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  • Six Manufacturers Appeal MDOs

    Six Manufacturers Appeal MDOs

    Six small manufacturers—American Vapor Company, Breeze Smoke, Elite Brothers, Lead by Sales (doing business as White Cloud Cigarettes), Vapermate, and Vertigo Vapor (doing business as Baton Vapor)—have filed appeals against the U.S. Food and Drug Administration’s marketing denial orders (MDOs), according to Vaping360.

    The companies all received MDOs between May 2024 and June 2025 and filed petitions for review in the Fifth Circuit within 30 days.

    While American Vapor Company is the only petitioner located within the Fifth Circuit’s jurisdiction, the other manufacturer’s recruited retail co-petitioners located within the jurisdiction, as allowed by the Supreme Court earlier this year. The Fifth Circuit has consolidated the cases as they are challenging on the same grounds and share the same attorneys.

    Azim Chowdhury and Eric Gotting of Keller and Heckman are representing the companies.

  • FDA’s Makary Wants Retailers to Crack Down on Illegal Nicotine Products

    FDA’s Makary Wants Retailers to Crack Down on Illegal Nicotine Products

    The U.S. Food and Drug Administration (FDA) Commissioner Dr. Marty Makary issued a statement today (September 30) announcing that the organization is launching a nationwide initiative to boost compliance among retailers that sell vaping products, part of a broader effort to address the rise of youth vaping. The campaign is scheduled to reach more than 300,000 stores, including vape shops, gas stations, and convenience stores.

    According to the FDA, as much as 54% of vaping products sold in the United States are illegal, many flavored with fruit or candy, or packaged with gimmicks like built-in video games and Bluetooth speakers. None of these products are authorized for sale, and regulators warn they often contain toxic chemicals such as formaldehyde, lead, and acrolein.

    To help retailers comply, the FDA is mailing educational packets that include a list of the 39 e-cigarettes and 20 nicotine pouches legally allowed on the market, along with QR codes linking to real-time updates online. Retailers will also receive information about the new Searchable Tobacco Product Database, covering more than 17,000 authorized products across all categories, plus a calendar of compliance reminders such as enforcing the minimum age of 21 and checking photo IDs.

    “We know that most businesses want to follow the law,” Makary said in the statement. “The purpose of this initiative is to help retailers better understand relevant laws and regulations, removing any excuses for noncompliance. We are particularly interested in increasing compliance around the distribution and sale of illegal vaping products, which are often marketed to, and widely consumed by, American teens.”

    Mailings will begin this fall, and additional free resources are available through the FDA’s Tobacco Education Resource Library.

    “Retailers are on the front line of protecting youth and young adults from the dangers of nicotine addiction, and we urge them to take this responsibility seriously by swiftly pulling illegal e-cigarettes from their store shelves,” said Kathy Crosby, CEO of Truth Initiative, who points out that illicit products are cheap and easier to get than ever. “Voluntary compliance is important, but it’s imperative that the FDA do more to hold those retailers, distributors and manufacturers who continue to break the law accountable.”

    Read the entire FDA statement here.

  • FDA Posts New Materials for IQOS Renewal Applications

    FDA Posts New Materials for IQOS Renewal Applications

    The U.S. Food and Drug Administration announced today that its Tobacco Products Scientific Advisory Committee (TPSAC) will convene October 7, to evaluate the renewal applications of Philip Morris Products S.A. for its IQOS 2.4 and IQOS 3.0 heated-tobacco systems and associated HeatSticks. These devices were originally granted Modified Risk Tobacco Product (MRTP) orders in 2020 and 2022, allowing the marketing of reduced-exposure claims—specifically, that heating (not burning) tobacco significantly lowers exposure to harmful chemicals.

    The renewal will hinge on whether PMI can demonstrate that post-market evidence continues to support those claims under section 911(g)(2) of the Food, Drug, and Cosmetic Act.  The FDA has republished redacted application materials and opened a public comment period; speakers at the TPSAC meeting may submit data supporting or critiquing PMI’s dossier.

    “A vital mission of FDA is to make tobacco-related disease and death a part of America’s past,” officials from PMI said in a statement. “Smoke-free products, like IQOS, play a critical role in helping achieve that mission and provide adults who smoke with a real opportunity to change. IQOS, when marketed with the reduced-exposure claim, promotes complete switching and reduction in cigarette consumption.”

    Should the renewal be approved, PMI would retain authority to market IQOS with MRTP claims; if rejected, those claims could expire, undermining the company’s “reduced-exposure” positioning in the U.S. market.

    The outcome will not only be of interest for PMI, but for the broader heated tobacco and smoke-free sectors looking for regulatory precedents.

  • 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.