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  • Midwest Goods Responds to FDA Seizure, Says Actions are ‘Troubling’

    Midwest Goods Responds to FDA Seizure, Says Actions are ‘Troubling’

    Following yesterday’s (September 10) news that federal officials seized $86.5 million worth of illicit vapes in Chicago, Midwest Goods confirmed that agents from the Food and Drug Administration (FDA) and U.S. Marshals executed a civil seizure warrant at its facilities, targeting more than 75 brands of bottled e-liquids used in refillable vaping devices. The company said it is fully cooperating with authorities.

    In a statement, Midwest emphasized that the products cited in the warrant are manufactured in the U.S. by companies employing “hundreds, if not thousands,” of American workers. Many of the e-liquids, the company said, are tied to premarket tobacco product applications (PMTAs) that have been pending with the FDA since as far back as September 2020, despite a statutory requirement for review within 180 days. Midwest noted that the FDA has previously allowed these products to remain on the market during the prolonged review process.

    “Midwest has always attempted to work cooperatively with FDA,” the company said in its statement. “After a recent FDA inspection in August, we advised FDA that we had removed from our product catalog and inventory several ENDS products about which FDA inspectors had inquired. We also offered to remove other ENDS products from our product catalog if FDA was concerned about our continuing to offer them for sale. FDA acknowledged receipt of our correspondence, but did not request that we stop selling any other products.”

    The company called the enforcement action “troubling,” particularly in light of reports that FDA is preparing to expedite reviews of products tied to larger companies with more recent applications, while seizing long-pending independent products. It pledged to continue cooperating with federal authorities while reserving the right to challenge the seizure in court.

    Read the full statement here.

  • HHS and CBP Seize $86.5 Million in Illegal E-Cigarettes in Largest U.S. Operation

    HHS and CBP Seize $86.5 Million in Illegal E-Cigarettes in Largest U.S. Operation

    Today (September 10), the U.S. Department of Health and Human Services (HHS), announced the seizure of 4.7 million unauthorized e-cigarette units in Chicago with an estimated retail value of $86.5 million. Working with the FDA and U.S. Customs and Border Protection (CBP), HHS said it was the largest operation of its kind.

    The shipments, mostly originating from China, were found to contain misleading product descriptions and undervalued entries, apparently aimed at evading duties and FDA safety review.

    “We will never allow foreign actors to threaten the health of America’s children,” said HHS Secretary Robert F. Kennedy, Jr. “Today we took decisive action to protect kids from illegal vape products.”

    So far this year, the FDA and CBP have stopped more than 6 million unauthorized e-cigarettes valued at over $120 million. All seized products lacked the required pre-market authorization from the FDA. In addition, the FDA contacted 37 importers responsible for these shipments, reminding them of their legal obligations and requesting full compliance within 30 days.

    “The FDA and our federal partners are taking strong actions to shore up America’s borders and stop the flow of illegal vaping products into our country,” said FDA Commissioner Marty Makary. “If a product has not been authorized by the FDA, CBP will seize, detain or destroy it.”

  • FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    The U.S. Food and Drug Administration is set to fast-track reviews of nicotine pouches from Philip Morris International, Altria, Reynolds American, and Turning Point Brands in a pilot program launching Monday, according to Reuters. According to transcripts of an agency meeting last Friday, the agency aims to complete assessments by December, providing a quicker path to market for products like Zyn, on!, Velo, Fre, and Alp. The initiative comes amid pressure from the Trump administration to accelerate approvals and streamline the review process for the fastest-growing category of U.S. tobacco alternatives.

    The pilot program will reportedly feature reduced and expedited reviews, more frequent communication between FDA staff and companies, and a focus on essential scientific and safety data, including product characterization, manufacturing consistency, and abuse-liability information. For products already on the market without full authorization, the process could remove uncertainty over legality and potential enforcement actions. Tobacco firms have long lobbied for a faster FDA authorization route, noting that lengthy reviews have allowed competitors to capture market share in the meantime.

    “Adult nicotine and tobacco consumers are increasingly seeking nicotine pouches as a smoke-free alternative, and the industry is rapidly growing in response,” said Laura Leigh Oyler, vice president of U.S. Regulatory Affairs at Haypp Group, who will be speaking at GTNF 2025 in Brussels on the U.S. regulatory landscape. “These consumers deserve a marketplace of FDA-reviewed product choices to support their journey away from more harmful products. 

    “It makes sense that our government should also work to meet the demands of citizens, supporting a regulatory regime that quickly reviews well-designed and well-tested products from responsible and compliant manufacturers. This is a positive step not just for the regulator and the regulated industry, but for the millions of American adults looking for products they can trust.”

  • Georgia Judge Vacates FDA Graphic Cigarette Warning Rule

    Georgia Judge Vacates FDA Graphic Cigarette Warning Rule

    A federal judge in South Georgia struck down the U.S. Food and Drug Administration’s (FDA) rule requiring graphic health warnings on cigarette packs and ads, siding with Philip Morris USA and Georgia retailers, according to The Atlanta Journal-Constitution. U.S. District Judge Lisa Wood ruled that the FDA failed to disclose all raw data used in developing the 2020 rule, preventing stakeholders from offering meaningful feedback. While Wood rejected most of the plaintiffs’ arguments, she vacated the rule, citing a violation of the Administrative Procedures Act.

    The Georgia plaintiffs, including the Georgia Association of Convenience Stores, argued the rule would cost millions, force retailers to “speak against their own products,” and deter customers by making convenience stores unwelcoming. It said the FDA arbitrarily focused on certain smoking-related risks over others without explanation, and claimed it ignored countless red flags in its studies. The FDA defended its process, noting the warnings aimed to better inform consumers of smoking risks.

    The decision marks another setback in the FDA’s long-running effort to implement graphic warnings under the 2009 Family Smoking Prevention and Tobacco Control Act. A similar case is pending in Texas, where a judge has already blocked enforcement until appeals are resolved.

    The case is likely to head to the 11th Circuit Court of Appeals.

  • 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.