Category: VV Exclusive

  • Philippine Dept. of Education Supports Vapor Rules

    Philippine Dept. of Education Supports Vapor Rules

    Credit: GEO TV

    The Department of Education (DepEd) in the Philippines has expressed its support towards stricter measures on electronic nicotine delivery systems (ENDS) and electronic non-nicotine delivery systems (ENNDS), according to a statement penned by the agency’s leader.

    “On matters related to substance use prevention, education alone is not enough. In their classes, we teach our learners how to reject harmful substances. Outside these classes, we need policies and structures that will help reinforce our learners’ health-promoting choices, complementing what we teach them in school,” Secretary Leonor Magtolis Briones wrote in her support statement. The letter was released during a public hearing on the provisions of the Vaporized Nicotine Products Regulation Act, according to press note.

    The Senate hearing explored regulations on age restriction, online trade, product flavors, among other items. Currently, vaping products and heated tobacco products (HTPs) are already regulated under Republic Act 11467 (RA 11467), signed by President Rodrigo Roa Duterte in January 2020. Under RA 11467, selling vapor products and HTPs to persons below 21 years old is prohibited. However, the pending bills in the Senate, similar to the substitute bill at the House of Representatives, intend to reduce the minimum age of restriction to 18.

    “This a real concern for us in DepEd. Before the pandemic, the Philippine Pediatric Society (PPS) has coordinated with us to explore the determinants of e-cigarette use among [Grades 7 to 9] learners [and results showed] that 6.7 percent [of 11,500 learners surveyed] have tried and are using e-cigarettes,” Briones said.

    The PPS survey results showed that the top reasons for using vape among DepEd learners are online accessibility (32%), varied flavors (22%), and the belief that e-cigarettes are safer than tobacco (17%).

    “Especially now that we are in a pandemic, I appeal to our legislators to approach the issue from a health perspective. We are all first-hand witnesses of how any threat or attack to a country’s health system eventually affects every other sector of public life, from economics to education,” Briones noted in her statement.

  • Predicting Policy Position

    Predicting Policy Position

    white house
    Credit: Rene Deanda

    Policy experts weigh in on the vaping industry’s future under the Biden administration.

    By Maria Verven

    Within days of assuming office, U.S. President Joe Biden issued executive orders to respond to Covid-19, by far the biggest global health threat in over 100 years. It may be months or even years before anyone knows how the new administration and the U.S. Centers for Disease Control and Prevention (CDC) and its new director, Rochelle Walensky, will respond to another major health threat: the 480,000 annual deaths caused by combustible cigarettes.

    Vapor Voice interviewed vapor industry leaders and legislative experts for their opinions on how the vapor industry might fare under the new administration. The panel includes:

    Mark Anton, executive director, Smoke-Free Alternatives Trade Association (SFATA)

    “Let’s get the junk science funded by big pharma and the tobacco Master Settlement Agreement out of the narrative of harm reduction. The federal government must be guided by the best science to ensure responsible decision-making.”

    Gregory Conley, president, American Vaping Association (AVA)

    “Legal nicotine vaping products are far less hazardous than smoking and serve a vital public health role in helping adult smokers quit.” 

    Michael Siegel, professor, Department of Community Health Sciences, Boston University School of Public Health 

    “Vaping is, for many smokers, a life-saving health decision. It is much safer than smoking and is literally saving the lives of smokers who would likely die if they weren’t able to stop smoking.”

    David T. Sweanor, adjunct professor, advisory board chair, Centre for Health Law, Policy & Ethics, University of Ottawa

    “It’s the smoke, stupid.”

    Vapor Voice: What policy changes might the Biden administration make regarding vaping products?

    Anton: During the Biden administration, SFATA is taking the lead in youth prevention with the creation of the Responsible Industry Network, which we presented to HHS and the FDA. This would allow adults to access flavors while protecting small businesses through the FDA’s PMTA (premarket tobacco product application) process.

    Mark Anton SFATA
    Mark Anton / Credit: SFATA

    Adults need access to products that help them transition away from combustible cigarettes, so unfavorable e-cig policies and flavor bans should not be on their agenda. Vaping is truly a good tool for tobacco harm reduction. The industry is made up of former smokers who strive to develop the best manufacturing practices without the FDA’s help. To protect against youth use, SFATA supports the enforcement of T21 [Tobacco 21], passed by Congress and signed by the president. Covid[-19] policies have prevented true enforcement.

    Finally, the CDC should always give true assessments and release reports to the media and medical and public health journals. Last year, the CDC failed to give a full accounting of EVALI (vaping-related lung illnesses), when they should have made a declarative statement that vaping nicotine e-cigs was not the cause.

    Conley: Sadly, there is no use answering this question as there’s no indication whatsoever that the Biden Administration will make favorable decisions with regard to vaping products. I would be thrilled to be wrong, but after a decade of fantasizing about smart policy and regulations and only getting the opposite, it’s time to stop dreaming and work within the broken system we have.

    Siegel: Introduce legislation to ban the sale of tobacco products, including vaping products, with the exception of stores only open to [consumers] 21-plus that only sell these products. And direct health insurance companies to cover electronic cigarettes just as they cover other forms of nicotine-replacement therapy.

    Encourage physicians to promote vaping for smokers who are unable to quit using other means. And direct the CDC, FDA and other national health agencies to endorse the use of vaping products for smoking cessation, especially when traditional medications do not work. Finally, discontinue the requirement for PMTAs for vaping products and, instead, directly regulate these products by forcing the FDA to promulgate safety regulations.

    Sweanor: Follow the science on relative risk and communicate truthfully with the public. And empower those who use nicotine to have control over their health though ready access to a wide range of low-risk alternatives to cigarettes and risk proportionate regulation of the spectrum of products. Access to alternatives to cigarettes should be no less urgent a public health goal than access to Covid[-19] treatments and vaccines. Government policy should reflect this urgency.

    What were the most egregious policies implemented during the Trump administration? 

    Anton: Clearly, CDC misinformation about EVALI, falsely accusing e-cigarettes and seeking to ban flavors without sufficient scientific evidence is high on the list of misguided policies. And despite all the research to the contrary, they created hysteria by calling e-cigarette use by minors an ‘epidemic’ when it was not. The true epidemic is 480,000 smokers dying every year from smoking combustible cigarettes.

    Conley: [Former]President Trump created a wave of issues when he declared that flavored vaping products should be banned because they were killing people. He was undoubtedly being fed bad information from his advisors, but it was ridiculous coming from the supposed pro-business, anti-regulation POTUS. Even Trump’s biggest fans realized that one of his flaws was his inability to hire competent people who shared his worldview. Putting Alex Azar in as Secretary of Health and Human Services assured there would be no positive movement to reform vaping regulations at any of the agencies HHS oversees.

    conley
    Greg Conley / Credit: AVA

    Siegel: The ban on flavored e-cigarettes in pod systems and the requirement that companies must submit PMTAs to stay on the market both need to be reversed. There does need to be regulation of nicotine strengths, especially for nicotine salts, but getting rid of flavors isn’t going to solve the problem of youth vaping, and it is hurting many adult ex-smokers.

    Sweanor: I think the biggest failure was the failure to remove the mounting barriers confronting less hazardous products such as e-cigarettes. After a steep decline in cigarette sales by substituting safer products, particularly vaping, cigarettes started making a comeback as the CDC and other agencies engaged in a massively misleading campaign against vaping.

    Meanwhile, the FDA put vaping at a marketplace disadvantage compared to cigarettes. Research showed those most at risk were misinformed about the relative risks.

    At the end of Biden’s term, what state do you think the vaping industry will be in?

    Anton: The outlook is not very bright for the small vaping industry based on Biden’s cabinet selections; many have anti-vaping outlooks and ignore the multitude of studies in support of the harm reduction potential of vaping products. The focus has been on youth use even though it’s decreasing at record levels. Much of the vapor industry success or demise will hinge on the Biden administration’s willingness to look honestly at the science. Additionally, Congress has pushed to ban flavors despite the fact that flavors are an important tool for the average smoker to quit smoking.

    Politics have clouded the potential of this industry’s ability to reduce harm in the U.S. regarding smoking combustible cigarettes. If the Biden administration follows this path, we will be worse off. But if they choose science and real life, it will be better. Much hinges on the role the FDA will play in issuing marketing authorizations.

    Conley: Right now, most adult vapers can easily access tens of thousands of different vaping products in every flavor you can think of. While there will always be a gray market and internet sales, the legal market will never be as free as it is today.

    Four years from now, there will still be a legal market for tobacco-derived nicotine vaping products authorized by the FDA. It may not be a great market, but it will exist. Companies with authorized products will do everything in their power to disrupt the gray market such as stand-alone devices, nicotine-free or tobacco-free nicotine e-liquids that many vapers rely on.

    Siegel: It will probably be worse off. If the administration enforces the PMTA rules, many vaping products will be taken off the market. Big tobacco companies and a few large independent companies will dominate the market. The growth of the e-cigarette sector will wane. Many ex-smokers will return to smoking, and e-cigarettes will no longer serve as an off-ramp for as many smokers.

    dr michael siegel
    Dr. Michael Siegel

    Sweanor: Ultimately, disruptive technology, science, rationality and human rights will win, and cigarettes will go the way of previous categories of unreasonably hazardous goods and services. The question of whether that happens within four years depends on the way politics unfolds and the emergence of leaders who see the opportunity and relentlessly pursue it.

    Is limiting the level of nicotine a viable solution for users of conventional tobacco?

    Conley: Bloomberg-funded prohibitionists and legislators who can’t differentiate between classes of vaping products are not going to be swayed by nicotine limits. Their goal is prohibition. When you give in to the prohibitionists, all you’re doing is guaranteeing they’ll be back next year to argue that we need flavor bans because nicotine limits didn’t work.

    Siegel: Yes. Limiting nicotine in e-cigarettes will help reduce youth addiction to these products. There is also evidence that very low nicotine cigarettes can result in much lower levels of addiction in cigarette smokers.

    Sweanor: No. It’s a replication of the disastrous Volstead Act that ushered in Prohibition, which forced beer and wine to have no more than a minimum level of alcohol.

    sweanor-web
    David Sweanor

    The total U.S. nicotine market is over $80 billion, and the cigarette market alone is over $60 billion, with tens of millions of consumers. The products are far more dependence-producing than alcoholic beverages. A prohibitionist policy is very unlikely to garner political acceptance and could rapidly lead to the sort of entrepreneurship and criminality long associated with other abstinence-only campaigns.

    Many who are pushing for such a policy also oppose the wide availability of consumer-acceptable low-risk alternatives to cigarettes, demonstrating that this is a flawed moralistic strategy rather than a pragmatic public health one.

    What chance do any of these proposed changes/solutions have at being implemented?

    Anton: The previous FDA leadership has called the millions of smokers who have transitioned from combustible cigarettes to flavored vapor products ‘anecdotal evidence’ without investing any funds into research. The Biden administration and the new FDA leadership now has the opportunity to affect public health on a massive scale by investigating this hypothesis.

    The U.K.’s National Health policy recommends that smokers who want to quit switch to vaping. They recognize vaping is safer than cigarettes. This is from the country that put warning labels on cigarette packs four years before the U.S. The Responsible Industry Network is a framework that will help prevent youth access, limit marketing to age-restricted stores and develop a pathway to prevent the loss of tens of thousands of small businesses. It brings together all the elements of the Tobacco Control Act (TCA)—protecting youth from smoking and tobacco use while assisting millions of adults who are trying to stop smoking.

    While these are foundational items of the TCA and the FDA, politicians are missing the opportunity to help millions of current smokers because vaping is so politicized and youth use and access to vapor products has been blown out of proportion.

    Siegel: The likelihood [that] these policies will be implemented is very low. I just don’t think the mainstream tobacco control and health organizations support the idea of harm reduction in tobacco control.

    Sweanor: I have little ability to discern the likelihood of rational policies, in part because the current politics around nicotine seem to favor a War on Drugs mentality where the pursuit of total abstinence takes precedence over a public health orientation. Much will depend on Americans who use nicotine, a demographic Biden appears to care very much about.

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

  • Thrown Under the Bus

    Thrown Under the Bus

    London double bus
    Credit: Albrecht Fietz

    If society wants a smoke-free world, it cannot allow promising products to die of neglect.

    By George Gay

    Browsing the internet recently, I came across a report claiming that 22 countries with, according to my calculation, a total population of about 2.6 billion, or 34 percent, of the worldwide population, had banned the use of vaping products. I cannot vouch for the accuracy of those figures, but I guess they would be at least as accurate as the widely accepted estimates of worldwide, annual tobacco-related deaths.

    At the same time, many people are living in countries where certain forms of vaping products are banned (Japan, for example, with a population of about 126 million) or where the appeal of vaping products has been deliberately and sometimes severely narrowed by, for instance, restricting flavors (the U.S., 328 million) or limiting nicotine levels (countries of the EU, 448 million post-Brexit).

    Looking at this situation, I couldn’t help wondering whether a person with the foresight 15 years ago to have predicted the arrival on the market of products whose consumption was far less risky than was the consumption of combustible cigarettes and that could substitute for those cigarettes would have foreseen also the wide-ranging and often visceral hostility that has greeted their arrival.

    I can’t help feeling that our seer would have dismissed as ridiculous the idea that these new products, vaping devices as it turned out, would be so badly served by so many governments, companies, organizations and individuals. She would surely have found it incomprehensible that smokers would be let down so badly.

    Why? Well, as is still the case, 15 years ago, the combustible cigarette was the pariah consumer product and, we were told, no amount of effort was being spared in trying to do away with it. It was claimed that this was the only product that killed its consumers when used as it was designed to be used, and this claim was employed to underpin the justification for legislating for the degradation of both the product and its packaging, and the restriction of cigarette sales.

    man holding up hand stop
    Credit: Nadine Shaabana

    And it was not only the product that was seen as unacceptable. Cigarette manufacturers had cynically manipulated their products to make them “more addictive” and thereby keep consumers hooked and the profits rolling in. And consumers were little better. So, in the U.K. at least, they were attacked by officialdom as being smelly and then denormalized to the point where they and their secondhand smoke were cut off from normal society.

    Given this, and given that vaping is recognized by most sensible people to be hugely less risky than is smoking, why is it that vaping has had such a rough ride? There are, of course, any number of reasons based on the vested interests and breath-taking hypocrisy of some individuals, researchers, companies, organizations and governments, for all of whom and which the continued use of tobacco represents a nice little earner.

    But here I would like to speculate about another possible reason. Could the U.K. government at least have decided that the problem of tobacco smoking has been overblown? No, let me put that another way. Could it be that the government has decided that the net problem caused by smoking—that is, the smoking negatives minus the smoking positives—has been overblown, especially when compared with other problems it must confront? For instance, I guess it is becoming just too difficult to ignore the elephant in the morgue: the pollution-related deaths, many of which, I assume, overlap with tobacco-related deaths.

    According to Damian Carrington, environment editor, writing in the Guardian on Jan. 26, a global review in 2019 concluded that air pollution may be damaging every organ in the human body as inhaled particles travel around it and cause inflammation. And it is instructive, I think, that a statement made late last year by the U.N. secretary general, Antonio Guterres, pointing out that air pollution is killing nine million people a year, has, unusually, not been trumped by the World Health Organization coming up with an even higher figure for tobacco-related deaths.

    But I have a more specific reason for believing that the U.K. government might be letting smoking slip down its list of priorities. While it has been progressive in respect of encouraging the use of vaping as a means of getting people to quit smoking, during the Covid-19 pandemic, it has steadfastly refused to allow vape shops to open during lockdowns; that is, it has deemed them not to be essential, whereas a shop selling plugs for the basin in your bathroom apparently is essential. This indicates to me that the government doesn’t put much importance on encouraging people to quit smoking, though that is not to say it isn’t happy to dabble in such an enterprise.

    OK, I hear you ask, could it be that the government does believe that encouraging people to quit smoking is important, but, right now, in the face of a deadly pandemic, such encouragement has had to take a back seat?

    There are a number of reasons why I don’t think this is the case. One is that the government has found the time to deal with all manner of pet issues during the pandemic, such as its undermining of the BBC in an attempt to better control its image. Another was Brexit, which was hugely time-consuming, but its deadline our erstwhile fellow members of the EU had been willing to postpone.

    However, the most telling reason in my view was the government’s announcement at the end of March 2020 that it was to axe Public Health England, an executive agency of the department of health and social care, and transfer some of its responsibilities, but not its smoking prevention and some other obligations, to a new organization, the National Institute for Health Protection.

    Meanwhile, while the government seems to be taking its foot off the quit-smoking pedal, there are some for whom the very existence of the pandemic is seen as underlining the need for the government to encourage the switch from smoking to vaping. The usual suspects have been only too willing to tell smokers, without, I suspect, any solid evidence, that they are at increased risk of suffering severe symptoms if they are infected with Covid-19. And one respected public health professional has argued that the emphasis should be placed on fighting noncommunicable health problems because, in that way, we will all be leaner and fitter to fight the next pandemic. Hmm.

    I cannot agree with these people’s reasoning, but I do maintain that this is not the time to let the opportunities offered by new generation products slip through our fingers. And in this regard, I would like to put in a word for Kind Consumer and Voke, whose fortunes I have followed on and off for a number of years. Voke, as I wrote about last year, is a product that was developed by Kind and licensed by the U.K. Medicines and Healthcare products Regulatory Agency as a medicinal product that is a safer alternative to smoking. Voke is not a vaping product but an alternative nicotine-delivery system that uses pharmaceutical-standard inhaler technology in a device that closely resembles a traditional cigarette in both the way it looks and in the way a consumer, in using the device, mimics most of the rituals of smoking.

    Voke, which has no batteries and no electronics and therefore generates no heat and no chemical reactions, produces no smoke nor vapor, just an invisible, odorless aerosol, so it can be used anywhere. And its environmental credentials are good given that it is a relatively simple device made of metal, card and plastic: materials that can be recycled.

    Last year, I wrote that, in theory at least, Voke should be a game-changer and that it would be interesting to follow its fortunes on the market to discover how committed smokers and vapers were to the pursuit of reduced risk.

    I’m now concerned that I may never know. Voke was launched in November 2019 exclusively online, but when I visited the Voke website in January this year, this is what I was told: “Due to Covid-19 and the current financial climate, we are unable to accept any orders.”
    Meanwhile, a Sky news story toward the end of last year said it was understood that Kind, which had raised £140 million from investors since it was set up [in 2006], had, at the beginning of December, called in the administrators and that they had signed off on the sale of Kind’s assets to OBG Consumer Scientific, a subsidiary of Pharmaserve, a privately owned group, for £1.6 million.

    Pharmaserve, which is based in Runcorn, U.K., did not respond to requests for information, so I am unaware of what fate awaits Voke. However, one source told me that Pharmaserve had been part of the Voke supply chain, providing the device’s cannisters, and this aligns with information provided by Kind, which said last year that one of two manufacturing sites it was using was at Runcorn (the other was said to be at Waterford in Ireland). If this is the case, it is quite possible that the product will be relaunched.

    It would certainly be a crime if Voke were allowed to disappear without fully testing whether it can become a game-changer. There is no doubt that, because it delivers a cool aerosol rather than a warm vapor, it presents a challenge to smokers wishing to switch. But, at the same time, its nicotine delivery is efficient enough that it has to deliver only a low dose, 0.45 mg, from which, if the U.S. Food and Drug Administration is correct, it could be inferred that it creates a significantly lower risk of sustaining addiction than do cigarettes or e-cigarettes.

    And Voke seems to have some as-yet untested advantages over cigarettes and electronic cigarettes when it comes to sales channels. While the product had a medicines license that allowed it to be prescribed by a doctor in the U.K., it had also an over-the-counter drug or general sales list label, so it could have been sold anywhere from pharmacies to major retailers, corner shops and garage forecourts. And there was no reason why Voke, under another name and possibly modified, could not be sold in other jurisdictions simply as a consumer product.

    Many societies that claim they want to become smoke-free have thrown obstacle after obstacle into the path of vaping devices. Surely, we are not going to let Voke fail for the want of a little investment. According to the Sky story, Kind had been looking to raise only another £36 million to deliver a revised business plan, so here, perhaps, was an opportunity for a tobacco company—or even the U.K. government.

    man breaking cigarette
    Credit: Martin Budenbender

    Of course, the U.K. government is ideologically opposed to public involvement in the private sphere, but there were some good reasons why it could have justified keeping Kind and Voke going. I don’t know why Kind got to the point where it had to call in the administrators, but certainly, fate had not been kind to it. When, in 2009, Kind set out in earnest on the development of Voke, it immediately found itself in a commercial bind.

    At that time, when vaping devices were still something of a novelty, it was believed that, under the then forthcoming revised EU Tobacco Products Directive, all such products sold in the EU would need to have a medicines license. But such a requirement fell by the wayside; so Voke, a device being developed at great expense within the constraints necessary to make it conform with a medicines license, was destined to compete with devices developed at less expense without such constraints. And to cap it all, Voke was launched just as the world was hit by the start of the coronavirus pandemic.

    If societies believe that tobacco smoking is as harmful as it is generally made out to be, and if they are truly aiming to go smoke-free, they cannot afford to allow the army of naysayers to keep throwing vaping devices under the bus, and they certainly cannot allow a promising product to die of neglect.

  • Restrictive Sales

    Restrictive Sales

    The regulatory wave is crashing down on internet ENDS retailers.

    By Nicholas A. Ramos, Agustin E. Rodriguez and Bryan M. Haynes

    Online businesses selling electronic nicotine delivery systems (ENDS) to consumers must contend with a “patchwork quilt” of state laws. This patchwork of laws creates significant regulatory uncertainty and risk for businesses selling online in this space. There are many legal issues facing online retailers, like bans or restrictions on “flavored” tobacco products, minimum age and age-verification requirements, and state and local licensing and tax requirements. This article discusses some of the key legal issues associated with selling ENDS to consumers online and highlights proposed state legislation that may impose more requirements on the industry.

    State licensing

    Online retailers looking to comply with the myriad of state laws should first look at the states in which consumers purchase their products and, for each state, identify potentially applicable licensing laws. States may require licensing or registration under tax laws, health and welfare laws, and/or general business laws before online retailers may sell to consumers in their states. Idaho, for example, requires licenses from its Department of Health and Welfare to prevent youth access to tobacco products and electronic smoking devices. Washington, D.C., however, requires a basic business license from its Department of Consumer and Regulatory Affairs.

    In addition, online retailers of ENDS should determine whether state licensing law definitions actually cover their products. While states have required licenses for the sale of tobacco products for years, they have only recently added definitions of ENDS to their licensing statutes. ENDS may be covered under licensing laws either because the category is explicitly defined, or the definition of tobacco products is broad enough to cover ENDS products.

    Nicholas A. Ramos

    Online retailers should also determine whether state licensing laws actually cover remote sales. Some states only require licenses for retailers that have a “place of business” or “business location” in their states. Hawaii, for example, is unique in that it requires ENDS retailers to obtain a registration from the Hawaii Attorney General. At this time, however, the Attorney General only requires retailers to register if they are located in the State, which excludes out-of-state online retailers.

    It is also important to keep in mind that most state laws regulating ENDS were only passed within the last 3-5 years. Many of those new laws simply amended existing tobacco product laws, and legislatures may not have carefully incorporated those changes in all of the critical statutory sections. Consequently, there are often situations in which the legal requirements are not clear. In those cases, it may be prudent to reach out to regulators to better understand how they interpret their statutes.

    State taxes

    When online retailers face ambiguous licensing laws, it may be helpful to look to the purpose of those laws. For example, if licenses are required by a tax department, the online retailer should look at the tax statute to determine who and what is subject to taxes. Many states require licenses to facilitate payment of sales or excise taxes.

    Almost all states impose sales and use taxes on remote sales of products. For out-of-state online retailers, most states follow the analysis outlined in South Dakota v. Wayfair, Inc., 138 S. Ct. 2080 (2018), which generally permits a state to impose sales tax on an out-of-state seller where the seller has a “substantial nexus with the taxing State.” Some states require a business or tax registration to file returns and pay sales taxes.

    Missouri, for example, does not tax or regulate ENDS as tobacco products, but it requires online retailers to obtain a retail sales tax license for sales tax purposes. Furthermore, states typically only require sales taxes from remote sellers when a certain sales volume or revenue threshold has been met. Virginia, for example, requires a remote seller to register for the collection of sales and use tax if it received more than $100,000 in gross revenue from sales in Virginia or engaged in 200 or more separate retail sales transactions during the previous or current calendar year.

    In addition, like state licensing laws, the applicability of excise taxes to ENDS products sold online can depend on the specific product definitions in the relevant statutes. Some states’ excise tax statutes explicitly define and include ENDS products, while others attempt to fit those definitions into terms like “tobacco products” or “other tobacco products.” Utah, for example, explicitly taxes “electronic cigarette substances,” “prefilled electronic cigarettes,” “alternative nicotine products,” “nontherapeutic nicotine device substances,” and “prefilled nontherapeutic nicotine devices” in its Electronic Cigarette and Nicotine Product Licensing and Taxation Act.

    Agustin E. Rodriguez

    Some states explicitly exclude ENDS from definitions that would subject them to excise taxes. Texas, for example, provides defines taxable “tobacco products” to exclude e-cigarettes, or any other device that simulates smoking using a mechanical heating element, battery, or electronic circuit to deliver nicotine or other substances through inhalation.

    It is also important to keep in mind that states tax various parts of ENDS products in different ways. Virginia, for example, imposes an excise tax on liquid nicotine products at the rate of $0.066 per milliliter of liquid nicotine, but the State does not impose taxes on other components of ENDS. Washington, D.C., on the other hand, taxes vapor products by making the tax rate equal to the cigarette tax, expressed as a percentage of the average wholesale price of a pack of 20 cigarettes.

    Finally, if online retailers determine state excise tax laws apply to their ENDS products, they must still determine who is required to pay those taxes and when they are due. For example, some states, like Kentucky, require that excise taxes be paid by the licensed distributor that first possesses the ENDS products for sale to a retailer or unlicensed person in the State.

    Potential penalties & enforcement climates

    Online retailers facing ambiguous licensing statutes should consider two major factors in their risk analysis—statutory penalty provisions and enforcement climate.

    Penalties for operating without a license can be steep. In Idaho, for example, it is a criminal offense to sell ENDS without a permit issued by the Department of Health and Welfare. In addition, a court may impose a fine of $1,000 per day beginning the day following the date of citation as long as the illegal ENDS sales continue.  In other states, however, penalties are relatively low. In Montana, for example, failure to obtain a vapor product license is punishable by a civil penalty of $100.

    Finally, online retailers should consider the enforcement climate surrounding regulation of ENDS products in certain states. For example, Attorneys General in various states have filed lawsuits against an ENDS manufacturers and online retailers. Although these cases do not directly implicate licensing or tax issues, enforcement actions by Attorneys General may suggest a more aggressive enforcement climate when it comes to licensing or tax violations.

    Proposed state legislation

    Online retailers should expect upcoming state legislative sessions to be fairly active with regard to regulation of ENDS products. In Colorado, for example, there is no current nicotine products or ENDS tax or licensing scheme. But Colorado HB20-1472 established a voter referendum on whether there should be a tax on “nicotine products,” which would include “products that contain nicotine and that are ingested into the body.”

    Bryan M. Haynes

    In Georgia, the legislature is considering a bill that will amend its tax and revenue laws “to provide for excise taxes to be levied on certain alternative nicotine products and vapor products” and to “require licensure of importers, manufacturers, distributors, and dealers of alternative nicotine products or vapor products.” HB 1229.

    South Carolina is also considering a bill (H.4714) that will “provide for the levying, assessment, collection, and payment of certain taxes on vapor products.”

    These are just a few examples of states that are considering ways to regulate and tax ENDS products. Therefore, it is important for online retailers to incorporate accurate state legislative tracking into their compliance strategies.

    Conclusion

    As with any other new technology, the law is often playing catch up with new business models and products, like the online sale of ENDS products. But given the issues discussed above, online retailers should prioritize compliance with varying state laws to reduce the risks of enforcement action.

    Nicholas A. Ramos is an associate with Troutman Pepper. His practical advice enables clients to navigate regulatory compliance and licensing issues, complex investigations, and high stakes enforcement actions that arise under state and federal law.

    Agustin E. Rodriguez serves as counsel for Troutman Pepper and has almost two decades of experience counseling tobacco companies in-house and in private practice on tobacco product regulation, taxation and multi-jurisdictional state and local enforcement issues.

    Bryan M. Haynes is a partner with Troutman Pepper who specializes in tobacco industry regulatory compliance and enforcement matters. He efficiently assists clients in complying with regulatory obligations and managing risk, consistent with clients’ business objectives.

  • Gay: Shuttering Public Health England Bad for Public Health

    Gay: Shuttering Public Health England Bad for Public Health

    Credit: Glassdoor

    The axing of Public Health England could have a lasting negative impact on public health.

    By George Gay

    Reading through the U.K. Vaping Industry Association’s (UKVIA) Aug. 28 statement on “the transferal of responsibilities from Public Health England [PHE] and the future of harm reduction,” I was reminded why the UKVIA has been successful in advancing the interests of vaping and, in doing so, encouraging smokers to switch to a less risky form of nicotine consumption.

    In the face of a move by the U.K. government that conceivably could cause a significant setback to vaping, the association refused to engage with the negative. It did what it had to do; it accentuated the positive by performing a well-choreographed verbal sword dance while mentioning only in passing that the blades on the floor could deprive it of a few toes and perhaps much else.

    The UKVIA statement was in response to an announcement by the government that, at the end of March, it was to axe Public Health England, an executive agency of the Department of Health and Social Care, and transfer some of its responsibilities, but not its smoking prevention and some other obligations, to a new organization, the National Institute for Health Protection (NIHP). PHE has for a long time supported the use of vaping as a method of helping smokers quit their tobacco habit, and its declarations that vaping is at least 95 percent less risky than is smoking have been widely and confidently quoted in recent years; so the government’s announcement was a significant and potentially negative development.

    The UKVIA acknowledged this risk in passing but concentrated on encouraging the government to ensure that the transition of responsibilities from the PHE to other agencies was as smooth as possible. It began its statement, issued under the name of its director, John Dunne, by saying it would like to place on record its thanks for PHE’s considerable contribution to harm reduction and smoking cessation in recent years.

    “The independent and progressive stance taken by PHE has undoubtedly improved the health of the nation and saved lives,” it said. “In particular, PHE’s support of vaping as a vital harm reduction tool ensures an admirable legacy of falling smoking rates in the U.K., with all of the associated benefits to public health and the NHS [National Health Service]. PHE’s evidence-based approach provided many adult smokers with the reassurance they needed to explore the full range of smoking cessation options available to them.”

    Deflecting attention

    Let’s halt the statement there for a moment because I’m sure that a lot of readers will be wondering why PHE is being axed when it has done such a good job. Well, as is mentioned above, PHE’s responsibilities go beyond smoking prevention, and part of its remit has required it, along with other agencies, to engage in the fight against the coronavirus pandemic and the resulting Covid-19 disease outbreak. And since the U.K. government has proved to be scarily incompetent in the face of the coronavirus pandemic but a dab hand at shifting the blame for its incompetence onto others, PHE, one of the more publicly recognizable health agencies, was always going to be at risk.

    On Aug. 28, The Guardian, in a leader column, described the decision to abolish PHE during a pandemic as reckless, adding that it was part of the government’s strategy of casting about for scapegoats for its failings during the pandemic. The leader was headed: “[Prime Minister Boris] Johnson’s donkeys have failed the frontline workers they lionized.”

    The Guardian wasn’t alone in condemning the government’s action. On Sept. 2, a piece by the newspaper’s health policy editor, Denis Campbell, described how Britain’s doctors and public health experts had warned the prime minister that the abolition of PHE would damage the fight against obesity, smoking and alcohol misuse. “More than 70 health organizations have written to Boris Johnson outlining their fears about last month’s controversial decision to axe PHE, which prompted claims it was an attempt by ministers to deflect attention from their own failings over the coronavirus crisis,” Campbell wrote.

    Rearranging the deck chairs

    There was no way that the UKVIA was going to be drawn into this dispute and, in its statement, it merely noted that many of PHE’s responsibilities would be overseen by the newly formed NIHP, “which will take a lead role in safeguarding the U.K. from novel health risks.

    “The UKVIA completely acknowledges the need for new ways of working in combatting modern challenges and supports the government’s prioritization of public health,” the association said.

    “It is further reassuring that Secretary of State for Health and Social Care Matt Hancock confirmed his ongoing commitment to health improvement while announcing the NIHP’s formation. This is a commitment which the UKVIA shares and thoroughly supports.”

    You can see the UKVIA’s point. I mean, we are where we are, and there is little point in trying to reason a government with an 80-seat majority out of a position into which it seems not to have reasoned itself. But there is no reason not to have a parting shot, and I think the Liberal Democrats’ health spokesperson, Munira Wilson, had the situation nailed when, according to Campbell’s piece, she said: “Now is not the time to rearrange the deck chairs.”

    One of the dangers as I see it is that the government made its decision to axe PHE without having thought through what should happen to all of PHE’s responsibilities, including its role in preventing smoking. In other words, it was rearranging the deck chairs without any idea of where to put many of them; so the worry must be that some will wind up overboard as jetsam.

    And it was clear that the UKVIA too was concerned about this aspect of the government-announced changes. “To protect the many successes of vaping in U.K. public health, as well as empowering further positive change in the future, it is vital that this progressive, evidence-based culture continues,” the association’s statement said. “Whenever responsibilities are transferred, there is a risk that invaluable institutional knowledge and memory is lost. This would be to the detriment of the U.K.’s millions of smokers and vapers and cannot be allowed to happen in this case.

    “The UKVIA therefore calls upon the custodians of PHE’s former responsibilities, in the event that they are indeed reallocated, to continue their positive approach towards harm-reduction technologies. Independent reviews, studies and statements, all focused on facts rather than hearsay, have been a cornerstone of a successful British vaping industry which supports adult consumers to make a positive change for their health.

    “The UKVIA will continue to do its utmost to ensure that adult smokers and vapers have access to the high-quality products they need as well as the reliable information and advice needed to empower their choices. Assistance in this regard from public health bodies is vital to ensuring that the positive potential of vaping is not squandered in the U.K. We look forward to engaging constructively with all public health partners.”

    Hoping for the best

    I have no idea how this will pan out because there is much going on in the U.K. at the moment that will impinge on health issues. The U.K. government is in the process of breaking—I use the word with care—its final bonds with the EU and trying to sell off the last of the family silver—the NHS—to the highest bidders as part of a trade deal with the U.S., though it remains to be seen whether any nation will want to sign a deal with a country that, as this piece was being written, was openly talking about breaking international law so as to renege on part of the Brexit withdrawal agreement signed by Johnson in January with the EU.

    In part of his story, Campbell quoted Wilson as describing the axing of the PHE as “nonsensical.” She is right of course, but only if you assume that the aim of the government is to improve public health, and nothing I have observed in the actions of the government would lead me to believe that it is particularly interested in such munificence. I would guess that if the work of the PHE in supporting vaping and, therefore, smoking reduction, is continued, it will be down to luck, not to the deliberate actions of the government.

    Whatever happens, all is not lost in the U.K. vaping sector. The UKVIA is used to navigating the choppy waters of vaping rules and regulations. In March, it wrote to the government asking that specialist vape shops be allowed to stay open during the coronavirus lockdown and requesting support for the industry during and after the crisis was over. It made the point that because such shops had bucked the trend of high-street attrition, and because they provided much-needed specialist advice, they were the source of economic and health benefits to the communities they served.

    The UKVIA won the backing of Sir Kevin Barron, former MP and honorary fellow of the Royal College of Physicians, and further argued that closing vape stores would be a potentially counterproductive move that could place further strain on the already overstretched NHS. Due to the stress caused by the coronavirus pandemic, vapers who could not access their specialist stores and the advice available there were at risk of falling back onto cigarettes, which were more readily available.

    On this occasion, the UKVIA was not successful, in part I would guess because the government would have taken the view that closing specialist shops would not have prevented vapers from obtaining their products, or at least substitutes for their usual products, in the food and corner shops that were allowed to stay open, and, for those with internet access, via online suppliers.

    But though it was not successful, the UKVIA again chose not to embrace the negative. While continuing to lobby the government to review its decision on vape stores, it switched its focus to keeping its members informed about their obligations under government guidelines and the opportunities still open to them, such as online or home delivery services in the case of retail outlets. And following a report in a national newspaper that a vape shop owner had been arrested by police after keeping their retail outlet open despite the government directive, the association issued another note urging vape stores to adhere to government guidance to remain closed during the current lockdown.

    “We understand that we are talking about people’s livelihoods here, but it is paramount that the industry follows the government guidance,” said Dunne. “We have to wait until we get the green light to reopen.”

    And the green light was triggered on June 15, at which point the UKVIA praised the U.K.’s vaping businesses for the responsible approach they had taken during the 10-week lockdown. In a statement issued at the time, the association said it believed that the entrepreneurial spirit that had seen many vaping companies transform their business models overnight would mean they would be well placed to bounce back.

    “The response from the industry to the challenging conditions has been both staggering and exemplary,” Dunne was quoted as saying. “I know that our members that make up a large share of the vaping market have been working around the clock to provide online and home delivery services to the 3.2 million vapers across the country.”

    And this strategy has apparently worked for both vapers and vaping businesses. Feedback from UKVIA members indicates that few stores closed permanently because of the lockdown. Overall, demand is said to have stabilized, though it is probably inevitable that some vapers will have returned to smoking, either temporarily or permanently. Part of that demand has almost certainly shifted permanently to different supply streams.

    Many retailers saw big increases occur in their online sales, and it must be assumed that at least some vapers who discovered home delivery services during lockdown will stay with such services. It is difficult to know how this will pan out over the long term, but there are reasons to be positive. The sorts of services offered by high-street retailers have probably appealed mainly to novice vapers, and with about 3 million vapers and 7 million smokers in the U.K., the potential for recruiting more vapers to high-street shops must be high.

    Having said that, the uptake of vaping in the U.K. has slowed in recent years and, for reasons that will be familiar to readers of this magazine, it is proving harder to persuade large numbers of smokers to move to vaping. Concerns around this situation can be discerned in at least two of the UKVIA’s four strategic objectives: to reassure smokers about vaping so they continue to see vaping as the best way to quit their smoking habit and to give confidence to existing vapers about vaping so that they don’t go back to smoking or other alternative ways to break their former smoking habit.

    Another objective is to heighten the understanding among the political/public health community of the positive impact that vaping has had, and continues to have, and highlight the potential adverse impact of vapers returning to smoking and smokers not transitioning across. This brings us back to the beginning of the story by raising the question of whether the realization of this objective will be made more difficult if the UKVIA has to start afresh with a new public health body.

    This story can be found in Issue 5, 2020 of Vapor Voice.

  • GTNF: Future of Nicotine Industry is Less-Risky Products

    GTNF: Future of Nicotine Industry is Less-Risky Products

    vapers in bar

    With clearer information, more smokers would switch to lower-risk products.

    By VV Staff

    There are several reasons why people use nicotine. According to Neal Benowitz, professor of medicine, biopharmaceutical sciences, psychiatry and clinical pharmacy at the University of California San Francisco, those reasons include pleasure, stimulation and mood modulation. However, many users don’t understand the adverse effects and risks associated with different delivery mechanisms.

    “Clearly, the decision involving long-term use of the drug for individuals or society depends, at least in part, on adverse health effects. For example, the casual use of cocaine or heroin are discouraged by society because they are hazardous to health,” explains Benowitz. “We know nicotine, per se, is much less hazardous than cigarette smoking, regardless of potential health concerns. That’s a successful argument for electronic nicotine-delivery systems [ENDS].”

    Speaking at a panel titled, “The Future of Nicotine,” during the 2020 Global Tobacco & Nicotine Forum (GTNF) in September, Benowitz said that one of the major questions surrounding tobacco control is whether society can accept nicotine use if the harms were reduced. He says that possibility exists. “The FDA [U.S. Food and Drug Administration] can be a big part of making this happen … there is a misconception surrounding the harm of nicotine compared to combustible products,” which are more deadly than ENDS.

    While acknowledging the validity of Benowitz’ point, Michael Cummings, professor of psychiatry and behavioral sciences at the Medical University of South Carolina, cautioned against the unintended consequences of regulation. Banning a specific delivery mechanism for nicotine, he said, presents a risk. Cummings referred to the FDA’s vision, formulated in 2017, of a world where cigarettes would no longer create and sustain addiction and where adults who need or want nicotine could get it from less-harmful alternative sources.

    “But it seems like we’re going the wrong direction … If we adopt regulations to ban the sale of vaping products as some states and many countries around the world have done, what would be the effect? Well, the effect is that cigarette sales will go up,” said Cummings. “That’s a bad thing. Regulating vaping products like they’re cigarettes—which they’re not—banning flavors, banning internet sales … [these actions] would have a detrimental effect of actually driving up cigarette sales to the detriment of the lower-risk products.”

    Also speaking during the GTNF panel, Clifford E. Douglas, director of the Tobacco Research Network and an adjunct professor of Health Management and Policy at the University of Michigan School of Public Health, said that consumers clearly need a much better understanding of the true nature, including the relative risk, of different tobacco and nicotine products.

    “This includes the fact that nicotine is the root cause of the epidemic of tobacco-related illness and death because it hooks in smokers and keeps many smoking who otherwise would quit,” he explained. “While complete information on all the potential risks and benefits of [vapor products] is not yet available, there is sufficient information … to end deadly combustible tobacco use [which is] responsible for approximately half a million deaths a year and 30 percent of all cancer deaths in the United States.”

    Asked by moderator Clive Bates, director of Counterfactual Consulting, whether there was a regulatory environment possible that incorporated the relative risk of the different types of nicotine-delivery systems, Stefanie Miller, managing director of FiscalNote Markets, said “no.”

    “[There is] no trust among the general public for companies that produce a product containing nicotine, and that is largely based on a misconception around the difference between nicotine and combustible tobacco use. After predatory behavior and negligence of tobacco companies in the 20th Century, most people see this as very black and white. Tobacco companies are bad, and anti-tobacco efforts are purely good,” said Miller. “I think [everyone] who’s tuned in right now knows that the situation is far more nuanced and … the regulations are not accommodative of that nuance.”

    Benowitz says that another major problem with the message on less-risky nicotine products is that there is very little science on the long-term effects of ENDS products. “We have an array of new products, any of which are inhalable,” he said. “We have a lot of short-term data that is promising in terms of reduced exposure in the short term, but we really don’t know about the future long-term consequences.”

    Miller added that cigarette manufacturers could help change the misconceptions surrounding nicotine. It’s the large manufacturers who could make it a goal to end combustible nicotine-delivery systems. “If you’re really clear about setting a strategic goal, and then you do everything possible to accomplish it, you’re more likely than not to win,” she said. “I think that this is [an] important enough [goal] to try.”

    Benowitz said that regulators need to help consumers better understand that the regulators support a shift to less-risky products. He says that only then can the goal of getting rid of combustible products be accomplished.

    “We’re not doing this because nicotine is bad,” he said. “We’re doing this because nicotine sustains harmful cigarette smoking … there are other products that [can deliver] nicotine that are much less harmful.”

  • Gay: Tax Vapor Lower Than Cigarettes for Public Health

    Gay: Tax Vapor Lower Than Cigarettes for Public Health

    Credit: Phong Nguyen

    Encourage smokers to switch to vapor products by taxing them lower than traditional cigarettes.

    By George Gay

    Recently, I was intrigued by the following heading that appeared above the abstract of a scientific paper: “Flavors enhance nicotine vapor self-administration in male mice.” I guess that, as a nonscientist used to reading general stories, I was drawn to the fact that there seems to be no human agency in the activities described. The flavors seem to operate of their own accord and the male mice “self-administer” those flavors.

    Notice, too, how the flavors not only increase the uptake of nicotine vapor in male mice, they also “enhance” that uptake, presumably introducing some sort of measurable qualitative increase to the process. And what about this self-administering business? It seems to suggest that the male mice in question have personalities or egos, which I would be happy to accept but which raises the question of whether it was morally acceptable that these mice should have been used as a means to an end. I would say no.

    Of course, if the mice did display signs of selfhood, I hope the researchers took care in interpreting their reactions. There is a danger of significant error in drawing human-centric conclusions about the behaviors of nonhuman animals being made to take part in human-designed experiments since those behaviors might be driven by the ways in which nonhuman animals uniquely experience their lives and that we do not understand.

    Such experiments on nonhuman animals seem to me to be simply preposterous. Professor Sir George Pickering was apparently once quoted in the British Medical Journal as saying, “The idea, as I understand it, is that fundamental truths are revealed in laboratory experiments on lower animals and are then applied to the problem of a sick patient … It is plain nonsense.”

    In the abstract, the researchers sidestep this problem by dropping any mention of the male mice from their “Conclusions and Implications.” The final sentence of the implications states, “This suggests that flavors in electronic nicotine-delivery systems significantly increase the risk of addiction-related behaviors among users of vaping products.” Obviously, the researchers have moved from male mice to humans because mice cannot be seen to be “users of vaping products.” And this move cannot, to my mind, be justified.

    I have two other gripes with this research as it was described in the abstract. One is that it cannot be morally acceptable to conduct experiments on nonhuman animals so that human animals can pretend to learn a little more about the silly—pleasurable, but nevertheless silly—habit they have invented called vaping. If they want to learn about the effects of vaping on themselves, they should gird up their loins and carry out the experiments on themselves. And, of course, ditto all the other silly things that humans like to get up to.

    The second gripe is that the research is pointless. Basically, it ends up suggesting that flavors are attractive—at least to some, I presume. I mean, doh! And despite this, the researchers have the cheek to mention as part of their conclusion “the need [my emphasis] to continue investigating the role electronic nicotine-delivery system (ENDS) flavors play in vaping-related behaviors.” I don’t think so. I think the researchers are confusing “desire” with “need,” which is a little worrying if the object of the exercise is to study addiction.

    But let’s leave the scientific world behind because, while I was intrigued by the heading quoted at the start of the abstract, I was astonished by one introducing a recent general story: “Illicit cigarette smuggling could be key to fighting PPE fraud.”The heading seems to imply there is a form of cigarette smuggling that is not illicit, that is licit, an idea I firstly dismissed as daft. But the heading kept nagging at my brain and I started to wonder whether the headline writer had a point.

    My confusion arose, I think, because I realized that whereas licit can mean lawful, it can have a softer meaning—something like “allowable.” So, if I were entering a country with 1,000 cigarettes on which I had no intention of paying duty even though the country in question required local duty to be paid on personal imports of cigarettes greater than 100, I would be smuggling or attempting to smuggle 900 cigarettes.

    I would be committing an unlawful act and liable to the penalties imposed by that country for such breaches of the law. But, as I understand things, I would be in the clear if I were a diplomat from another country and those cigarettes were in my bags, and in this case, I think that it would be arguable that I was smuggling in a licit or allowable way.

    And perhaps we could take this further. It might be stretching a point, but let’s extend the meaning of “licit” through “allowable” to “reasonable.” In fact, it’s not that much of a stretch; after all, the U.S. Food and Drug Administration uses the word “adulterated” as a synonym for illicit, and therefore, I presume, uses the word “unadulterated” as a synonym for licit, so, as I understand it, a cigarette is licit if it is unadulterated—if it contains nothing not declared in its list of ingredients—even though consumption of that cigarette will have you inhaling no end of toxins—unadulterated toxins presumably.

    In any case, let’s say my status has fallen on hard times and I’m no longer a diplomat but a gig worker being paid starvation wages so as to keep the multibillionaire owner of the company I work for in the luxury to which she has become accustomed. And let’s say that despite my lowly financial status, the government—with the help of the World Health Organization and its track-and-trace system (property, not people)—requires that I pay the same taxes on a pack of cigarettes as does the owner of the company. Might it be reasonable or licit in these circumstances for me to say, “you can stick your tax-paid cigarettes where the sun doesn’t shine” and take advantage of the services of my local smuggler?

    After all, it cannot be reasonable—dare I say licit—that each of us pays the same level of tax on our cigarettes, and here’s why. Cigarette taxes are there, we are told, to discourage people from smoking, but it would be absurd to suggest that the same level of taxes would discourage me, the gig worker picking up $10,000 a year, and the multibillionaire, picking up $100 million a year.

    If the powers that be reckon that taxes of $5 per pack of cigarettes are going to deter me, they should make the multibillionaire pay $50,000 per pack in taxes. Anything less would not be fair on the multibillionaire because she would not be discouraged from smoking and her health would be endangered. And I care deeply about the well-being of multibillionaires.

    To my mind, not only is the heading odd, but the story is too. At one point, we are told that the same networks developed to smuggle cigarettes and tobacco are now being used to perpetuate medical and personal protective equipment (PPE) fraud. This seems to imply that existing cigarette smuggling networks reach into the places where PPE is used: hospitals and care homes, for instance, and, frankly, I find this implausible. Surely, the networks that would be used, at least those at the sharp end of the supply chain, would be those that reach naturally into those facilities—perhaps those providing counterfeit drugs.

    Once again, we seem to have a story that attempts to blame smokers for the evils of the world. And to me, this makes no sense because it allows us to ignore, and therefore not address, the real causes of PPE fraud: the inappropriate and often cruel interactions of human animals with nonhuman animals that give rise to zoonotic diseases; globalization and the free flow of goods and people from centers of such interactions to the rest of the world, which ensures the “efficient” spread of these diseases; the overreliance on the market economy that in the case of the current coronavirus pandemic meant that not enough PPE was available or obtainable at quick notice; and the poor or nonexistent due diligence performed by governments left exposed, by their own policies, to such shortages.

    Address these issues and you are on your way to preventing PPE fraud. Approach the problem by trying to eliminate tobacco smuggling and you are at best going to put a dent in such trade, but you will leave yourself open to PPE fraud—and much else.

    What has this got to do with you, a reader interested in issues about vaping? Well, the story seems to imply that not only are some smokers indirectly responsible for PPE fraud but that their actions could lead to a spike in the U.S. in the illegal trade in electronic and heat-not-burn cigarettes. I’m not sure, but I think the argument goes something like this: Tobacco regulation is causing more people to quit smoking, and some of these quitters are turning to vaping, which is the subject of a crackdown in the U.S. that will make licit vapor devices harder to obtain. Hence the predicted spike in the illegal trade in such devices.

    Overall, the message seems to be that smokers should keep smoking but only tax-paid cigarettes because the illegal tobacco trade funds groups such as ISIS, the Irish Republican Army, Hezbollah and al-Qaeda. Once again, the smoker gets it in the neck for events that are so far out of her control that she might as well be blamed for sunspots.

    There is not even an aside to suggest that the actions of ISIS, the Irish Republican Army, Hezbollah and al-Qaeda might be down to politics, ideology and the desire by governments, companies and shareholders to promote the sale of arms. There is no question raised about how much of the tax paid on a pack of cigarettes goes toward governments promoting arms sales. And there’s not even a whisper that religions might be playing a part in the activities of these groups. It’s all down to smokers who buy illicit cigarettes.

    Is it? Of course not. Smokers are the victims. Many smokers are paid starvation wages in the gig economy and, we are told, are addicted to tobacco, so they are forced into the arms of smugglers when they can no longer afford the unreasonable tax and increased pricing demands made of them by governments and manufacturers. It is deeply unfair, or illicit, for manufacturers making billion-dollar annual profits to introduce several cigarette price increases in a year and then blame impoverished, addicted smokers for turning to the illegal trade and thereby supporting ISIS, or whatever. They need to examine their own actions.

    In a fair or licit world, the solution would be clear. We don’t have to drag ISIS and the Irish Republican Army into the fight. And we don’t have to send researchers out with a brief to prove that sunspot activity is particularly prevalent directly above where smokers congregate outside pubs. We just have to charge a fair, or licit, price for cigarettes.

    Of course, if your moral compass is able to lead you around experiments on nonhuman animals but runs you into a brick wall when it comes to allowing others to enjoy a cigarette, there is another answer—apart from trying to reset your moral compass, that is.

    Encourage smokers to switch to vaping and other low-risk nicotine consumption, and definitely don’t discourage them from making the switch. And don’t get into the same fix with vaping as you did with smoking by piling on high levels of tax and creating a highly monopolized industry that is able to increase prices without due regard for the consequences of such actions.

    What are the chances that things will change? Poor, I would say. I go along with whoever said that the one thing we learn from history is that we learn nothing from history.

  • NicVape Faces Suit Over SantiHands Brand Sanitizer

    NicVape Faces Suit Over SantiHands Brand Sanitizer

    Professional Disposables International (PDI) has files suit against South Carolina-based NicVape over its new SantiHands brand hand sanitizer. PDI has been producing Sani-Hands alcohol wipes since 1995.

    PDI filed a complaint on Sept. 11 in U.S. District Court, White Plains, for trademark infringement. NicVape, PDI claims, “willfully intended to trade on plaintiff’s reputation and to cause confusion” between SantiHands and Sani-Hands.

    PDI says it is a pioneer in manufacturing alcohol prep pads and germicidal disposable wipes. Nice-Pak Products Inc., an affiliated company, was granted the Sani-Hands trademark in 1995 for antiseptic, premoistened towelettes, according to an article on westfaironline.com.

    The wipes are more than 99 percent effective against many bacteria, viruses and fungi, according to PDI, in preventing infections. Sani-Hands are marketed to health care staff and patients and foodservice patrons who don’t have access to soap and water.

    NicVape’s wipes began showing up in August at Home Depot stores, the complaint states, in the Bronx, Hawthorne, Port Chester and Fairfield, Connecticut. PDI says it asked NicVape to cease and desist from using the SantiHands mark, but NicVape has not responded, according to the story.

    The complaint claims that many new hand sanitizer makers do not use the stringent manufacturing and testing procedures that PDI employs. It also notes that the FDA has recently recalled hand sanitizers that contain toxic alcohols, but provides no evidence that SantiHands does so.

    A National Drug Code filing lists SantiHands’ active ingredient as alcohol, at 80%. The product label, as depicted in a photo exhibit in the lawsuit, shows its composition as 80 percent ethyl alcohol.

    PDI’s Sani-Hands has 70 percent ethyl alcohol.

    PDI accuses NicVape of trademark infringement, dilution of Sani-Hands’ reputation for excellence, false designation of origin and unfair competition. It is demanding that NicVape stop using the SantiHands mark, destroy the products, and abandon its application for a trademark.