TobaccoReporter logo

Tag: FDA

  • 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.

  • FDA Establishes Closing Date for Public Comments on MRTP Renewal Applications for IQOS Products

    FDA Establishes Closing Date for Public Comments on MRTP Renewal Applications for IQOS Products

    Today (November 6, 2025), FDA established the closing date for the public comment period on the modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products S.A. for several IQOS heated tobacco products. Public comments on these applications must be submitted to the appropriate docket by 11:59 p.m. ET on December 8, 2025, to ensure they are considered by FDA:

    The application materials, redacted in accordance with applicable laws, can be found on FDA’s website. Before making a final determination on an MRTP application, FDA takes into consideration all relevant information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC).

    FDA held a TPSAC meeting to discuss these renewal applications on October 7, 2025. The public was able to attend virtually and present comments to the committee. Materials from the meeting are available on FDA’s website.

    For the latest updates on any MRTP applications under scientific review, sign up to receive email alertsExternal Link Disclaimer. 

  • Acting CTP Director Offers ‘Groundbreaking’ Views at FDLI

    Acting CTP Director Offers ‘Groundbreaking’ Views at FDLI

    Bret Koplow, Acting Director of the FDA Center for Tobacco Products (CTP), outlined a notable change in the agency’s approach to tobacco regulation, emphasizing tobacco harm reduction as a central principle, as he opened the Food and Drug Law Institute (FDLI) Tobacco and Nicotine Policy Conference on October 28.

    Chris Allen, CEO of UK-based consultancy Broughton, called the keynote “one of the most significant speeches we’ve heard in years,” marking the FDA’s first public acknowledgment of harm reduction as a principle embedded in its regulatory framework in years, while public health expert Cliff Douglas posted on X that the speech was “refreshing and potentially groundbreaking,” noting Koplow’s clear articulation of the benefits of switching from cigarettes to alternative products.

    According to social media posts from the two experts, Koplow highlighted the importance of streamlining review and authorization processes to make harm reduction measures effective, and said the FDA will soon provide guidance on the continuum of risk for tobacco and nicotine products and signaled potential support for expanding flavored e-cigarettes using age-gating technology if they serve public health goals. He also stressed the need for a regulated marketplace of authorized reduced-risk products, warning that without proper oversight, unregulated alternatives could dominate the market.

    “This is encouraging, but we will need to see what form this takes and how well it is executed. The follow-up panel on the future of tobacco policy in the context of #MAHA [Make America Healthy Again] correctly highlights the welcome change in tone in Director Koplow’s remarks,” Douglas wrote, referencing the conference’s opening panel,
    The Future of Tobacco Policy: Aligning CTP’s Present with MAHA’s Vision, which featured industry experts Beth Oliva, Cheryl K. Olson, Jeff Weiss, Jeffrey Willett, and Robyn Gougelet. “This should not be overlooked, as his clear articulation of the benefits of switching from cigarettes to pouches and vapes, for example, is refreshing and potentially groundbreaking.”

    Allen agreed, saying that the industry has sought FDA clarity for years.

    “This was more than a language shift. It was a reframing of how CTP interprets the ‘appropriate for the protection of public health’ standard at the heart of the Tobacco Control Act,” Allen wrote. “This shift opens the door for more transparent communication on relative risk, more efficient regulatory pathways, and ultimately, a more pragmatic approach to reducing smoking-related disease and death.

    “It’s not just a policy update, it’s a philosophical evolution.”

    After speaking on the MAHA panel that followed Koplow’s remarks, Olson said it was a pleasure hearing the director’s talk about shifting schemes.

    “Government framing of nicotine is overdue for a rethink,” Olson wrote on LinkedIn. “Smoking rates are stuck among vulnerable groups such as older adults. If you look at what government websites say about smoking cessation, they mostly give the same advice they’ve given for decades. The old HHS Framework assumes that people who smoke are passive victims of industry manipulation. 

    “If MAHA is about empowering people to make choices…that could help create a new framework that puts the needs of people who use nicotine at the center.”

  • Public Health Groups Drop Lawsuit Over FDA Menthol Ban Delay

    Public Health Groups Drop Lawsuit Over FDA Menthol Ban Delay

    A coalition of public health organizations, led by the African American Tobacco Control Leadership Council (AATCLC), voluntarily dismissed its lawsuit against the Food and Drug Administration (FDA) yesterday (October 27). The lawsuit, originally filed in the U.S. District Court for the Northern District of California in November 2024, sought to compel the FDA to finalize a long-awaited rule banning menthol cigarettes. The plaintiffs’ action comes after the incoming Trump administration officially withdrew the proposed menthol ban in January 2025, effectively making the lawsuit’s core demand moot, according to Bloomberg.

    The case centered on the FDA’s “unreasonable delay” in issuing a final rule, which began with a Notice of Proposed Rulemaking in May 2022. The Biden administration’s failure to finalize the rule, reportedly due to political concerns, prompted the legal challenge. However, the subsequent administrative reversal under the new presidential administration closed the door on this particular federal strategy.

    With the federal avenue for a menthol ban now closed, the public health advocates involved in the lawsuit have confirmed they will shift their focus to state and local-level initiatives, according to Bloomberg. By voluntarily dismissing the case, the plaintiffs can redirect their resources and strategic efforts toward more viable legal and political pathways. The dismissal was filed “without prejudice,” meaning the case could theoretically be refiled, but the current political climate and regulatory withdrawal make a renewed federal challenge unlikely in the near term.

  • Former CTP Director Says Tobacco Control Burden Shifts to States

    Former CTP Director Says Tobacco Control Burden Shifts to States

    Former director of the FDA’s Center for Tobacco Products Dr. Brian King, said the Trump administration’s reductions in federal funding, including millions of dollars previously allocated to tobacco control and prevention programs, have shifted the responsibility for such efforts to state and local governments. King, who is now the executive vice president of the Campaign for Tobacco-Free Kids, highlighted the implications during a keynote address at the Coalition for a Tobacco-Free Hawai‘i annual meeting, urging local leaders to document tobacco’s impacts and advocate for continued public health protections.

    King pointed to cuts affecting major agencies, including the CDC, NIH, and FDA, which traditionally provide funds for state-level tobacco control initiatives. Hawai‘i Public Radio said the CDC’s Office on Smoking and Health was eliminated, resulting in a loss of $70 million annually for tobacco control programs and $15.1 million for state quitlines. While the full impact of these federal cuts has yet to be felt, King warned that once programs lose funding entirely, many initiatives may face staffing reductions or elimination.

  • Philip Morris Urges FDA TPSAC to Recommend Continued Modified-Risk Marketing of IQOS

    Philip Morris Urges FDA TPSAC to Recommend Continued Modified-Risk Marketing of IQOS

    Experts from Philip Morris International presented evidence to the Tobacco Products Scientific Advisory Committee (TPSAC), according to a PMI press release. The committee, comprised of independent scientific researchers, provides nonbinding recommendations to the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP).

    The full-day meeting on October 7 was part of the FDA’s customary review of PMI’s request to continue marketing versions of its IQOS heated-tobacco products in the U.S. as modified-risk tobacco products (MRTPs), a necessary step while FDA completes its review of pending applications for IQOS ILUMA (a later version of the IQOS models that are currently authorized by the FDA) to reach and transition even more legal-age adults away from combustible cigarettes.

    “The evidence presented at this meeting, as also noted by the FDA, further supports the agency’s original conclusions that led the FDA to authorize the IQOS system as a modified-risk tobacco product,” said Stacey Kennedy, PMI U.S.’ CEO. “We encourage the FDA to continue efforts to establish a timely scientific review process for smoke-free products—including for IQOS ILUMA, which has been pending FDA review for nearly two years and has globally shown even higher rates of legal-age adults fully switching from combustible cigarettes—that are a better choice for legal-age adults who would otherwise use traditional tobacco products, including combustible cigarettes.”

    Initially granted by the FDA in 2020, the MRTP designation for the IQOS system authorizes PMI to communicate to legal-age consumers that: “AVAILABLE EVIDENCE TO DATE: The IQOS system heats tobacco but does not burn it. This significantly reduces the production of harmful and potentially harmful chemicals. Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

    During the meeting, representatives from PMI and committee members discussed a range of scientific, technical, and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented additional evidence and research demonstrating high levels of complete switching among current legal-age smokers while maintaining low levels of use by unintended populations.

    Addressing committee members, Keagan Lenihan, VP and Chief External Affairs Officer for PMI U.S., said: “CTP’s mission is to make tobacco-related disease and death a part of America’s past. Smoke-free products, like PMI’s IQOS system, play a critical role in helping CTP achieve this mission and provide adults who smoke with a real opportunity to change. The IQOS system, when marketed with the reduced-exposure claim, promotes complete switching from combustible cigarettes.”