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Category: FDA

  • FDA Schedules IQOS TPSAC Review

    FDA Schedules IQOS TPSAC Review

    The U.S. Food and Drug Administration has slated a meeting of its Tobacco Products Scientific Advisory Committee (TPSAC) for October 7, 2025, to evaluate the renewal applications for Philip Morris Products S.A.’s modified-risk status on several IQOS products. The review will cover five products: Marlboro Amber HeatSticks, Marlboro Green Menthol HeatSticks, Marlboro Blue Menthol HeatSticks, the IQOS 2.4 system holder and charger, and the IQOS 3.0 system holder and charger. These products were originally authorized under modified-risk orders in 2020 and 2022, using claims of reduced exposure to harmful chemicals, not reduced risk of disease. The upcoming meeting will assess whether the scientific standards continue to be met under the provisions of the Family Smoking Prevention and Tobacco Control Act.

    The original approvals allowed claims that switching completely from cigarettes to IQOS significantly reduces exposure to harmful and potentially harmful chemicals without asserting reduced risk of disease or safety. The FDA required postmarket surveillance, annual reporting, and a limited lifecycle for each MRTP order. Renewal applications have now been submitted to ensure compliance continues beyond the original expiry periods.

    The TPSAC review will take place at FDA’s White Oak Campus in Silver Spring, MD, and is open to the public both in-person and via webcast. Stakeholders, from industry participants to public health advocates, may provide oral testimony between 1:00–2:00 p.m. ET, with written comments accepted through September 25, 2025. Requests to speak must be submitted by September 11, 2025, along with a summary of the intended presentation. The federal register notice confirms that meeting materials will be posted ahead of time and background documents may appear online up to two business days before.

    TPSAC’s recommendations to FDA will focus on whether the products continue to meet statutory criteria: significant reduction in exposure, potential impact on tobacco initiation and cessation, youth uptake, and overall population health considerations. While TPSAC’s opinion is non-binding, its analysis is a key input for FDA’s final determination. New data from postmarket studies and annual reports, which were updated and posted online as of July 29, 2025, will inform the scientific discourse.

  • FDA Seeks Nominations for the Tobacco Products Scientific Advisory Committee

    FDA Seeks Nominations for the Tobacco Products Scientific Advisory Committee

    The U.S. Food and Drug Administration is requesting nominations by Aug. 25, 2025, for voting members to serve on the Tobacco Products Scientific Advisory Committee (TPSAC). Individuals may self-nominate or be nominated by any interested person or organization.

    Specifically, TPSAC is seeking to fill five vacancies with physicians, dentists, scientists, or healthcare professionals practicing in oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, engineering, or any other relevant specialty. Included in the five vacancies is one vacancy for a representative of the general public and one vacancy for an employee of federal, state, or local government. Selected members will be invited to serve for terms of up to four years, which will begin on Feb. 1, 2026, after the current members’ terms expire.

    All nominations for membership should be sent electronically to the FDA Advisory Nomination Portal or by mail to Advisory Committee Oversight and Management Staff. Please see the Federal Register notice for further information. Nominations received after Aug. 25, 2025, will be considered for nomination to the committee as later vacancies occur.

    TPSAC advises the FDA in its responsibilities related to the regulation of tobacco products, such as any application submitted by a manufacturer for a modified-risk tobacco product. The committee reviews and evaluates safety, dependence, and health issues concerning tobacco products and provides appropriate advice, information, and recommendations to the FDA commissioner.

  • FDA Embraces “Radical Transparency” by Publishing CRLs

    FDA Embraces “Radical Transparency” by Publishing CRLs

    On July 10, the U.S. Food and Drug Administration (FDA) published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024, marking a significant step in the Agency’s broader initiatives to modernize and increase transparency.

    By making the CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved.

    “For far too long, drug developers have been playing a guessing game when navigating the FDA,” said FDA Commissioner Marty Makary. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”

    “Because the FDA has historically refrained from publishing CRLs for pending applications, sponsors often misrepresent the rationale behind FDA’s decision to their stakeholders and the public,” the press release said. “According to a 2015 analysis conducted by FDA researchers, sponsors avoided mentioning 85% of the FDA’s concerns about safety and efficacy when announcing publicly that their application was not approved. Moreover, when FDA calls for a new clinical trial for safety or efficacy, that critical information is not disclosed approximately 40% of the time. Lessons learned from non-approvals are also not shared within the industry, leading companies to repeatedly make similar mistakes.”

    This initial batch of published decision letters associated with since-approved applications is now accessible to the public at openFDA. The Agency is in the process of publishing additional CRLs from its archives and is continuously exploring ways of providing the public with greater transparency into its decision-making process.

    On the surface, this all sounds like good news for companies that have spent years frustrated by FDA backlogs. What actually changes remains to be seen.

    “Commissioner Makary’s announcement raises questions about whether this effort is truly ‘radical transparency’ or just a repackaging of existing requirements,” Sarah Wicks and Michelle L. Butler wrote for FDA Law Blog. “The key difference may lie in timing and ease of access; despite the statutory requirement under FDAAA, action packages are often slow to appear on FDA’s website, especially following staffing disruptions at FDA.

    “It is currently unclear whether FDA intends to publish CRLs close in time to their issuance or for applications that are not subsequently approved. The prospect of publication of such CRLs would likely be of great concern to many applicants and of great interest to their competitors. Regardless, we will be watching to see how this radical transparency initiative unfolds.”

  • Makary Updates First 100 Days Leading FDA

    Makary Updates First 100 Days Leading FDA

    FDA Commissioner Marty Makary issued a statement today (July 10) to update the work that has been accomplished in his first 100 days leading the organization and create a roadmap for future objectives.

    “The FDA regulates products that account for 20% of all U.S. consumer spending, and our work impacts the lives of every American,” he said. “Over the past 100 days, we’ve launched dozens of key initiatives across the full range of the FDA’s purview to help make food healthier for children and families, accelerate meaningful cures and treatments, and modernize the agency with transparency, gold-standard science, and common sense.”

    The statement then listed dozens of bullet points highlighting the work being done, the majority of which focused on pharmaceuticals and food manufacturing. Under the heading “Administration – Gold-Standard Science & Common Sense,” Makary said the FDA was protecting American consumers by combating illegal vapes. “In collaboration with U.S. Customs and Border Protection, seized nearly $34 million worth of illegal, youth-appealing e-cigarette products originating in China,” it said.

    Makary also pointed to the FDA’s implementation of AI to assist all departments in reviewing products, of particular interest to the nicotine industry that has dealt with years of little to no movement regarding vapes and alternative products.

    “Completed a successful first AI-assisted scientific review pilot, demonstrating that internal AI tools can greatly reduce the time reviewers spend on mundane tasks or non-productive busywork,” the statement said. “Launched Elsa, a generative AI tool designed to help all FDA employees – from scientific reviewers to investigators – work more efficiently. Elsa is just an initial step in the FDA’s larger plans to integrate AI into agency processes.”

    “I’m excited by what the talented FDA team have been able to achieve in 100 days by embracing gold-standard science, radical transparency, and common sense,” Makary said. “This is just the beginning. We’ll continue to introduce initiatives to modernize the agency.”

    Read the entire press release here.

  • FDA: New PATH Study Data Files Available for Researchers

    FDA: New PATH Study Data Files Available for Researchers

    The Population Assessment of Tobacco and Health (PATH) Study released two new data sets today (July 1), including an innovative data type for researchers on locale that can provide a fresh resource for research questions.

    The Wave 7.5 Special Collection Public-Use Files are now available from FDA’s Center for Tobacco Products and NIH’s National Institute on Drug Abuse. These Wave 7.5 files contain questionnaire data from youth (12-17 years old) and young adults (18-22 years old) collected between April 2023 and December 2023. Adult and youth/parent Location Characteristics Restricted-Use Files from Wave 6 (2021) and Wave 7 (2022–2023) have also been released. These variables characterize a respondent’s neighborhood of residence as one of four basic locale types: city, suburban, town, or rural. Providing an enhanced measure of a respondent’s location improves the ability of researchers to understand relationships between tobacco use behaviors and community characteristics. Researchers are encouraged to submit a request to obtain data access.

    In addition to these newly released data files, the Wave 7.5 Special Collection Restricted-Use Files were also made available in April 2025. Researchers may continue to request access to the Wave 1-Wave 7 Restricted-Use Files and Biomarker Restricted-Use Files. Data and documentation from the Public-Use Files are also available for download with updated Master Linkage Files.

    The PATH Study is a household-based, nationally representative, longitudinal study of youth (12-17 years old) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act.

    Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com.

  • FDA Updates Tobacco Application Forms; Effective Immediately

    FDA Updates Tobacco Application Forms; Effective Immediately

    Today (June 6), the FDA posted six updated or new forms that are required for submitting new tobacco product applications under the premarket tobacco product application (PMTA) and Substantial Equivalence (SE) pathways. Starting July 6, 2025, applicants must use these forms in their PMTA and SE Report submissions. If applicants do not use the latest version of the forms or do not complete them properly, FDA generally intends to refuse to accept the application.

    The updated forms reflect public comments and are part of FDA’s work to promote efficiency, effectiveness, and transparency to improve its tobacco product application review process. The latest versions of the forms offer new instructions and additional details on the information applicants are required to include. Ultimately, these forms can help applicants submit higher-quality applications to facilitate FDA’s review.

    A list of the updated forms is below. Use of old versions of the forms will no longer be accepted after the 30-day notice period.

    Updated PMTA forms:

    • Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission
    • Form FDA 4057a – Premarket Tobacco Product Application Amendment and General Correspondence Submission
    • Form FDA 4057b – PMTA Unique Identifying Information for New Tobacco Products (formerly referred to as a grouping spreadsheet)

    Updated or new SE forms: 

    • Form FDA 3965 – Tobacco Substantial Equivalence Report Submission
    • Form FDA 3965a – Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission (formerly Form FDA 3964)
    • Form FDA 3965b (NEW) – SE Unique Identifying Information for New Tobacco Products

    To assist applicants’ proper use of Form FDA 4057b and Form FDA 3965b, FDA is releasing version 2.0 of its Product Form Validator Tool. Applicants may use the tool for both forms to validate the data and confirm if a completed form is consistent with FDA ingestion requirements before submission.

    If applicants have questions about the forms, they can email AskCTP@fda.hhs.gov or call 1-877-287-1373 between 9 a.m. and 4 p.m. EST. Additionally, applicants can explore FDA’s PMTA tips. 

  • House Working with Trump’s $6.8B FDA Budget

    House Working with Trump’s $6.8B FDA Budget

    House appropriators advanced a bill to fund the FDA for fiscal 2026 on a party-line vote out of a subcommittee yesterday (June 5)— but, according to Politico, the bill has a long path ahead before it potentially becomes law. The topline number from the House bill aligns with President Donald Trump’s budget proposal, which sought $6.8 billion for the FDA.

    The budget calls for $3.2 billion in direct appropriations, with the rest coming from user fee revenue. It also represents a $300 million cut in taxpayer funding compared to what the House Appropriations subcommittee sought last year for fiscal 2025.

    According to Politico, the Senate is likely to fund the agency at a higher level than the House. Sen. John Hoeven, the Republican senator in charge of FDA appropriations, said Trump’s proposal is a starting point.

    “We now have the president’s budget proposal,” Hoeven said. “But we’re going through our process now, and it will be different. … I think that you’ll see when we bring it out that we adequately fund FDA.”

  • Koplow Tabbed New CTP Chief

    Koplow Tabbed New CTP Chief

    U.S. Food and Drug Administration Commissioner Marty Makary announced that Bret Koplow will be acting director of the Center for Tobacco Products, according to emailed announcements reported by Bloomberg.

    Koplow has worked for the agency in various roles since 2011, serving as senior counselor to the commissioner in the Immediate Office of the Commissioner since early 2020, where he focused principally on regulatory, policy, and operational matters involving CTP, including work on e-cigarettes, cigars, and other tobacco products. Before joining the Commissioner’s Immediate Office, he served as senior counsel in the FDA’s Office of the Chief Counsel, and before that served in the FDA’s Office of Legislation as the Senior Advisor for Oversight.

    The agency is facing pressure to crack down on illicit products, improve new product submission procedures, and change how it approaches foreign inspections.

    “Bret Koplow—an attorney and longtime FDA bureaucrat,” Gregory Conley, a harm-reduction advocate posted on X. “This would seem to signal the Biden era status quo will continue for now.”

    Makary also announced Elizabeth Miller will serve as the acting associate commissioner for the Office of Inspections and Investigations, filling two high-profile vacancies. The former top tobacco regulator, Brian King, was pushed out during agency-wide layoffs in April.

  • Don’t Gamble Your PMTA: Bet on Your Quality System

    Don’t Gamble Your PMTA: Bet on Your Quality System

    By: Gabriel Muñiz

    The recent leadership changes and staffing reductions at the FDA’s Center for Tobacco Products (CTP) have created a moment of uncertainty, but also opportunity, for the tobacco and nicotine industry. With shifting priorities and new leadership on the horizon, some manufacturers see a chance to reset the regulatory conversation. While some companies are using this moment to tighten up operations and reinforce compliance in order to have a better chance at a favorable premarket tobacco product application (PMTA) outcome, others are taking a gamble, scaling back on quality systems and asking themselves, “Do we really have to keep doing all of this?”

    The question often centers around the expectations outlined in 21 CFR Part 1114 and the commitments companies made in their PMTAs. In a push to save costs, some manufacturers are reportedly reducing quality oversight, cutting corners in documentation, and stepping away from key controls they originally described in their PMTAs. The rationale? If enforcement is slowing down, maybe the FDA won’t notice or maybe it won’t matter.

    That’s a risky assumption.

    A PMTA is more than a regulatory formality. It’s a company’s game plan. A commitment to how the product will be manufactured, tested, controlled, and distributed. If your application included a robust quality management system (QMS), specific product testing protocols, or detailed supplier qualification processes, you’re expected to follow through. Along with the science, those commitments were the basis on which the FDA evaluated whether your product was “appropriate for the protection of public health.”

    Under Section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA has the authority to withdraw or suspend a marketing granted order (MGO) if it determines that a tobacco product is no longer “appropriate for the protection of public health,” the standard upon which PMTAs are evaluated and approved. If an inspection or oversight activity reveals that a company has significantly deviated from the manufacturing methods, testing protocols, or quality systems described in its PMTA, the FDA may conclude that the product no longer meets the criteria for market authorization. While there hasn’t yet been a public case of an MGO being rescinded solely for failure to follow internal PMTA commitments, the legal basis for such action is clear. An MGO is conditional—it depends on a company continuing to manufacture its product as promised. Deviating from that blueprint introduces real regulatory risk.

    While some in the industry viewed the Fifth Circuit’s ruling in Bidi Vapor v. FDA as a signal that the tide was turning in manufacturers’ favor, the outcome in FDA v. Wages and White Lion Investments LLC made it clear: Companies are still expected to meet regulatory requirements and support their products with quality data and compliance. The courts may question FDA procedures, but they won’t eliminate the work required to maintain market authorization.

    Even in a more industry-friendly political environment, the responsibility to protect public health isn’t going away. The current administration may support regulatory efficiency and streamlined processes, but not at the expense of consumer safety. Companies that ignore or scale back their quality systems risk finding themselves unprepared when FDA inspections or compliance reviews resume in full force.

    Now is the time for manufacturers to take stock of their internal systems and ensure alignment with their PMTAs. This includes verifying that quality controls, personnel training, document management, complaint handling, and supplier oversight are functioning as described. A comprehensive, well-maintained QMS doesn’t just satisfy regulatory requirements; it builds trust and stability, especially in a time of change.

    This transition at CTP represents a golden opportunity, but only if companies take the right approach. Cutting corners today to save money may end up costing you far more if it puts your MGO at risk. Regulatory clarity, product stability, and long-term market access depend on more than a favorable headline—they depend on daily operational integrity.

    The FDA may be shifting, but its core mandate remains. This is the moment for responsible manufacturers to lead by example, double down on quality, and show that this industry can thrive without sacrificing quality or consumer trust. For those willing to roll the dice, just remember, being the first company to lose an MGO over PMTA noncompliance isn’t the kind of milestone you want your brand remembered for.

    Gabriel Muñiz, an independent consultant with EAS Consulting Group, is a regulatory compliance expert with extensive experience in the tobacco industry. Muñiz’s tenure at the FDA, particularly as a director within the Office of Regulatory Affairs (ORA), involved leading compliance and enforcement activities for the agency’s tobacco program. His work in building the tobacco operations program and shaping tobacco regulatory policy was instrumental in the development of key compliance strategies and regulatory frameworks, including the proposed tobacco product manufacturing practices. After his FDA career, Muñiz further honed his skills at Juul Labs, where he played a key role in developing premarket tobacco product applications and ensuring alignment with evolving federal regulations. His deep expertise in tobacco regulation will be invaluable to EAS’ clients seeking strategic compliance advice and navigating tobacco-related regulatory challenges.

    About EAS Consulting Group

    EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by the FDA, USDA, and other federal and state agencies. As part of Certified Group, EAS Consulting Group delivers expert regulatory solutions our customers can feel confident in—so the world can trust in what it consumes. Our network of over 200 independent consultants enables EAS to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.

  • FDA Whistleblower Dishes on Agency’s Shortfalls

    FDA Whistleblower Dishes on Agency’s Shortfalls

    David Oliveira, who recently left the FDA after six years as a senior staffer, is speaking out about problems at the agency under the Biden administration, including tobacco control, diversity, equity and inclusion, and failures to combat China flooding the U.S. market with illicit vapes after the FDA’s top tobacco official was removed from his position. 

    “Many of us had been anticipating it for quite some time. We knew that change was drastically needed at FDA when it came to Tobacco Control,” Oliveira said in an interview with Fox News Digital. “Because Tobacco Control had really gotten out of control, there were many, many failures in core missions for the center that needed dramatic change and new leadership.

    “Many of us, whether it be from public health, consumers, small business owners, industry, and including even Senator Dick Durbin, who last year at a hearing said to Brian King, ‘It looks to me that you have fallen down on the job.’ So really, it runs the spectrum of people who are unhappy with what’s gone on recently with FDA in terms of tobacco regulation.

    “I frequently would attend shows and visit vape shops, and I was somewhat a canary in a coalmine, and would report back as to what I was seeing, and I would warn them that what I was seeing on the ground was out of control. We had a lot of people in the building who would go online and try to do some surveillance, but when you get out into the real world and you see the number of vape shops that are flooded with these illicit products, and I started to warn them about the amount of nicotine that was in these devices. We went from a Juul device, which had around 200 puffs, which was the equivalent of one pack of cigarettes, then I started seeing 5,000 puffs. I brought that warning back to the center, and then the following year would see 10,000 puffs. Now on the market, you can see 40,000 and 50,000 puffs. This is what the Chinese have done. They have not sought to get products authorized. They will introduce the latest and greatest technology. I saw a Santa one that was red and white. They’ll introduce flavors like Gummy Bear, Blow Pop, and Fruit Rollups, and these things that are absolutely youth-appealing because they do not care.” 

    View the 15-minute interview here.