Tag: e-cigarettes

  • Connecticut AG Submits Testimony on Flavor Ban

    Connecticut AG Submits Testimony on Flavor Ban

    Connecticut Attorney General William Tong submitted testimony concerning House Bill 6488 stating that he fully supports the state’s proposed ban on flavored vaping and other tobacco products.

    He also expressed concern that the “An Act Concerning Cigarettes, Tobacco Products, Electronic Nicotine Delivery Systems and Vapor Products” bill as currently written exempts the most widely used flavor—menthol—which must be included in the ban to deter youth addiction.

    “Ending the sale of flavored tobacco products, including menthol, will have an enormous impact in reducing the number of people who die or suffer debilitating preventable illness from tobacco use, significantly reducing the number of young people who become addicted to tobacco products, and reversing the youth e-cigarette epidemic,” Tong states. “A comprehensive flavor ban that includes menthol will save thousands of Connecticut lives, protect public health, and advance health equity. It should be implemented immediately.”

    Connecticut Attorney General William Tong

    Tong stated that his office has a long history of battling tobacco companies “from negotiating the Master Settlement Agreement in the 1990s to the recently announced settlement with Juul, we have focused our efforts on combatting the insidious ways that Big Tobacco has marketed to children.”

    The bill is the most recent effort by members of the legislature’s Public Health Committee to take flavored nicotine products off the market in an effort to reduce smoking and vaping among young people. Similar legislation has failed to make it across the finish line during recent legislative sessions.

    In May of last year, for the third year in a row, an effort to ban flavored vaping products in Connecticut couldn’t muster enough support.

    Connecticut lawmakers heard testimony on legislation that would ban the sale of flavored tobacco and vape products as well as prohibit the use of vapes while in a vehicle with a child.

    Connecticut is one of few states in the region that has not adopted a prohibition on flavored e-cigarettes. New York, New Jersey and Rhode Island have barred the sale of flavored vaping products. Massachusetts banned all flavored tobacco items, including flavored cigars, cigarettes and vaping goods.

  • Bloomberg Commits $420 Million to Fight Nicotine

    Bloomberg Commits $420 Million to Fight Nicotine

    Bloomberg Philanthropies has committed another $420 million over four years to the Bloomberg Initiative to Reduce Tobacco Use. This fourth investment brings Bloomberg’s total commitment to tobacco control to more than $1.58 billion since 2005.

    The Bloomberg Initiative to Reduce Tobacco Use is helping cities and countries implement measures such as smoke-free public places, banning tobacco advertising, increasing tax on tobacco products, requiring graphic warnings on cigarette packaging and mass-media public awareness campaigns.

    Currently, the initiative spans more than 110 low- and middle-income countries (LMICs)—including China and India, which together account for nearly 40 percent of the world’s smokers.

    Critics of Bloomberg’s agenda say his policies fuel corruption and drive countless people back to smoking combustible cigarettes. In a release, the American Vapor Manufacturers Association (AVM) stated that despite his “pretensions and self-aggrandizement, the tragic reality is that Michael Bloomberg is bankrolling a prohibition campaign that aims to stigmatize and outlaw the single most effective smoking cessation method ever devised, nicotine vaping.”

    The AVM states that it has extensively documented that Bloomberg’s money is used to coerce public officials, pay lobbyists, and even install personnel in public institutions. “It funds front groups that have no genuine following but peddle demonstrable misinformation to the public,” the release states. “The money is even used to bribe journalists through dark money grants to rig the news coverage of this crucial public health issue. It is thoroughly corrupt and happening at a scale that shocks the conscience.

    From the new $420 million in funding, $280 million will be aimed at reducing tobacco use in LMICs and $140 million will target reducing e-cigarette use among teenagers in the United States.

    “Over the past two decades, we’ve made major progress in reducing tobacco use and the death and disease connected to it, but it continues to take a devastating toll, and it remains the leading cause of preventable death,” said Michael R. Bloomberg, founder of Bloomberg Philanthropies and WHO Global Ambassador for Noncommunicable Diseases and Injuries, in a statement.

    “This latest investment will help to spread strategies that have proven so effective at saving lives — including smoke-free laws and advertising restrictions—to more nations and communities around the world.”

  • Japan Poised to Allow Medical Marijuana Sales

    Japan Poised to Allow Medical Marijuana Sales

    Credit: Alona

    The government in Japan is poised to allow the use of medical marijuana to treat patients with intractable diseases, according to the outline of bills revealed last week.

    The government is considering submitting bills including one to revise the Cannabis Control Law during the current Diet (the national legislature of Japan) session, according to Japan News.

    The proposed revision would also criminalize the use of marijuana without a prescription.

    In countries including the United States and Britain, medicine made from cannabis plants is used to treat patients with intractable epilepsy and other diseases for which existing drugs are ineffective. In Hong Kong, however, THC and non-intoxicating CBD are both banned.

    Cannabis plants contain a substance that has an intoxicating effect, which is one of the reasons why the use of marijuana in medicine is prohibited in Japan. The proposed revision would enable such patients to use drugs made from cannabis plants.

    On the use of marijuana, there are currently no penalties for using it because farmers who cultivate cannabis with permission from prefectural governors might intake substances from the plant during harvesting.

  • Survey Reveals Scale of Advocacy for Safer Nicotine

    Survey Reveals Scale of Advocacy for Safer Nicotine

    Knowledge-Action-Change (KAC) has released a global survey investigating the role and activities of consumer organizations advocating for access to safer nicotine products (SNPs) and tobacco harm reduction.

    Carried out by KAC’s Global State of Tobacco Harm Reduction project, the research was published in Public Health Challenges.

    It reveals that there are 54 active consumer advocacy groups working around the world to raise awareness about, and promote the availability of and access to, SNPs, which include nicotine vaping products (e-cigarettes), Swedish-style snus, nicotine pouches and heated-tobacco products.

    The authors of the survey found that the vast majority of organizations (42) were operated entirely by volunteers, most of whom had successfully quit smoking with the help of SNPs.

    Only seven of the groups had any contracted or paid staff (13 people globally), and for the last full year, the total funding for all organizations surveyed amounted to $309,810. This is in stark contrast to the millions of dollars spent on campaigns by actors, such as Bloomberg Philanthropies, seeking to limit access to SNPs, such as nicotine vaping products. The paper also notes that none of the consumer advocacy organizations reported receiving funding from tobacco or pharmaceutical companies.

    This paper starkly demonstrates the major imbalance in resources available to consumer organizations advocating for access to safer nicotine products and those opposed to tobacco harm reduction, unfairly skewing the debate.

    Many of these organizations are members of four regional umbrella organizations covering Latin America (ARDT Iberoamerica), Africa (CASA), Europe (ETHRA) and Asia-Pacific (CAPHRA).

    “This survey offered a unique opportunity to map these advocacy organizations for the first time and provide valuable insight into how they are operating all over the world,” said Tomasz Jerzynski, lead author and data scientist for the Global State of Tobacco Harm Reduction project. “The sustainability of these organizations is one of the main concerns that has come out of the data. All of these groups face challenges due to their small numbers of core workers and their dependence on volunteers.”

    “This paper starkly demonstrates the major imbalance in resources available to consumer organizations advocating for access to safer nicotine products and those opposed to tobacco harm reduction, unfairly skewing the debate,” said Gerry Stimson, report author, director of KAC and emeritus professor at Imperial College London. “It also highlights why consumer groups must be recognized as legitimate stakeholders in the policy sphere.”

  • PMI, BAT Recognized Again for Gender Equality

    PMI, BAT Recognized Again for Gender Equality

    Philip Morris International and BAT were included in the 2023 Bloomberg Gender-Equality Index (GEI).

    PMI made the index for the third year running, achieving an overall score of 80.6 percent.

    “Achieving gender balance at all levels of the company is one of our top priorities, and I am delighted that our efforts are recognized again in this year’s index,” said Silke Muenster, chief diversity officer at PMI. “While we are making significant progress, we know we need to keep our foot on the acceleration pedal. An inclusive workplace that leverages the full talents of both women and men is crucial to our smoke-free vision, making our organization more innovative, resourceful and engaged.”

    In 2022, PMI achieved its target of ensuring at least 40 percent female representation in managerial roles and announced a new target to achieve 35 percent of women in senior roles by the end of 2025, among other targets.

    BAT, which participated in the index for the first time, received a score of 75 percent. BAT was recognized for creating an inclusive culture for women via its recruiting initiatives, adoption of family-friendly policies, sponsoring programs dedicated to educating women, and support of community programs. Inclusion in the index follows BAT being named as a Global Top Employer for a sixth successive year.

    “Recognition in this year’s Bloomberg Gender-Equality Index demonstrates our commitment to addressing gender diversity and highlights our concerted global efforts to provide transparent reporting,” said Hae In Kim, BAT’s director of talent, culture and inclusion. “With more than 50,000 employees worldwide, our diversity and inclusion strategy is truly global, and I continue to be incredibly proud of the collective efforts made by all our employees.”

    The GEI measures gender equality performance globally across five pillars as set by Bloomberg: leadership and talent pipeline, equal pay and gender pay parity, inclusive culture, anti-sexual harassment policies, and external brand. The 2023 Bloomberg GEI comprises 485 companies from 45 countries and regions.

  • Milwaukee, Wisc. Wants to Ban New Vape Shops

    Milwaukee, Wisc. Wants to Ban New Vape Shops

    Credit: FellowNeko

    Leaders in the U.S. city of Milwaukee, Wisconsin, debated a proposal for an ordinance Tuesday that would prevent some electronic cigarette sales across the city in the future.

    “The explosion of vape shops, particularly when concentrated in a small geographic area, may have harmful impacts on the public health, safety, and welfare of our residents,” said Milwaukee’s District 3 Alderman Jonathan Brostoff, according to CBS58.

    Part of the Milwaukee Zoning, Neighborhoods & Development Committee meeting Tuesday morning discussed a plan to prevent new vape shops from doing business in the city.

    The proposal would prevent new shops from selling e-cigarettes for six months.

    During this trial period, officials would also prevent other businesses from opening if they plan on selling e-cigs.

    “Part of the goal of this is going to be, ultimately, to look at both concentration and location–for example, proximity to schools, things of that nature,” added an Alderman.

    Neighborhood Services Commissioner Erica Roberts said this request would be complicated for a number of reasons.

    “There are many different types of uses that would sell this type of product, everything from grocery stores to gas stations, convenience stores…” Roberts expressed.

  • Proposed EU Vape Tax Needs to be Done Properly

    Proposed EU Vape Tax Needs to be Done Properly

    Unless properly structured, Europe’s tobacco and vapor tax plans may not achieve their public health objectives.

    By Stefanie Rossel

    The European Commission’s (EC) December 2022 proposal for an update to the 2011 EU tobacco excise directive came with a first: In addition to a significant hike in cigarette excise rates, the draft also calls for a bloc-wide vaping levy.

    According to the proposal, the current minimum EU excise tax rate of €1.80 ($1.92) should increase to €3.60 per pack of 20 cigarettes. This would double excise duties in member states with low cigarette taxes (in eastern European countries, a pack of cigarettes can currently sell for under €3) and affect excise duties in countries such as Luxembourg and Austria, where cigarette prices are low relative to income. The EU hopes to generate an additional €9.3 billion in revenue from the tax harmonization, which would be a welcome windfall for pandemic-struck and inflation-struck member states. If enacted, the proposal would also increase taxes on hand-rolled tobacco.

    E-cigarettes with less than 15 mg of nicotine per milliliter of liquid would attract a 20 percent excise duty, and stronger products would be subject to a duty of at least 40 percent. In the EU, nicotine content of e-liquids is limited to 20 mg per milliliter. According to the draft proposal, heated-tobacco products (HTPs) would attract a 55 percent excise duty, or a tax of €91 per 1,000 items sold.

    The proposed legislation would harmonize the fragmented EU vapor market, where each member state taxes vapor and HTP products at its own rates. It is part of a push aimed at accelerating the reduction of smoking rates throughout the EU. As part of the common market’s Beating Cancer Plan, introduced by the EC in February 2021, health officials seek to lower the current EU smoking prevalence of 26 percent to 20 percent by 2025 and achieve a “tobacco-free generation”—that is, a smoking rate of below 5 percent—by 2040.

    The draft was released only weeks after the EC imposed a ban on flavored HTPs to cut the growth in demand among younger consumers. Responses were mixed. While some argued that union-wide taxes are necessary because less harmful products still present risk, tobacco harm reduction advocates warned for unintended consequences.

    Too High, Too Complex

    David Sweanor

    “Simply increasing cigarette taxes is a blunt instrument when trying to reduce the health toll from cigarette smoking,” says David Sweanor, adjunct professor of law at the University of Ottawa in Canada. “It is far more powerful than other standard anti-smoking measures but has limitations and constraints that are often overlooked. Price sensitivity is real, but many people who smoke cigarettes will seek to deal with increased costs through access to contraband, the cross-border trade, simply changing the way they smoke without achieving health improvements, or further diminishing their overall well-being by redirecting expenditures from healthier purchases to the purchase of cigarettes.”

    Taxing low-risk alternatives reduces the incentive to switch from cigarettes and can make illicit cigarettes more competitive, according to Sweanor. In his view, it is akin to making alcoholics who give up drinking by taking up jogging pay a tax on running shoes. “It misses the point of how taxes can be justified due to the relative health impact of certain behaviors,” he says.

    Dustin Dahlmann

    Dustin Dahlmann, president of the Independent European Vape Alliance, believes that EU policy should be guided by scientific evidence. “Science around the world agrees that vaping is significantly less harmful than smoking,” he says. “E-cigarette taxes that are too high [to] prevent socially disadvantaged groups in particular from switching to e-cigarettes. In the first instance, there should not be excise duties for electronic cigarettes, as they are a means for smokers to switch to less harmful alternatives. If further harmonization of excise duties is considered, legislators should take into account the significant differences in risk profile between tobacco cigarettes and electronic cigarettes and apply the excise duties methodology accordingly, i.e., proportionality to the harm reduction benefits brought about by tobacco replacement products.”

    In practice, this would mean a maximum excise duty of €1 per 10 mL or €0.10 per 1 mL of e-liquid, and it should be applied only to e-liquids with nicotine, according to Dahlmann. “The EU draft imposes a combination of an ad valorem and a specific volume base excise that would be an administrative burden for small and medium enterprises and fiscal authorities due to the additional complexity. Giving two options will lead to uncertainty, defeating the purpose of a harmonization of excise rates.”

    Illicit Trade Could Increase

    The question about how the EU’s revised tobacco tax directive would impact the illicit cigarette market is justified. The experience of France provides a cautionary tale. Following a tax increase of almost three times the EC’s minimum level, the illicit market in that country more than doubled, from 13.7 percent in 2017 to 29.4 percent in 2021, leading to an estimated loss of €6.2 billion in tax revenues in 2021, according to a KPMG report. In general, the study found, illicit consumption in the EU increased by 3.9 percent, or 1.3 billion cigarettes, in 2021, which corresponds to a loss of €10.4 billion in taxes.

    How the suggested excise duty increase would impact markets with relatively low income and high smoking levels, such as Greece (42 percent smoking prevalence) and Bulgaria (38 percent), is anybody’s guess. “I have worked globally on illicit trade issues for decades,” says Sweanor. “There is much we can do to limit the trade, but the economics makes [illicit cigarette trade] so lucrative that it is hard to imagine bringing it under control so long as there remains a significant market for cigarettes. Markets meet needs, including illicitly. Cigarettes are extraordinarily inexpensive to make, and taxes and the huge profit margins of Big Tobacco create a business opportunity many people can be expected to see as a money spinner. The real answer is to facilitate disruptive technology that makes cigarettes as undesirable to consumers as unsanitary food or leaded petrol.”

    To achieve the latter, the EC would have to acknowledge the harm reduction and smoking cessation potential of novel tobacco products. In February 2022, the EU Parliament became the world’s first elected chamber to endorse THR when it adopted a resolution on cancer prevention and treatment that notes that e-cigarettes “could allow some smokers to progressively quit smoking.” Dahlmann praised the move as a “landmark declaration” that would help reassure smokers of the benefits of switching to vaping. “All other EU institutions—and in particular the European Commission—should take this on board and ensure that policy follows science, not the other way around,” he said at the time.

    Sweanor is less upbeat. “The taxation of low-risk products reflects an understanding of differential risks. But it fails to come to terms with the full magnitude of the harm from cigarette smoking and the enormous potential to dramatically reduce it. When we are looking at hundreds of thousands of annual deaths, surely it is a public health emergency—and policies should reflect that. Language such as “could allow some smokers…” and policies that limit the relative acceptability of low-risk alternatives indicate that the extent of the public health opportunity is not fully grasped.”

    Differentiated Approach Required

    Whether the EU is prepared to part ways with anti-novel nicotine product sentiment of the World Health Organization Framework Convention on Tobacco Control (FCTC), which the common market has ratified, remains to be seen.

    “The EU is obligated to support tobacco harm reduction as a signatory to the WHO’s FCTC as stipulated in the introduction, article 1 (d) of the treaty,” says Dahlmann. “The FCTC requires the EU to not only allow reduced-risk products but to actively promote them. However, this definition is not actively supported by the WHO. The rule here is much more ‘quit or die.’”

    “The WHO’s FCTC process has followed in the footsteps of narcotics protocols in being hijacked by ideologues who seek an abstinence-only approach on drugs where total abstinence is simply not a viable nor a humane goal,” Sweanor adds. “As with those narcotics protocols, caring governments that follow the Enlightenment principles of science, reason and humanism will either creatively skirt such guidelines or simply ignore them. This is something we are now seeing unfolding globally with cannabis policies.”

    The goal of the new tax directive to create a smoke-free European society, he says, is noble and achievable—and far more quickly than envisioned in that 2040 goal. “But it requires bold rather than tentative steps. Policymakers should act in ways consistent with cigarette smoking being a public health crisis of enormous importance,” says Sweanor. “The best way to tackle this is by use of cross-elasticities, of empowering and facilitating people who smoke cigarettes to make healthier choices. This is accomplished by measures such as the widest possible cost differential between lethal cigarettes and low-risk alternatives. Given the horrendous death and disease tool from cigarettes, this should be a huge priority.”

    “E-cigarettes need to remain accessible and affordable to smokers from all socioeconomic backgrounds who wish to quit smoking,” says Dahlmann. “E-cigarettes offer smokers an alternative that is 95 percent less harmful than smoking. Switching from tobacco to vapor has positive individual, social and economic implications and should be encouraged, not penalized by the tax system. If taxes make vaping more expensive than smoking, many smokers will lose an incentive to switch to the much less harmful alternative. We therefore would see no chance of achieving the EU’s ambitious goals.”

    Before it is enshrined in law, the proposal will have to be agreed on by all EU member states. BAT already noted that this is merely the beginning of a long legislative process. “I assume there will be amendments, but we do not yet know their likely nature,” says Sweanor. “The proposal could be changed to help facilitate a rapid public health breakthrough as people abandon lethal cigarettes in huge numbers. Or it could be amended to make that a pipe dream.”

    This article first appeared in Vapor Voice‘s sister publication Tobacco Reporter.

  • Cannabis Regulators Could Learn From Nicotine

    Cannabis Regulators Could Learn From Nicotine

    Photo: Darren415

    Nicotine’s lessons for cannabis regulation

    By Cheryl K. Olson and Willie McKinney

    From the industry perspective, regulation of tobacco products by the U.S. Food and Drug Administration went from impatient foot-tapping to a lurching roller-coaster ride. The recently released “operational evaluation” of the FDA’s tobacco program, requested by Commissioner Robert Califf, lays out in sedate but clear terms some causes of industry’s frustrated exhaustion: years of delay in establishing requirements. Sudden major shifts in policy. Cycles of litigation and reprieve.

    Based on feedback from FDA employees, and people from industry and public health, the independent Reagan-Udall Foundation for the FDA made recommendations to start repairing the regulatory mess. After “observ[ing] that CTP [Center for Tobacco Products] has been forced to operate primarily in a reactive mode, moving from one challenge to the next,” the first recommendation to the agency is to get proactive. The Reagan-Udall panel encouraged the CTP to make time now to “think strategically about where it is today and where it needs to go in the next several years.”

    This advice might apply equally to whatever future the FDA faces with regulation of cannabis products. The FDA has authority over cannabis and its dozens of biologically active chemical compounds, including CBD and THC. Although marijuana falls under the federal Controlled Substances Act, the 2018 Farm Bill removed hemp (a low-THC cannabis plant and its derivatives) from that definition.

    Principal Deputy Commissioner Janet Woodcock recently announced in a press release that existing regulatory frameworks for food and supplements are not appropriate for CBD. “The agency is prepared to work with Congress” on a new pathway, she stated.

    What might we take from the U.S. tobacco experience to ease headaches for future cannabis regulation? Below are some points to ponder in three areas: regulatory structure, medical versus recreational use, and the effects of misinformation on regulation.

    What Should a New Structure Look Like?

    First, what regulatory structure makes sense: Should the FDA create an all new one for cannabis products, or should it employ some existing channels? Consider the tobacco parallel.

    “Safe and effective” is the FDA’s traditional standard for evaluating drugs and medical products. In the 1990s, then Commissioner David Kessler tried to assert the FDA’s authority to regulate nicotine as a drug—intended by industry to affect the body’s structure or function—and cigarettes as delivery devices. A 2000 Supreme Court ruling found that the “s and e” standard left no room for regulation of tobacco.

    In 2009, when Congress chose to place tobacco under FDA jurisdiction, a novel department was created. But this promising, fresh science-based regulatory approach for tobacco faced headwinds. This Center for Tobacco Products was largely staffed by people rotated from elsewhere in the FDA. The “appropriate for the protection of public health” (APPH) tobacco standard was a difficult departure from their accustomed ways and views. The combination of suspicion from past industry misbehavior and the political uproar over youth vaping fostered an “us versus them” mindset. The founding legislation’s focus on cigarettes, the most deadly of tobacco products, affected attitudes toward emerging alternative nicotine products with the potential to greatly reduce disease risks for people who smoke.

    Perhaps there is light at the end of the tunnel. The FDA appears to recognize that shoehorning cannabis into existing structures has its own problems. Each type of intended use must find a fit in an existing department, such as human food, veterinary products, cosmetics or drugs. Under the Federal Food, Drug and Cosmetic Act, a drug is any product (including marijuana or hemp) intended to affect the structure or function of the body or intended to diagnose, cure, mitigate, treat or prevent disease.

    What factors will influence staff mindset about cannabis in these various departments? How will that affect regulation?

    Medical vs. Recreational Pathways

    Another issue: How best to regulate cannabis for medical versus recreational use? Like tobacco, cannabis has been used historically for medical purposes, such as treating pain. Both nicotine and cannabis are reportedly used to self-medicate for mental health disorders. Use of marijuana to manage mood disorders is reportedly higher in states with medical marijuana laws. But there currently is no such thing as “medical” marijuana. (This is not unlike the confusion over what constitutes “natural” food.) The FDA drug pathway would create medical cannabis. A standardized product would be evaluated for quality, safety and efficacy for a particular medical indication.

    We lack randomized, controlled clinical trial data on whether cannabis effectively treats disorders such as depression. However, such studies could be done by industry and submitted to the FDA’s Center for Drug Evaluation and Research. Several specialty products containing THC or CBD (e.g., for chemotherapy-related nausea or severe forms of epilepsy) have emerged from this path.

    But what regulatory pathway might recreational cannabis take? And what complications arise from product format and route of administration: smoked, vaped, applied to skin or eaten? Where would combusted flower fit?

    Nicotine is regulated by the FDA as a drug and as a recreational product. Two paths for cannabis also make sense. Although there is overlap (to get technical: Gum bases that contain nicotine are regulated as both pharmaceuticals and recreational tobacco products), combusted tobacco products that contain nicotine are only regulated by the Center for Tobacco Products.

    We propose that Congress modify the 2009 Tobacco Control Act to give the CTP authority over combusted and vaped cannabis. Such products are very unlikely to pass the “safe and effective” drug standard, but the APPH standard may be applicable to recreational cannabis. And the CTP has built up expertise in combusted and vaped products.

    Keep Moral Panic Out of Regulation

    A third issue deserving of thought is how to prevent moral panic and misinformation from derailing the potential benefits of cannabis. One lesson from nicotine is how these can fog the ability of regulators, politicians and the public to see data clearly.

    Research shows that youth use of nicotine and cannabis (as well as alcohol and other substances) overlap. A 2022 analysis of Population Assessment of Tobacco and Health study data found that more than half of e-cigarette users aged 15 to 24 had vaped cannabis. At the population level, teen cannabis youth has been fairly stable for the last quarter century. However, there will be concerns that the spread of state laws legalizing cannabis for adults could ease access for youth.

    Once it takes hold, misinformation is hard to uproot. Witness stubborn rates of misbelief that the outbreak of vaping-related lung injuries (e-cigarette or vaping product use-associated lung injury, or EVALI) were caused by e-cigarettes instead of THC vapes adulterated with vitamin E acetate.

    We see signs of a potential moral panic over cannabis. When the Centers for Disease Control and Prevention noted that marijuana vaping was most often linked to EVALI, the Wall Street Journal editorial board decried the “risky social experiment [of] legalizing and especially destigmatizing cannabis”—a drug that “could be damaging young brains for a lifetime.” News reports tout studies suggesting higher potency cannabis could mean higher risks of addiction and health harms.

    Research to clarify the specific nature of cannabis risks to youth is needed. We also need research on the current state of cannabis misinformation, including overly rosy views of risk that could create a backlash when problems are publicized. Using the results of this research for outreach ASAP, before the pot panic gets rolling, could soften the impact.

    Scrutinize and Enforce

    To avoid repeating mistakes of the past, we also need rigorous oversight. The FDA has been criticized for reluctance to use its powers to remove illegal nicotine vapes from the market. Some companies continue to sell despite warning letters. We need to study what cannabis products drive youth use and proactively target those makers and distributors.

    Products likely to attract underage users deserve particular scrutiny. Although no deaths were reported, a study in the journal Pediatrics2 documented a worrisome increase in child poisonings from edible cannabis products. To protect both adult access and child well-being, it’s common sense to require that edibles come in clearly marked, child-resistant packaging with no resemblance to candy.

    We have tools to unmask the bad actors. Youth will tell us in surveys what products they buy. The FDA’s own National Youth Tobacco Survey identified products not legally on the market, such as Puff Bar and Hyde, as favorite brands (Hyde was identified through write-in responses).

    With nicotine, regulatory delays and gray areas (such as regulation of synthetic nicotine) were abused by companies willing to skirt the law for quick profit. We see analogous situations with cannabis. One example is hemp-derived delta-8 THC products, said to produce a milder high similar to that from marijuana-derived delta-9 THC. Sales are rising fast. So are concerns. There are safety risks from impurities created during delta-8 manufacturing. And public confusion over delta-8’s legal status could complicate marijuana legalization efforts.

    The Reagan-Udall Foundation review of the CTP highlighted the need for “truthful and accurate information to help adult consumers make informed decisions about the role of nicotine” and product-specific risks. This applies equally to cannabis.

    This article first appeared in Vapor Voice‘s sister publication Tobacco Reporter.

  • Hong Kong Begins Ban on CBD, Same Penalty as Heroin

    Hong Kong Begins Ban on CBD, Same Penalty as Heroin

    Credit: Proxima Studio

    Once legal in the city, Hong Kong began enforcing its ban on CBD, labeling it as a “dangerous drug” and imposing harsh penalties for its possession on Wednesday. The move is forcing fledging businesses to shut down or revamp.

    THC, the psychoactive ingredient of marijuana has long been illegal in Hong Kong.

    CBD was once legal in the city, and cafes and shops selling CBD-infused products were popular among young people, according to AP.

    But all that has changed with the prohibition, which took effect Wednesday but had been announced by the government last year. CBD-related businesses have closed down while others have struggled to remodel their businesses. Consumers dumped what they saw as a cure for their ailments into special collection boxes set up around the city.

    The new rule reflects a zero-tolerance policy toward dangerous drugs in Hong Kong, a semi-autonomous southern Chinese business hub, as well as in mainland China, where CBD was banned in 2022.

    In contrast. the U.S. Food and Drug Administration recently concluded that a new regulatory pathway for cannabidiol (CBD) is needed. The regulatory agency states it will seek guidance from the U.S. Congress. The new rules would need to balance individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.

  • CTP to Release Reagan-Udall Response in February

    CTP to Release Reagan-Udall Response in February

    The Head of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) said in a perspective released today that the Center recently received the findings from the Reagan-Udall Foundation’s independent evaluation of its program and is in the process of closely reviewing the feedback. In February, the Center will provide an update on its planned actions in response to the evaluation.

    When the Reagan-Udall Foundation submitted its recommendations to Robert Califf, commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the PMTA process.

    CTP Director Brian King also announced the Center has accepted for review more than 8,600 marketing applications for synthetic products. In a recently released perspective, King said the center received more than 1 million premarket tobacco product applications (PMTAs) from 200 companies by May 14, 2022.

    “FDA has also issued refuse-to-accept (RTA) letters for more than 925,000 products in applications submitted by May 14 that do not meet the criteria for acceptance,” King wrote. “The RTA letters state that it is illegal to sell or distribute the product in the U.S. marketplace without a premarket authorization.”

    Brian King / Credit: FDA

    He also stated that in 2022, CTP participated in 52 meetings with stakeholders – averaging one per week – including 25 meetings since King became director. King also stated that starting when the FDA was given the authority by Congress to regulate non-tobacco nicotine products in April 2022, the CTP has issued more than 75 warning letters to manufacturers through Jan. 20, 2023, including manufacturers of brands popular among youth, such as Puff Bar.

    “We have also issued over 585 warning letters to retailers for the sale of non-tobacco nicotine products to underage purchasers as of December 2022. In October 2022, the U.S. Department of Justice (DOJ), on behalf of the FDA,” filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers that failed to submit PMTAs and continued to sell products,” wrote King.

    In a court filing last week, the FDA stated it will take until possibly December 31, 2023, before it completes the PMTA review process for some of the most popular vapes on the market.

    Much like an earlier op-ed this year, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. 

    King also failed to address the conclusion of a recent investigation conducted by the  U.S. Office of Special Counsel that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.