Author: Taco Tuinstra

  • CTP Outlines Responses to Reagan-Udall Report

    CTP Outlines Responses to Reagan-Udall Report

    Photo: Tada Images

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) on Feb. 24 outlined the steps it plans to take in response to an external evaluation of its operations conducted by evaluators working through the Reagan-Udall Foundation.

    The expert panel issued its final report on Dec. 19, 2022, and included 15 recommendations across a number of areas.

    To address concerns raised in the report about transparency, the CTP said it would appoint internal transparency liaisons within each CTP Office, who will be responsible for objectively identifying areas for transparency enhancement. The center will also create a new webpage to feature its responses to citizen petitions and will resume posting scientific policy memos and reviewer guides “when appropriate.”

    To enhance efficiency of its premarket tobacco product application review process, the CTP said it has started developing a more efficient framework for high-quality reviews. The center said it aims to better communicate on scientific issues and practices; hire additional staff and increase internal communication to improve scientific engagement and deliberation. Among other activities, the CTP said it will resume posting of scientific policy memos and reviewer guides, along with communication through public events, such as workshops and listening sessions.

    The CTP also expressed its intention to hold more frequent meeting of the Tobacco Products Scientific Advisory Committee to obtain input on scientific issues.

    To improve its operations in the areas of regulations and guidance, the CTP said it will create a new policy unit within the Office of the Center Director that would be responsible for providing overall policy coordination across the CTP.

    The FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products.

    Recognizing opportunities to enhance its compliance and enforcement work, the CTP said it will convene a summit related to enforcement with senior officials from the Department of Health and Human Services, the FDA, and the Department of Justice (DOJ). The CTP will consider whether statutory changes are needed to assist the center in enforcing the law. It will also explore approaches to achieve compliance outside of judicial enforcement actions through DOJ.

    The CTP said it plans to create a comprehensive webpage for all enforcement activities for products that are illegally marketed without FDA authorization; routinely reach out to industry stakeholders to keep them apprised of new enforcement priorities and updates; and enhance the FDA’s tobacco product marketing order webpage. Planning has already begun for development of a searchable public database of all tobacco products that have an FDA marketing order, according to the center.

    To improve engagement on its public education campaigns, the CTP said it will develop, publish and promote resources that describe the mechanisms it currently uses to solicit and consider public input on its campaigns. It will also explore new ways for soliciting and considering public input on its campaign program.

    Consistent with the Reagan-Udall report recommendation, the CTP is also engaging with relevant entities within FDA, the Department of Health and Human Services, and the Office of Personnel Management to identify solutions to facilitate more timely and efficient hiring of professionals that match CTP’s needs.

    To achieve its goals, the CPT stressed the importance of having appropriate resources, which it suggested could be raised through additional user fees for regulated products, including e-cigarettes. “Since the agency’s fiscal year 2020 budget request, the FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products,” said FDA Commissioner Robert Califf in a statement.

    A detailed description of the CTP’s plan for addressing the Reagan-Udall recommendations is available at the center’s new website.

  • Malaysia PM Wants Rules for Nicotine E-Liquids

    Malaysia PM Wants Rules for Nicotine E-Liquids

    Photo: Max

    The government of Malaysia wants to regulate and tax nicotine liquids, reports New Straits Times, citing Prime Minister Anwar Ibrahim.

    Speaking during the presentation of the government’s 2023 buget, Anwar said that although vape with nicotine is illegal, the product is still being sold widely with an estimated market size of more than MYR2 billion. “Would it not be great if it is monitored and taxed to discourage the usage of vape,” asked Anwar, who is also the finance minister.

    While welcoming the proposal to introduce a regulatory and taxation framework for e-cigarettes, industry groups insisted on consultations. “Regulations and tax rates need to be balanced given it will impact local industry players,” said The Malaysian Vape Chamber of Commerce.

    In his presentation, Anwar also expressed support for the Generational Endgame (GEG) bill, which would make it illegal for people born after 2007 to buy tobacco products, including e-cigarettes.

    The Advanced Centre for Addiction Treatment Advocacy (ACATA) said the government must conduct more studies on the GEG proposal before making any decision.

    While ACATA is encouraged by the government is taking steps to regulate vape, the agency said prohibition was likely to backfire. “There is substantial and credible evidence to prove that vape products are less harmful than smoking cigarettes,” the organization stated. It also cited evidence showing that vaping is effective in helping smokers to quit smoking cigarettes without attracting many never-smokers. ACATA cited a 2020 study, which found that only 0.6 percent of Malaysian nonsmokers vape.

    The Malaysian Vapers Alliance, meanwhile, expressed disappointment that the government supported the GEG proposal, saying that cigarettes and vapor products should be treated differently, given the vast difference in risk they present.

  • U.S. Court Orders Elfbar to End U.S. Vape Sales

    U.S. Court Orders Elfbar to End U.S. Vape Sales

    Photo: md3d

    A U.S. federal judge on Feb. 23 ordered Shenzhen Weiboli Technology to stop marketing its Elfbar e-cigarettes in the U.S., finding that VPR Brands, which makes and sells Elf brand vapes, is likely to succeed on its claims that the Elfbar vapes infringe its trademark, reports Law360.

    According to U.S. District Judge Aileen M. Cannon, VPR has shown there is a likelihood of confusion and the company stands to suffer harm if its Chinese competitor is allowed to keep selling the Elfbar vapes.

    In November, VPR asked for an injunction blocking Shenzhen Weiboli from continuing to use the Elfbar mark, arguing the alleged infringement is costing VPR about $100 million because of the effect on future sales.

    VPR claims Shenzhen Weiboli is not only infringing VPR’s Elf trademark but also its patent for its e-cigarette device.

    While there is no direct evidence that Shenzhen Weiboli deliberately intended to adopt the Elf mark to take advantage of the existing trademark, Judge Cannon wrote that the company was well aware of the Elf mark and that there was potential for confusion, as the U.S. Patent and Trademark Office denied the registration of an Elfbar trademark specifically for those reasons.

    VPR welcomed the judge’s decision. “VPR is pleased that the court found Elf is a strong trademark and granted the injunction,” said Joel B. Rothman of Sriplaw, which represented VPR in the case. “The injunction will allow VPR to move quickly against infringers and counterfeiters in the marketplace.”

    An attorney for Shenzhen Weiboli said the company intends to appeal the order.

  • 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.

  • Advocates Clarify Science Controversies Ahead of COP10

    Advocates Clarify Science Controversies Ahead of COP10

    Photo: Alliance

    Tobacco harm reduction advocates are keen to clarify controversies surround the science on nicotine and vaping ahead of the Conference of the Parties (COP10) to the World Health Organization’s Framework Convention on Tobacco Control (FCTC), which will take place in November 2023.

    The Coalition of Asia Pacific Tobacco Harm Advocates (CAPHRA) has written FCTC delegation heads to help inform their respective countries’ positions.

    In its letter, CAPHRA notes that two high-profile studies, which have been quoted by tobacco controllers regarding the dangers of nicotine and vaping, have since been retracted and removed from significant medical journals.

    “The first retraction is an article published in February 2022 in The World Journal of Oncology, claiming that nicotine vapers face about the same cancer risk as cigarette smokers,” CAPHRA wrote.

    Another article, in the Journal of the American Heart Association, which reported an association between vaping and heart attacks was also retracted. Astoundingly, advocates noted, this article is still used as a reference in the FCTC guidelines around e-cigarettes.

    Consumers’ rights to choose to use less harmful products to switch from smoking remain under tremendous threat from FCTC’s continuing failure to address scientific evidence, democratic processes and human rights.

    In addition, the THR regional advocacy group sent delegates a bibliography of key and current studies that disprove some of the more outrageous claims around harm.

    On the supposed “youth vaping epidemic,” CAPHRA noted “a new survey from the Centers for Disease Control and Prevention and Food & Drug Administration suggests that youth vaping rates appear to be dropping, compared to pre-pandemic levels… In fact, youth vaping in the U.S. has plummeted by 60 percent over the past two years.’  

    “Consumers’ rights to choose to use less harmful products to switch from smoking remain under tremendous threat from FCTC’s continuing failure to address scientific evidence, democratic processes and human rights,” says CAPHRA executive coordinator Nancy Loucas.

    The CAPHRA representatives reminded the health leaders that the FCTC has a mandate to pursue Harm Reduction as a core tobacco control policy—a position it has failed to acknowledge or implement since its inception, according to CAPHRA.

    “WHO and its FCTC continue to press for signatory states to adopt ever more restrictive policies, including outright bans, based on dubious science. Delegates to COP10 should be representing the rights and aspirations of the citizens,” wrote the CAPHRA member organizations.

    “Consumers have the right to make choices that help them avoid adverse health outcomes and smokers have the right to access less harmful nicotine products as alternatives to smoking. Please take account of these rights when making and presenting your submissions to COP10,” the letter concluded.

  • “Common Language” Video Attracts Ire of THR Advocates

    “Common Language” Video Attracts Ire of THR Advocates

    Tobacco harm reduction activists have criticized a John Hopkins School of Public Health video calling for “common language” in tobacco control.

    The video features Johanna Cohen, Bloomberg professor of disease prevention and director of the school’s Institute for Global Tobacco Control.

    “With the introduction and marketing of new nicotine products, it’s not only the marketplace that has diversified,” Cohen says in the video. “The number of terms used to describe these products has expanded significantly as well. Often with word choice that serves tobacco industry interests.

    “Accuracy and consistency are extremely important because language can shape our thinking, including setting boundaries for discourse and policy options.”

    The video, however, did not go over well with some vapers; one comment on the video states, “If we accept Joanna Cohen’s language, then we—People Who Use Safer Nicotine to avoid toxic forms of tobacco—would be accepting the language of our oppressors. What she does not seem to understand is that this is not a battle between tobacco control and evil industry. There are real human beings involved, with lived experience. Cohen clearly has zero empathy for us.”

    “This is a bit rich coming from the people who call e-cigarettes ‘tobacco products’ and use the term e-cigarette or vaping use-associated lung injury to describe an illness that has nothing to do with e-cigarettes.

    Chris Snowdon, head of lifestyle economics at the Institute of Economic Affairs, also criticized the video. “This is a bit rich coming from the people who call e-cigarettes ‘tobacco products’ and use the term e-cigarette or vaping use-associated lung injury to describe an illness that has nothing to do with e-cigarettes,” he said.

    In the video, Cohen recommends “using ordinary, precise terms without additional adjectives” with the goal of “establish[ing] a common language.”

    “What’s regrettable,” writes Alex Norcia on Filter, “is that there is an important conversation to be had about terminology in the tobacco and nicotine field, but the video, from an institution funded by anti-vaping billionaire Michael Bloomberg, misses that opportunity.”

    “When it comes to language and terminology, it seems to me that people in public health get overly preoccupied with what incumbent tobacco companies are doing, when their actual focus should be on consumers and people who actually use these products,” said Danielle Jones, the president of the board of CASAA.

    “Using the language of the people using the products, which is typically the terminology most well known, should be their focus in order to facilitate clear communication and not confuse people. For instance, not knowing the established terminology when writing survey questions for people who vape can lead to erroneous results if the respondents misunderstand what the researchers are asking,” Jones said.

    Another viewer commented, “WE use these devices. WE define the terms. You need to stop talking and start listening.”

  • New Zealand Solicits Feedback on Vaping Restrictions

    New Zealand Solicits Feedback on Vaping Restrictions

    Photo: Brian Jackson

    New Zealand’s government is seeking feedback on measures to help reduce the number of young people vaping, reports a The Times Online.

    According to Associate Health Minister Ayesha Verrall, vaping is becoming increasingly popular among New Zealand youth, including among youngsters who have never smoked.

    “Vaping has a role to play in ensuring smokers who wish to quit smoking can do so using vaping products; however youth vaping rates are too high and we need to strike a better balance,” she was quoted as saying.

    The proposed measures include proximity restrictions for all new specialist vape retailers, so they are not near schools and sports grounds; restrictions on flavor names to avoid attracting youth; and restrictions on single-use vaping products, which are cheaper and more easily accessible than other e-cigarettes.

    In addition, the government wants to reduce the maximum concentration of nicotine salts in single-use products from 50mg/mL to 35mg/mL and require vaping companies to print serial or batch numbers on their products to make them traceable.

    The consultation document is available on the Ministry of Health website with submissions closing at 5pm on March 15.

  • COP10 Delegates Urged to Consider Harm Reduction

    COP10 Delegates Urged to Consider Harm Reduction

    Photo: lovelyday12

    The Coalition of Asia Pacific Tobacco Harm Advocates’ (CAPHRA) nine member organizations have written to Framework Convention for Tobacco Control delegation heads from around the world, urging them to review the evidence that supports a tobacco harm reduction (THR) approach ahead of COP10.

    With governments sending delegates to COP10 in November 2023, CAPHRA was keen to send leaders comprehensive reference material for their COP10 planning, submission writing and deliberations.

    COP10 will held in Panama and is hosted by the World Health Organization’s FCTC.

    ‘We do this on behalf of the four million current users of safer nicotine products in the wider Asia Pacific region. As you are aware, our region bears the brunt of the harm and death from combustible and unsafe oral tobacco globally,’ said the letter.

    The CAPHRA representatives reminded the health leaders that the FCTC has a mandate to pursue harm reduction as a core tobacco control policy.

    “It has been known for decades that tar and carcinogens found in tobacco smoke, cause the death and disease associated with smoking, not nicotine. Research has proven that nicotine, while usually mildly addictive in the same way as caffeine, is not a health issue,” they wrote.  

    The letter also called on delegates to deplore FCTC’s policy to conduct COP10 sessions behind closed doors.

    “Delegates to COP10 should be representing the rights and aspirations of the citizens whose taxes are paying for their attendance, who expect them to speak on their behalf, acknowledge the science underpinning the harm reduction benefits of ENDS, and maintain democratic principles,” they wrote.

    The CAPHRA representatives asked countries to take into account, when making their COP10 submissions, that consumers have the right to make choices that help them avoid adverse health outcomes. What’s more, people who smoke have the right to access less harmful nicotine products as alternatives to smoking.

    The evidence-based documentation was wrapped up in a recently released white paper, titled “The Subversion of Public Health: Consumer Perspectives,” which was presented by CAPHRA executive co-ordinator Nancy Loucas at the Fifth Asia Harm Reduction Forum.

  • China Set to Restrict Most E-cigarette Shipments

    China Set to Restrict Most E-cigarette Shipments

    Photo: ikurdyumov

    China’s State Tobacco Monopoly Administration (STMA) plans to limit the number of vapor products a person can carry on them, reports The Global Times.

    According to a notice published Nov. 23, a person can possess a maximum of six “smoking devices,” 90 e-cigarette cartridges and 180mL of e-liquid.

    On the same day, the STMA and the State Post Bureau jointly announced restrictions on the delivery of vapor products. Each shipment may contain a maximum of two “sets,” six cartridges and 12mL of e-liquid.

    Each recipient is allowed to accept delivery of no more than one shipment of vapor products per day.

    In April, China’s tobacco regulator approved mandatory national standards for e-cigarettes that came into effect in October.

  • Video: TGA Boss Admits Issues With Australian Rule

    Video: TGA Boss Admits Issues With Australian Rule

    The head of the Australia’s Therapeutic Goods Administration (TGA) has acknowledged shortcomings in the country’s vaping regulations, according to tobacco harm reduction activist Colin Mendelsohn.

    Writing on his website, Mendelsohn says TGA boss John Skerrit “has finally admitted the disastrous and predictable failure of Australia’s vaping regulations,” which among other things require vapers to obtain a doctor’s prescription to buy nicotine-containing e-cigarettes

    During questioning in Australia’s Senate, Skerrit acknowledged not only that there has been a dramatic increase in youth vaping, but also that large numbers of low-quality products are entering the country and are being sold on the black market, according to Mendelsohn.

    In addition, Skerrit noted that only 1,353 out of 130,000 registered doctors have applied to be authorized e-cigarette prescribers and less than 10 percent of adult vapers have a prescription for nicotine.

    According to Mendelsohn, Skerritt had previously promised a review of the regulations, which were introduced on Oct. 1, 2021, at three, six and 12 months. Instead, he wrote, the TGA and government had a secret meeting of unnamed vaping experts.

    Mendelsohn said it is likely that further restrictions and enforcement will be recommended by “the experts” to double down on their de facto prohibition. “This will only lead to greatly reduced legal vaping and more deaths from smoking,” he wrote.