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Tag: FDA

  • Report: FDA, DEA Lack Ability to Enforce Hemp Ban

    Report: FDA, DEA Lack Ability to Enforce Hemp Ban

    Last week the Congressional Research Service (CRS)—the nonpartisan investigative office that advises U.S. lawmakers—issued a report warning that both the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) do not have the resources (i.e. funding, staff, and infrastructure) necessary to enforce the new policy set to take effect in 2026 that would ban “intoxicating hemp products.” The measure, added to last month’s federal spending deal, redefines hemp to prohibit products containing more than 0.4 mg of total THC per package, effectively banning popular hemp-derived cannabinoids such as delta-8 THC, HHC, and high-THCA products.

    “It remains unclear if and how federal law enforcement will enforce the new prohibitions,” the CRS was quoted on December 3. “Both FDA and DEA may lack the resources to broadly enforce the laws prohibiting intoxicating hemp products on the market.”

    Industry participants cautioned that an unfunded ban could drive unregulated and illicit sales. Dino Awadisian, founder of Mamba Brand, said the lack of a regulatory framework risks expanding the black market and called for structured federal oversight instead.

    “A law with no funding is not enforcement—it’s theater,” Awadisian said. “This will not protect the public. It will only reward unsafe, unregulated, and untraceable products.”

    The report also flagged potential new restrictions on hemp and cannabis seeds, which could be regulated based on genetic potential rather than THC content, exposing seed distributors to legal risk. Industry advocates are urging lawmakers to replace prohibition with nationally funded licensing, testing, age restrictions, and packaging standards.

  • FDA Launches Web-Based PMTA Forms

    FDA Launches Web-Based PMTA Forms

    Today (December 3), FDA launched web versions of four forms in CTP Portal Next Generation (CTP Portal NextGen) for applicants submitting and amending premarket tobacco product applications (PMTAs) and Substantial Equivalence (SE) Reports. FDA transitioned from CTP Portal to CTP Portal NextGen—a “new, improved web portal” for submitting tobacco product applications electronically—in early 2025. The web forms allow applicants to create, validate, and submit PMTA and SE Report submissions directly through CTP Portal NextGen.

    The web-based forms include Forms FDA 4057, 4057a, 3965, and 3965a. Industry stakeholders with active CTP Portal accounts had the option to test and provide feedback on the new web functionality of the forms during online development. Creating these web-based forms is part of FDA’s work to promote efficiency, effectiveness, and transparency to improve its tobacco product application review process.

    According to the FDA, the new portal includes step-by-step instructions on completing the forms; a more user-friendly interface that helps guide applicants through the submission process; the ability for multiple users to work on a submission at the same time and easily save drafts; and real-time, automatic validation, ensuring all required fields are completed before submission.

    PDF versions of FDA’s PMTA and SE Report forms will remain available for applicants who choose not to use the web-based versions. These PDFs can still be downloaded and submitted electronically through CTP’s Document Control Center or uploaded via eSubmitter. FDA has also released updated PDF versions of Forms 4057, 4057a, 3965, and 3965a, correcting minor technical issues since their original posting in June 2025. Beginning Jan. 2, 2026, applicants using PDF forms must use these updated versions. Failure to use the current forms — or to complete them correctly — will generally result in FDA refusing to accept the application.

  • 5th Circ. Grills FDA on PMTA Rules

    5th Circ. Grills FDA on PMTA Rules

    A Fifth Circuit panel questioned the U.S. Food and Drug Administration this week, raising doubts about whether it properly considered the impact of its 2021 rule requiring premarket authorization for new tobacco products on small businesses. According to Law 360, the judges questioned whether the agency complied with the Regulatory Flexibility Act, which mandates that regulators assess how new rules affect smaller firms. Vape companies argue the FDA relied on outdated economic data and imposed disproportionate costs that could drive many small manufacturers out of the market.

    During oral arguments in New Orleans, the panel pressed the FDA on its shift in position between 2016 and 2021, when the agency moved from a more flexible approach to requiring extensive scientific evidence for new products. The judges also asked whether the health risk information requirements were discretionary or mandated by the Tobacco Control Act. The skepticism suggests the court is weighing whether the FDA’s rulemaking process adequately accounted for the realities faced by small vape businesses.

    The case comes amid broader challenges to the FDA’s handling of Premarket Tobacco Product Applications (PMTAs), including disputes over flavored e-cigarette denials. If the Fifth Circuit finds the FDA violated the Regulatory Flexibility Act, the agency could be forced to revisit its rulemaking, potentially easing compliance burdens for smaller companies.

  • FDA Deploys Agentic AI to Assist Regulatory Reviews

    FDA Deploys Agentic AI to Assist Regulatory Reviews

    The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities to all agency employees, a move expected to streamline complex, multi-step regulatory tasks — including pre-market reviews, post-market surveillance, inspections, and compliance activities that would be of interest to those in the tobacco and nicotine industries.

    The new systems allow staff to build multi-model AI workflows capable of planning, reasoning, and executing tasks under human oversight. The tools are optional and operate within a secure GovCloud environment, with no training on industry-submitted data.

    In an email to StatNews, an FDA spokesperson called the tool “exploratory” and said that the AI agents do not make regulatory decisions. “All outputs from AI are reviewed and validated” by FDA staff “before being incorporated into any official regulatory action, ensuring that the AI remains a support tool rather than a decision maker,” he wrote.

    The deployment follows the success of Elsa, an internal LLM tool launched in May and now used by more than 70% of FDA personnel. The agency is also launching a two-month Agentic AI Challenge, with selected projects to be showcased in January 2026.

    FDA Commissioner Marty Makary said the upgrades mark a major step in modernizing regulatory operations, while Chief AI Officer Jeremy Walsh highlighted the potential to accelerate and validate safety assessments across all FDA-regulated sectors — including tobacco.

  • USA Vape Lab Sues FDA Over PMTA Delay

    USA Vape Lab Sues FDA Over PMTA Delay

    USA Vape Lab, maker of the Naked100 line of bottled e-liquids, filed suit against the Food and Drug Administration, alleging it unlawfully delayed action on its premarket tobacco applications for more than five years. The suit was filed November 21 in the U.S. District Court for the District of Columbia.

    In the complaint, the Huntington Beach, Calif.–based company says it submitted extensive PMTAs for its flavored and tobacco e-liquid products ahead of the September 9, 2020 deadline. Despite a Tobacco Control Act provision requiring FDA to issue decisions within 180 days, the agency has yet to act, the suit states. USA Vape Lab is asking the court to order FDA to issue final determinations.

    The company also argues FDA must consider what it describes as robust population-level evidence included in its submissions. According to the filing, a randomized controlled trial showed nearly one-third of participants achieved six-month cigarette abstinence when using Naked100 e-liquids—quit rates the company claims are two to three times higher than those reported for FDA-approved nicotine replacement therapies. USA Vape Lab further alleges that flavors such as Really Berry and Strawberry Pom demonstrate net public-health benefits that outweigh potential youth risks and exceed those of comparable tobacco flavors.

    “We felt that we had no choice but to initiate this lawsuit,” founder Huy Nguyen said in a statement, criticizing the agency for years-long delays while threatening enforcement actions against products lacking marketing orders.

    USA Vape Lab manufactures a range of popular e-liquids, including American Patriots, Crisp Menthol, and Lava Flow.

  • Good Cop 2.0 Concludes with Focus on Prohibitionist Policies

    Good Cop 2.0 Concludes with Focus on Prohibitionist Policies

    The final day of Good COP 2.0 highlighted the global consequences of strict, prohibitionist tobacco control measures. Speakers drew attention to the rise in illicit trade, gang violence, and punitive enforcement, attributing these outcomes to policies like heavy taxation and rigid pre-market approval systems promoted under WHO guidelines, which often overlook scientific evidence and consumer behavior.

    “There is a portion of people that you’ll never reach by only appealing to the evidence,” said author Jacob Grier. “It’s also important to change the framing and shift the culture.”

    Panel discussions explored the real-world harms of fundamentalist approaches and stressed the importance of including consumer perspectives in policymaking. Experts also outlined frameworks for effective, humane nicotine regulation, including suggestions that U.S. reforms might require a partial repeal of the Tobacco Control Act and a more measured FDA approach.

    The event concluded with an open forum, allowing participants to reflect on the week’s discussions and emphasizing the urgent need for reform within the WHO’s FCTC framework to create balanced, evidence-based global tobacco policy.

    “Of the funds that are contributed to the WHO, a significant percentage goes to the FCTC Secretariat,” said professor Tikki Pangestu. “Only a small amount goes toward running the programs. Meanwhile, a growing percentage of WHO funding comes not from member nations, but from outside groups with dubious agendas.”

  • FDA Schedules TPSAC Review of ZYN Applications

    FDA Schedules TPSAC Review of ZYN Applications

    The U.S. Food and Drug Administration announced a January 22, 2026, virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) to review modified risk tobacco product (MRTP) applications submitted by Swedish Match USA for 20 ZYN nicotine pouch products. These products—already authorized for sale through the PMTA pathway in January 2025—include flavors such as Cool Mint, Citrus, Coffee, Peppermint, and Wintergreen, each in 3 mg and 6 mg strengths. The company is seeking permission to market the pouches with the claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

    Under federal law, MRTP applications must demonstrate that a product, as actually used by consumers, reduces individual health risks and benefits overall population health. TPSAC’s review will focus on scientific evidence regarding ZYN’s relative health risks, consumer comprehension of the proposed claim, and the potential public health impact of granting a modified risk order. The meeting will be held virtually, open to the public, captioned, and recorded.

    Public comments may be submitted to Docket No. FDA-2025-N-0835 through January 21, 2026, with comments received by January 7 provided directly to TPSAC. The FDA is also inviting individuals to request oral presentation slots during the meeting’s public comment period. Redacted MRTP application materials are available on the FDA’s website, and the agency will consider all public input and TPSAC recommendations before issuing a final decision.

  • Ispire, IKE Tech Applaud FDA’s Illicit Vape Market Mandate

    Ispire, IKE Tech Applaud FDA’s Illicit Vape Market Mandate

    Ispire Technology Inc. and IKE Tech LLC issued statements welcoming the U.S. FDA’s newly funded mandate to crack down on the illicit vape market, following the passage of a continuing resolution signed by President Trump. The legislation directs the FDA to allocate at least $200 million toward electronic nicotine delivery system enforcement, including $2 million for a multi-agency task force with the DOJ and DHS to block illegal imports.

    IKE Tech President John Patterson called the strengthened enforcement a critical response to a market where “nine out of 10 vapes on shelves are illegal.” He said current border controls and tracking systems are failing, and highlighted the company’s development of blockchain-secured authentication tags and AI-driven age-verification tools to help regulators and manufacturers instantly verify product legitimacy.

    Ispire co-CEO Michael Wang said enforcement must be paired with proactive technology to protect consumers and level the playing field for compliant companies. He noted that Ispire and IKE Tech have submitted a blockchain-enabled age-verification System-on-a-Chip to the FDA as part of a PMTA, offering a potential framework for secure, verifiable, and interoperable compliance across the U.S. vape market.

  • FDA to Allocate $200M Toward Combating Illicit Vapes

    FDA to Allocate $200M Toward Combating Illicit Vapes

    As part of the continuing resolution passed by Congress and signed yesterday (November 12) by US President Donald Trump to reopen the government, the Food and Drug Administration (FDA) will be required to allocate at least $200 million of its $712 million in user fees toward enforcing regulations on electronic nicotine delivery systems (ENDS). Of this amount, $2 million will support a multi-agency task force, including the Justice Department and Homeland Security, aimed at cracking down on illegal ENDS products imported from China and other countries.

    The FDA is also required to update its 2020 ENDS enforcement guidance within one year to include flavored disposable vapes and clarify the definition of disposable ENDS products. In addition, the law updates the Imports and Exports section of the Food, Drug, and Cosmetic Act to include tobacco products, strengthening the FDA’s authority to regulate their import alongside food, drugs, devices, and cosmetics.

    The agency must provide semi-annual reports to Congress on efforts to remove illegal ENDS products from the market, with the first report due within 180 days of enactment (November 12). The FDA is also expected to submit a report detailing its work to educate retailers on which products are legally allowed for sale.

  • Bill Introduced to Allow FDA to Destroy Illicit Chinese Tobacco Products

    Bill Introduced to Allow FDA to Destroy Illicit Chinese Tobacco Products

    Last week, Senator John Cornyn and Congresswoman Beth Van Duyne, joined by Senator Martin Heinrich and Congresswoman Debbie Dingell, introduced the “Ensuring the Necessary Destruction of Illicit Chinese Tobacco Act,” also referred to as the “END Illicit Chinese Tobacco Act” (END). The legislation would amend the Federal Food, Drug, and Cosmetic Act and allow the Secretary of Health and Human Services the authority to seize and destroy adulterated, misbranded, or counterfeit tobacco products, including vapes and e-cigarettes, imported from China, specifically giving the U.S. Food & Drug Administration (FDA) authority to do so.

    “By giving the FDA destruction authority over these imports, this legislation would turn off the spigot of illicit e-cigarettes and vapes flowing from China and address the public health crisis sweeping across our nation,” Sen. Cornyn said.

    Lawmakers cited the public health risks posed by counterfeit products, which dominate illicit youth-used e-vapor brands. The END Act would extend the FDA’s existing destruction powers, currently applied to certain drugs and medical devices, to tobacco products.

    “We have seen too many illegal vapes slipping through the enforcement cracks, posing health and safety risks to Americans,” said Rep. Van Duyne. “The END Act will give federal agencies the tools that they need to destroy these counterfeit or misbranded goods before they reach our shelves.”

    The bill is supported by major health organizations—including the Campaign for Tobacco-Free Kids, American Heart and Lung Associations—and industry groups like 7-Eleven and Altria.

    The bill has been introduced, but no date for markup or committee hearing has been publicly posted thus far.