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Tag: FDA

  • FDA Denies Marketing for blu Disposable E-Cigarette

    FDA Denies Marketing for blu Disposable E-Cigarette

    Today (August 19), the U.S. Food and Drug Administration (FDA) issued a Marketing Denial Order (MDO) for Fontem US, LLC’s blu Disposable Classic Tobacco 2.4% e-cigarette, prohibiting its marketing or sale in the United States. The decision bars the product due to insufficient evidence that it would help adult smokers quit cigarettes—and raises concerns about dual use increasing overall toxicant exposure. FDA emphasized that only e-cigarettes supported by robust evidence showing reduced harm or smoking cessation benefits have been granted market authorization.

    “While FDA-authorized e-cigarettes are a lower-risk alternative for adults who smoke cigarettes – especially if they completely switch – not all e-cigarettes are equal,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “FDA’s rigorous scientific review ensures authorized e-cigarettes provide a net benefit to public health.

    “In this case, the company did not provide sufficient evidence of a benefit that outweighs the risk, particularly given evidence that adults who smoke generally do not stop or significantly curtail consumption of cigarettes when using this product.”

    Tobacco products that receive an MDO from the FDA may not be introduced or delivered for introduction into interstate commerce and must be removed from the market. Manufacturers, distributors, and retailers who sell or distribute this product in interstate commerce are violating the law and are at risk of enforcement action. The company may submit a new application for the product subject to this MDO.

    Industry observers interpret today’s decision as part of an increasingly stringent FDA posture, where even incumbent market players face rejection unless they clearly demonstrate both consumer and public health benefits. FDA-authorized products to date are limited to those with compelling evidence, and remain largely within tobacco-flavored, closed-system formats

    Fontem joins smaller U.S.-based e-cigarette companies ECS Global, Texas Select Vapor, Fumizer, and American Vapor Inc. that received MDOs in the last month.

    See the FDA’s notification.

  • PMI Urges FDA to Educate Doctors on Harm-Reducing Alternatives

    PMI Urges FDA to Educate Doctors on Harm-Reducing Alternatives

    A new white paper from Philip Morris International U.S. (PMI U.S.) warns that many American healthcare providers misunderstand nicotine and tobacco harm reduction, limiting their ability to advise patients on safer alternatives to smoking.

    Survey results cited in the report show that half of medical professionals incorrectly believe nicotine causes cancer, while most are unaware which products are FDA-authorized for reduced harm. The paper stresses that the real health risks come from tobacco combustion, not nicotine itself, and switching to FDA-reviewed smoke-free products can significantly reduce harm for adults who continue to use nicotine.

    PMI U.S. calls on the FDA to actively educate providers, noting that 93% of surveyed doctors want guidance on lower-risk products and 95% would share it with patients. The report highlights that the U.S. is falling behind other countries in offering scientifically validated smoke-free options and emphasizes the need for science-based policy in tobacco harm reduction.

    The white paper is available here.

  • Vaping Industry Battles North Carolina E-Cig Ban

    Vaping Industry Battles North Carolina E-Cig Ban

    A coalition led by the Vapor Technology Association is appealing North Carolina’s new vaping law, which bans the sale of e-cigarettes not approved or pending approval by the FDA. The law, effective May 1, 2025, has already removed popular brands like Elf Bar and Geek Bar from store shelves. The law mandates that only e-cigarette products with U.S. Food and Drug Administration (FDA) marketing authorization may be sold in the state, enforced through a product registry managed by the state Revenue Department. Products must be certified and listed or removed within a 60-day grace period.

    Industry groups argue that the state is overstepping federal authority and violating constitutional protections and that the law discriminates between tobacco-derived and synthetic nicotine products, raising concerns under the Equal Protection Clause.

    A lower court refused to block the law, and the case now heads to the Fourth Circuit Court of Appeals, with national implications for state regulation of nicotine products. The outcome could determine whether entire product categories, such as flavored disposables, can be restricted, potentially reshaping the balance between state and federal oversight.

  • Federal Judge Rules FDA Tobacco Penalties Unconstitutional Without Jury Trial

    Federal Judge Rules FDA Tobacco Penalties Unconstitutional Without Jury Trial

    On Friday (August 1), in a landmark ruling, a federal judge sided with vape company Wulferic, LLC in its lawsuit against the U.S. Food and Drug Administration (FDA), declaring the agency’s civil penalties process unconstitutional under the Seventh Amendment.

    Wulferic, which operates as Vapor Lab, had been fined by the FDA for selling unauthorized e-liquids. The company challenged the penalty, arguing it was entitled to a jury trial. U.S. District Judge Reed O’Connor agreed, ruling that the FDA’s administrative process for assessing fines violated the constitutional right to a jury in civil cases. The decision could significantly weaken the FDA’s enforcement powers over tobacco and nicotine products.

    “The Wulferic decision is the first case to find that the FD&C Act’s CMP provision for tobacco products is unconstitutional — but the catch is that it didn’t actually order FDA to stop carrying on as usual with respect to anybody else,” Andrew J. Hull and Peter G. Dickos wrote for the FDA Law Blog. “Wulferic threatens to significantly dismantle FDA’s arsenal of actions to enforce compliance with the FD&C Act’s tobacco provisions, and we expect many more similar challenges to follow if FDA stays on its current course.”

  • Senators Demand Answers from FDA Over Juul Approval

    Senators Demand Answers from FDA Over Juul Approval

    A coalition of Democratic U.S. senators is pressing the Food and Drug Administration (FDA) for answers after it issued marketing granted orders (MGOs) for Juul e-cigarettes. Led by Senate Majority Whip Dick Durbin, the group—also including Senators Richard Blumenthal, Tammy Baldwin, Ed Markey, Jeff Merkley, Jack Reed, Ron Wyden and Elizabeth Warren—sent a letter to FDA Commissioner Marty Makary last week expressing deep concern over the agency’s reversal of prior marketing denial orders (MDOs) issued to Juul Labs Inc. in 2022.

    The lawmakers cited potential conflicts of interest, pointing to ties between former Trump administration officials and Juul’s lobbying efforts. They also highlighted Juul’s $1.1 billion settlement with 48 states over allegations of youth-targeted marketing.

    “We are deeply troubled by the appearance of conflicts of interest between the Trump administration and the e-cigarette industry in the United States,” the senators wrote, requesting detailed responses to their questions by August 22.

    The FDA has not yet responded publicly to the letter.

  • U.S. Retail Groups Urge White House to Crack Down on Illegal Chinese Vapes

    U.S. Retail Groups Urge White House to Crack Down on Illegal Chinese Vapes

    A coalition of major U.S. retail and energy associations is calling on the White House to take urgent action against the surge of illegal vape products entering the country from China. In a joint letter sent July 18, the National Association of Convenience Stores (NACS), along with Energy Marketers of America, National Association of Tobacco Outlets (NATO), National Association of Truck Stop Operators (NATSO), and the Society of Independent Gasoline Marketers of America (SIGMA), said illicit vapes are undercutting legitimate retailers and exposing regulatory failures.

    The groups blame the FDA’s Center for Tobacco Products (CTP) for poor enforcement and slow product approvals, urging reforms and tighter border controls.

    “The convenience store and travel center industries are facing a crisis of illicit product from China,” the letter said. “Vape and e-cigarette products have been flooding our country for years and drawing business away from law-abiding retailers.

    “We need change at the Center for Tobacco Products and help from the federal enforcement agencies to clean up this mess. We are asking for your help to do that.”

  • 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.

  • Wisconsin Vape Law Sparks Federal Lawsuit Over FDA Authority

    Wisconsin Vape Law Sparks Federal Lawsuit Over FDA Authority

    A Wisconsin trade group filed a federal lawsuit aiming to block a new state law regulating vape product sales, claiming it oversteps federal authority and threatens thousands of small businesses. Wisconsinites for Alternatives to Smoking and Tobacco (WiscoFAST) filed the suit in the U.S. District Court for the Western District of Wisconsin, challenging Wisconsin Statute 995.15, which took effect July 1.

    The law empowers the Department of Revenue to fine sellers and manufacturers $1,000 per day starting September 1 if they sell vape products not authorized by the FDA. So far, only 34 e-cigarette products have FDA marketing approval.

    WiscoFAST is seeking a preliminary injunction, arguing the law violates the Supremacy Clause of the U.S. Constitution by encroaching on the FDA’s exclusive authority under the Federal Food, Drug, and Cosmetic Act (FDCA). They also say it breaches the Equal Protection Clause of the 14th Amendment by unfairly banning some non-tobacco nicotine products.

    “[The law] will strip Wisconsinites of their right to purchase the vaping products they use to stay smoke-free, while threatening to shutter 3,000 small businesses that are vital to our state’s economy,” said Tyler Hall, president of WiscoFAST. “This law disregards the FDA’s careful approach to regulating ENDS and could push former smokers back to deadly combustible cigarettes. We’re fighting to protect consumer choice and the livelihoods of thousands of Wisconsin workers.”

    The American Lung Association (ALA) also disagrees with the new law, saying it likely won’t improve public health. Molly Collins, the ALA’s Wisconsin advocacy director, argued that raising the purchase age and increasing vape prices would be more effective.

  • FDA Embraces “Radical Transparency” by Publishing CRLs

    FDA Embraces “Radical Transparency” by Publishing CRLs

    On July 10, the U.S. Food and Drug Administration (FDA) published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024, marking a significant step in the Agency’s broader initiatives to modernize and increase transparency.

    By making the CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved.

    “For far too long, drug developers have been playing a guessing game when navigating the FDA,” said FDA Commissioner Marty Makary. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”

    “Because the FDA has historically refrained from publishing CRLs for pending applications, sponsors often misrepresent the rationale behind FDA’s decision to their stakeholders and the public,” the press release said. “According to a 2015 analysis conducted by FDA researchers, sponsors avoided mentioning 85% of the FDA’s concerns about safety and efficacy when announcing publicly that their application was not approved. Moreover, when FDA calls for a new clinical trial for safety or efficacy, that critical information is not disclosed approximately 40% of the time. Lessons learned from non-approvals are also not shared within the industry, leading companies to repeatedly make similar mistakes.”

    This initial batch of published decision letters associated with since-approved applications is now accessible to the public at openFDA. The Agency is in the process of publishing additional CRLs from its archives and is continuously exploring ways of providing the public with greater transparency into its decision-making process.

    On the surface, this all sounds like good news for companies that have spent years frustrated by FDA backlogs. What actually changes remains to be seen.

    “Commissioner Makary’s announcement raises questions about whether this effort is truly ‘radical transparency’ or just a repackaging of existing requirements,” Sarah Wicks and Michelle L. Butler wrote for FDA Law Blog. “The key difference may lie in timing and ease of access; despite the statutory requirement under FDAAA, action packages are often slow to appear on FDA’s website, especially following staffing disruptions at FDA.

    “It is currently unclear whether FDA intends to publish CRLs close in time to their issuance or for applications that are not subsequently approved. The prospect of publication of such CRLs would likely be of great concern to many applicants and of great interest to their competitors. Regardless, we will be watching to see how this radical transparency initiative unfolds.”

  • 22nd Century Advances FDA Renewal for VLN

    22nd Century Advances FDA Renewal for VLN

    22nd Century Group, Inc. announced that it is proceeding with the Modified Risk Tobacco Product (MRTP) renewal process for VLN, its flagship line of reduced-nicotine content cigarettes.

    First authorized by the FDA in December 2021, VLN remains the only combustible cigarette with MRTP designation, permitted to market key reduced-harm claims such as “95% less nicotine” and “Helps you smoke less.” The renewal, due in December 2026, comes as the company expands its VLN portfolio through partnerships and patented low-nicotine plant varieties.

    “Our MRTP authorization for VLN cigarettes stands apart as one of the most unique and innovative tools in the tobacco industry, leading the fight in Tobacco Harm Reduction to reduce the health harms of smoking,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “Our VLN cigarette is the only product that meets the FDA’s guideline for low nicotine based on its proposed low-nicotine mandate issued in January 2025.

    “While the FDA’s mandate has not yet become a final ruling, we expect that the FDA will fully support our MRTP renewal for VLN.”