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  • FDA Urges Child-Resistant Packaging on Nicotine Pouches

    FDA Urges Child-Resistant Packaging on Nicotine Pouches

    The U.S. Food and Drug Administration (FDA) is calling on nicotine pouch manufacturers to use child-resistant packaging to prevent accidental exposure among young children, though the agency acknowledges that all 20 FDA-authorized nicotine pouch products currently feature child-resistant packaging, so the news release appears to be aimed at pending or future applications.
     

    “ZYN is the only nicotine pouch authorized by the FDA as appropriate to protect public health,” officials from Philip Morris International said in a response to the FDA announcement. “In making that conclusion, the agency noted that ZYN’s packaging is designed to be child-resistant—and has been since its launch 11 years ago.”


    The concentrated nicotine in pouches can be harmful to children even in small amounts. From April 2022 to March 2025, about 72% of reported nicotine pouch exposure cases involved children under age five.
     
    “The fruity flavors and bright, colorful designs of nicotine pouch products could resemble candy and seem attractive to children,” said FDA Commissioner Dr. Marty Makary. “Manufacturers should consider what steps they can take to prevent accidental exposures and ingestion.”
     
    The news release was paired with consumer information that advises parents to store all nicotine products securely and to contact Poison Control if ingestion occurs.

  • NJOY Sues FDA Over Delays in Flavored E-Cigarette Approval

    NJOY Sues FDA Over Delays in Flavored E-Cigarette Approval

    NJOY LLC, a subsidiary of Altria Group, filed a lawsuit in federal court in Louisiana last week (August 21), accusing the U.S. Food and Drug Administration (FDA) of unlawfully delaying its review of applications to market flavored e-cigarettes. According to NJOY, the FDA has failed to adhere to statutory deadlines stipulated in the Family Smoking Prevention and Tobacco Control Act. The company claims such delays unfairly hinder its efforts to provide adult smokers with reduced-risk alternatives to combustible tobacco.

    According to the filing, in December 2020, the FDA denied NJOY’s application with only one deficiency listed: that the flavored products’ applications did not show they “would increase the likelihood of complete switching among adult smokers, compared to the Rich Tobacco and Menthol varieties” (products that were granted marketing authorization). In March 2021, NJOY responded, providing data showing the flavored products’ switch rates were 29-68% higher than the approved products after six months of use. The FDA has yet to respond despite repeated requests for updates, leading to last week’s lawsuit.

    Additionally, the filing states that documents received during a Freedom of Information Act request revealed that the Office of Science’s epidemiology staff concluded that NJOY adequately addressed the flavor-specific deficiency and that the products were associated with higher rates of cessation, and also that unrequested sales restrictions and reporting requirements offered by NJOY would, according to the Office of Health Communication and Education, mitigate concerns about potential youth initiation.

    The lawsuit underscores growing tensions between major industry firms and the FDA, which is facing a massive backlog of Premarket Tobacco Product Applications, particularly as sales of unauthorized flavored vaping products continue to surge. NJOY argues the delays not only burden its business, but also limit smokers’ access to potentially less harmful products.

  • FDA Seeks Public Comment on Two Tobacco Topics

    FDA Seeks Public Comment on Two Tobacco Topics

    The U.S. Food and Drug Administration (FDA) filed a pair of public inspection documents scheduled to be published tomorrow (August 22) regarding the regulations surrounding children and adolescents purchasing tobacco and nicotine products, and the marketing and labeling of such products. The documents will each open a 60-day public comment period under the Paperwork Reduction Act.

    The first guidance, document  2025-16068, focuses on tobacco retailer training programs, detailing recommended elements that would include federal law requirements restricting access to, and the marketing and promotion of, covered tobacco and nicotine products. It would also focus on company policies, age verification methods, practical refusal techniques, and the health risks associated with tobacco use.

    The FDA would advise retailers to require employees to pass written tests before selling tobacco products, with refresher training held at least annually, and to keep such training records for four years to demonstrate compliance. The guidance also encourages strong hiring and management practices, such as informing staff of youth access laws, conducting internal compliance checks, and documenting corrective actions.

    “We assume that 75% of tobacco retailers already have some sort of age and identification verification training program in place,” the filing made by Grace R. Graham, deputy commissioner for Policy, Legislation, and International Affairs, said. “We expect that some of those retailer training programs already meet the elements in the guidance, some retailers would update their training program to meet the elements in the guidance, and other retailers would develop a training program for the first time. Thus, we estimate that two-thirds of tobacco retailers would develop a training program that meets the elements in the guidance.”

    FDA estimates the proposal will affect about 79,700 retailers nationwide, creating an annual reporting burden of nearly 2 million hours, plus over 191,000 hours for recordkeeping.

    The second guidance, document 2025-16067, reminds tobacco companies of their obligation to notify the agency before using new advertising or labeling formats for cigarettes and smokeless tobacco. The requirement, authorized under the Federal Food, Drug, and Cosmetic Act, aims to ensure compliance with restrictions on tobacco marketing and promotion.

    Under federal regulations (21 CFR part 1140), manufacturers, distributors, and retailers of cigarettes or smokeless tobacco must submit notice to FDA at least 30 days in advance if they plan to use a form of advertising or labeling that is not already permitted, such as where newspapers, magazines, billboards, point-of-sale materials, and direct mail are permissible.

    Comments can be made for either guidance online at www.regulations.gov, or mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

  • 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.