TobaccoReporter logo

Tag: CTP

  • 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 While there hasn’t yet been a public case of an MGO being rescinded solely for failure to follow internal PMTA commitments, the legal basis for such action is clear.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.

  • Brian King, Dozens of Staffers Out at CTP

    Brian King, Dozens of Staffers Out at CTP

    The Associated Press is reporting that Brian King, the Food and Drug Administration’s chief tobacco regulator, was removed from his post this morning (April 1) amid sweeping cuts at the agency and across the federal health workforce. According to sources familiar with the situation, King sent an email to staff saying, “It is with a heavy heart and profound disappointment that I share I have been placed on administrative leave.”

    King was removed from his position and offered reassignment to the Indian Health Service, according to a person familiar with the matter who did not have permission to discuss the matter publicly and spoke on the condition of anonymity. Dozens of staffers in the FDA’s Center for Tobacco Products (CTP) also received notices of dismissal Tuesday morning, including the entire office responsible for enforcing tobacco regulations.

    In recent years, the CTP has been besieged by criticism from all sides, including politicians, anti-smoking advocates, and tobacco and vaping companies. Under King, the FDA rejected applications for millions of flavored e-cigarettes, citing insufficient data that the products would help adult smokers while not becoming popular with underage kids. Those rejections have resulted in multiple lawsuits against FDA from vape makers.

    “King, who joined the agency in 2022, has been vigorously criticized by vaping lobbyists for ordering thousands of companies to remove their fruit and candy-flavored e-cigarettes from the market,” the AP wrote. “During his time at FDA, teen vaping has fallen to a 10-year low.”

    The latest changes mean that nearly all of FDA’s top leaders overseeing drugs, food, vaccines, medical devices, and now tobacco products have resigned or retired in recent months. This comes after Robert F. Kennedy Jr.’s moves to fire 3,500 FDA staffers and push ahead with plans to scrutinize ultra-processed foods, childhood vaccines, antidepressants, and other long-established products.

  • CTP Updates Compliance Website

    CTP Updates Compliance Website

    Credit: Postmodern Studio

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has announced an enhancement to its website, which will more easily present information about tobacco compliance check outcomes.

    The agency noted in a statement that the database is designed to be a resource for various audiences, including the general public, public health groups and the tobacco industry.

    The new database offers the ability to search for various compliance and enforcement outcomes among brick-and-mortar and online retailers, including warning letters, civil money penalties and no-tobacco-sale orders.

    Previously, this information lived in various locations across the FDA website, so the enhancement will allow site visitors to more easily find outcomes from the FDA’s compliance and enforcement efforts of retailers in one centralized location, according to reports.

    This centralized database will be updated monthly with the latest compliance check outcomes. “The enhancements to this database reflect CTP’s continued efforts to optimize transparency and communication with stakeholders,” the statement continued.

  • System Overload

    System Overload

    The broken U.S. new tobacco product application process revealed by the numbers

    By Steven McDonald

    “How long will it take?” is a question often raised by project managers and executives alike. Typically, a reasonable estimate can be generated, but when it comes to predicting the time it will take for a review of a tobacco product application with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), any time estimate is met with skepticism.

    The CTP provides performance metrics for new tobacco product applications, which were evaluated for this article to determine if the time an application meanders through the regulatory pathways could be deduced. The backlog of applications brings into question the agency’s capabilities of managing its processes and ability to conduct timely reviews. Unfortunately, the backlog distorts the CTP’s internal process data for reviews and obfuscates the time estimation for a submission. In addition, significant gaps in the data do not allow for robust deductions.

    Following is an overview of the steps for the different regulatory pathways, the collection and evaluation of the CTP’s (performance) metrics and reporting data, and the ramifications thereof for future submissions. Readers should be aware that the CTP’s past performance may not be an indicator of future results.

    Application Process and Performance Metrics

    In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gave the FDA broad authority to regulate the manufacturing, distribution and marketing of tobacco products. This includes decisions on whether new tobacco products can be marketed and evaluation of new tobacco product applications.

    New tobacco products can be submitted for review through three pathways: substantial equivalence (SE), exempt from SE (EX), or premarket tobacco product application (PMTA). A fourth submission type, modified-risk tobacco product application, is not a pathway for new tobacco products but a pathway to obtain permission to make advertising “claims” specific to a particular product.

    Historically, the applications accepted through the SE and EX pathways have been for cigarettes, smokeless tobacco and roll-your-own products. In August 2016, the FDA’s tobacco authority was extended to all “deemed” tobacco products, including electronic nicotine-delivery systems (ENDS), cigars, hookah and pipe tobaccos. In addition, in 2022, Congress passed a law clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source (nontobacco-derived nicotine (NTN)). The vast majority of applications in the PMTA pathway have been for ENDS. Both the deeming rule and the NTN law led to a crushing number of new product applications submitted to the FDA in 2020 and 2022, respectively.

    The CTP posts the estimated number of submissions that are currently at each step on a somewhat regular basis and then publishes the totals for the fiscal year. Unfortunately, the level of detail provided and the frequency for the updates has not been consistent. However, by making use of the currently available information (through fiscal year 2023), annual values for the process steps can be estimated. The data and information, primarily gathered from the Tobacco Product Applications: Metrics and Reporting webpage was collected and compiled for SE, EX and PMTA submissions. For new tobacco product applications, the procedures for the SE and EX pathways are identical, and the PMTA pathway includes an additional step: acceptance review, filing review (PMTA only), scientific cycle reviews and determination.

    The enormous number of submissions from fiscal years 2020 and 2022 is working its way through the system, evident from the data, but the backlog indicates that the review process may have overwhelmed the CTP’s capabilities and distorts the internal process data.

    Substantial Equivalence

    The data for SE is provided in Table 1 for the calendar years 2013–2016 and the federal fiscal years (October to September) hence. It is assumed that these values for SE, in particular, marketing orders, Not Substantially Equivalent (NSE) Orders and Withdrawn, include the provisional SE report applications. Briefly, a “provisional tobacco product” is one that was introduced between Feb. 15, 2007, and March 22, 2011, and for which a provisional SE report had been submitted on or before March 23, 2011. The final three rows, Estimated Administrative (Admin) Backlog, Estimated Office of Science (OS) Backlog and Estimated Total Backlog, are calculated values derived from the data provided. Since there may be additional (unreported) applications, these estimates should be considered conservative.

    Table 1: Annual Data for Substantial Equivalence

    The metrics are divided into the different phases of the regulatory process: administrative review of the submissions (Accepted, Refuse-to-Accept, Total Received), determinations (Marketing Orders, NSE Orders, Withdrawns) and the calculated values (Total Final Actions, Estimated Admin Backlog, Estimated OS Backlog, Estimated Total Backlog).

    The calculated values for Total Final Actions are annual determinations: the sum of RTA, SE, NSE and Withdrawn. The remainder of the calculated values (Backlogs) should be considered estimates as the data missing from prior years may impact the accuracy of the results.

    The Estimated Administrative Backlog is a cumulative value, the difference between those applications received and those processed (Accepted or Refused). For example, the Estimated Administrative Backlog for fiscal year 2021 includes the values from fiscal years 2020 and 2021. The Estimated OS Backlog is calculated similarly, beginning in fiscal year 2020, as the difference between those applications accepted to be reviewed and those with determinations (SE, NSE or Withdrawn).

    Of note is the over 7,000 applications received by the CTP in 2020, which was likely due to the court-ordered submission deadline for newly deemed products such as cigars, pipe tobacco and waterpipe tobacco. Yet at the end of fiscal year 2021, the backlog of applications (neither accepted nor refused to accept) is less than 500. That number has since swelled to over 1,000, including over 100 submissions in fiscal year 2023 that remained unopened. In fact, during the October 2023 stakeholder engagement meeting, the CTP admitted that none of the SE reports submitted after Sept. 8, 2020, have undergone even an acceptance review.

    The thousands of applications from the Estimated OS Backlog and Estimated Total Backlog is staggering. This is in stark contrast to the few hundred Total Final Actions, interrupted only by a spike of Refuse-to-Accept determinations in fiscal year 2021.

    Using the historical CTP data and calculated estimates, projections for the CTP’s future throughput can be made. For example, it will take more than six years for the backlog of applications to work through the system with a 20 percent increase in staff and an insignificant number of future SE report submissions. In addition, if one considers a “first in, first out” application process, the time delay for a marketing order for any new SE report applications will be significant.

    Exempt from SE

    The annual data for Exempt from SE is provided in Table 2. The table structure and calculations are the same as Table 1. Similar to SE applications, the calculated Backlog values should be considered estimates as the data missing from prior years may impact the accuracy of the results.

    Table 2: Annual Data for Exempt from Substantial Equivalence (EX)

    The Estimated Administrative Backlog for fiscal year 2023 is less than 100 (during the October 2023 stakeholder engagement meeting, the CTP asserted that the EX backlog had been cleared). The Estimated OS Backlog and Total Backlog has been consistently over 1,000. This is in stark contrast to the few hundred Found Exempt Orders averaged annually.

    Calculated similarly as that of the SE report throughput (a 20 percent increase in staff and an insignificant number of future Exempt submissions), it will take 16 months for these applications to work through the system if the same rate for reviews is maintained. As with the SE applications, the large number from the Total Backlog suggests that the time delay for marketing orders for any new EX applications will be more than a year (but significantly less than an SE submission) if one considers a “first in, first out” application process.

    Premarket Tobacco Product Application

    The annual data for PMTAs is provided in Table 3. Again, the final three rows are estimates, calculated values derived from the data provided, and since there may be additional (unreported) applications, these estimates should be considered conservative.

    Table 3: Annual Data for Premarket Tobacco Product Application

    The metrics provided by the CTP are divided into the different phases of the regulatory process: administrative, filing and determination. A staggering number of applications were received in the fiscal year 2020 through 2022 time frame, and to date, nearly 25 million applications have been rejected without substantive review. The calculated values in the table are generated similarly as for the SE and EX tables.

    As the CTP has stated on several occasions (most recently on Jan. 22, 2024, in the press release announcing the marketing denial order (MDO) for flavored Blu e-cigarette products), the “FDA has received applications for more than 26 million deemed products and has made determinations on 99 percent of these applications.” The Estimated Admin Backlog at the end of fiscal year 2023 is over 60,000, and the Estimated OS Backlog is over 300,000. It is difficult to estimate the time for these applications to receive substantive review; however, if one considers the Marketing Granted Order (MGO) and MDO values from fiscal year 2022 as a guideline, values can be determined.

    Based on these estimated values, a modest 20 percent increase in staff, and a limited number of future PMTA submissions, it will take more than 16 years for the applications under scientific review (Estimated OS Backlog) to receive a determination. If one considers the Estimated Total Backlog of applications calculated with the same parameters, it will take nearly 30 years for all the currently submitted applications to receive a determination.

    Finally, the substantive review of the PMTAs for specific “covered applications” (brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar, and those that have a 2 percent or more sales volume as determined by Nielsen) is under a Maryland Federal District Court order (Am. Acad. of Pediatrics v. FDA (AAP), 379 F.Supp.3d 461, 492 (D. Md. 2019)). The original court-imposed deadline to complete the reviews was Sept. 9, 2021, which the agency was unable to meet. Based on the most recent (Jan. 24, 2024) status report filed with the district court, the CTP will take action on 100 percent of these applications by June 2024. This date has been pushed back on several occasions, indicating that even the CTP cannot predict how long it will take.

    Steven McDonald is principal scientist, scientific engagement, at ITG Brands.
  • FDA Seeks Nominations for TPSAC

    FDA Seeks Nominations for TPSAC

    Image: freshidea

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) is requesting nominations by Oct. 11, 2023, for a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee (TPSAC). Individuals may self-nominate or be nominated by any interested person or organization.

    In addition, the CTP is seeking any industry organizations interested in participating in the selection of this TPSAC nonvoting representative.

    Nomination materials for prospective TPSAC candidates and letters from industry organizations interested in participating in the selection process should be sent to the CTP by Oct. 11, 2023. Please see the Federal Register notice for further details on the nomination and selection procedures.

    TPSAC advises the CTP in its responsibilities related to the regulation of tobacco products. The committee reviews and evaluates safety, dependence and health issues concerning tobacco products and provides appropriate advice, information and recommendations to the FDA commissioner.

  • Public Meeting on PMTA Process

    Public Meeting on PMTA Process

    Credit: JHVEPhoto

    The U.S. Food and Drug Administration will hold a two-day public meeting on the agency’s premarket tobacco product application (PMTA) process on Oct. 23–24, 2023.

    The meeting will be held on the FDA’s White Oak Campus in Silver Spring, Maryland, and will be in a hybrid format with the option to attend virtually.

    Staff from the Center for Tobacco Products’ Office of Science will present on topics related to the PMTA process and be available to respond to questions received from stakeholders on the topic, according to a press note.

    Additional information, including registration and question submission processes, will be available soon.

  • Registration Open for CTP Listening Session

    Registration Open for CTP Listening Session

    Credit: Postmodern Studio

    Registration is open for the virtual listening session on the development of the Center for Tobacco Products’ (CTP) five-year strategic plan, which will take place on Aug. 22 beginning at 10 a.m. EDT.

    The virtual listening session is an opportunity to verbally provide open public comment on the development of the new strategic plan, including proposed strategic goals. After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan, including proposed goal areas. Registered speakers will then have approximately four minutes each to verbally share their comments on any topics related to the strategic plan. Submit a request to verbally provide open public comment by Aug. 14 at 11:59 p.m. EDT.

    Registration also includes a “listen-only” option for those who want to attend the session but do not request to speak. Listen-only registration slots are unlimited, but registration is required. There is no deadline to register for listen-only slots.

    In addition to this listening session, the public can submit electronic or written comments to the Federal Register notice. Electronic comments must be submitted, and written comments must be postmarked, by Aug. 29.

  • CTP Reports Progress on Reagan-Udall Review

    CTP Reports Progress on Reagan-Udall Review

    Image: Tobacco Reporter archive

    Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), published a statement summarizing the CTP’s progress in addressing the recommendations from the Reagan-Udall evaluation.

    At the request of FDA Commissioner Robert Califf, the Reagan-Udall Foundation evaluated the CTP’s operations. In December, the foundation submitted its report, which identified several problems hindering the agency’s ability to regulate the industry and reduce tobacco-related disease. Among other recommendations, the foundation urged the CTP to make process improvements and increase transparency.

    According to King, the CTP has made significant strides in putting its plans for improvement into action. The agency, he said, is on track to issue proposed goals this summer, and to release the final plan by December 2023. The CTP intends to hold a public meeting in summer 2023 to seek stakeholder feedback about the strategic plan.

    Meanwhile, said King, the CTP Ombuds Office is leading the creation of an operational strategy to improve transparency and information sharing across all programmatic areas, including through the establishment of transparency liaisons. Externally, the center is planning for upcoming public meetings to gather stakeholder input. CTP also published a webpage of all the tobacco products-related citizen petitions received by the center to provide the public with information about such citizen petitions that is easy to access and user-friendly.

    According to King, the center has reviewed 99 percent of tobacco product applications submitted over the past three years, authorizing 23 tobacco-flavored e-cigarette products and devices. The CTP is currently planning a public meeting to take place in fall 2023 regarding the application review process.

    Meanwhile, the center is in the process of finalizing rules related to menthol cigarettes and flavored cigars and continues to work toward publishing a proposed rule that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.

    CTP also recently proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.

    King also highlighted the CTP Office of Science leadership’s participation in conferences and external meetings. For example, representatives from the Office of Science recently presented at the Food and Drug Law Institute’s Nicotine Product Regulatory Science Symposium, the E-Cigarette Summit and the TMA annual meeting (see Todd Cecil’s TMA presentation here).

    “I am proud of the significant progress the center has made to date in addressing the external evaluation recommendations, and I am confident that we’ll continue to make important strides in continuing to build and strengthen FDA’s tobacco program in the future,” said King.

    A comprehensive list of CTP status updates for each Reagan-Udall Foundation recommendation is available here.

  • CTP Hires Health Equity Advisor

    CTP Hires Health Equity Advisor

    The U.S. Food and Drug Administration Center for Tobacco Products (CTP) has hired Charlene Le Fauve as its first senior advisor for health equity.

    “Dr. Le Fauve is a behavioral scientist and addiction researcher with 25 years of federal work experience related to health equity and health disparities research,” the CTP wrote on its website. “She has dedicated her career to advancing health equity and the health of underserved and underrepresented populations through research and research workforce development.”

    Most recently, Le Fauve served as the senior advisor to the chief officer for scientific workforce diversity at the National Institutes of Health (NIH). In this role, she educated national audiences about NIH’s role in scientific workforce diversity and health equity research.

    Prior to her NIH role, Le Fauve held various leadership roles, such as the deputy director of disparities research and global mental health at the National Institutes of Mental Health and the senior policy coordinator and lead for the Center for Medicare and Medicaid Services Team at the Department of Health and Human Services.

    “Diversity, Equity, Inclusion, and Accessibility are core values of CTP, and efforts are underway to ensure that the full scope of the Center’s work is reflective of these principles. In this new position, which is the first of its kind for any Center at FDA, Dr. Le Fauve will work with all of CTP’s Offices to ensure health equity is integrated into the Center’s programmatic plans and priorities,” the CTP said.

    “She also will serve as CTP’s primary representative in a variety of activities that promote and facilitate the reduction of tobacco-related health disparities, including during external meetings, conferences, and presentations.”

  • New Resources to Help Amend PMTAs

    New Resources to Help Amend PMTAs

    Credit: Postmodern Studio

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has created two new resources to help applicants prepare and submit amendments to their premarket tobacco product applications (PMTAs): Fact Sheet—Amendment Tips: Completing Form FDA 4057a and Video—Using the CTP Portal.

    The fact sheet provides quick tips for completing Form FDA 4057a—Premarket Tobacco Product Application Amendment and General Correspondence Submission. In most circumstances, the CTP can only accept PMTA amendments for review that include Form FDA 4057a. In general, when submitting amendments for a PMTA, the FDA will review the required Form FDA 4057a first. If required content is missing from the form, the FDA may not continue reviewing the amendment.

    The video provides an overview of the CTP Portal and how to use it, including how to find application submission tracking numbers online.

    Recently, CTP Director Brian King outlined several new actions to enhance the center’s efficiency, effectiveness and transparency. These activities include enhanced communication on scientific issues and practices. By providing these new resources, the CTP is aiming to better support applicants navigating the PMTA process.