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  • 5th Circ. Grills FDA on PMTA Rules

    5th Circ. Grills FDA on PMTA Rules

    A Fifth Circuit panel questioned the U.S. Food and Drug Administration this week, raising doubts about whether it properly considered the impact of its 2021 rule requiring premarket authorization for new tobacco products on small businesses. According to Law 360, the judges questioned whether the agency complied with the Regulatory Flexibility Act, which mandates that regulators assess how new rules affect smaller firms. Vape companies argue the FDA relied on outdated economic data and imposed disproportionate costs that could drive many small manufacturers out of the market.

    During oral arguments in New Orleans, the panel pressed the FDA on its shift in position between 2016 and 2021, when the agency moved from a more flexible approach to requiring extensive scientific evidence for new products. The judges also asked whether the health risk information requirements were discretionary or mandated by the Tobacco Control Act. The skepticism suggests the court is weighing whether the FDA’s rulemaking process adequately accounted for the realities faced by small vape businesses.

    The case comes amid broader challenges to the FDA’s handling of Premarket Tobacco Product Applications (PMTAs), including disputes over flavored e-cigarette denials. If the Fifth Circuit finds the FDA violated the Regulatory Flexibility Act, the agency could be forced to revisit its rulemaking, potentially easing compliance burdens for smaller companies.

  • Korea Labels Synthetic Nicotine as ‘Tobacco’

    Korea Labels Synthetic Nicotine as ‘Tobacco’

    South Korea’s National Assembly passed a major amendment to the Tobacco Business Act yesterday (December 2), closing a long-criticized loophole by classifying liquid e-cigarettes that use synthetic nicotine as “tobacco.” The tobacco law change was part of a broader package of 79 livelihood-related bills and 16 budget measures passed during the session.

    Officials say the move addresses a regulatory blind spot that allowed widespread use of synthetic nicotine—which they said accounts for 95% of the market— without taxation or consistent public health controls. Lawmakers expect the change to generate roughly 930.1 billion won ($632 million) in new tax revenue once implemented. The measure had stalled repeatedly since 2016 “due to industry opposition,” but this time cleared the plenary session with bipartisan support.

  • Strategic Partnership to Elevate Cannabis Data Use

    Strategic Partnership to Elevate Cannabis Data Use

    Paradym Solutions and BDSA announced a strategic partnership designed to reshape how cannabis companies use data. At the core of the collaboration is the integration of Paradym’s advanced analytics and semantic AI with BDSA’s comprehensive market intelligence. This combination aims to move the industry beyond static reporting toward real-time, unified insights that can guide decision-making and growth.

    Technologically, the partnership focuses on building a new data ecosystem that mirrors the rigor of mature Consumer Packaged Goods markets. Paradym’s platform will enable clients to merge internal datasets with BDSA’s market data, producing sophisticated analytics that can be applied directly to business strategy. The companies plan to co-develop new metrics and standardized reporting attributes, setting a precedent for how cannabis businesses manage and interpret data.

  • J.C. Newman Restoring Part of Tampa’s Cigar Heritage

    J.C. Newman Restoring Part of Tampa’s Cigar Heritage

    J.C. Newman Cigar Company announced that the final phase of construction began last week on the historic Sanchez y Haya Hotel in Tampa’s Ybor City. Built in 1910, the building was once a hub for cigar workers, located across the street from J.C. Newman’s famed El Reloj factory, but has fallen into disrepair after decades of neglect.

    Now owned by J.C. Newman, the building has been structurally stabilized, stripped to its bones, cleared of a long-running bat infestation, and prepared for total revival. Backed by $18 million in public and private investment, including major support from Hillsborough County and Tampa’s CRA, it is scheduled to open as a boutique hotel and cigar destination in November 2026.

    J.C. Newman president Drew Newman said the project is a “responsibility and tribute to Tampa’s cigar story.”

    Click here to see coverage of the story on Tampa Bay’s Fox 13.

  • Young Children Gaining Access to Nicotine Products: Kenyan Survey 

    Young Children Gaining Access to Nicotine Products: Kenyan Survey 

    According to the 2024 Data on Youth and Tobacco in Africa survey, Kenya is facing a rise in tobacco experimentation among extremely young children, claiming that smokeless tobacco and roll-your-own cigarettes are reaching children as young as 5 years old. According to the survey, 6.5% of adolescents had tried tobacco at least once, and 2.5% used it within the past 30 days.

    Researchers said children as young as 6 had tried manufactured cigarettes, nicotine pouches, and/or shisha, while vape use was found by age 9. Only 5.4% of the youth surveyed reported being denied purchase of e-cigarettes, and 8.7% were blocked from purchasing cigarettes.

  • Using Tobacco with Cannabis Tied to Unique Brain Changes: Study

    Using Tobacco with Cannabis Tied to Unique Brain Changes: Study

    A small study from McGill University suggests that people who use both tobacco and cannabis show distinct brain chemistry changes compared to cannabis-only users. Published in Drug and Alcohol Dependence Reports, the study said brain scans revealed higher levels of the enzyme FAAH, which regulates the endocannabinoid system and has been linked to addiction and anxiety. This may help explain why co-users often report worse mental health outcomes.

    While the study did not include tobacco-only users and remains preliminary, researchers say the findings highlight a possible molecular mechanism behind the risks of combined use and could inform future treatments for cannabis use disorder.

  • Malaysian Raid Seizes $2.7M in Illicit Vapes

    Malaysian Raid Seizes $2.7M in Illicit Vapes

    Malaysia’s Customs Department detailed the seizure of more than RM13 million ($2.7 million) worth of illicit vape devices and liquids during an October raid on a storage warehouse in Padang Besar. Officers discovered 719,250 units, including over 211,000 devices and 508,000 liquids, all of which were believed to be undeclared and lacked the required Health Ministry import permits.

    The products, imported from China, had arrived via Kuala Lumpur International Airport before being transported to Perlis. A man in his 40s is under investigation, and authorities are probing whether the stock was intended for domestic sale or re-export.

  • Korea Busts Cigarette Smuggling Operation

    Korea Busts Cigarette Smuggling Operation

    Seoul Regional Customs referred three people to prosecution for smuggling packs of cigarettes and falsifying customs declarations to evade taxes. Authorities said the suspects re-imported 1.75 million exported cigarette packs by claiming they were being sent to a third country, while concealing the goods in a warehouse in Busan and declaring shipments as water bottles and newspapers. The scheme reportedly avoided around 6.1 billion won ($4.2 million) in taxes.

    According to The Korea Times, the ringleader, already on trial for a similar smuggling case, had amassed significant assets, including a high-value Seoul apartment, which authorities have seized in coordination with prosecutors.

  • Supreme Court Told Cannabis Ban is Outdated

    Supreme Court Told Cannabis Ban is Outdated

    Two libertarian advocacy groups — the Cato Institute and Pacific Legal Foundation — filed amicus briefs supporting a petition in Canna Provisions Inc. v. Bondi/Garland, which asks the U.S. Supreme Court to reconsider the federal marijuana ban under the Controlled Substances Act (CSA). They argue that the Court’s 2005 ruling in Gonzales v. Raich, which upheld federal authority over intrastate cannabis activity, is outdated given widespread state legalization and shifting federal enforcement.

    A third group, the Americans for Prosperity Foundation, has also filed a brief urging the Court to take the case, claiming the CSA’s application to state-regulated, intrastate marijuana markets exceeds Congress’s commerce-clause powers.

    A recent federal appeals court decision rejecting a similar challenge reaffirmed that Raich remains controlling — underscoring that only the Supreme Court can revisit the precedent.

    The justices will consider the petition at their December 12 conference and announce on December 15 whether they will hear the case. A ruling limiting federal authority over intrastate cannabis activity could have broader implications for federal-state regulatory power, potentially affecting future oversight of nicotine products, heated tobacco, and other controlled substances.

  • Charlie’s Holdings’ New Factory to Serve Texas Market

    Charlie’s Holdings’ New Factory to Serve Texas Market

    Yesterday (December 1), Charlie’s Holdings, Inc. announced the opening of its first U.S.-based manufacturing facility in Huntington Beach, California, which will exclusively produce the company’s own brands, including the Pachamama 25K line. The move ensures full compliance with Texas’ new law banning certain vape products imported from China and other restricted countries.

    “We originally expected our US-filling facility to mitigate Far East shipping delays and to lessen tariff costs, but Texas’ new domestic manufacturing requirements have also created a massive sales opportunity for Charlie’s,” Charlie’s president Henry Sicignano III, said. “Demand is so great, we now plan to devote 100% of our current U.S. manufacturing capacity to the state of Texas; if all goes well, and if we expand our U.S. manufacturing initiative in the coming months, we believe Texas could double Charlie’s sales forecasts for 2026.”

    This week, 300 retail accounts across Texas will begin receiving shipments of Charlie’s U.S.-filled disposables.

    “To my knowledge, Pachamama is the only vapor products brand that has been on the market for more than a decade and is now fully compliant with Texas domestic manufacturing requirements,” said Ryan Stump, Charlie’s co-founder and Chief Operating Officer.