Tag: United States

  • Oregon Court of Appeals Approves Local Flavor Ban

    Oregon Court of Appeals Approves Local Flavor Ban

    The Oregon Court of Appeals upheld a Washington County ban on flavored tobacco sales.

    Washington County commissioners approved Ordinance 878 in 2022, but it was not enforced because a circuit court judge overturned it.

    In his opinion, Circuit Judge Andrew Erwin wrote that prohibiting the sale of flavored tobacco must come from the state, not the county.

    The county appealed the judge’s decision, and the court found that the county is not preempted by state law. According to Washington County’s website, businesses will be inspected each year to ensure compliance with the ordinance.

    Tony Aiello, Jr., the attorney for the plaintiffs-respondents, released a statement, saying, in part, “My Clients are disappointed with the decision by the Court of Appeals today and intend to seek review by the Oregon Supreme Court.

    “We read the Court of Appeals’ decision to conflict with itself in several places and are optimistic that the Oregon Supreme Court will reach a different conclusion if our case is granted review.”

  • U.S. Marshals Seize $700,000 in Unauthorized Vapes

    U.S. Marshals Seize $700,000 in Unauthorized Vapes

    Photo: APchanel

    The U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California. The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.

    “FDA has been unequivocally clear that we are committed to using the full scope of our enforcement tools—including seizures—to hold those who peddle unauthorized e-cigarettes accountable,” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “The writing is on the wall for those in the tobacco product supply chain who fail to heed the law.”

    This action represents the first time the U.S. Food and Drug Administration and the Department of Justice (DOJ) have seized tobacco products in coordination with the U.S. Marshals Service.

    The seizure initially targeted products being held and sold by MDM Group, a distributor doing business as Eliquidstop.com. FDA issued a warning letter to MDM Group in May 2023, for offering unauthorized, flavored e-cigarette products for sale or distribution. In January 2024, FDA conducted a follow-up inspection of the firm and determined that it continued to commercially market its illegal products. While conducting the seizure at MDM’s facility, the agencies were informed that several firms may have an ownership interest in the unauthorized e-cigarettes seized.

    As of April 2024, the FDA had issued approximately 670 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and issued more than 550 warning letters to retailers for the sale of unauthorized e-cigarettes. The agency has also filed civil money penalty complaints against more than 50 e-cigarette manufacturers and more than 100 retailers for manufacture and/or sale of unauthorized new tobacco products, as well as complaints for permanent injunction against seven e-cigarette manufacturers.

  • U.S. Vape Market Topped $2.67 Billion in 2021

    U.S. Vape Market Topped $2.67 Billion in 2021

    Photo: auremar

    The 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, while the total topped $2.67 billion, according to the Federal Trade Commission’s (FTC) third report on e-cigarette sales and advertising in the United States, which was released on April 3, 2024. E-cigarette companies also spent $90.6 million more advertising and promoting their products in 2021 than in 2020.

    The FTC report examines two main types of e-cigarettes. Some have rechargeable batteries and changeable prefilled cartridges; others are disposable after running out of charge or e-liquid. Reported sales of cartridge products increased from $2.13 billion in 2020 to $2.5 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 2021 report also provides details on some characteristics of e-cigarette products, including flavors and nicotine concentration, as well as the bundling of the components in cartridge systems. The data 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 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 the advertising and promotion of 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.

  • PMI Names Parman as U.S. Communications Officer

    PMI Names Parman as U.S. Communications Officer

    Photo: PMI

    Philip Morris International has appointed Travis Parman as vice president and chief communications officer of the U.S.

    “We are thrilled that Travis is joining us in our bold ambition to deliver a smoke-free future in the United States. We’re on a mission to replace cigarettes—the most harmful form of nicotine consumption—as soon as possible with science-based smoke-free alternatives that are a better choice than continued cigarette use,” said Stacey Kennedy, president of the Americas region and CEO of PMI’s U.S. business, in a statement. “With his passion for positive change and deep communications experience in the U.S. and internationally, Travis will be a valuable addition to our leadership team.”

    Parman joins PMI from AppHarvest, a tech-driven sustainable food company based in Kentucky, where he served as chief communications officer since 2020. He previously held multiple roles with the Renault-Nissan-Mitsubishi Alliance in Paris; Nashville; and Yokohama, Japan—most recently as vice president of international communications and global engagement.

    Prior to his work with the alliance, he held public relations and communications leadership roles at General Motors, Ally Financial and PulteGroup. Parman holds a master’s degree in communications management from the Newhouse School of Public Communications at Syracuse University and a bachelor’s degree in communications from the University of Tennessee.

    “Joining PMI at such a pivotal moment in the company’s journey toward a smoke-free future provides the perfect opportunity to drive meaningful change, which has been a hallmark throughout my career as a communicator,” said Parman.

  • Major Bill to Boost Vape Tax Introduced in Congress

    Major Bill to Boost Vape Tax Introduced in Congress

    Credit: Splitov27

    Last week, lawmakers in the U.S. introduced the CARE For Moms Act in Congress. That bill would increase healthcare for expecting and new mothers, while also exponentially increasing the taxes for vaping, roll-your-own, cigars and other tobacco products.

    The tobacco tax language in the CARE Act was copied and pasted out of the Tobacco Tax Equity Act, a bill that has been introduced as a rider in bills introduced in previous sessions of Congress but it failed to gain any traction, according to halfwheel.

    That could change after Sen. Ron Wyden and Sen. Dick Durbin have now introduced the Tobacco Tax Equity Act of 2023 in the Senate as a standalone bill, while Rep. Raja Krishnamoorthi introduced the bill in the House of Representatives.

    The tobacco tax-related language includes:

    • New taxes for e-cigarettes;
    • Doubling the tax on roll-your-own tobacco;
    • A more than 16x increase on pipe tobacco;
    • Doubling the tax on small cigars;
    • A massive tax hike for premium cigars;

    For premium cigars, the language removes the existing federal excise tax of 52.75 percent, capped at 40.26 cents per cigar, and replaces it with a weight-based tax of $49.56 per pound.

    Because it’s a weight-based tax, the difference between the existing tax and the new taxes would vary depending on how heavy the cigar is. For cigars robusto or larger, it would likely more than triple the current federal tax rate.

  • White House Set to Step Up Fight Against Smoking

    White House Set to Step Up Fight Against Smoking

    Photo: Alexander Ryabkov | The White House

    The White House on Sept. 13 announced a $240 million investment to fight cancer, along with a slew of new health resources to further the administration’s “Cancer Moonshot” initiative.

    The announcements from the Biden Cancer Moonshot include:

    • New investments to reduce the impact of menthol and other flavored commercial tobacco products in communities that experience health disparities
    • A new plan to decrease the impact of smoking on Americans’ health by expanding efforts to prevent smoking and to support everyone who wants to quit. To ensure Americans who want to quit have the support they need, the Department of Health and Human Services will finalize its Framework to Support and Accelerate Smoking Cessation this year.
    • New smoking cessation resources for underserved communities, including American Indian, Alaska Native and Black communities, to reduce cancer health disparities.
    • A new pilot program to increase veteran engagement in tobacco use treatment. The Department of Veterans Affairs, in collaboration with the National Cancer Institute, will conduct a clinical demonstration project to assess how to more effectively engage veterans in tobacco-use treatment programs.
    • New resources and actions to reduce exposures to environmental carcinogens. The Environmental Protection Agency (EPA) is launching gov/cancer, with new information and prominently featured resources from EPA and other federal agencies about secondhand smoke, smoking cessation and other cancer-related topics.

    Tobacco harm reduction activist have been urging Biden administration to embrace less harmful alternatives in its Cancer Moonshot initiative. “If President Biden is serious about beating cancer, then embracing tobacco harm reduction is not just an option, it’s a necessity,” said Michael Landl, director of the World Vapers Alliance (WVA), in a statement.

    Landl pointed to the examples of Sweden and the United Kingdom, which he said have proven the effectiveness of vaping and other less harmful products in reducing smoking rates. “Instead of fighting less harmful alternatives, the Biden Administration needs to embrace vaping as a smoking cessation aid,” he said.

    The investments in programs aiming to reduce smoking among marginalized groups would be more impactful if they included harm-reducing alternatives, according to Landl.

    “To achieve the desired outcomes in cutting cancer-related deaths, it’s imperative that the United States foster a comprehensive harm reduction strategy that acknowledges vaping’s potential to save lives. Many smokers fail to quit, so to beat cancer we need to get real about that and encourage the use of less harmful alternatives such as vaping,” he said.

    The WVA urged the Biden administration to develop an inclusive strategy that incorporates a range of less harmful alternatives to smoking. “Flavor bans, high taxation on safer nicotine products and the overly bureaucratic FDA approval process must end immediately,” said Landl.

  • 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.

  • New Report Finds FDA Fails in Enforcing MDOs

    New Report Finds FDA Fails in Enforcing MDOs

    Photo: Postmodern Studio

    The U.S. Food and Drug Administration has failed to follow through after issuing warning letters to online tobacco products and vapor product sellers, according to a report by the Health and Human Services Office of the Inspector General (OIG).

    Between 2010 and 2020, the FDA issued warning letters to 899 online retailers but “took no enforcement actions,” according to the report.

    The FDA enforcement schedule, as of March 2022, calls for the following actions: first violation—warning letter; second violation within a 12-month period—fine of up to $320; third violation within a 24-month period—fine of up to $638; fourth violation within a 24-month period—fine of up to $2,559; fifth violation within a 36-month period—fine of up to $6,398; sixth violation within a 48-month period—fine of up to $12,794; and five or more repeated violations within 36 months—no-tobacco-sale order of 30 calendar days or six months or permanent.

    The OIG report criticizes the FDA’s lack of transparency, which it says makes it hard to track the FDA’s performance. The report suggests that the FDA collaborate with the Bureau of Alcohol, Tobacco, Firearms and Explosives on oversight of online tobacco retailers; complete its rulemaking on non-face-to-face sales of tobacco products as required by the Tobacco Control Act; collect data to support process and outcome measures for its oversight of online tobacco retailers; and publish information and performance data on its oversight of online tobacco retailers.

    In a response, the FDA did not dispute a lack of enforcement actions and agreed with the first and fourth suggestions, stating it is in the process of making those changes. The organization was noncommittal regarding the other two suggestions.

    The OIG report is separate from the Reagan-Udall Foundation review of the FDA’s Center for Tobacco Products.

  • Biden Signs First Federal Standalone Marijuana Bill

    Biden Signs First Federal Standalone Marijuana Bill

    President Joe Biden officially signed the first piece of standalone federal cannabis reform Friday. The U.S. president signed a marijuana research bill into law that cleared the House in July and the Senate last month.

    The act is aimed at providing federal support to facilitate research of cannabis and its potential health benefits. The law gives the U.S. attorney general 60 days to either approve a given application or request supplemental information from the marijuana research applicant.

    The Marijuana and Cannabidiol Research Expansion Act also creates a more efficient pathway for researchers who request larger quantities of cannabis.

    The act does three things:

    • Provides a mechanism for the scientific study of cannabidiol and cannabis for medical purposes;
    • Arranges a pathway for the FDA to approve the commercial production of drugs containing or derived from cannabis; and
    • Protects doctors who may now discuss the harms and benefits of using cannabis and cannabis derivatives.

    The president remains opposed to federal cannabis legalization, but he campaigned on a number of more modest marijuana reforms, including promoting research, decriminalization and rescheduling cannabis under the Controlled Substances Act (CSA), according to the National Law Review.

    Biden also issued a mass pardon for Americans who’ve committed federal marijuana possession cases in October and directed an administrative review into cannabis scheduling. The White House recently listed those actions among the “top accomplishments” for the president.

  • FDA Issues Guidance on Perception, Intention Studies

    FDA Issues Guidance on Perception, Intention Studies

    The U.S. Food and Drug Administration Today issued a final guidance on Guidance perception and intention studies.

    This guidance, “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies,” is intended to help applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product (MRTP) application, a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report).

    TPPI studies can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products, according to the FDA.

    These studies provide critical information during the review of product applications and this guidance provides recommendations on how to perform these studies.

    This final guidance addresses the following scientific issues for applicants to consider when designing and conducting TPPI studies to support tobacco product applications:

    • Developing study aims and hypotheses
    • Designing quantitative and qualitative studies
    • Selecting and adapting measures of study constructs
    • Determining study outcomes
    • Selecting and justifying study samples
    • Analyzing study results

    This guidance document is intended to provide clarity to applicants regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed as recommendations for consideration, unless specific regulatory or statutory requirements are cited.