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Tag: Henry Sicignano

  • Trump Administration Looking to Change PMTA Process

    Trump Administration Looking to Change PMTA Process

    The Trump administration is reportedly preparing changes to the FDA’s review process for new tobacco products that could make it faster and easier for products such as flavored vapes and nicotine pouches to receive marketing authorization, according to The Wall Street Journal. The FDA is expected to revisit requirements established in 2021 for Premarket Tobacco Product Applications (PMTAs), following years of industry criticism over lengthy reviews.

    Reuters reported it could not independently verify the report, but quoted an HHS spokesperson as saying, “The Trump administration is committed to keeping nicotine out of the hands of kids, getting ⁠counterfeit vaping products off the streets and providing safer alternatives for adults who want to quit smoking cigarettes.”

    Industry groups and companies welcomed the potential changes. Laura Leigh Oyler, vice president of regulatory affairs at Haypp Group USA, said the FDA has not met congressional review deadlines for noncombustible products and has authorized fewer than 100 reduced-risk products compared with thousands of combustible products. “An overhaul isn’t just welcome, it’s necessary,” Oyler said, adding that the current process has contributed to the influx of foreign, illicit products.

    Charlie’s Holdings also supported the reported changes, saying it has been seeking FDA authorization for certain tobacco-derived nicotine e-liquids since 2020 and hundreds of synthetic nicotine products since 2022. CEO Henry Sicignano said the PMTA process has imposed high costs on smaller U.S. businesses while illicit products have entered the market. Charlie’s said it currently retains 678 timely filed PMTA assets and expects a streamlined authorization process to increase the value of its portfolio.

  • 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.