Author: Timothy Donahue

  • Governor Signs Kentucky Vape Registry Law

    Governor Signs Kentucky Vape Registry Law

    Andy Beshear (Credit: State of Kentucky)

    On April 5th, Kentucky Governor Andy Beshear signed House Bill 11 into law. This makes Kentucky the sixth state in the US with a registry law. The bill was passed quickly in both houses of the Kentucky General Assembly on March 28. The new law will go into effect on January 1st, 2025.

    Under the new Kentucky law, it will be illegal to sell vaping products that do not have marketing authorization from the U.S. Food and Drug Administration or are still under review by the agency. This law also applies to products that have received a marketing denial order (MDO), unless the MDO has been stayed or reversed by the FDA or a court. Manufacturers are required to certify that each product complies with state requirements before allowing its sale in Kentucky.

    Among other things, the bill also:

    • Require the Secretary of State to create and publish a list of certain tobacco product retailers;
    • Require the Department of Alcoholic Beverage Control to create and maintain a tobacco noncompliance database and reporting system;
    • Require wholesalers to verify a retailer’s presence in the database prior to transactions;
    • Establish and impose fines for wholesalers that unlawfully sell to a retailer that is in the noncompliance database;
    • Make ineligible any retailer with unpaid fines that are more than 60 days overdue from selling Tobacco Control Act-covered products until the fines are paid;
    • Direct manufacturers of Tobacco Control Act-covered products to provide safe harbor certification to wholesalers and retailers of their products;
    • Prohibit a retailer from selling Tobacco Control Act products to persons under 21 years of age.

    PMTA registry laws are already being enforced in Alabama, Louisiana and Oklahoma. Wisconsin passed a registry law in December and will become effective July 1, 2025. Utah also passed a registry bill that included a flavor ban that will become active on Jan. 1, 2025.

  • Ohio Preemption Law Forces 14 Cities to File Lawsuit

    Ohio Preemption Law Forces 14 Cities to File Lawsuit

    Credit: Zach Frank

    The Ohio General Assembly passed a preemption law earlier this year that prevents cities and counties from enacting tobacco regulations that are stricter than the state laws.

    The law was enacted after lawmakers overrode Governor Mike DeWine’s veto, which came after a year-long battle over the banning of flavored tobacco sales.

    This week, 14 cities filed a legal challenge to the law that, if successful, would allow those cities to introduce their own rules even if they are more stringent than state rules.

    The cities of Columbus, Bexley, Cincinnati, Cleveland, Dublin, Gahanna, Grandview Heights, Heath, Hilliard, Oxford, Reynoldsburg, Upper Arlington, Whitehall, and Worthington filed the case in Franklin County. The plaintiffs claim the law violates the state’s constitution, specifically a line that states that cities “have the ‘authority to exercise all powers of local self-government and to adopt and enforce within [their] limits such local police, sanitary and other similar regulations, as are not in conflict with general laws.’”

    According to Patrick Lagreid of Halfwheel, the suit also argues that the ban would adversely affect citizens. The Ohio legislature passed the preemption law during a special session, which DeWine later vetoed.

    The ban was again passed by the state’s General Assembly as part of its budget proposal, then vetoed again by DeWine before the General Assembly voted to override the veto in January. The case seeks a temporary injunction to keep the ban from going into effect on April 24.

    Republican state lawmakers have tried multiple times to prohibit local governments from restricting the sale of tobacco, only to be thwarted by DeWine’s vetoes.

    In 2022, he struck down such a proposal. Last July, he struck the provision from the rest of the state budget, saying that local bans were “essential” to curb nicotine use, especially among children, without a statewide ban in place.

  • CTP Hires Director of Health Communication and Education

    CTP Hires Director of Health Communication and Education

    Courtesy: US FDA

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has hired Anne Rancourt as its next director of CTP’s Office of Health Communication and Education.

    Rancourt comes to CTP from the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) where she serves as the Communications Director.

    Rancourt has more than two decades of experience working in strategic communications, behavior change programs and journalism, including nearly 14 years within the federal government, according to a release.

    At NIDA, Rancourt is responsible for managing the communication branch that oversees the dissemination of a nearly $2 billion scientific research portfolio on substance use and addiction, including tobacco and e-cigarette use.

    She also advises the Institute director on communication strategies, informing agency leaders on broad public health, education, and scientific policy matters and issues.

    Prior to her tenure at NIDA, Rancourt led press outreach and media strategy on HIV as a Communications Section Chief at the National Institute of Allergy and Infectious Diseases (NIAID).

    Earlier in her career, Rancourt led media and digital outreach strategies for The Heart Truth campaign at NIH’s National Heart, Lung and Blood Institute.

    Rancourt was selected after an extensive nationwide search, multiple interview panels that evaluated a substantial and well-qualified applicant pool, and clearance through important FDA ethics and security processes.

    She will begin the new position on May 19th.

  • ATR: Scott Veto a ‘Huge Relief’ for Vermont Vapers

    ATR: Scott Veto a ‘Huge Relief’ for Vermont Vapers

    Credit: Carsten Reisinger

    Vermont Governor Phil Scott returned Senate Bill 18, a sweeping ban on flavored tobacco, vapor, and all other nicotine-containing products, without a signature after it passed the Senate 18-11 and the House 83-53. Both fell short of enough votes to override the veto.

    Tim Andrews, director of Consumer Issues for Americans for Tax Reform (ATR), said Scott’s veto is a “huge relief” to Vermonters who rely on vaping products to avoid returning to combustible cigarette use. He also said, “Rejecting the tax hike will make it easier for those who currently smoke to achieve cessation using vapor products, as flavors are proven to be a crucial factor in an adult smoker’s decision to quit.”

    In his veto letter, Scott described S.18 as “hypocritical and out of step with other initiatives that have been passed”. Alongside the double standard of enacting a tobacco flavor ban post the legalization of cannabis (flavored varieties included) in 2020 and state advertisement of flavored alcohol products, the bill also compromises the state’s revenue stability, the ATR wrote in a press release.

    This bill would have resulted in an estimated revenue loss of between $7.1 to $14.2 million in fiscal year 2027. Nearby Massachusetts has already experienced similar consequences as a result of its own flavor ban, seeing a $17 million loss in tobacco tax revenue to New Hampshire, which gained $18 million in revenues as residents drove across the border to purchase flavored products, according to ATR.

  • Qnovia Appoints Four to Scientific Advisory Board

    Qnovia Appoints Four to Scientific Advisory Board

    Photo: Mariakray

    Qnovia has appointed four new members to its scientific advisory board (SAB). The new members are Neal Benowitz, professor at the University of California at San Francisco, Ian M. Fearon, independent consultant, Darla E. Kendzor, professor at University of Oklahoma Health Sciences Center, and Nicole Nollen, professor at University of Kansas.

    “Our newly appointed advisors bring world-class scientific and multi-disciplinary expertise and reaffirm our commitment to advance novel therapies for the millions of people who seek to quit smoking,” said Qnovia CEO Brian Quigley in a statement.

    “We are grateful for the leadership of the chair and founding member of our SAB, Dr. Jasjit S. Ahluwalia, a professor at Brown University, who has been instrumental in shaping the direction of our SAB over the past year. The expansion of our SAB complements the regulatory expertise of our policy and regulatory strategy advisor, Mitch Zeller, who served a prior appointment as director of FDA’s Center for Tobacco Products.”

    Qnovia is a pharmaceutical company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRx.

    “Looking ahead, our SAB will serve a critical role as we advance the clinical development of our lead asset, QN-01, towards FDA and MHRA approval,” Quigley said. “We believe our proprietary drug-device combination platform has the potential to be a first-in-class and best-in-class treatment for smoking cessation.

    “Last fall, QN-01 demonstrated a superior pharmacokinetic profile compared to existing nicotine replacement therapies in our first-in-human Phase 1 clinical trial. We plan to submit our IND and CTA to the regulatory bodies and look forward to commencing our Phase 1/2 clinical study this year. Overall, we are highly encouraged by the data we have generated to date and believe that 2024 is going to be a pivotal year for Qnovia,” he added.

  • Thailand Cracking Down on Vaping in Schools

    Thailand Cracking Down on Vaping in Schools

    Credit: a3701027

    Thailand’s Office of the Basic Education Commission (OBEC) is set to implement strict measures, including personal belongings checks, in an attempt to curb the use of vapes in schools after a “surge” in usage among students.

    The Deputy Secretary-General of OBEC, Thee Pawangkanan, has expressed concerns over the increasing usage of e-cigarettes among Thai students aged 13-15. According to media reports, there have also been cases of vape usage among first-graders, as young as six and seven years old, making them the youngest smokers.

    Obec is considering conducting bag searches to screen for illegal and inappropriate objects, including e-cigarettes, before students enter classrooms. Pawangkanan said the measures will be imposed at schools starting on May 15, the first day of the new term.

  • FTC Report Finds Major 2021 Vape Sales Boost

    FTC Report Finds Major 2021 Vape Sales Boost

    Credit: JIRSAK

    The Federal Trade Commission issued its third report on e-cigarette sales and advertising nationwide. The report found combined sales of cartridge-based and disposable e-cigarette products to U.S. consumers by nine leading manufacturers increased by approximately $370 million between 2020 and 2021.

    The total topped $2.67 billion. E-cigarette companies also spent $90.6 million more advertising and promoting their products in 2021 than in 2020.

    Reported sales of cartridge products increased from $2.133 billion in 2020 to $2.496 billion in 2021; sales of disposable, non-refillable e-cigarette products increased from $261.9 million in 2020 to $267.1 million in 2021.

    The data also shows that in 2021, 69.2 percent of e-cigarette cartridges either sold or given away contained menthol-flavored e-liquids, and the rest were tobacco-flavored.

    Disposable e-cigarettes are not covered by the flavor restrictions imposed by the U.S. Food and Drug Administration. In 2021, “other” flavored devices made up 71 percent of all disposable devices sold or given away, with the most popular subcategories being fruit-flavored and fruit & menthol/mint-flavored products.

    These two subcategories alone made up more than half of all disposable e-cigarette devices sold or given away in 2021.

    According to the report, expenditures for advertising and promoting e-cigarettes increased from $768.8 million in 2020 to $859.4 million in 2021, with the three largest spending categories being price discounts, promotional allowances paid to wholesalers, and point-of-sale advertising.

    Together, these three categories accounted for almost two thirds of expenditures in 2021.

    Finally, the report discusses steps that e-cigarette companies took in 2021 to deter or prevent underage consumers from visiting their websites, signing up for mailing lists and loyalty programs, or buying e-cigarette products online.

    These steps include the use of online self-certification to verify users were at least 21 years old and following state laws requiring an adult signature upon delivery of e-cigarette products.

    The Commission vote approving the FTC’s E-Cigarette Report and related data tables for 2021 was 3-0.

    Youth vaping, however, is down drastically. Government data shows youth vaping dropped more than 60 percent last year compared to 2019.  Around 5.3 million middle school and high school students reported vaping in 2019, with more than 2.1 million youth reporting vaping in 2023.

  • Oversight Committee to Question FDA Commissioner

    Oversight Committee to Question FDA Commissioner

    Robert Califf (Photo: FDA)

    The U.S. House Oversight and Accountability Committee will question U.S. Food and Drug Administration Commissioner Robert Califf as part of an investigation into the agency’s handling of tobacco and nicotine products regulation, among other issues, according to a press release.

    Last year, the committee announced an investigation into the FDA Center for Tobacco Products (CTP). “We have deep concerns that the CTP’s decisions have been influenced by political concerns rather than scientific evidence,” wrote Oversight Committee chairman James Comer in a letter for Califf. “Comments from FDA staff to RUF [the Reagan-Udall Foundation] … reflect such concerns.”

    Other members of Congress have also questioned the FDA’s commitment to fair regulation, with a bipartisan group of senators asking Califf in 2023 to explain the FDA’s premarket tobacco product application process.

    The hearing is scheduled for April 11 at 1 p.m. EDT. It will be live streamed on the committee website and on YouTube.

  • Alabama Governor Expected to Sign Possession Ban

    Alabama Governor Expected to Sign Possession Ban

    Credit: David Mark

    In Alabama, a bill to place the same restrictions on vaping products as are on tobacco products has unanimously passed both the house and senate and is headed to Governor Kay Ivey for her signature.

    The bill bans the possession of vaping products and devices by people under 21.

    “This is a tremendous first-step to help end underage vaping,” a spokesperson said, according to media. “We want parents, educators, coaches and others to have the authority to take away vapes from young people.

    “It allows law enforcement to seize vapes without having to conduct expensive tests to determine whether the device contains an illegal substance. Simple possession constitutes a violation.”

  • Digital Age Checks Deployed in the Netherlands

    Digital Age Checks Deployed in the Netherlands

    Similar technology has also been trialed in Italy. (Photo: Innovative Technologies)

    Parts of the Netherlands have implemented face scanners to check consumers’ ages before selling cigarettes to them, according to Dutch News.

    About 100 outlets have opted for face scanners so far. The camera uses artificial intelligence to scan a customer’s face and estimates their age based on features such as skin condition and wrinkles. If the customer is thought to be over 25, the transaction can continue, but if not, the machine will ask to scan the customer’s ID.

    “The process is similar to that at airports,” said Theo Snijders, CEO of H@nd, the scan-making firm.

    The legal framework was devised with product safety organization NVWA, privacy watchdogs and lawyers to ensure that customers’ personal data are not compromised. The scanners do not store data and only record the number of scans. According to Snijders, a scan is not a condition for buying tobacco as that would be illegal.

    Sellers caught not complying with age check requirements could face fines up to €9,000 or a temporary loss of their license to sell tobacco products.

    Beginning July 2024, tobacco products can only be legally sold at specialist stores and gas stations.

    Tech firms and vape stores have been experimenting with digital age-verification tools in various markets. Tobacco Reporter profiled one such project in Italy  in its December 2023 edition. (See “Beyond Face Value”).