firm has not submitted a premarket tobacco product application to the FDA, and does not have a marketing authorization order to manufacture, sell or distribute these products in the U.S.

    “Nicotine gummies are a public health crisis just waiting to happen among our nation’s youth, particularly as we head into a new school year,” said FDA Commissioner Robert M. Califf in a statement. “We want parents to be aware of these products and the potential for health consequences for children of all ages—including toxicity to young children and appeal of these addictive products to our youth. The FDA will not stand by as illegal products infiltrate the marketplace.”

  • Charlie’s Holdings: 58% Revenue Growth First Half 2022

    Charlie’s Holdings: 58% Revenue Growth First Half 2022

    Charlie’s Holdings, parent to Charlie’s Chalk Dust e-liquids, says its best-selling e-liquids are in the substantive review phase of the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process.

    The company remains in the select minority of 2020 PMTA submissions that are still viable; the company also submitted PMTAs for more than 700 additional products prior to the May 14, 2022 FDA deadline, according to a press release. Prior to the FDA’s May 14 deadline, Charlie’s successfully filed new PMTAs for its synthetic nicotine Pacha Syn products.

    “Charlie’s positive momentum continued in the second quarter and first half of 2022, highlighted by our 36 percent and 58 percent year-over-year revenue growth,” stated Matt Montesano, CFO for Charlie’s Holdings. “We continued to diversify and expand Charlie’s robust product line, as represented by our new 12ml Pacha Syn Disposable line and our refreshed Pacha Syn e-liquid line, both of which launched in the second quarter of 2022.

    “At the same time, we continued to operate the business with tight fiscal controls, as demonstrated by our further reduction of operating expenses, as a percentage of revenue, to 46 percent during the second quarter.”

    Financial Results for the Six Months Ended June 30, 2022:

    • Revenue: For the six months ended June 30, 2022, revenue was $15.5 million, an increase of $5.7 million, or 58%, compared with $9.8 million for the same period last year. The increase in revenue was primarily due to a $4.8 million increase in sales of our nicotine-based vapor products and a $0.9 million increase in sales of our hemp derived products. The increase in our nicotine-based vapor product sales was driven by sales of our new 8ml Pacha Syn Disposable line, which launched in December 2021, as well as our 12ml Pacha Syn Disposable and refreshed Pacha Syn e-liquid lines, both of which launched in the second quarter of 2022.
    • Gross Profit: For the six months ended June 30, 2022, gross profit was $6.5 million, an increase of $1.4 million, or 28%, compared with $5.1 million for the same period last year. The resulting gross margin was 41.9%, compared with 51.6% for the same period in 2021. The decrease in gross margin is primarily due to an increased percentage of our sales coming from Charlie’s Pacha Syn Disposable product line, which carries a lower unit margin relative to the Company’s other products, as well as comparatively higher freight and delivery expenses and a larger reserve for inventory obsolescence related to certain of our retired hemp-derived wellness products.
    • Total Operating Expenses: For the six months ended June 30, 2022, total operating expense, including general and administrative, sales and marketing expense and research and development costs, were $6.7 million, an increase of $1.2 million, or 22%, compared with $5.5 million for the six months ended June 30, 2021. The increase in operating expenses was primarily attributable to sales and marketing costs related to enhanced trade-show activity during the quarter in furtherance of our plan to grow market share across the nicotine and hemp-derived product categories and $0.8 million in research and development costs associated with our 2022 PMTA submissions. Operating expenses as a percentage of revenue decreased to 43%, from 56%, for the periods compared.
    • Operating Loss: For the six months ended June 30, 2022, operating loss was $0.2 million, a decrease of $0.2 million, or 51%, compared with an operating loss of $0.4 million for the six months ended June 30, 2021.
    • Net Income/Loss: For the six months ended June 30, 2022, net income was $0.1 million, compared with a net loss of $0.4 million for the six months ended June 30, 2021.
  • Gallup Poll Claims U.S. Wants Stricter Vape Rules

    Gallup Poll Claims U.S. Wants Stricter Vape Rules

    Credit: Andrey Popov

    Six in 10 Americans would like the laws and regulations dealing with electronic cigarettes to be stricter, a view shared by majorities of men, women and all age groups, according to a new poll from Gallup.

    Views on e-cigarettes are also bipartisan, with more than half of Republicans, independents and Democrats wanting stricter laws.

    The latest findings, from Gallup’s annual Consumption survey, conducted July 5-26, come after the U.S. Food and Drug Administration voted in June to ban the sale of a popular brand of e-cigarettes.

    That decision is now under appeal.

    The 61 percent of Americans currently in favor of stricter e-cigarette laws is slightly more than the 54 percent who held this view last year but similar to the 64 percent recorded in 2019.

    Across all years, few adults have said the laws for e-cigarettes should be less strict, including 7 percent holding this position today.

    The poll also found that a majority of Americans favor taking nicotine, but not menthol, out of cigarettes.

  • Delnevo Appointed Chairperson of FDA’s TPSAC

    Delnevo Appointed Chairperson of FDA’s TPSAC

    Delnevo

    Cristine Delnevo, director of the Rutgers Center for Tobacco Studies and a professor of Health Behavior, Society and Policy at the Rutgers School of Public Health, has been appointed chairperson of the U.S. Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC). Her appointment as chair will run through Jan. 31, 2025.

    Delnevo was appointed to serve on the committee in March 2021. Established in 2009, TPSAC reviews and evaluates safety, dependence and health issues related to tobacco products and provides advice, information and recommendations to the FDA’s commissioner. The FDA commissioner selects the committee members from among people with expertise in medicine, medical ethics, science or technology involving the manufacture, evaluation or use of tobacco products.

    “I have valued the importance of this FDA advisory committee since the signing of the Family Smoking Prevention and Tobacco Control Act in 2009,” said Delnevo in a press note published by Rutgers. “This advisory committee plays an important role in several ways, perhaps most notably on the review of modified risk tobacco product applications, as required under the Tobacco Control Act.”

    Delnevo’s expertise spans population-level tobacco behavior trends, particularly non-cigarette tobacco products like cigars and e-cigarettes, tobacco control policy and regulation, and survey methods research.