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Tag: FDA

  • BAT Stock Surges, Despite Legacy Combustibles Shrinking

    BAT Stock Surges, Despite Legacy Combustibles Shrinking

    Shares of British American Tobacco climbed 13.99% in London trading last week to £48.64 on May 15, as investors reacted to a mix of regulatory, legal, and capital signals. Market attention followed the U.S. Food and Drug Administration authorization of flavored Glas ENDS products, seen as a reference point for how flavored e-cigarettes may fare under the PMTA pathway, even though the decision did not involve BAT’s Vuse brand. Sentiment was further supported after a U.S. court dismissed a sanctions-related criminal case tied to BAT’s prior North Korea compliance matter, confirming the company had fulfilled its deferred prosecution agreement, alongside continued focus on BAT’s planned £1.3 billion 2026 share buyback and growth prospects for its newer nicotine portfolio, including VELO.

    In contrast, BAT Bangladesh reported a 14% year-on-year drop in cigarette volumes and a 34% decline in profit for Q1 2026 amid higher taxes, inflationary pressure, and weaker consumer purchasing power, underscoring the diverging performance between BAT’s legacy combustible markets and investor expectations tied to reduced-risk product expansion.

  • How LIMS supports GMP compliance

    How LIMS supports GMP compliance

    ~ The impact of LIMS in modern labs, from data integrity and traceability to materials management and quality control ~

    Good Manufacturing Practice (GMP) compliance is fundamental for laboratories operating in regulated industries such as pharmaceuticals, medical devices, medicinal cannabis, and reduced-risk nicotine products. Ensuring data integrity, maintaining traceability, and enforcing controlled processes are all essential components of GMP. Here, Chris Allen, CEO of contract research organisation Broughton, explains the critical role of laboratory information management systems (LIMS) in supporting these requirements.

    Regulators are no longer just inspecting facilities; they are interrogating data. From the US Food and Drug Administration (FDA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada, there is a clear and consistent expectation that companies must demonstrate complete data integrity, traceability and control across the product lifecycle.

    Paper-based systems or fragmented digital tools can make this difficult to achieve consistently. Against this backdrop, LIMS are rapidly evolving from operational tools into critical infrastructure for GMP compliance.

    Ensuring data integrity and traceability

    A well-designed LIMS embeds these controls directly into laboratory workflows, helping ensure processes are followed correctly and records remain secure, complete, and auditable.

    Key capabilities of LIMS that support GMP data integrity include full audit-trail systems that record user actions and changes, version control for methods, products, and specifications, electronic signatures for reviews and approvals, and permission-based access controls to manage user roles and system permissions.

    Together, these features help laboratories maintain confidence in their data while ensuring they are inspection-ready. This both reduces the chances of failing inspections and makes audits less disruptive.

    Traceability of materials and proper equipment management are also essential elements of GMP compliance. Laboratories must maintain visibility over the reagents and materials used during testing, while ensuring that instruments remain calibrated and fit for purpose.

    A LIMS can support this through integrated management of lab resources, including stock batch traceability, stock expiry monitoring, stock status controls, and equipment maintenance and calibration scheduling.

    By centralising this information, laboratories can reduce compliance risks while improving operational efficiency.

    Importantly, the impact of LIMS goes beyond compliance alone. Leading organizations use these systems to gain greater operational control and insight as real-time visibility of laboratory data allows quality teams to identify trends, investigate anomalies and make informed decisions more quickly. This can support faster batch release timelines, improved product consistency and more proactive risk management. In this sense, LIMS is not just a compliance tool, but a platform for continuous improvement.

    Supporting quality control

    Quality management processes, such as identifying and investigating out-of-specification results, are essential components of GMP laboratory operations. Managing these processes manually can introduce delays or increase the risk of errors.

    Within a LIMS environment, testing results can be automatically assessed against predefined specifications, allowing the system to immediately flag potential issues. Investigation workflows can then be initiated and tracked in the system, ensuring corrective actions are documented and managed consistently.

    Embedding these quality processes in the LIMS helps laboratories maintain structured, auditable procedures that align with regulatory expectations.

    Future-proofing labs with LIMS

    As regulatory expectations continue to evolve, the importance of robust digital infrastructure will only increase. Laboratories must manage growing data volumes, support increasingly complex supply chains, and respond to more stringent oversight.

    In this environment, LIMS is no longer a ‘nice to have’, but a foundational component of modern GMP compliance that enables organizations to meet today’s requirements while preparing for those of the future.

    For companies operating in highly regulated sectors, the question is no longer whether to adopt LIMS, but how effectively it can be implemented to support both compliance and long-term operational excellence.

    Broughton has developed its own LIMS platform, LabHQ, to address the real-world challenges laboratories face when operating in highly regulated environments. Drawing on its experience delivering GMP testing services, LabHQ was designed to support the workflows, traceability and data integrity requirements that laboratories need to meet regulatory expectations. To find out more, visit the Lab HQ website.

  • RFK Jr.’s Spokesperson Resigns Over Flavored Vape Shift

    RFK Jr.’s Spokesperson Resigns Over Flavored Vape Shift

    Richard Danker, assistant secretary for public affairs at the U.S. Department of Health and Human Services, resigned in a letter to Donald Trump after the U.S. Food and Drug Administration authorized several fruit-flavored e-cigarette products, arguing the decision could expose minors to nicotine addiction and health risks. According to ABC News, Danker said the authorization conflicted with recent department guidance on youth risks from flavored nicotine and criticized senior officials in Robert F. Kennedy Jr.’s office for supporting it. An HHS spokesperson said political appointees are expected to advance the administration’s “Make America Healthy Again” agenda and that those who disagree are free to leave. The development follows the departure of former FDA commissioner Marty Makary, who reportedly clashed with the White House over pressure to approve flavored vape products. The FDA recently authorized four devices by GLAS, including mango and blueberry pods, marking a notable shift as the agency continues efforts to curb illicit youth-targeted vaping products.

  • FDA Makes ENDS PMTA Roundtable Materials Available

    FDA Makes ENDS PMTA Roundtable Materials Available

    Today (May 14), FDA released materials from its Feb. 10 Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products, providing the public and industry with a detailed look at discussions between agency officials and small manufacturers. Led by Dr. Matthew Farrelly and moderated by Dr. Todd Cecil, the sessions focused heavily on product characterization, manufacturing controls, pharmacological and toxicological data, and how applicants can demonstrate adult benefit through longitudinal or randomized studies. FDA said the purpose of the roundtable was to solicit feedback on how to improve the efficiency and clarity of PMTA reviews while remaining bound by statutory requirements under the Tobacco Control Act.

    Industry participants used the forum to reiterate concerns about the lack of objective scientific benchmarks guiding ENDS applications, arguing that uncertainty around testing parameters—particularly for open-system products—and the inability to update long-pending PMTAs create significant barriers for small businesses. The Vapor Technology Association, through Executive Director Tony Abboud, said members appreciated the opportunity for dialogue but left the meeting seeking clearer standards and more predictable regulatory expectations.

    Find the FDA’s resources below:

    FDA ENDS Roundtable Hub

    FDA ENDS Roundtable Video

    FDA ENDS Roundtable Transcript

  • CTP Director Touts Progress, Future in Statement

    CTP Director Touts Progress, Future in Statement

    The FDA’s Center for Tobacco Products says it has made significant progress in streamlining the review of premarket tobacco product applications (PMTAs), reducing its backlog by approximately 70% in 2025 and eliminating the queue for initial acceptance review. In a statement dated May 7 and released today (May 13), acting Director Bret Koplow said new efficiencies are allowing applications to move into review almost immediately, while accelerated filing and scientific review processes—particularly for nicotine pouches and electronic nicotine delivery systems—are helping bring compliant products to market more quickly.

    Koplow also highlighted the success of a pilot program for nicotine pouch applications, which led to authorizations for six products within three months, a record pace for the agency. The FDA plans to apply lessons from the pilot more broadly, including expedited review for product modifications and increased real-time communication with applicants, signaling a shift toward faster but still science-based regulatory decision-making in the nicotine category.

    Read the full release here.

  • Makary Resigns, Diamantas New Interim FDA Head 

    Makary Resigns, Diamantas New Interim FDA Head 

    Today (May 12), President Donald Trump confirmed earlier reports from White House officials that FDA Commissioner Dr. Marty Makary was stepping down after just over a year in the role, following a turbulent tenure that included growing friction over tobacco and nicotine policy. A White House official said the resignation was tied to “process at the FDA” rather than a single issue, though pressure had been building around the agency’s pace on key decisions, including flavored vape authorizations. Reports in recent weeks indicated frustration within the administration that the FDA had moved too slowly on advancing nicotine-related priorities, with one official bluntly stating: “What a mess Makary turned out to be.” He will be replaced on an interim basis by FDA food chief Kyle Diamantas.

    Makary’s leadership coincided with heightened scrutiny over the FDA’s handling of next-generation nicotine products, particularly flavored vapes, which have remained largely blocked pending extensive scientific review. The issue became a flashpoint within the administration, with critics arguing the agency had failed to align with broader policy goals aimed at expanding alternatives for adult smokers. At the same time, the FDA maintained its stance on requiring strong evidence of public health benefit, leaving the market tightly restricted and contributing to ongoing tension between regulators, industry stakeholders, and policymakers.

    His tenure was also shaped by broader political battles that indirectly impacted tobacco regulation, including disputes over drug approvals and internal agency direction, which critics said created uncertainty around regulatory timelines. For the tobacco and nicotine sector, Makary’s departure could signal a potential shift in FDA priorities, particularly as pressure mounts to accelerate decisions on reduced-risk products and flavored alternatives. The leadership change comes at a critical moment for the industry, with regulatory direction expected to play a central role in shaping market dynamics and product innovation in the years ahead.

    Since the news broke, interested observers have been responding in what is generally seen as a positive for the industry.

    “We have been disappointed by the pace of nicotine product reviews at the Center for Tobacco Products,” said Laura Leigh Oyler, VP of Regulatory Affairs at Nicokick.com. “If recent reporting is accurate, Commissioner Makary’s removal should be treated as an opportunity to refocus the FDA on timely, evidence-based decision-making. Adult consumers, responsible manufacturers, and retailers need a regulatory process that produces decisions, not indefinite uncertainty.

    “CTP already has the scientific expertise needed to evaluate nicotine product applications and make appropriate determinations under the law. The next FDA commissioner should remove unnecessary bottlenecks and make clear that pending reviews will be decided by FDA scientists, not politicians.”

    Vapor Technology Association Executive Director Tony Abboud said he met with Makary last week and felt the Commissioner realized the PMTA process needed to improve quickly.

    “The VTA now looks forward to continuing its constructive engagement with Acting FDA Commissioner Kyle Diamantas and whoever is ultimately selected to permanently lead the agency moving forward,” Abboud said. “For years, VTA has advocated for a regulatory framework that provides clear scientific requirements, transparent standards, and consistent enforcement against bad actors and illicit products.

    “We remain committed to working with FDA leadership, the Administration, and policymakers to modernize the PMTA process, strengthen responsible marketing standards, and ensure the United States leads with a balanced regulatory approach grounded in science, harm reduction, and common sense.”

    One of the bluntest responses came from Ross Marchand, Executive Director of the Taxpayers Protection Alliance, who said, “At long last, Makary is out. Since taking the helm of the agency last April, the Commissioner has made it far more difficult than it needs to be to bring new therapies to market. Millions of Americans have paid the price for this soap opera of suddenly spurned approvals, goalpost shifting, and even apparent violations of trade secret law.

    “The FDA needs a leader who will stand up for patients and allow access to new and innovative therapies. Makary’s successor must embrace market innovation and break with the prohibitionary policies of the past.”

  • FDA Files MRTP Renewal for Two 22nd Century Products

    FDA Files MRTP Renewal for Two 22nd Century Products

    Today (May 12), FDA filed two modified risk tobacco product (MRTP) renewal applications for scientific review for 22nd Century Group Inc. products VLN King and VLN Menthol King. Both products are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes.

    The renewal follows MRTP orders first granted in 2021, which are set to expire in December 2026, requiring FDA reauthorization for continued marketing with reduced-risk claims. The agency has begun releasing redacted application materials for public access and has opened a docket for public comment, allowing stakeholders to submit data and feedback as part of the review process.

  • FDA Changes PMTA Structure

    FDA Changes PMTA Structure

    On May 8, the FDA issued updated guidance outlining its current enforcement approach for electronic nicotine delivery systems (ENDS) and nicotine pouch products without premarket authorization, emphasizing that its policies are nonbinding and reflect the agency’s current priorities. The guidance indicates that while unauthorized products remain illegal, the FDA does not intend to prioritize enforcement against products with pending and sufficiently complete applications under scientific review, allowing the agency to better allocate resources.

    The document also clarifies that enforcement will focus on products with higher public health risks, including those appealing to youth or lacking required safety features, while encouraging manufacturers to provide transparency around application status. The FDA said it will maintain a public-facing list of products under review, as part of efforts to improve visibility for stakeholders and streamline regulatory oversight.

    “For four years, nicotine pouch manufacturers, suppliers, and retailers like Nicokick.com have been patiently waiting for authorization decisions, and this guidance finally gives them the ability to stop operating in a grey area of regulation,” said Laura Leigh Oyler, Vice President of Regulatory Affairs for Nicokick.com. “For an agency that typically operates without much clarity, this is mind-blowingly clear — file a PMTA for your product that includes everything the FDA has explicitly listed they expect to see, wait 180 days, and then you can launch your product in the market. This is a ground-breaking announcement for American consumers who deserve a wealth of options as they try to leave cigarettes behind.”

  • WSJ: Trump Ready to Fire Makary

    WSJ: Trump Ready to Fire Makary

    According to The Wall Street Journal, President Donald Trump signed off on a plan to remove FDA Commissioner Marty Makary, though the decision has not yet been finalized and could still change. The report, citing people familiar with the matter, said Makary has faced mounting criticism within the administration over his management of the agency, including clashes with officials at the Department of Health and Human Services and the White House. His handling of key policy areas—including drug approvals, vaccines, and vaping regulation—has drawn particular scrutiny.

    The reported move follows a turbulent period at the FDA marked by leadership turnover and internal disruptions, including recent high-profile departures and ongoing restructuring efforts. Earlier in the week, Trump reportedly criticized Makary for not moving quickly enough on authorizing flavored vaping and nicotine products, an issue that has become a point of tension within the administration.

    Makary, a former Johns Hopkins surgeon nominated in late 2024 and confirmed in 2025, has been a visible figure in the administration’s health agenda, including its “Make America Healthy Again” initiative. While no official confirmation has been issued by the White House or HHS, sources cited in the report indicated growing consensus among senior officials that a leadership change at the FDA may be imminent.

  • 22nd Century Reports $4.1M in Revenue as it Focuses on Future

    22nd Century Reports $4.1M in Revenue as it Focuses on Future

    22nd Century Group reported first-quarter 2026 revenue of $4.1 million, with a continued focus on expanding its reduced-nicotine VLN cigarette portfolio and distribution footprint. The company said it is gaining traction with adult smokers, with products now available in more than 2,000 stores across 20 states and targeting over 5,000 retail locations by the end of 2026.

    The company is positioning its proprietary low-nicotine technology as aligned with potential future FDA standards, while pursuing a broader product pipeline across cigarettes, filtered cigars and other formats. Despite ongoing net losses, 22nd Century said it is prioritizing distribution growth, regulatory engagement, and margin improvement, with plans to expand licensing opportunities and advance multiple PMTA submissions to support long-term growth.