Author: mikem

  • FDA Tobacco Case Heads to Supreme Court

    FDA Tobacco Case Heads to Supreme Court

    The Supreme Court will hear oral arguments on Tuesday in a clash between RJR Vapor and the U.S. Food and Drug Administration (FDA) centered around the rules in which the FDA can be challenged in court. The FDA argues that the Tobacco Control Act allows cases to be argued in one of three areas: in the D.C. Circuit, in the place where the plaintiff resides, or in the place where it has its principal place of business. RJR Vapor, a subsidiary of British American Tobacco based in North Carolina, however, is trying to challenge the FDA in the conservative U.S. Court of Appeals 5th Circuit based in Louisiana.

    RJR Vapor filed a petition for review along with Avail Vapor, a Texas retailer, and by a trade association for Mississippi gas stations and convenience stores that sell RJR Vapor’s products— states that reside in the 5th Circuit. RJR’s North Carolina home resides in the 4th Circuit, which had previously turned their appeal against the FDA denial of applications aside. The 5th Circuit, however, previously ruled against the FDA denials, saying the government agency was sending companies on “a wild goose chase.”

    RJR Vapor and the retailers argue the law states “any person adversely affected” can challenge the FDA, to include retailers within the 5th Circuit trying to sell RJR Vapor’s popular menthol-flavored Vuse brand e-cigarettes who could potentially go out of business. In 2016, the FDA rejected RJR Vapor’s application, saying the product would not be “appropriate for the protection of the public health.”

    The FDA argues that its rulings are “always or nearly always” regulating the manufacturer and that any effects on retailers are indirect and thus irrelevant, and that allowing this case in the 5th Circuit would allow “ready evasion” and create incentives for “forum-shopping.” The FDA contends the stakes are high in this case, as the 5th Circuit’s previous ruling would allow manufacturers to get around federal restrictions and cherry-pick the courts where its cases would be heard.

    The FDA approached the Supreme Court, and in October 2024, it agreed to hear the case. RJR Vapor argues the Supreme Court doesn’t have the authority to rule over “non-final” cases like this one to begin with, and wants the case dismissed without decision.

  • PMI Expands in Medical Cannabis

    PMI Expands in Medical Cannabis

    At the end of last week, Avicanna Inc., a commercial-stage, international biopharmaceutical company based in Canada, announced a “scientific and medical affairs” collaboration agreement with Vectura Fertin Pharma, a subsidiary of Philip Morris International (PMI). Avicanna, who specializes in cannabinoid-based medicine, has a clinical R&D department that has led to the commercialization of more than 30 proprietary, evidence-based finished products.

    The two companies formed a Scientific and Medical Affairs Committee that will focus on improving the understanding of medical cannabis access and applications in Canada.

    “PMI has consistently shown interest in the medical side of cannabis,” Aaron Grey, managing director at Alliance Global Partners, an investment firm highly active in the cannabis space, told Forbes. “Their 2016 investment in Syqe Medical was medical-focused, and this Avicanna partnership continues in that vein. PMI’s public-facing interest in cannabis has been more about the medical side than recreational or consumer products.

    “I think this is a multi-decade strategy. Usage trends among young adults are shifting—they’re moving away from tobacco and alcohol and toward cannabis. Big Tobacco sees this and wants to capture that new, growing consumer base. Companies like British American Tobacco have divisions like ‘Beyond Nicotine’ to address these trends, and cannabis is part of that vision. This isn’t just about hedging; it’s about preparing for a long-term consumer shift.”

    Forbes’ Javier Hasse wrote that PMI’s entry into Canada’s well-regulated cannabis market gives it a strategic testing ground with an eye on the U.S. market.

    “For big tobacco in general, most of the major players have made investments in cannabis,” said Grey. “For example, Altria invested $1.8 billion in Cronos Group, and Imperial Brands invested CAD 125 million in Auxly. In November 2023, BAT invested CAD 125 million in Organigram, forming an investment pool and an R&D partnership. These are all ways Big Tobacco is exploring the cannabis space, and I see PMI’s partnership with Avicanna as part of that broader trend.”

  • China’s E-Cigarette Exports Slide in 2024

    China’s E-Cigarette Exports Slide in 2024

    China’s e-cigarette exports declined to $11 billion in 2024 according to the nation’s General Administration of Customs, a decline of 1.1% from the previous year.

    The United States accounted for 36% of China’s exports ($3.7 billion), followed by the U.K. ($1.2 billion), South Korea ($717 million), and Germany ($677 million).

    Chinese exports peaked at $19 billion in 2021 but have declined each year since due to comprehensive worldwide regulations. 

  • No Vape Ban in Luxembourg

    No Vape Ban in Luxembourg

    While several neighboring countries and the European Commission are working toward banning vapor devices, Luxembourg is not.

    “We are adopting an approach based on observation and analysis of measures taken abroad,” the nation’s Ministry of Health said. “This enables us to assess the impact of these initiatives and to determine what further action, if any, could be envisaged in Luxembourg.”

    “From a health point of view, these products contain high doses of nicotine, encouraging rapid dependence, particularly among young people, and potentially leading them to other forms of tobacco consumption.”

    However, the Ministry believes that “a ban targeting disposable vapes alone would be limited in its effectiveness,” and is instead calling for a global approach that would include all electronic cigarettes and thus be “more coherent in addressing these issues.” The ministry says no studies have been carried out on the potential effect of vape sale bans in neighboring countries, and as it is, lower taxes mean that tobacco tourism is still very popular in Luxembourg.

    A 2023 bill to change the law on tobacco products is currently in committee. The bill specifically concerns the withdrawal of certain exemptions for heated tobacco products and was amended to include regulation on nicotine pouches. The text aims to ban certain flavors and limit the nicotine content of these products, however, disposable electronic cigarettes are not included in the bill.

  • TIMB Sets New Deadlines for Tobacco Licenses

    TIMB Sets New Deadlines for Tobacco Licenses

    The Tobacco Industry and Marketing Board (TIMB) in Zimbabwe has revised its deadlines for buying A-class licenses from December 31 to March 31 for buying and October 31 for renewing of each year. This applies to contractors who directly buy unprocessed tobacco from growers and to individuals or entities who purchase self-financed unprocessed leaf at the auction floors.

    An A-class buying license allows holders to buy self-funded unprocessed tobacco at licensed auction floors without requiring prior contractual obligations with the growers.

    “The new deadline dates are meant to align with the Contractors Compliance Administration Framework which all contractors must sign before they get a contracting license,” TIMB said in a statement. “The review of deadline dates will also address longstanding challenges such as delayed input delivery and non-compliance with minimum input package requirements, which have historically disadvantaged farmers.

     “Renewing or applying for a new A-class buying license by October 31 will also allow buyers to timeously secure funding so they can purchase tobacco in the next marketing season.”

    Tobacco is Zimbabwe’s second major foreign currency earner after gold predominantly produced by smallholder farmers who were allocated land under the land reform program the country embarked on in 2000. In 2024, the country’s tobacco export earnings increased by 16.6 percent to US$1.4 billion from the export of 243.3 million kilograms.

  • New EPR Requirements for Companies Selling Tobacco and Nicotine Products

    New EPR Requirements for Companies Selling Tobacco and Nicotine Products

    A wave of new “Extended Producer Responsibility” (EPR) programs is beginning to impact companies placing packaged products, including tobacco products, on the market in U.S. states, including California, Colorado, Maine, Minnesota, and Oregon. 

    Kathryn C. Skaggs, a partner with Keller and Heckman, writes “The five EPR programs for packaging enacted thus far have different facets. However, at their core, each of the EPR programs requires companies that sell packaged products (with some limited exceptions) to join a newly formed, state-recognized organization (typically called a “Producer Responsibility Organization” or “PRO”) and pay annual dues based on the amount and type of packaging placed on the market in that state. California’s PRO, for one, must collect $500,000,000 annually from producers of covered products, like single-use packaging. Producers also will need to eventually meet certain sustainability goals for single-use packaging, such as ensuring compostability or recyclability of packaging or meeting minimum post-consumer recycled content targets. What is more, the EPR programs encompass not just primary packaging that directly contacts a good, but often shipping and display packaging as well.”

    EPR program obligations typically fall on the “producer” of the covered product, generally defined to be the brand owner that places a packaged good on the market. Accordingly, it is the companies marketing the finished products, not packaging companies, that will need to register as producers of tobacco product packaging in the states with packaging EPR programs.

    Certain state EPR programs – including Colorado’s and Minnesota’s – also include “paper products” as a covered product. While tobacco companies making roll-your-own (RYO) papers and other such paper-based products may be able to avail themselves of certain exemptions, they must assess this on a case-by-case basis.

    Skaggs says the existing EPR laws do not include any explicit exemptions for tobacco product packaging or paper used in tobacco products. Accordingly, absent another applicable exemption, tobacco product manufacturers are likely to meet the producer definition under the state EPR laws, and thus will need to register with applicable state PROs, pay dues based on the product packaging sold in the state, and eventually meet certain goals for the packaging.

    In complying with the state EPR schemes, the tobacco and nicotine product industries can expect to face not only supply chain challenges (e.g., the availability of post-consumer recycled content), but also possibly significant regulatory hurdles under the Family Smoking Prevention and Tobacco Control Act. Under the EPR programs, producers may need to make changes to product packaging to meet sustainability targets. Changes to the container-closure system for a legally marketed tobacco product may well require a new premarket authorization from the U.S. Food and Drug Administration (FDA), which can be a costly and timely endeavor. 

  • Stock Buybacks Underway

    Stock Buybacks Underway

    Several large tobacco industry stalwarts have continued with stock buyback programs this week.

    British American Tobacco announced the repurchase of 134,079 ordinary shares at an average price of 2,904.6775 pence per share as part of its ongoing buyback program. This move is aimed at reducing the number of shares in circulation, potentially increasing the value of remaining shares and benefiting shareholders. Following the completion of this transaction, the company will have 2,208,154,745 shares outstanding, with 133,266,206 held in treasury, thereby impacting shareholders’ notifications under regulatory guidelines.

    Imperial Brands PLC announced the repurchase and cancellation of 152,276 of its ordinary shares as part of its GBP 1.25 billion share repurchase program. This transaction, executed through Morgan Stanley on the London Stock Exchange, aims to reduce the overall number of shares in circulation, potentially enhancing shareholder value by increasing earnings per share.

  • Hawaii Introduces Generational Bill Against Tobacco Products

    Hawaii Introduces Generational Bill Against Tobacco Products

    The Hawaii State Senate introduced a bill on January 16 that would seek to implement a generational ban on tobacco and nicotine product purchases for anyone born after January 1, 2005.

    The bill, SB429, introduced by Sens. Karl Rhoads and Stanley Chang, would prohibit the possession or consumption of a tobacco product in a public place by a person born after that date. Violations for the consumer would include having their products seized and destroyed and would receive a fine ranging from $10 to $50, while the retailers who sold the products would face fines between $500 and $2,000. The bill has not yet been assigned to a committee, but if passed as written, would go into effect on Jan. 1, 2026.

    The bill states “’tobacco product, means any product made or derived from tobacco that contains nicotine or other substances and is intended for human consumption or is likely to be consumed, whether smoked, heated, chewed, absorbed, dissolved, inhaled, or ingested by other means.  ‘Tobacco product’ includes but is not limited to a cigarette, cigar, pipe tobacco, chewing tobacco, snuff, snus, or an electronic smoking device. ‘Tobacco product’ does not include drugs, devices, or combination products approved for sale by the United States Food and Drug Administration, as those terms are defined in the Federal Food, Drug, and Cosmetic Act.”

    The bill further explains, “The legislature also finds that a prohibition based on a person’s date of birth is fair to everyone—those who have not yet attained the age of twenty-one and cannot presently purchase tobacco will never be able to buy it, while the right to purchase tobacco will remain available to those who are legally permitted to do so and who may have already formed addictive habits as a result.”

  • Growers: Pakistan Government to Establish New Tobacco Board

    Growers: Pakistan Government to Establish New Tobacco Board

     Representatives of farmers in Khyber Pakhtunkhwa (KP), Pakistan, petitioned the Pakistan Tehreek-e-Insaf-led provincial government to establish the Pakhtunkhwa Tobacco Board through legislation to protect and safeguard the rights and interests of poor growers in the province.

     “According to Pakistan’s Constitution, agriculture is a provincial subject,” said Liaqat Yousafzai, central president of the Tobacco Growers Association Pakistan. “However, the federal government had illegally and unconstitutionally taken control of it. Now, under the downsizing policy, the federal government has decided to either abolish or transfer certain government departments and institutions to the provinces, including the Pakistan Tobacco Board (PTB).”

    He urged the provincial government to seize the opportunity and set up the Pakhtunkhwa Tobacco Board to stop the ongoing exploitation of growers at the hands of existing PTB and the multinational and national tobacco companies. Local leaders have long argued control of tobacco should be handed over to the province as per the constitution.

    The Tehreek-e-Ittehad Kashtkaran Pakhtunkhwa leaders, including TIKP’s chairman Arif Ali Khan, senior vice-chairman Dawood Jan Khan of Ismaila, vice-chairman Iqbal Khan of Shewa, general secretary Asfandyar Khan, joint secretary Shahab Khan, Ahmad Jan Kaka of Marghuz and others also attended the meeting.

    “Now that the federal government has decided to withdraw from it and transfer the Pakistan Tobacco Board to the province, it is the responsibility of the KP government to move forward and take the control of the province’s most lucrative crop, tobacco, into its own hands,” Khan said.

    The speakers said the existing PTB was established in 1968 but did not include any provisions for the protection of the interests of tobacco farmers. Some protections for farmers were added over time, however, “due to the federal government’s lack of interest and at the behest of tobacco companies, the implementation of these laws had not been carried out in recent years, and the tobacco crop has been under the control of multinational companies,” they said. 

  • FDA Authorizes 20 ZYN Pouch Products

    FDA Authorizes 20 ZYN Pouch Products

    Today, the U.S. Food and Drug Administration (FDA) authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. This is the first time the agency has authorized products commonly referred to as nicotine pouches, which are small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip. 

    The FDA determined that the specific products receiving marketing authorization met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. This standard considers the risks and benefits of products to the population as a whole.

    “As a public health scientist and former Director of the Office of Science at FDA’s Center for Tobacco Products, I couldn’t be more excited for public health with FDA’s decision today,” Matt Holman, vice president of U.S. Scientific Engagement and Regulatory Strategy at PMI said on X. “Authorizing products that can help the nearly 30 million smokers in the United States switch to a better form of nicotine has the potential to save countless lives.”

    Among several key considerations, the agency’s evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorized products pose a lower risk of cancer and other serious health conditions than such products. The applicant also provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products.

    “To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products. “In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

    Additionally, the FDA found that the applicant showed these nicotine pouch products have the potential to provide a benefit to adults who smoke cigarettes and/or use other smokeless tobacco products that is sufficient to outweigh the risks of the products, including to youth. As part of its evaluation, the FDA reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years. For example, the 2024 National Youth Tobacco Survey showed that 1.8% of U.S. middle and high school students reported currently using nicotine pouches.

    “It’s critical that the manufacturer market these products responsibly to prevent youth use,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health.”

    While today’s actions permit these specific tobacco products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they “FDA approved.” There is no safe tobacco product; youth should not use tobacco products and adults who do not use tobacco products should not start. 

    The FDA will closely monitor the marketing and use of these products. To reduce the potential for youth exposure to advertising of these products, the authorizations impose stringent marketing restrictions for digital, television, and radio, including measures to ensure ads are carefully targeted to adults ages 21 and older and the demographics of the audiences reached by the ads are tracked and measured by the manufacturer. The company also stated that they intend to implement additional measures to restrict youth access, reduce youth appeal, and limit youth exposure to their labeling and advertising, such as: not using mass-market advertising on radio and TV; employing actors/models for marketing that are no younger than 35 years old, or styled to appear under 35; and avoiding any content designed to target youth, including characters, images or themes. The agency may suspend or withdraw a marketing granted order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product no longer meets the necessary public health standard, such as if there is a notable increase in youth initiation.

    The products for which the FDA issued marketing granted orders are the following, each with two nicotine strengths (3 milligrams and 6 milligrams): ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint and ZYN Wintergreen. Importantly, today’s actions are specific to these products only; the authorizations do not apply to any other nicotine pouch or other ZYN products. Additionally, the authorization does not allow the company to make reduced-risk claims about the authorized products, which would require a modified-risk tobacco product application.

    Today’s actions are the latest of many the FDA has taken to ensure all new tobacco products marketed in the U.S. undergo science-based review and have received marketing authorizations by the agency. To date, the FDA has received applications for nearly 27 million products and has made determinations on more than 26 million of those applications. This includes authorization of other flavored oral tobacco products, including nicotine mints and chews in 2021 and mint smokeless tobacco in 2015. To find a list of tobacco products that may be legally marketed and sold in the U.S., visit the FDA’s Searchable Tobacco Products Database.