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Category: Global Regulation

  • CTP Hires New Office of Science Director

    CTP Hires New Office of Science Director

    Matthew Farrelly (Credit: RTI International)

    The new director of the U.S. Food and Drug Administration’s tobacco science division is Matthew Farrelly, former chief scientist and director of the Center for Health Analytics, Media, and Policy for RTI International.

    In an announcement, the FDA’s Center of Tobacco Products (CTP) stated that Farrelly’s extensive work in the field of tobacco and nicotine science for more than 25 years, and being recognized internationally as an expert with proven leadership and organizational management skills will help him succeed as the director of the CTP’s Office of Science.

    “He has led or been involved with numerous scientific endeavors related to tobacco control policies and regulatory approaches, including those related to graphic health warning labels, excise taxes, smoke-free policies, quitlines, state tobacco control programs, retail advertising, and flavored tobacco products,” the release states. “He has also extensively researched the influence of mass reach health campaigns, including FDA’s The Real Cost.”

    Farrelly also has authored or co-authored over 120 articles in peer-reviewed scientific literature, according to the release. He earned his Ph.D. in Economics from the University of Maryland at College Park.

    Farrelly joins the CTP as the agency faces a series of major tobacco-related decisions, including a potential ban on menthol cigarettes, lowering nicotine levels, and the next step in its ongoing attempt to regulate Juul and other electronic cigarettes.

    Farrelly will replace Matt Holman, who left the position last year to join Philip Morris International. Holman was hired in 2017 and took over for David Ashley.

  • A Teaching Moment

    A Teaching Moment

    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.

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
    Willie McKinney is the founder of McKinney Regulatory Science Advisors. He’s held senior regulatory roles at major tobacco product companies and served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee.
  • FDA Denies Two Vuse Menthol Vapor Products

    FDA Denies Two Vuse Menthol Vapor Products

    Photo: rangizzz

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for R.J. Reynolds Vapor Co.’s Vuse Vibe Tank Menthol 3.0 percent and the Vuse Ciro Cartridge Menthol 1.5 percent.

    “Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of the FDA’s Center for Tobacco Products. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”

    “Existing evidence demonstrates that nontobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” the FDA wrote in a statement.

    “Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote a complete switch or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarette products. Data from the 2022 National Youth Tobacco Survey found that Vuse was the second most common brand youth e-cigarette users reported ‘usually’ using.”

    “Today’s decision pertains to the specific application submitted for review by FDA,” said King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”

    In assessing the implications of the most recent MDOs for RJRV’s parent company, BAT, Morgan Stanley noted that Vuse Vibe and Vuse Ciro represent only a small portion of BAT’s overall e-cigarette sales in the U.S.

    “Should it choose to appeal, we would expect its products to remain on the market as the appeal is ongoing, resulting in minimal/no operating impact,” the investment bank wrote in a note to investors.

    Morgan Stanley said the MDO provides another example of the FDA’s ongoing reluctance to approve menthol e-cigarette flavors. To date, the agency has approved only tobacco-flavored e-cigarettes.

    The financial institution also noted that the FDA has granted both a premarket tobacco product application and modified-risk tobacco product designation to IQOS’ menthol variant, which may make it one of the few menthol reduced-risk alternatives on the market.

    The FDA is targeting publishing a final rule to ban menthol cigarettes in August 2023, but considering expected industry litigation, final implementation could be five to six years away, according to Morgan Stanley.

  • 22nd Century Submits CBD Drug Master File

    22nd Century Submits CBD Drug Master File

    Image: Tobacco Reporter archive

    22nd Century Group filed a U.S. drug master file (DMF) to the U.S. Food and Drug Administration for cannabidiol (CBD) API from GVB Biopharma, a 22nd Century Group company, according to a company press release.

    “GVB Biopharma is widely recognized for the quality and consistency of its Cannabinoid extracts and ingredients,” said James A. Mish, CEO of 22nd Century. “We are now leveraging these capabilities with our DMF filing to meet the increasing regulatory demands of the supplements markets.”

    Additionally, 22nd Century and GVB Biopharma have entered into an agreement with Cannabinoid API Solutions (CAS) and Transo-Pharm for global sales, marketing and distribution of GVB’s Cannabinoid APIs. Transo-Pharm is a well-established supplier and distributor of pharmaceutical APIs to a broad portfolio of branded and generic finished drug product manufacturers, including more than 75 current active, ongoing development programs.

    “The partnership with Transo-Pharm will accelerate opportunities to supply our APIs to the largest and most innovative pharmaceutical and consumer goods manufacturers in the world,” said Mish.

  • FDA Launches Online Vaping Resource Center

    FDA Launches Online Vaping Resource Center

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration has launched the Vaping Prevention and Education Resource Center, which provides free science-based, standards-mapped materials that teachers can use to help their students understand the risks associated with vaping and nicotine addiction. The Center for Tobacco Products also developed free materials for parents and teens.

    Teachers will find lesson plans, interactive tools, infographics and videos with tobacco facts and tips about how to teach teens about the dangers of vaping.

    Parents will find fact sheets, videos and resources to help them understand and recognize vapes, talk with their children and keep the conversation going over time.

    According to the FDA, students will find real-life stories and relatable content to help them understand vaping, nicotine addiction, common myths about vapes and how to say no to vaping.

    The resource center will be continuously updated, according to the FDA.

  • Mexico Tightens Tobacco Laws

    Mexico Tightens Tobacco Laws

    Image: sezerozger | Adobe Stock

    Mexico has banned smoking in public places, reports Mexico News Daily.

    The country has also prohibited the advertising, promotion and sponsorship of tobacco products, which means that cigarettes cannot be displayed inside shops. E-cigarettes and heated-tobacco products are also facing tighter new restrictions, particularly indoors, as per BBC. Last year, Mexico banned the import, sale and distribution of vaping and heated-tobacco products.

    Several other Latin American countries have also passed legislation to create smoke-free public spaces. Last year, for example, Panamanian President Laurentino Cortizo also signed legislation banning the sale of vapor products in his country.

    However, Mexico’s legislation is considered to be the most wide-ranging in the Americas.

    Critics have cautioned against unintended consequences. Given the prevalence of corruption in Mexico, they fear that some police officers will use the smoking ban as a pretext for demanding bribes.

  • Taiwan Lawmakers Approve Vape Ban

    Taiwan Lawmakers Approve Vape Ban

    Photo: sharafmaksumov

    Lawmakers in Taiwan approved amendments to the Tobacco Hazards Prevention Act that would ban e-cigarettes, raise the legal buying age for combustibles and require heated-tobacco products to comply with strict regulations, reports Taiwan News.

    People caught using unauthorized vapor products or tobacco-heating devices risk fines of between TWD2,000 ($66) and TWD10,000.

    Manufacturers and sellers of such products would be required to submit health risk assessment reports backed by product samples. Unauthorized tobacco manufacturers, importers and advertisers are subject to fines ranging from TWD10 million to TWD50 million, according to the amendments.

    Other changes involve raising the legal smoking age from 18 to 20, increasing the proportion of tobacco package warning messages from 35 percent to 50 percent and designating childcare centers and schools as no-smoking areas.

    The amendments to the Tobacco Hazards Prevention Act were proposed in part due to concern about the growing popularity of vaping among youth.  

    The share of e-cigarette users in junior high schools grew from 1.9 percent in 2018 to 3.9 percent in 2021, according to a survey by the Health Promotion Administration, while the share in senior high and vocational schools rose from 3.4 percent to 8.8 percent during the same period. Some critics blame flavors for the increase.

    The clauses on e-cigarettes and heated-tobacco products are to take effect one month after the amendments’ contents are announced to the public. The clauses on vapes with additional flavors as well as regulations on packaging are to take effect one year after the amendments are announced.

    The last time the Tobacco Hazards Prevention Act was amended was in 2009.

  • New Zealand Solicits Feedback on New Rules

    New Zealand Solicits Feedback on New Rules

    Photo: Brian Jackson

    New Zealand’s government is seeking feedback on measures to help reduce the number of young people vaping, reports 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 50 mg/mL to 35 mg/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 5 p.m. on March 15.

  • Vietnam Wants to Ban New Tobacco Products

    Vietnam Wants to Ban New Tobacco Products

    Image: Faraz | Adobe Stock

    Vietnam’s Ministry of Health has called for a ban on all new tobacco products following the publication of a study suggesting that youth vaping has led to more hospitalizations for psychosis, hallucinations or respiratory failure, reports VietnamPlus.

    A recent study found that the e-cigarette smoking rate among students increased to 3.5 percent in 2021 from 2.6 percent in 2019, according to Nguyen Thi Thu Huong, an official from the Vietnam Tobacco Control Fund at the Ministry of Health.

    “E-cigarette devices that look like USB drives, pen or pen boxes are making it tough for parents to detect and keep their kids from vaping,” said Nguyen Huu Hoang, a lecturer from the Medical Education Center at Ho Chi Minh City’s University of Medicine and Pharmacy. “They also make young people curious and excited by their eye-catching, fashionable and modern designs.”

  • Menthol and Nicotine Timelines Accelerated

    Menthol and Nicotine Timelines Accelerated

    Image: pingebat | Adobe Stock

    The Biden administration released its Unified Agenda and Regulatory Plan for fall 2022, which includes moving forward the timeline for a federal ban on menthol-flavored cigarettes, reports The Winston-Salem Journal.

    There are eight rules that address the tobacco industry, and three have “notable changes” from the spring 2022 plan, according to Jain Gaurav, a Barclays analyst. These include: Rules on a menthol ban in cigarettes and flavored cigars have moved to the “final rule stage” versus the “proposed rule stage”; rules to ban characterizing flavors in cigars have also progressed to the final rule stage; and the nicotine cap proposed standard development has been moved from May to October.

    “We continue to believe the Food and Drug Administration’s focus is going to revolve around the evaluation of premarket tobacco [product] applications of deemed products, notably e-cigarettes, in the next few months,” Gaurav said.

    “The FDA intends to publish a final (menthol) rule by August 2023. We expect a two-[year] to three-year cycle from the day FDA passes any rule to the time such rule survives the inevitable court challenges.

    “We don’t expect a menthol cigarette ban from the FDA implemented (if it were to pass) at least until 2026.”

    A cigarette menthol ban could have negative impacts on tobacco stocks with a significant U.S. presence, according to Gaurav and other tobacco industry analysts. Menthol cigarettes account for 35 percent of cigarettes sold in the U.S.

    “While there is some risk, a federal ban on menthol cigarettes could reduce smoker initiation and potentially be a catalyst that prompts a number of smokers to quit, thereby having some negative impact on cig volumes,” said Bonnie Herzog, Goldman Sachs analyst, “we continue to believe a more likely scenario is for menthol cig users to convert to nonmenthol cig products or to reduced-risk products that have a menthol variant, such as e-vapor.”

    It is expected that the FDA will face lawsuits from tobacco manufacturers and anti-smoking groups if the ban goes through because Congress exempted menthol from banned flavorings in traditional cigarettes in the federal Tobacco Control Act in 2009.

    In June, the FDA issued its proposal to reduce nicotine content in traditional cigarettes to minimal and potentially nonaddictive levels as early as May 2023.

    “We think it will take a decade or longer for the FDA to introduce nicotine caps due to the long nine-step process at the FDA, the inevitable litigation and then the one year given to retailers to get rid of the excess inventory,” Gaurav said.