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Tag: U.S. Food and Drug Administration

  • FDA Proposal Would Allow Oversight of Foreign Manufacturers

    FDA Proposal Would Allow Oversight of Foreign Manufacturers

    The U.S. Food and Drug Administration proposed a rule requiring foreign tobacco product manufacturers to register their manufacturing facilities and list the tobacco products they sell in the U.S., closing a regulatory gap that currently exempts overseas manufacturers from requirements already imposed on domestic companies. The agency said the proposal would strengthen its ability to identify and take action against illegal tobacco products—particularly unauthorized disposable e-cigarettes—and create a more level playing field for U.S. manufacturers.

    If finalized, the rule would require both foreign and domestic manufacturers to register their establishments, submit detailed product information, and update registrations annually and product listings twice a year. Foreign facilities would also become subject to FDA inspections, giving the agency greater oversight of products before they enter the U.S. market. Manufacturers would also be required to maintain records of labeling, advertising, and consumer information for at least four years.

    According to the FDA, the proposal would improve enforcement by providing more comprehensive information on tobacco products manufactured for the U.S. market and expanding oversight of foreign producers. Acting Center for Tobacco Products Director Bret Koplow said the rule would help ensure all companies selling tobacco products in the U.S. operate under the same standards while strengthening the agency’s ability to keep illegal products out of the marketplace. Public comments will be accepted through Sept. 14.

  • 5th Circ. Backs FDA’s Block on Vape Marketing

    5th Circ. Backs FDA’s Block on Vape Marketing

    The U.S. Court of Appeals for the Fifth Circuit upheld the U.S. Food and Drug Administration’s denial of marketing applications for menthol-flavored e-cigarette products submitted by two vape manufacturers, ruling that the agency reasonably concluded the products’ potential benefits for adult smokers did not outweigh the risks of youth initiation. The decision affirms the FDA’s application of the “appropriate for the protection of public health” standard required under the Premarket Tobacco Product Application (PMTA) pathway.

    The ruling, against Triton Distribution and Vapetasia LLC, reinforces the FDA’s authority to reject flavored vaping products where applicants fail to provide sufficient evidence that the products offer a net public health benefit.

  • FDA Reports Efforts Prevented 450K Youth from Vaping

    FDA Reports Efforts Prevented 450K Youth from Vaping

    The U.S. Food and Drug Administration published new information in a special issue of the American Journal of Preventive Medicine highlighting the measurable public health impact of its youth tobacco prevention efforts, particularly the “The Real Cost” campaign. According to studies featured in the issue, the campaign is estimated to have prevented roughly 444,252 U.S. youth from initiating e-cigarette use between 2023 and 2024, while also reducing an estimated $42 million in illegal e-cigarette sales that would have otherwise been consumed by minors. The findings are based on peer-reviewed research and analyses conducted by FDA scientists and external collaborators, reinforcing the campaign’s effectiveness in shaping youth behavior at scale.

    FDA officials, including leadership from the Center for Tobacco Products, emphasized that the results demonstrate how sustained, evidence-based public education can materially shift youth attitudes and reduce nicotine initiation. The special journal issue compiles 12 studies examining campaign reach, audience segmentation, behavioral impact, and cessation engagement. One analysis found that roughly three-quarters of surveyed youth reported exposure to at least one prevention ad, with especially strong reach among higher-risk groups, while another showed more than 253,000 visits driven to the SmokefreeTeen cessation platform, including over 11,000 completed quit plans.

    The FDA’s broader claim is that “The Real Cost” campaign — launched in 2014 for cigarettes and expanded in 2018 to address vaping — has become a long-running model for data-driven prevention messaging. Officials argue that its demonstrated impact on youth behavior and attitudes provides a foundation for expanding educational efforts, including potential messaging aimed at influencing adults who smoke toward cessation and harm reduction, while maintaining a continued focus on preventing youth initiation.

  • FDA Releases Meeting Materials for Zyn’s MRTP Application  

    FDA Releases Meeting Materials for Zyn’s MRTP Application  

    Today (January 20), the U.S. Food and Drug Administration released meeting materials ahead of a virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) to review modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 Zyn nicotine pouch products. The materials include a draft agenda, background documents from both the applicant and the FDA, and draft questions for committee consideration, and are available on the FDA’s 2026 TPSAC Meeting Materials and Information page.

    The virtual TPSAC meeting is scheduled for January 22. FDA opened Docket No. FDA-2025-N-0835-0020  for public comments related to the meeting, with submissions due by 11:59 p.m. ET on January 21. Comments specific to the ZYN MRTP applications may also be submitted under a separate docket, Docket No. FDA-2025-N-0835-0001, which was established on June 18, 2025.

    Visit the event webpage to learn more about attending the meeting online

  • Senate Confirms New FDA Commissioner

    Senate Confirms New FDA Commissioner

    Last week the U.S. Senate confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the U.S. Food and Drug Administration by a 56-44 vote. During his confirmation hearing, Makary said his goals for the agency were “more cures and meaningful treatments for Americans,” and offered several insights as to how he would achieve those goals throughout the hearing.  

    In the past, Makary has been critical of the FDA, in 2021 calling for “fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it.” Reporting to Health and Human Services Secretary Robert F. Kennedy Jr., Makary’s leadership of the FDA also includes its Center for Tobacco Products (CTP). However, it’s not yet clear how he will approach CTP’s looming issues of reviewing premarket tobacco product applications (PMTAs), the illicit vape market, and other tobacco-related issues.

    Much of the confirmation hearing centered around past problems, including those with Covid-19 vaccines, the pharmaceutical industry, and various other issues that have often gained headlines of late, but he did not commit to specifics in that venue.

    “I have no preconceived plans on mifepristone policy except to take a hard look at the data and to meet with the professional career scientists at the FDA who have reviewed the data,” he said at his hearing. “We now have a generational opportunity in American healthcare. President Trump and Secretary Kennedy’s focus on healthy foods has galvanized a grassroots movement in America. Childhood obesity is not a willpower problem, and the rise of early-onset Alzheimer’s is not a genetic cause. We should be, and we will, be addressing food as it impacts our health.”

    When asked about the backlog of cases the FDA has across all departments, Makary did not rule out leveraging artificial intelligence and making other regulatory changes to streamline the drug review process. He suggested FDA reviewers could use AI “to help reviewers in the review process—not to replace human reviews, but to improve efficiency.”

    National Association of Tobacco Outlets (NATO) Executive Director David Spross told CSP on Friday that “NATO looks forward to working with Dr. Makary and the team at FDA on tobacco and nicotine product regulatory issues, including for the FDA is to support tobacco harm reduction policies by authorizing more PMTA vapor and nicotine pouch product applications that provide adult smokers with more choices.”

    Spross added that there is a “need for more transparency from the agency by providing retailers more information on illicit products, specifically in the vapor and nicotine pouch categories.”

    Makary is a surgical oncologist and health policy researcher who has spent more than 20 years at Johns Hopkins.

    “I am pleased to congratulate Dr. Makary on his new role as FDA commissioner,” said Johns Hopkins University President Ron Daniels. “We are fortunate to have one of our senior faculty members at the School of Medicine undertake this critical service to the nation.

    “An accomplished clinician and widely published health policy researcher, Dr. Makary has had a storied career at Johns Hopkins that reflects the research and clinical acumen and openness to different ideas and approaches undergirded by academic freedom that are the hallmark of our great institution,” said Daniels.

    Makary founded the Johns Hopkins Center for Surgical Trials and Outcomes Research and co-developed a surgical safety checklist used in operating rooms worldwide. He is a member of the National Academy of Medicine and has published more than 300 peer-reviewed articles and three New York Times bestselling books on healthcare.

    Senate also confirmed Jay Bhattacharya as the new director of the National Institutes on Health.

  • FDA Rule on Nicotine Content Clears OMB

    FDA Rule on Nicotine Content Clears OMB

    The Biden administration has moved closer to implementing a rule that would limit nicotine levels in cigarettes, with the proposal clearing an Office of Management and Budget review on Friday.

    Public health experts are optimistic about the potential impact. Studies suggest significantly reducing nicotine—by as much as 95%—could render cigarettes non-addictive, prompting many smokers to quit or transition to less harmful alternatives like e-cigarettes or nicotine pouches. Dorothy Hatsukami, a tobacco policy researcher, noted that minimally addictive cigarettes have shown promise in helping people quit smoking.

    However, critics warn of unintended consequences. Guy Bentley of the libertarian Reason Foundation argued that restricting nicotine levels could effectively ban cigarettes, fueling a black market and benefiting foreign entities.  “Biden’s ban is a gift with a bow and balloons to organized crime cartels with it, whether it’s cartels, Chinese organized crime, or Russian mafia. It’s going to keep America smoking, and it’s going to make the streets more violent,” said Rich Marianos, former assistant director of the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and the current chair of the Tobacco Law Enforcement Network.

    The future of the rule remains uncertain given the upcoming change of administration and the likelihood of litigation by industry.

  • FDA Issues Final Guidance on Testing Methods

    FDA Issues Final Guidance on Testing Methods

    The FDA has published final guidance for the tobacco industry on the “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.” This guidance provides recommendations for tobacco manufacturers on how to generate validation and verification data for analytical methods supporting regulatory submissions, including Substantial Equivalence (SE) reports, Premarket Tobacco Product Applications (PMTA), and Modified Risk Tobacco Product Applications (MRTPA). It also applies to testing and reporting harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke.

    The updated guidance finalizes the draft issued in December 2021, incorporating comments received from stakeholders. Key changes include updates reflecting recent statutory revisions, such as the inclusion of synthetic nicotine under the definition of tobacco products, and clarifications on alternative validation procedures. The guidance also supports the use of national and international standard test methods and provides detailed recommendations on laboratory accreditation, statistical methods, and analytical test method validation, helping the industry produce more reliable and consistent data for regulatory purposes.

  • FDA Tightens Oversight on Vape, Pouch Imports

    FDA Tightens Oversight on Vape, Pouch Imports

    The FDA has updated import alerts 98-07 and 98-06 to strengthen the regulation of unauthorized e-cigarettes and other tobacco products entering the country. The changes clarify that all new vapor products must have FDA authorization to be marketed legally in the U.S. Under Import Alert 98-07, unauthorized vapor imports may face detention or refusal of entry without physical examination. The update also provides clearer guidance for importers, customs brokers, and federal partners, including links to the FDA’s searchable database of authorized tobacco products.

    Import Alert 98-06 focuses on non-e-cigarette tobacco products, including smokeless tobacco and nicotine pouches such as NOIS, LYFT, and SKRUF. These products, like vapor products, may also be detained if unauthorized. The FDA emphasized that mis-declared products remain a key focus, citing the seizure of three million units of unauthorized vapor products worth $76 million in collaboration with U.S. Customs and Border Protection. To date, the FDA has authorized only 34 vapor products and devices, underscoring its commitment to enforcing compliance and preventing illegal products from entering the market.

  • FDA Submits Proposal to Limit Nicotine

    FDA Submits Proposal to Limit Nicotine

    The U.S. Food and Drug Administration has submitted a proposal to limit the amount of nicotine in tobacco products, reports CNN.

    The FDA has been discussing limiting nicotine levels since 2018, and this week, the FDA submitted the proposal to the Office of Management and Budget (OMB). This move comes as the Biden administration enters into its last weeks and President-elect Donald Trump prepares to take office in January 2025.

    “A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain combusted tobacco products, when finalized, would be among the most impactful population-level actions in the history of U.S. tobacco product regulation,” the FDA said in a statement.

    “Once finalized, this rule could be a game-changer in our nation’s efforts to eliminate tobacco use,” said Harold Wimmer, president and CEO of the American Lung Association. “Making tobacco products nonaddictive would dramatically reduce the number of young people who become hooked when they are experimenting. To fully address the toll of tobacco on our nation’s health and across all communities, it is critical to reduce nicotine levels to nonaddictive levels in all commercial tobacco products, including e-cigarettes.”

    “Certainly, there would be individuals who would benefit from substantially lower nicotine levels and find it easier to quit,” said Rose Marie Robertson, a cardiologist and chief science officer at the American Heart Association. “It’s really hard to quit. I’ve seen patients over many years who have gotten the wake-up call with a heart attack or a stroke and really want to improve their health and reduce their risk, but it’s just very, very hard to do.”

    The submitted proposal does not mean that there will be any immediate changes. The OMB’s approval process can take months, and there must be a public comment period. It is likely that the tobacco industry will sue the government as well, as has been seen with other proposed regulations.

    It is unclear what will happen with the proposal following the change in presidency. In Trump’s first term, the Trump administration signaled that it wanted to limit nicotine, but during this year’s election season, the tobacco industry donated heavily to Republicans, and Trump’s pick for chief of staff was previously a tobacco lobbyist.

  • FDA Warns Retailers for Illegal Sales

    FDA Warns Retailers for Illegal Sales

    The U.S. Food and Drug Administration issued warning letters to 115 brick-and-mortar retailers for selling unauthorized vaping products. The warning letters cite the sale of disposable e-cigarette products owned by Chinese manufacturers and marketed under popular brand names, including Geek Bar Pulse, Geek Bar Skyview, Geek Bar Platinum, and Elf Bar. 

    The warning letters result from the FDA’s ongoing enforcement efforts, in coordination with state partners, to identify and crack down on the sale of unauthorized e-cigarettes, according to the agency. FDA has contracts with states, territories, or third-party entities to assist with compliance check inspections of retail establishments.  

    Findings from the 2024 National Youth Tobacco Survey indicated that 5.8 percent of current youth e-cigarette users reported using products under the Geek Bar brand. FDA’s review of additional rapid surveillance data and preliminary data from the Population Assessment of Tobacco and Health Study has also identified the brand as popular or youth-appealing. 

    Warning letter recipients are given 15 working days to respond with the steps they will take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalty. 

    A new tobacco product must have FDA authorization before it can be legally marketed, and generally, products without authorization are at risk of enforcement action. To date, the FDA has authorized 34 e-cigarette products and devices.