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  • FDA Authorizes Juul E-Cigarettes in Tobacco and Menthol Flavors

    FDA Authorizes Juul E-Cigarettes in Tobacco and Menthol Flavors

    Today (July 17), the U.S. Food and Drug Administration (FDA) issued marketing granted orders (MGOs) for Juul Labs’ original e-cigarette device and refill cartridges in tobacco and menthol flavors.

    As part of its 2020 application, Juul submitted over 110 scientific studies to FDA covering nonclinical, clinical, and behavioral science. Following rigorous evaluation of the data, FDA decided that an MGO for the Juul System was “appropriate for the protection of public health” – the standard required by statute for authorization.

    “Today’s FDA authorization of Juul products marks an important step toward making the cigarette obsolete,” company CEO K.C. Crosthwaite said in a statement. “More than 2 million adult Americans have switched completelyaway from deadly cigarettes using Juul products. Meanwhile, underage use of our products is down 98% since 2019, to one-half of one percent of youth. 

    “We strongly support FDA’s role in regulating tobacco and nicotine products. Americans who use nicotine deserve an orderly, reliable market in which they can confidently choose from a wide array of smokefree nicotine products that are high-quality, innovative, backed by rigorous research, made in FDA-inspected manufacturing facilities, and marketed and sold responsibly.”

    The approval marks a major reversal after the FDA banned Juul’s products in 2022, citing concerns over public health. That decision was quickly stayed following an appeal by the company and formally rescinded in June 2024. During this time, Juul products remained on the market.

    “The decision follows wider expectations in the industry that the Trump Administration would ease regulatory hurdles for launching new vapes and other smoking alternatives,” Emma Rumney wrote for Reuters. “Some companies have seen FDA applications for new nicotine products languish for years or, like Juul, faced rejections that were challenged in court.”

    The approval breathes new life into Juul, which had faced regulatory roadblocks and financial turmoil after the initial ban. It also potentially signals a broader shift in FDA oversight, as the agency faces growing pressure over delays in product reviews and the proliferation of unauthorized nicotine products in the market. Juul’s authorization is seen as a potential bellwether for other pending applications in the vaping industry, the WSJ suggested.

  • Florida Court Expands “Smoking” Definition

    Florida Court Expands “Smoking” Definition

    A Florida appeals court widened the definition of “smoking” Wednesday (Feb. 26) in affirming a judge’s determination that Global Hookah owed the state $1.4 million in taxes. The 2-1 decision said the company wasn’t entitled to recoup excise taxes because its tobacco leaves fell within a state statute’s definition of “other tobacco products” regardless of whether the tobacco was actually smoked by customers.

    Global Hookah argued that its products, which consist of tobacco leaves mixed with glycerol, sugar syrup, and flavorings, are heated, not combusted, and thus should not be considered tobacco for tax purposes. It was seeking a refund from taxes paid between April 2016 to January 2019.

    The First District Court of Appeal ruled that “a fair reading of ‘smoking’ encompassed the process of consuming the vapor that occurs through the process of using the leaves,” and that the state’s 1985 law was intended to tax tobacco products regardless of the details in which they were consumed.

    “As a means to yield vaporized nicotine for inhaling, there is no meaningful difference between combusting cut-up tobacco leaves, on the one hand; and subjecting those cut-up leaves to high heat by burning something else,” Judge Adam Tanenbaum wrote for the majority. “Global’s claim that the vapor from its product differs from ‘traditional’ smoke feels like splitting hairs — the ordinary person, whether in 1985 or today, would not recognize the difference.”

    Judge L. Clayton Roberts dissented, saying, “While there may be policy reasons to tax all nicotine delivery products, we cannot use the intent of the Legislature to effectively amend the adopted text.”

  • Smok Appeals Marketing Denial Orders

    Smok Appeals Marketing Denial Orders

    Image: Wasan

    China-based Shenzhen IVPS, the parent to Smok brand vaping devices, has appealed the U.S. Food and Drug Administration’s marketing denial orders (MDOs) for six of the company’s open-system vaping devices.

    IVPS filed the appeal with the New Orleans, Louisiana-based U.S. Court of Appeals for the 5th Circuit and was joined in the suit by a Dallas, Texas-based distributor of the Smok products that were denied marketing.

    The FDA claimed that it had issued the MDOs for the premarket tobacco product applications (PMTAs) for the Smok products because the applications “failed to provide sufficient data to characterize constituent delivery, product stability and product abuse liability.” The agency also stated that Smok failed to provide a specific e-liquid, and consumers could use any e-liquid in the devices.

    Shenzhen IVPS challenges those assertions, saying it “invested more than $30 million in its applications, which totaled well over 600,000 pages in all, and collaborated with the world’s leading laboratories to conduct robust harmful and potentially harmful constituent aerosol testing, in vitro toxicology testing and toxicological analysis, accelerated and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies to test the products’ potential abuse liability profiles,” according to a press release.

    “FDA is using isolated data from testing of the devices with e-liquid formulations that the products’ instruction manuals specifically warn are not compatible with these devices and ignoring the overwhelmingly positive toxicological and safety profile of these products,” said Shenzhen IVPS CEO Welfer Ouyang.

    On Jan. 3, the U.S. Court of Appeals for the 5th Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting PMTAs of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.

    The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.

    The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.