Tag: Regulatory

  • Taxes Increasing Gap Between Regulatory Intentions and Market Realities

    Taxes Increasing Gap Between Regulatory Intentions and Market Realities

    At the Global Tobacco and Nicotine Forum (GTNF) in Brussels, a panel moderated by Tim Phillips, Managing Director of Tamarind Intelligence, explored how taxation and tariffs are shaping the future of nicotine products in a rapidly evolving market. Speakers included Christa Pelsers (BAT), Stefano Santi (Philip Morris International), and Maria Angelova (Socotab Frana SA).

    In “It’s All About Tax — The Complex World of Excise and Tariffs,” Phillips opened by stressing that “the next few years are going to be vitally important,” as novel products—from vapes to nicotine pouches—continue to disrupt markets. “We’re seeing massive problems around illicit trade and tax collection,” he said, noting that in some countries, “more than half of the market may already be illicit.” The result, he warned, is a growing gap between regulatory intentions and market realities.

    Pelsers highlighted the speed of innovation and the challenges it creates for regulators. “For years, there was no innovation in tobacco, and now we have an explosion of new products—governments are still trying to catch up,” she said. Pelsers argued that taxation must be based on science, not politics, and criticized the European Commission’s fragmented approach: “The Commission is proposing that every member state can adjust its own rates. That makes things even more complex. We need harmonization to ensure fairness and functionality in the single market.”

    She also warned of geopolitical shifts impacting trade. “With U.S. tariffs, China is redirecting exports elsewhere. The EU’s response has been slow. The next few years will reshape who we trust as trading partners,” she said. “And if tax rates are set too high, it will be detrimental to innovation.”

    Santi emphasized that excise tax policy should not only collect revenue but also guide consumers toward less harmful products. “Ten years ago, my job was complexity five; now it’s fifty,” he said. “We need to balance taxation in a way that shifts the market without driving consumers to the black market.” He endorsed differentiated tax levels for different product types, saying, “If you raise taxes too fast, consumers will find cheaper, often illicit alternatives.”

    Santi called for leveraging member state experience to modernize EU tax policy and harmonize definitions. “The directive is a good start, but it’s lagging behind. Treating all products the same is a recipe for failure. Europe needs to protect its economic and manufacturing footprint.”

    Angelova added a perspective from the leaf tobacco sector, calling taxation “one of the quiet architects of humanity.” She warned that poorly designed taxes could devastate rural livelihoods. “Tobacco is an agricultural product that supports families. Nowhere else in the world is raw tobacco subject to excise tax,” she said. “Making local tobacco less affordable than imported tobacco doesn’t help anyone.”

    Angelova stressed the importance of practical implementation: “It’s not just about what we tax—it’s about how. Details make the difference. Track and trace systems are vital to ensure transparency and prevent unfair competition.”

    She concluded by urging policymakers to proceed with caution: “We’re trying to solve too many problems at once. We need to start addressing them one by one. Europe still has many families who rely on tobacco farming. Consumers won’t forget how we handle this.”

    The panel collectively underscored that while excise and tariff reforms are inevitable, their success will depend on nuance, balance, and genuine collaboration with industry to avoid unintended economic and public health consequences.

  • Supreme Court Favors FDA in Flavor Battle

    Supreme Court Favors FDA in Flavor Battle

    Today (April 2), the Supreme Court unanimously overturned a lower court’s decision that the U.S. Food and Drug Administration incorrectly blocked flavored nicotine e-liquids, rejecting e-cigarette makers that were challenging regulatory hurdles on tobacco products.

    E-liquid companies Triton Distribution and Vapetasia LLC claimed the FDA unlawfully denied the marketing authorization for flavored vape products and disputed that the products appealed to children, arguing that the government was harming nicotine-addicted adults by keeping a cigarette alternative off the market.

    The vape companies argued the FDA failed to review the company’s own scientific evidence, which demonstrates its flavored products were crucial to getting smokers to switch from combustible cigarettes to e-cigarettes. The Fifth Circuit Court agreed with the e-cigarette maker, ruling that “the agency’s rejection was arbitrary and capricious because the FDA relied on conflicting evidence requirements.” The court also faulted the FDA for dismissing “out-of-hand companies’ strategies to keep their products away from minors.” The agency said such efforts haven’t proven to be effective.

    Public health groups had already sued the FDA for not moving fast enough to review the products after the agency, in 2016, finalized rules for regulating them under the 2009 Family Smoking Prevention and Tobacco Control Act. Under the Act, vape companies were forced to submit applications to the FDA in order to bring new vape flavors to market, and the FDA was to assess the public health effects of those products. A rift, however, emerged over the agency’s criteria for approving or denying those applications, which culminated in the Fifth Circuit.

    The fight was brought to the Supreme Court in November with the FDA contending it correctly applied the Tobacco Control Act, saying it considered both the “likelihood that existing users of tobacco products will stop using such products” and the “likelihood that those who do not use tobacco products will start using such products.”

    Oral arguments in front of the Supreme Court centered on whether the FDA standards are a policy position or a substantive rule imposed without notice and comment. The Biden administration argued the standards fell into the policy bucket, pushing the court to give the agency deference to interpret its role under the Tobacco Control Act. 

    Under the Biden administration, the FDA rejected more than a million flavored products, saying companies failed to show that flavored vapes will do more to benefit public health by helping smokers quit tobacco products than the harm they cause by appealing to young people.

    Vaping companies hope they’ll find a friendlier regulatory environment under the Trump administration, as the President previously promised to “save” flavored vaping.

  • Regulatory Freeze Pending Review

    Regulatory Freeze Pending Review

    As the Trump Administration digs in, it has called for a regulatory freeze pending review across all agencies, citing five points:

    (1)  Do not propose or issue any rule in any manner, including by sending a rule to the Office of the Federal Register (the “OFR”), until a department or agency head appointed or designated by the President after noon on January 20, 2025, reviews and approves the rule.  

    (2)  Immediately withdraw any rules that have been sent to the OFR but not published in the Federal Register, so that they can be reviewed and approved as described in paragraph 1, subject to the exceptions described in paragraph 1. 

    (3)  Consider postponing for 60 days from the date of this memorandum the effective date for any rules that have been published in the Federal Register, or any rules that have been issued in any manner but have not taken effect, for the purpose of reviewing any questions of fact, law, and policy that the rules may raise.  

    (4)  Following the postponement described in paragraph 3, no further action needs to be taken for those rules that raise no substantial questions of fact, law, or policy.  For those rules that raise substantial questions of fact, law, or policy, agencies should notify and take further appropriate action in consultation with the OMB Director.

    (5)  Comply in all circumstances with any applicable Executive Orders concerning regulatory management.

    Should actions be identified that were undertaken before noon on January 20, 2025, that frustrate the purpose underlying this memorandum, the administration modify or extend this memorandum, to require that department and agency heads consider taking steps to address those actions.