Author: Staff Writer

  • The Voice of Reason

    The Voice of Reason

    The UKVIA does a commendable job of promoting sensible vapor regulations. Will health authorities listen?

    By George Gay

    In March, I received a press note entitled, “The U.K. Vaping Industry Association [UKVIA] blasts World Health Organization [WHO] and says it risks becoming an ‘enemy of harm reduction.’”

    The UKVIA cannot be described as a militant organization. It has firm ideas, but it prefers to work quietly and closely with the U.K. government, health authorities and anybody else willing to listen to its tale of running businesses that promote tobacco harm reduction while trying to turn a profit. So, the tone of the heading made me sit up.

    What the UKVIA objected to in the first instance was what it described as “[r]ecent recommendations made by the WHO study group on Tobacco Product Regulations that would prohibit electronic nicotine[-delivery] and nonnicotine-delivery systems where the user can control device features and liquid ingredients.”

    On the face of it, I can certainly understand the UKVIA’s concern. Banning such products would be like banning automobiles with accelerator pedals because they could be used to make a vehicle travel at beyond the speed limit or banning glasses because they could be used to mix mind-altering drugs with lemonade.

    It has been said—rightly in my view—that newspapers are organizations that cannot tell the difference between a bicycle accident and a world war. By the same token, it would seem the WHO has become an organization that cannot tell the difference between a pandemic and everyday life—admittedly, life in all its messiness.

    The UKVIA said the WHO had called also for a ban on vaping systems that have a higher “abuse liability” than conventional cigarettes have; systems that, for example, allow the user to control the emission rate of nicotine. In this case, I’m so underwhelmed by the sound of the problem that I can assume only that I have misunderstood what is being said here. Isn’t it the case that nicotine uptake is controlled by the inhaler at a subconscious level?

    In any case, I cannot see what business this is of the WHO. Does it want to micromanage every aspect of the lives of everybody on the planet? Is it going to start looking into the “abuse liability” of high-performance cars, over-proof alcohol and sickly candy bars? Of course, if it wants to make itself useful and if it is happy working at a national rather than a world level, it could end no amount of inflicted harm by helping to do something about the abuse liability and abuse reality of the many and increasing dictatorial regimes around the world.

    Empowered personal choice

    The director general of the UKVIA, John Dunne, believes the WHO poses a threat to smoking cessation and harm reduction in the U.K. “While the WHO is scheduled to hold a crucial summit on vaping in November 2021, known as COP9 [the Conference of the Parties to the WHO Framework Convention on Tobacco Control (FCTC)], it continues to find itself at odds with health and industry advocates,” he was quoted in the press note as saying.

    “Certain WHO positions are now so out of date, and so thoroughly refuted by the experts, that they may as well be saying the earth is flat. They deviate dramatically from leading experts, including Public Health England (PHE) and Action on Smoking and Health …

    John Dunne

    “Take for example vaping helping people to quit smoking, which the WHO says there is ‘little evidence’ of. As early as 2019, clinical trials were finding vaping to be almost twice as effective as nicotine-replacement therapy …

    “Just this month, … PHE … found in its Vaping Evidence Review 2021 that smoking quit rates involving a vaping product were higher than with any other method in every single English region. For the WHO to hold such contrary views is either bad science or bad faith. Both risk it becoming an enemy of harm reduction.”

    Dunne made the point that vaping’s success as an industry, and its potential for public health improvements, were built on empowering personal choice. “Different systems, styles and flavors give consumers the options they need to leave combustible cigarettes behind,” he said. “I would urge the WHO to engage with vapers, to hear their stories and discover the life-changing decisions they’ve made… Prohibition is simply not the answer.”

    The press note also said that the U.K. was due to send a delegation to the COP9 summit later this year, the first time it would be attending such a summit since leaving the EU, and it was to be hoped that this would provide an opportunity for it to promote harm-reduction. In addition, it said the UKVIA had been among expert guests invited by the All-Party Parliamentary Group for Vaping to advise on the COP9 delegation’s approach.

    “The U.K. has a genuine opportunity to promote harm reduction as a valid, progressive strategy for public health on the world stage,” said Dunne. “We must not allow misinformation to undermine this potential, irrespective of the source.”

    It is indeed to be hoped that the U.K. delegation to COP9 can bring a little reason to the table, assuming it gets to the table. From what we of the outer dark can ascertain, however, the FCTC does not brook dissent and, as part of its strategy to avoid it, tends to block the attendance at meetings of those not of the true faith. It will be interesting to observe what it will make of a delegation that has been in direct or indirect contact with a vaping body, assuming the delegation does not cave in and join the happy-clappies.

    Return to sender

    Meanwhile, the UKVIA has a further problem. In another press note in March, it said it was deeply concerned by news that U.K. businesses were being impacted by the U.S.’ “vape mail” ban, part of a congressional spending bill passed under former President Trump. By April 27 [after this report was written], leading carriers, such as UPS, FedEx, DHL and the U.S. Postal Service, were due to be off-limits for vaping shipments.

    FedEx had cited “cigarettes, cigars, loose tobacco, smokeless tobacco, hookah or shisha, vaporizers (and) e-cigarettes” as “tobacco products,” which would no longer be accepted. The UPS said it would prohibit “any and all noncombustible liquid or gel, regardless of the presence of nicotine, capable of being used with or for the consumption of nicotine” as well as “all related vape devices, products and accessories …”

    Again, we find ourselves in a bizarre world. I take it these bans are somebody’s idea of a health and safety policy, but, with more “premature deaths” worldwide attributed to outdoor pollution than to tobacco consumption, logically, the carriers should ban deliveries of everything—they should remove themselves from the roads, the air and the sea. Or there should at least be an acceptance that both tobacco smoke and vehicle pollution are health hazards and that whereas carriers might be trying to lessen the pollution they create by switching to cleaner vehicles, craft and vessels, the tobacco industry is trying to lessen the amount of tobacco smoke by getting consumers to switch to vaping, a task not made any easier by carrier bans. Of course, there is little the carriers can do to reverse this nonsense, but they could at least have a word with any politician ready to listen.

    “The vaping supply chain is a global one, bringing together resources and expertise from around the world,” said Dunne. “It is bitterly disappointing to see these American restrictions having a negative impact in the U.K., but the nature of the supply chain makes it inevitable. In the EU, too, we are hearing of vaping businesses being turned away from major carriers.

    “The potential impact on public health is grave as so many people are relying on shipped goods as a lifeline during the pandemic. Without proper access to harm reduction products, we know people can revert to smoking cigarettes, today in the U.S. but perhaps tomorrow in the U.K. With businesses already struggling through lockdown, and our health services under great strain, supply chain issues really are the last thing we need.

    “I call on the distribution industry, many of whom have been partners of the vaping industry for many years, to do all they can to support their U.K. customers and to avoid the blanket implementation of U.S. restrictions worldwide.

    “Furthermore, I call on the U.K. government to ensure that carriers in this country are free to continue to deliver vaping products to retailers and direct to consumers and to resist any urge to follow the U.S. down this regressive route.”

    I take it that the “vape mail” ban is largely about keeping vaping products out of the hands of young people. It’s a strange thing that the activities of adults, which have always been restricted by the need to guard against criminal activities, are now increasingly becoming restricted by perceived threats to young people—often inappropriately referred to as “children” when it becomes necessary to ramp up the emotional blackmail.

    Credit: Haiberliu

    Such restrictive measures would be acceptable in my view if they were applied across the board, but they are not. Young people are seen by many people in authority as having to be protected against the minuscule threat posed by vaping products while many youngsters are allowed to go hungry, threatening their development and negatively affecting their whole lives.

    It would seem that young people are granted protections when those protections do not inconvenience the majority of voters. See how far you would get trying to introduce a 20-mph speed limit in cities so as to cut the number of deaths and injuries suffered by young people in collisions with cars.

    The Conservative Party, which has been in government in the U.K. for more than 10 years, has a poor record on child poverty, which has shot up under its governance, and on child hunger, in the face of which it twice provided relief for the neediest children during lockdowns only after being shamed into doing so by a campaigning footballer.

    But, on the other hand, it has had a good record in respect of supporting the tobacco harm reduction potential of vaping, and the UKVIA is hoping the situation in the U.K. can be improved further following the country’s exit from the EU.

    On March 15, the UKVIA launched its Blueprint for Better Regulation in response to the U.K. government’s consultation on the Tobacco and Related Products Regulations (TRPR) (and the Standardized Packaging of Tobacco Products Regulations), in which it was seeking until March 19 feedback on the effectiveness of the legislation in achieving its objectives and any unintended consequences that may have occurred.

    In a foreword to the blueprint, Dunne said the review of the regulations represented a defining moment in the history of the vaping industry, one of the leading market disruptors in the 21st century responsible for a significant decline in smoking across the U.K. It also presented the biggest opportunity yet for the government to create fair and proportionate vaping regulation that supported its 2030 smoke-free target and ensured the sector could make a bigger contribution to the nation’s public health and economy in the future.

    To achieve such a goal, the UKVIA needs the help of the government to counter the misinformation currently providing an increasingly powerful drag on efforts to encourage people to switch from smoking to vaping. It needs the government’s help in mounting promotional campaigns aimed at such switching, and its permission to mount its own agreed consumer communication campaigns, including with those buying online. And it needs the freedom in which its members can develop vaping products capable of competing with conventional cigarettes on a nicotine-satisfaction basis.

    There is, of course, much more in the UKVIA’s blueprint. No such presentation would be complete without a discussion of the important role flavors play in encouraging people to switch. The blueprint looks at packaging and labeling, descriptors and product quality and safety. It supports age restrictions on the purchase of vaping products and the need to work with trading standards officers in ensuring such restrictions are enforced. And it wants the government to act in relation to vaping in public places.

    What are the chances? Well, Dunne appears to be confident, and, as is mentioned above, the government has in the past been supportive of the tobacco harm reduction argument made in respect of vaping; so it could be willing to work with at least some the UKVIA’s ideas, perhaps all of them. But caution must be advised.

    Two skills the U.K. government is known for are its shape-shifting and U-turns. And one concern must be the government’s likely reaction if it found that conversions to vaping picked up so fast that tax revenues from tobacco fell dramatically. It’s addicted to such revenue, especially since the promised Brexit dividend, not even mentioned in March’s budget, seems to have melted away.

  • Myst Raises ‘Tens of Thousands’ in New Funding

    Myst Raises ‘Tens of Thousands’ in New Funding

    Myst Labs, a Chinese e-cigarette maker co-founded in 2019 by Chenyue Xing, a chemist who was part of the team at Juul that invented nicotine salts, recently raised “tens of thousands of dollars” from a Series B funding round. The financing was led by its existing investor, IMO Ventures. Thomas Yao, CEO and another co-founder of Myst, is a founding partner of IMO Ventures.

    Credit: Myst

    The news comes after of one of China’s top tech policy makers that published a set of draft rules that would bring e-cigarettes under the same regulatory scope as traditional tobacco, which means vaping companies will need licenses for production, wholesale and retail operations in the world’s largest manufacturer and exporter of e-cigarettes.

    These changes, announced in March, will deal a blow to small producers with poor quality control, leaving the industry with a handful of established and compliant players, Fang Wang, head of marketing at Myst, told TechCrunch.

    For one, standardizing production is costly, Wang said. From ceramic coils, to batteries, to fragrance, every component and ingredient of a vape will need to meet stringent requirements. E-cigarette companies will also need to pay tobacco taxes, an important source of tax revenue for the Chinese government.

    The other challenge is how to lower nicotine content. Many current products on the market have a relatively high nicotine concentration at 3-5 percent, so if China is in line with the European Union standard of 1.7 percent, many small brands will be forced out of business because they lack the know-how to produce low-nicotine vapes that still satisfy users’ crave, suggested Wang.

    “We’ve received a lot of investor interest in the past few months. Before that, professional, institutional investors often avoided e-cigarette companies, but they are showing more willingness now as regulations take shape,” Wang added.

    Myst declined to list its other investors but said they include high-profile individuals involved in the e-bike sharing company Lime, Facebook and the bitcoin industry.

    Most of Myst’s current sales are from China, where it has opened 600 stores and plans to reach a footprint of 1,000 stores in the next few quarters. Overseas, the startup has a retail footprint in Malaysia, Russia, Canada and the United Kingdom, where it’s selling in over 30 shopping malls and a few hospitals through its distribution partner, Ecigwizard.

    The new funding will allow Myst to further expand its sales network and strengthen its research and development. The company prides itself on its product containing 1.7 percent nicotine, which it claims can deliver the effect of a 3 percent counterpart. At her lab, Xing is currently working on e-liquids with “natural tobacco contents” and without organic acids, additives that allow nicotine salts to vaporize and be absorbed.

    Myst is still a relatively small player compared to China’s market dominator Relx, which went public in New York earlier this year and submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration to sell in the U.S. But Yao is optimistic about Myst’s future. Vaping, he said, is one of the fastest-growing consumer categories in China. Myst’s recent sales are tripling every three months.

    “In other consumer areas, you rarely see a top player commanding 60-70 percent of the market, so there is still a lot of room for the top 10 players to grow,” the CEO said.

  • FDA Issues 103rd PMTA Warning to Custom Vapes

    FDA Issues 103rd PMTA Warning to Custom Vapes

    Since Jan. 1, 2021, the U.S. Food and Drug Administration (FDA) has issued a total of 103 warning letters to firms selling or distributing over 904,000 unauthorized vaping products and who did not submit premarket tobacco product applications (PMTAs) by the Sept. 9 deadline.

    Credit: Marcus Krauss

    In April alone, the regulatory agency issued a total of 24 warning letters to companies that manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal and therefore they cannot be sold or distributed in the U.S. While each of these 24 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively these firms have listed a combined total of more than 154,000 products with the FDA, according to an FDA statement.

    The 103rd warning letter was issued on March 6 and posted to the FDA’s website on the same day. The 103rd letter was received Mississippi-based Custom Vapes. The FDA states that the company did “manufacture, sell, and/or distribute to customers in the United States Custom Vapes Amaretto 3MG 3ML 70VG/30PG e-liquid product without a marketing authorization order.” The company is a registered manufacturer with over 2,300 products listed with the regulatory agency.

    Unfortunately, the FDA often only lists a product or two that a company is selling as illegal. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products.

    Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.

  • PMI Investigated for Smoke-Free ‘Advertisement’

    PMI Investigated for Smoke-Free ‘Advertisement’

    Photo: Arkadiusz Fajer

    The Dutch food safety body NVWA is investigating a campaign by Philip Morris International (PMI)  to promote smoke free alternatives, reports DutchNews.

    PMI has launched a new website for the products and promoted it with a page advert in the Telegraaf at the weekend. In that advert, the company said Dutch smokers have the right to information about smoke-free alternatives.

    While not mentioning the products by name, the advertisement does include the company’s brand name. Advertising tobacco products is illegal in the Netherlands.

    The NVWA investigation follows complaints by anti-smoking groups. If found to have broken the ban, PMI could be fined up to €450,000 ($546,010).

  • Great Expectations

    Great Expectations

    Priscilla Agoncillo, president of the Cannabinoid Industry Association, says the CBD market is poised for massive growth.

    The cannabidiol (CBD) market is growing rapidly. The market is also preparing for industry regulations from the U.S. Food and Drug Administration as well as the possibility of changing rules under a new hemp bill winding its way through the U.S. Congress. Speaking during an online forum presented by TMG, a tobacco media group, Priscilla Agoncillo, president of the Cannabinoid Industry Association (CBDIA), outlined the current state of the CBD industry and what manufacturers, retailers and consumers can expect through 2021.

    Estimates by New Frontier Data say the CBD market will increase from $390 million in 2018 to $1.3 billion in 2022. Additional research by BDS Analytics and ArcView Market Research suggests that CBD sales will reach more than $20 billion in 2024. CBD already comes in numerous forms, such as oils, tinctures, capsules, edibles, even topicals and cosmetics. CBD products also are expected to expand into infused beverages, suppositories, sprays, inhalers and a wide variety of hemp smokable products, according to Agoncillo. There will also be a significant increase in cosmetics and supplements that contain CBD as well as more novel drugs introduced as companies expand research and development efforts.

    “In distribution channels, despite strict rules and regulations, the number of dispensaries and authorized retail storefronts that sell cannabis-based products to consumers will be opening due to new regions and states legalizing (marijuana) to meet the demand of consumers,” Agoncillo said. “Additionally, with the increase of product types, more big-box retailers will be stocking more CBD products and fostering relationships with CBD companies in research and development.”

    Agoncillo expects the popularity of CBD products to continue to grow as the scientific evidence of CBD’s benefits comes to light. The research and findings will also boost efforts by companies looking to introduce new products and develop new uses for various types on cannabinoids, which will increase integration with new technology and delivery systems. There are currently an estimated 104 cannabinoids in the cannabis plant.

    Looking at the top CBD trends in 2021, Agoncillo says that niche market efforts will become larger and more formalized as brands continue to seek out less crowded consumer segments. This will further diversify and differentiate each brand and allow for businesses to achieve higher returns on investments (ROIs) on exploratory segmented marketing efforts.

    “Brands will move toward proven consumer packaged goods (CPG) models focused on brand family extensions, including the marriage of complementary products and product iterations. Companies will work towards developing diversified portfolios and specific consumer segmentation,” she said.” You will see brands that will follow the Procter & Gamble family of brands business model or create line extensions of existing brands.”

    Priscilla Agoncillo

    Moving forward, Agoncillo says that the success of the CBD market will be predicated on understanding consumer market entry and adoption trends. According to High Yield Insights, CBD gummies are the entry point for most new consumers (at a rate of 60 percent) before trying other types of CBD products. Another growing entry point is CBD-infused beverages. A recent CBD beverage study released by High Yield Insights and Innovate MR revealed just how much legroom there is in the CBD beverage segment, according to Agoncillo. Among 4,200 survey respondents, only 28 percent report finding “a CBD product brand or format that works for them,” according to the research.

    “We project exponential growth in this segment [along with increased] diversity and inclusivity. Asian, Black and Hispanic consumer marketing efforts will support cultural competence, particularly among the nation’s largest brands,” said Agoncillo, citing her organization’s market expectations. “We expect to see more focus on niche marketing as consumer brand loyalty shifts toward the brands that consumers believe, respect and understand. More brands will concentrate on the growth opportunities within the Asian, Black and Hispanic consumer market, which have remained relatively untapped by CBD companies. One of the first signals of brand dominance in this segment market is the introduction of unique campaigns, specifically built to appeal to Black and Hispanic consumers, as well as Spanish-language advertising, packaging and support.”

    Exploding anxiety rates and associated mental health issues, especially surrounding the Covid-19 pandemic, will also provide hemp and CBD brands with new opportunities to promote the efficacy of CBD. Agoncillo says her organization is seeing increased focus on this niche market, which can be tricky to navigate due to advertising restrictions.

    “Brands are finding value in workarounds that allow them to leap over ad restrictions via targeted keyword searches; 25 percent of new market entrants purchased CBD to cope with pandemic-related stress and anxiety,” she said. According to High Yield Insights, more than 83 percent of U.S. employees reported mental health issues during 2021, and over 67 percent of U.S. employers project another mental health crisis within the next two years.

    “We project heightened partnership and growth opportunities in CBD products focused on stress, anxiety and sleep. Staying ahead in CBD as a highly regulated, newly developing industry, it is important that you obtain legal counsel to assist in the understanding of changes in regulations as well as to help you keep up with the constantly changing atmosphere,” explained Agoncillo. “Keep your company in compliance with regulations, always. As many of the regulations have not been finalized to cover the entirety of the CBD industry, it is safer to always err on the side of caution by operating your company according to GMP and other top-tiered standards.”

    New regulations for the CBD industry are also on the horizon. Draft rules from the FDA are currently with the White House’s Office of Management and Budget; however, review of those rules is currently being postponed by the Biden administration. Agoncillo says that no one in the industry knows exactly what those rules entail.

    “It’s very interesting because I remember when that report came out; it was back in October 2020, and the media would contact us and ask for our opinions on what that report was and what the regulations are. The truth is that they didn’t release it to anyone,” she says. “Through the CBDIA, we have a lobbyist in Washington that’s dialed in and has his finger on the pulse of everything that’s happening. And they haven’t shown what those regulations are to anyone. However, we do know that it is suggested that things are moving towards GMP standards. In the U.K., they’ve adopted the novel foods application for their CBD products. They’ve moved full steam ahead there. So there’s a suggestion that it might follow that closely. But obviously, we don’t know until they actually come out. This is why it’s really important to be involved with different industry associations and different organizations because they are going to be the first to get the word of how it’s going to actually roll out.”

    Another legislative change is brewing in the U.S. Congress. On Feb. 4, 2021, Congress introduced another CBD deregulation bill, H.R. 841—the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021. If passed, the bill would legalize the marketing of hemp, CBD or any other ingredient derived from hemp in a dietary supplement, provided the supplement satisfies other applicable requirements. The bill is in committee as of this writing.

    Agoncillo says another important part of the success of a CBD business is participating and supporting the community. She says that owners can help their company succeed by joining and being active in relevant cannabinoid-related industry associations, attending and being present at key conferences and crafting business outreach accordingly. Owners also need to hire the right staff to help them grow.

    “Keep your CBD company ahead by staying on top of the latest medical research and/or participating in the R&D to further advance the science of CBD and the industry as a whole. Hire talent with five-plus years in the cannabis or hemp industry to help navigate through the development of the CBD segment of your business model,” she says. “You will need a seasoned insider that understands the culture and can effectively translate that to your company.”

    Experienced staff can help guide business owners through the smoke and mirrors to avoid pitfalls, harmful partnerships and assist in forming a proper strategy for a business model. Additionally, experienced talent will have key relationships and resources in place to assist in executing business endeavors, according to Agoncillo.

    “We need high-operating brands and companies out there to apply their talents and their products and their technologies into the CBD space. The consumers need it,” she says. “We want it. And there’s no better time to really sink your teeth into this industry. And it’s very exciting because we can form this industry into what we need it to be.”

  • Consumer’s Choice

    Consumer’s Choice

    INNCO works with consumer advocacy groups to promote tobacco harm reduction around the globe.

    By Timothy S. Donahue

    Most of the world’s cigarettes are consumed in low-income to middle-income countries (LMICs). From Armenia to Zambia, these countries can also have high rates of adolescent smoking, particularly among males. Rates in some countries can reach as high as 46 percent, according to the U.S. National Institutes of Health. Research suggests that 80 percent of the world’s combustible cigarette users are in LMICs.

    While numerous studies have shown otherwise, the World Health Organization (WHO) has long insisted that less risky nicotine products, including vapor products and e-cigarettes, are as harmful and dangerous as combustible tobacco products and should be banned or heavily regulated. The International Union Against Tuberculosis and Lung Disease (The Union), a Bloomberg partner for The Initiative to Reduce Tobacco Use, published its fourth position statement on e-cigarettes last year. It called for a blanket ban on all electronic nicotine-delivery systems (ENDS) and heated-tobacco products (HTPs) in all LMICs. These organizations, typically through groups funded by Michael Bloomberg, the billionaire anti-smoking advocate, will often donate millions of dollars to poor or struggling countries if governments agree to ban or heavily restrict access to less risky products.

    As a result of policies based on false information from organizations such as The Union and the WHO, nicotine consumers in LMICs often have no delivery system available other than combustible products. Experts say that the lure of massive amounts of funding is just too great for such countries to resist.

    The International Network of Nicotine Consumer Organisations (INNCO), a global advocate for sensible tobacco harm reduction (THR), states in a recent position paper that bans on ENDS are overly simple solutions that make the problems that come with combustible cigarette use worse. It also states that reduction and substitution are valid goals for smokers in LMICs as replacing combustible tobacco with alternative nicotine products can reduce risk of harm by at least 95 percent.

    “The hundreds of millions of people who smoke in these countries should have the ability to make decisions about safer nicotine products, particularly when their own health is on the line,” said Samrat Chowdhery, president of INNCO’s governing board. “Overly simplistic policy solutions, such as proposed bans on all ENDS and THR products by the Bloomberg Philanthropies-funded The Union, are being offered as a blunt and impractical tool for a situation that requires pragmatism and nuance.”

    The need for INNCO

    INNCO was founded in 2016 to build cooperation between the growing number of global associations that advocate for THR. An organization can join INNCO if they are nonprofit, consumer-controlled and focused on tobacco harm reduction. The organization has 40 members in 35 countries, including the U.S.-based Consumer Advocates for Smoke-free Alternatives Association, a well-established advocacy group that raises awareness and protects the rights of consumers to access reduced harm products. INNCO also has members from Canada, Denmark and Greece to the Philippines, Brazil and Kenya.

    The organization continues to grow. “We are enlisting new members in several countries,” Chowdhery told Vapor Voice after the release of the position paper in March. “We are helping consumers form organizations where there are none. Africa came on board, where we have four, five members from that region this year, and since 80 percent of smokers do live in LMICs, it’s an additional focus that we have developed. It is something that, with this paper, we want to really say, ‘OK. We want to participate in discussions on these issues in LMICs.’”

    Samrat Chowdhery

    When The Union released its position paper calling for outright bans, Chowdhery says the recommendations were discriminatory. It was centered on the idea that if LMICs would not be able to enforce regulations, the only other option was a total ban on reduced-risk products.

    “They were not very mindful of the situation where if you could not regulate, it’s likely that you will also not be able to enforce a ban either. We know this because it’s what has happened in Mexico, Brazil and Thailand, where there have been bans, but products are very easily available,” explains Chowdhery. “If they would have instead implemented some sort of a regulatory control, you could ensure that there are product standards, they’re not sold to minors … but only having them available on the black market, those controls are not there, and you end up increasing the level of population harms to health.”

    Typically, when organizations like the WHO or United Nations develop policy, the organizations involve the industry stakeholders. After all, these are the people and businesses that the policies impact, says Chowdhery. Tobacco is the only industry that consumers and stakeholders do not have a say in policymaking.

    “The media should be taking this up. There is some trickery here,” he says. “The way the debate has been developed and the way Article 5.3 is getting misused all the time—it is a tough fight, but we’re up for it … we have our lives in the balance.” Article 5.3 of the WHO Framework Convention on Tobacco Control (FCTC) states that when setting and implementing their public health policies with respect to tobacco control, “Parties shall act to protect these policies from commercial and other vested interests” of the tobacco industry. Many anti-tobacco organizations have interpreted this as a ban on all interactions with the industry.

    Words of reason

    In the paper, INNCO claims that blanket bans on vaping and HTPs are a detriment to LMICs. The report, “10 Reasons Why Blanket Bans of E-Cigarettes and HTPs in low-[income] and middle-income Countries (LMICs) Are Not Fit for Purpose,” warns policymakers that limiting nicotine consumption options to reduce harm will only increase the number of people smoking combustible tobacco. The paper lists the following reasons:

    • Bans are an overly simplistic solution to a complex issue and will not work.
    • Prioritizing the banning of reduced harm alternatives over cigarettes is illogical.
    • Reduction and substitution are valid goals for smokers in LMICs.
    • People who smoke have the right to choose to reduce their own risk of harm.
    • Reduced harm alternatives can significantly contribute to the aims of global tobacco control.
    • Lack of research in LMICs is not a valid reason to ban reduced harm alternatives.
    • The prohibitionist approach in LMICs is outdated, unrealistic and condescending.
    • Bans will lead to illicit markets with increases in crime and no tax revenue.
    • Banning reduced harm alternatives leads people back to smoking and greater harm.
    • Blanket bans in LMICs are a form of “philanthropic colonialism.”

    INNCO says many LMICs risk an increase in smokers as a result of their policies. Leveraging the paper’s findings, INNCO states that it will work with its global membership to inform policymakers in developing nations to help achieve risk-relative regulations and access to THR products

    “Africa is home to some of the highest-ranked smoker countries on the planet,” said Joseph Magero, chairman of the Campaign for Safer Alternatives, a pan-African nongovernmental member organization dedicated to achieving 100 percent smoke-free environments in Africa. “While improving overall public health has made great strides in these regions, efforts to directly address smoking cessation and harm reduction strategies have lagged due to limited or no access to safer, noncombusti[ble] nicotine products. By denying smokers access to much safer alternatives while leaving cigarettes on the market, policymakers would leave only two options on the table—quit or die.”

    Nancy Loucas of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA), a grassroots alliance of THR advocacy organizations and an INNCO member, said a blanket ban in LMICs is a form of philanthropic colonialism, suggesting that these countries and their citizens cannot be trusted with any level of self-determination. “Inhabitants are treated as second-class citizens, which is offensive,” she said. “There is no benefit in limiting choice of safer nicotine products but only the potential for increasing harm.”

    Samsul Arrifin, president of the Malaysian Organisation of Vape Entities (MOVE) and an INCCO member, concurred with the INNCO assessment, saying that “any move to deprive smokers and consumers of better alternatives to cigarettes, such as vapes, would only contribute [to] the problem that [it] seeks to address.”

    Francisco Ordonez of the Asociacion por la Reduccion de danos del Tabaquismo Iberoamerica, a network of consumer organizations in Latin America and an INNCO member, says that few LMICs have adopted even the most basic prevention measures suggested by the WHO. “Policymakers should embrace harm reduction as a valid goal, particularly in LMICs where access to cessation programs is extremely limited,” said Ordonez. “Replacing combustible tobacco with alternative nicotine products can significantly reduce the risk of harm by at least 95 percent. It works in industrialized nations and can do the same in LMICs.”

    The Bloomberg conundrum

    Much of the ire of the THR community is reserved for Bloomberg Philanthropies (BP). In September 2019, Bloomberg and Matthew Myers, president of the nonprofit Campaign for Tobacco-Free Kids, launched a $160 million three-year campaign to end what they described as an epidemic of e-cigarette use among kids. The campaign is supported by several large nonprofits, like the Truth Initiative, American Cancer Society, American Heart Association and American Lung Association. Together, the organizations are pushing for a national ban on flavored ENDS products in the U.S.

    Chowdhery says that Bloomberg is using philanthropy in an unprecedented manner. “I’ve not seen anyone do this. This is so insidious. You have Bloomberg-funded attack groups,” says Chowdhery. “They were anti-smoking for a long time until these new [reduced-risk] products came on the market. Then they expanded their focus to become anti-nicotine … they are becoming more and more radicalized, proposing more and more extreme ideas as we go along. You have groups that their only stopping-tobacco tactic is just attacking people. That’s their job. That’s all they do.”

    Bloomberg, both as an individual and through his foundation, has committed nearly $1 billion to combating tobacco use worldwide, most of it focused on LMICs, according to BP. “These policies are what we call philanthropic colonialism because they’re just pushing an idea they have, an idea a New York billionaire has, on countries, which may not be suited for this,” explains Chowdhery. “He’s not proposing those policies [total bans] in the U.S.”

    Chowdhery says Bloomberg and his charities spread lies and disinformation without any regard for the negative impact on public health. During an appearance on CBS News, Bloomberg suggested vaping lowers IQ, even though there is no evidence about a relationship between nicotine use and intelligence.

    Chowdhery hopes the INNCO position paper will be read by the policymakers working with Bloomberg. “That was the main objective of the paper: to reach out to policymakers, reach out to media and professionals and let them know … what is being proposed has another side to it,” said Chowdhery. “See, this is a David and Goliath problem. What they have are well-funded organizations to push this narrative. And what they also have is credibility because a lot of this is coming from [well-known nonprofit groups]. Even if they publish a paper with lots of misinformation and have a disclaimer: ‘We received a million dollars from Bloomberg but that did not influence our work.’ That is a big problem.”

    The push forward

    The pandemic hit INNCO hard. Chowdhery, a former journalist, founder of the Council for Harm Reduced Alternatives and the director of the Association of Vapers India, was approached to head INNCO in July 2020. He said the organization had a lot of plans for the year, including regional meetings and setting up networks, projects that required a lot of on-ground activities. Then everything needed to be scaled back. The year 2020 became about recalibrating INNCO’s efforts. “The year was full of uncertainty and adapting and doing things differently. We did a lot of online meetings and a lot of internal objectives online,” said Chowdhery. “We enrolled more members. When we put out a call for a CEO, we got 400 resumes.”

    Chowdhery says that the main goal for INNCO now is to have a say in policymaking and be recognized as a legitimate stakeholder in this tobacco control intervention. It won’t be easy. Already, groups funded by Bloomberg are trying to discredit INNCO. “Our strength is our membership base. They are organizations that might be poor but [are] passionate, and they are volunteering their time and effort[s]. That is the real strength, and we need to leverage that and get everyone on the same platform so that we speak with common messaging,” says Chowdhery. “This is the first year that we actually have a budget to do our work. Unfortunately, we’ve not started because of Covid-19. We’re getting a new CEO, who should be with us soon. Things are looking really good.”

    In a recent essay in the journal Science, “Evidence, Alarm and the Debate Over E-Cigarettes,” five experts in public health state that it is a mistake to restrict access to vaping products while leaving deadly cigarettes on the market. The authors include Cheryl Healton, the former chief executive of the Truth Initiative, who is dean of the New York University school of public health, as well as the deans of the schools of public health at Ohio State and Emory universities. The essay concludes: “Careful analysis of all the data in context indicates that the net benefits of vaped nicotine products outweigh the feared harm to youth.”

    Chowdhery says that 15 years ago, there were no groups championing tobacco consumer rights. It’s now, when safer means of consuming nicotine are available, that consumers want to have access to them. “We consider that a right. This campaign of misinformation and regulatory overreach is a disaster waiting to happen,” says Chowdhery. “People in tobacco control, they’re earning paychecks to develop a policy which they then get passed through Parliament somewhere and they believe their work is done and they go home. The problem is, did legislation stop the use of that product that day? No, it just went underground. It became riskier. Now, it’s costing people their lives.”

  • Alabama Medical Marijuana Bill Faces Filibuster

    Alabama Medical Marijuana Bill Faces Filibuster

    Legislation to authorize medical marijuana in Alabama stalled Tuesday in the state House of Representatives after Republican opponents used a filibuster to at least temporarily delay a vote.

    Credit: Sharon McCutcheon

    Representatives adjourned shortly before midnight without a vote after nearly 10 hours of debate on the Senate-passed bill. The bill is expected to return to the House floor on Thursday, according to the AP.

    The lengthy debate brought impassioned discussion that included lawmakers expressing fervent opposition or how they changed their minds on the issue after the illnesses of family members

    The bill would allow people with a qualifying medical condition to purchase marijuana after getting a recommendation from a doctor. More than a dozen conditions, including cancer, a terminal illness, depression, epilepsy, panic disorder and chronic pain would allow a person to qualify. The bill would allow marijuana in forms such as pills, skin patches and creams but not in smoking or vaping products.

  • Group Says South Africa Needs ENDS for Harm Reduction

    Group Says South Africa Needs ENDS for Harm Reduction

    For years, anti-tobacco lobbyists have summarily and very aggressively painted electronic nicotine-delivery systems (ENDS) with the same brush they use to condemn combustible cigarettes, turning an intentional blind eye to the important role that ENDS play in tobacco harm reduction. According to Asanda Gcoyi, CEO of the Vapour Products Association of South Africa (VPASA), this is in spite of the fact that highly reputable agencies such as the Royal College of Physicians and Public Health England have published evidence that ENDS are 95 percent less harmful than smoking.

    “This unscientific one-size-fits-all rhetoric by anti-smoking lobbyists has influenced certain governments around the world to pass legislation restricting the marketing and distribution of [ENDS] under the exact same legislation that applies to normal cigarettes,” Gcoyi said. “In South Africa, with the debate currently open around the impending Control of Tobacco Products and Electronic Nicotine Delivery Systems Bill (2018), we need to ensure that we do not head the same way.”

    In an editorial for IOL, Gcoyi states that, besides the damage this myopic approach does to the adult smoker who is trying desperately to find a less harmful alternative (or, at the very least, cut down) by using vaping devices, the broad-brush approach creates highly contradictory misunderstandings around possible underage users. “What our organization aims to do is to bridge the gap between government and the vapor products industry. To this end, we educate and engage the former, set standards for the latter, and collaborate with both,” said Gcoyi.

    This collaboration is currently specifically aimed at developing legal regulations that will ensure adult consumers continue to enjoy access to vapour products in order to use them for the purpose for which they were invented: as a harm reduction tool that may ultimately enable them to give up smoking altogether.

    “This means ensuring that EVPs are recognised for what they are, and the important role they have to play in terms of adult smokers. However, where we definitely don’t have a difference of opinion with the legislators is when it comes to restricting their access to the youth.”

    As a result, while waiting for the Bill to play out, VPASA launched its own youth access prevention campaign in March 2021, to institute self-regulation in the meantime. An important part of the campaign lies in training EVP retailers about the restriction of sales to young people. This also means combating the misinformation being distributed by anti-smoking lobbyists in terms of young users.

    “It is alarming enough that anti-smoking lobbyists purposely draw false parallels between combustible cigarettes and vaping products,” said Gcoyi. “But even more concerning is the misinformation around vaping products and youth. It can completely obliterate what organizations such as ours are doing in trying to ensure adult access, while also restricting sales to youth.”

  • Paul Hardman Joins Broughton as Head of Scientific Affairs

    Paul Hardman Joins Broughton as Head of Scientific Affairs

    Broughton Nicotine Services has appointed Paul Hardman as head of scientific affairs, the latest in a series of senior level appointments, as it continues to expand its services.

    The business, which has helps electronic nicotine device companies bring noncombustible products to market, is currently expanding its full-service regulatory consultancy into modern oral nicotine products, heated tobacco products and Cannabidiol products.

    A scientist with extensive experience in inhaled product development across pharmaceutical and consumer products, Hardman will have the task of growing the scientific affairs team to enable the business to grow and offer a premium consultancy experience for clients in the industry.

    “We’re delighted to have welcomed someone of his caliber into this new role,” said Nveed Chaudhary, chief regulatory officer of Broughton Nicotine Services. “His addition to the Broughton team will strengthen the business further as we look to expand our full-service regulatory consultancy. Paul will take responsibility for delivering product development and optimization activities, drawing on his years of industry leadership and experience.”

    Prior to joining Broughton, Hardman was scientific lead with Imperial Brands, where he was responsible for designing the testing strategy for the chemistry of inhaled and oral next-generation nicotine products, from assessing a variety of prototypes at the early stages of development through to characterization of products for submission through the U.S. Premarket Tobacco Product Application process.

    He began his career working at a specialist pharmaceutical company where he gained experience of dry powder and metered dose inhaler development, including for the treatment of local lung conditions and systemic absorption. Hardman also has experience leading the quality control department in a multinational pharmaceutical company involved in the production of generic nicotine lozenges.

    Paul’s addition to the Broughton team will strengthen the business further as we look to expand our full-service regulatory consultancy.

    Nveed Chaudhary, chief regulatory officer, BNS

    He began his career working at a specialist pharmaceutical company where he gained experience of dry powder and metered dose inhaler development, including for the treatment of local lung conditions and systemic absorption. Hardman also has experience leading the quality control department in a multinational pharmaceutical company involved in the production of generic nicotine lozenges.

    “I am passionate about the opportunity to work with multiple clients and really get to the heart of their products so that Broughton Nicotine Services can best serve these businesses by championing those points in their regulatory submissions,” said Hardman.  

    “My role will involve growing the team to enable us to deliver a highly effective offering as Broughton moves into new areas, and I am eager to build on the success the business has already achieved.”

  • No Update on When USPS Expects to Publish Vape Rules

    No Update on When USPS Expects to Publish Vape Rules

    The industry is still in flux. Many businesses closed or found more expensive shipping options. Some companies stopped shipping and then started again knowing that it could all end at any minute. As of this writing, however, the United States Postal Service (USPS) has yet to publish its final rule for mailing vaping products.

    Credit: Tomasz Zajda

    On April 19, the USPS issued guidance for exemptions to the requirements for mailing all vapor products, including cannabis. This was in response to the U.S. Congress placing electronic nicotine-delivery systems (ENDS) under the stringent mailing requirements of the Prevent All Cigarette Trafficking (PACT) Act. That guidance only references that a rule could be published at any time and the ban on mailing vaping products to consumers would take effect immediately after the rule is published.

    “A forthcoming final rule will determine whether electronic nicotine-delivery systems (ENDS) may continue to be mailed pursuant to certain statutory exceptions that are currently administered through an application process,” the guidance states. “Until the final rule is issued, ENDS are not subject to the PACT Act …”

    Many businesses ended shipping to consumers on or before April 26, a day before the assumed effective date of the USPS rules. The comment period closed March 22 and the USPS stated that it had received “numerous comments” pertaining to its proposed ENDS mailing rules. An e-mail to USPS media relations did not receive a response by this writing.

    The USPS is required to use a definition of ENDS so broadly that it can be interpreted to include and inhalable electronic delivery system for any product. These means restrictions also apply to ENDS products such as: “an e-cigarette; an e-hookah; an e-cigar; a vape pen; an advanced refillable personal vaporizer; an electronic pipe; and any component, liquid, part, or accessory of a device described [ENDS], without regard to whether the component, liquid, part, or accessory is sold separately from the device,” according to the law.

    Many in the industry think Congress overreacted placing ENDS under the PACT Act requirements. The PACT Act was intended to stop manufacturers from avoiding taxes on combustible tobacco products, not keep them out of the hands of youth. Congress said it amended the PACT Act to protect kids from vaping. There has been no evidence that youth can easily purchase vaping products online.

    This USPS says its just following the orders of Congress. It’s also turning out to be more complicated than just ending all vape mail. The USPS was inundated with exemption applications, none of which will be addressed until the final rule is published, according to the USPS.

    “Despite our best efforts, in order to ensure thorough and thoughtful consideration of the complex issues and voluminous comments by industry, individual, and governmental stakeholders, the Postal Service is unable to publish a final rule by today’s target date,” said David P. Coleman, a USPS spokesperson, in an email to Marijuana Business Daily, adding that his agency would “finalize the rule as soon as possible” and “mailers should be prepared for implementation upon publication anytime.”