Tag: CTP

CTP Updates Compliance Website

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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.
July 9, 2024
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.
March 1, 2024
FDA Seeks Nominations for TPSAC

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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.
September 18, 2023
Public Meeting on PMTA Process

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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.
August 17, 2023
Registration Open for CTP Listening Session

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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.
August 8, 2023
CTP Reports Progress on Reagan-Udall Review

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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.
June 29, 2023
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.”
May 22, 2023
New Resources to Help Amend PMTAs

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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.
April 12, 2023
Qnovia Adds Zeller to Advisory Board

Mitch Zeller, the former head of the U.S. Food and Drug Administration’s Center for Tobacco Product, has joined the advisory board of a company developing a first-of-its-kind smoking cessation inhalation product.
Zeller said Qnovia’s nicotine inhalation product, RespiRX, has the potential to be a “game changer” in lowering the use of combustible cigarettes.
The former director of the Center for Tobacco Products (CTP) from March 2013 until his retirement in April 2022, Zeller is now providing policy and regulatory strategy consulting to Qnovia, Inc.
The company is currently preparing an application to the FDA’s Center for Drug Evaluation and Research (CDER) for a cessation therapy which, if approved, will be the first inhaled prescription therapy to help tobacco smokers quit.
Zeller’s addition to the company’s advisory board comes as the FDA aims to finalize proposed bans on menthol cigarettes and flavored cigars by August. The FDA also plans to propose a rule limiting nicotine levels in cigarettes and some other tobacco products.
Zeller said access to Qnovia’s product can be one essential tool along with an administration-wide effort to provide support to those with nicotine addictions once those product standards take effect.
“Some people will be able to quit cold turkey, but a whole bunch won’t, and they will be seeking nicotine elsewhere,” Zeller said in an interview, told Bloomberg Law.
“The last thing that we want smokers to do if any of those policies go into effect is to simply switch to another tobacco product,” he added.
Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, according to Qnovia CEO Brian Quigley. Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG.
RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal byproducts.
RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product.
“The nebulizing unit (cartridge) gets replaced by the patient every one to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”
Late last year, Qnovia raised $17 million to continue the development of its RespiRx nicotine replacement product.
In June of 2020, the company appointed Quigley, a 16-year veteran of Altria Group, as its Chief Operating Officer. At Altria, Quigley served as CEO of its smokeless tobacco business from 2012 to 2018, a $2.3 billion business with over 800 employees,
March 31, 2023
House Oversight Committee Probes CTP

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The U.S. House Oversight and Accountability Committee will investigate the practices of the Food and Drug Administration’s Center for Tobacco Products (CTP), according to Vaping360.
Chairman James Comer is conducting the probe of the FDA’s regulation of tobacco and nicotine products through the CTP. The CTP has failed to effectively define and administer its tobacco and nicotine regulatory programs, resulting in industry uncertainty and unsafe products reaching the marketplace, according to a committee press release. In a letter to FDA Commissioner Robert Califf, Comer is requesting documents, communications and a staff-level briefing related to the CTP’s activities to ensure it is performing its regulatory function as intended.
“The Committee on Oversight and Accountability is conducting oversight of the Food and Drug Administration’s (FDA) regulation of tobacco and nicotine products through its Center for Tobacco Products (CTP). A recent evaluation of CTP by the Reagan-Udall Foundation (RUF) found that CTP has not clearly set out the most basic elements of its tobacco and nicotine regulatory programs. This has resulted in confusion, inefficiency, litigation and suspicions of political interference. CTP has fostered uncertainty in the marketplace and has allowed unsafe and unregulated products to proliferate. Therefore, we seek documents and information regarding CTP’s activities to enable transparency and to ensure the CTP is performing required functions,” wrote Comer.
An evaluation of the CTP by the Reagan-Udall Foundation stated that the CTP is unable to perform its basic functions and ensure that Americans have access to products that have the potential to lower the rate of smoking-related disease and death. Amidst unclear policies, stakeholders have even reported having to guess what the CTP’s regulations might be. Congressional oversight is needed to bring transparency to the CTP’s lack of clear policies that have resulted in market uncertainty, unregulated products and enforcement failures, according to the press release.
“We have deep concerns that CTP’s decisions have been influenced by political concerns rather than scientific evidence,” wrote Comer. “Comments from FDA staff to RUF, which are no longer available on its website, reflect such concerns. For example, one commenter said, ‘[i]n cases where reviews are finished and scientific decisions are made, they are also overruled by political agendas and pushed to change decisions.’ Another stated, ‘scientific disagreement is frowned upon, if not entirely suppressed,’ while a third said leadership was ‘… unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.’ FDA must clearly identify and publicize what scientific criteria are necessary for a product, to include [electronic nicotine-delivery system (ENDS) products] and smokeless products, to be authorized through the PMTA pathway and—where appropriate—the subsequent [modified-risk tobacco product applications (MRTPs)] pathway.”
Comer specifically asked the FDA to provide: FDA staff comments to the Reagan-Udall evaluation; all communications with the White House and Department of Health and Human Services (HHS) regarding tobacco or nicotine policy; documents and communications between the FDA and the Centers for Disease Control and Prevention (CDC) regarding CTP policies; documents and communications between the FDA and “public health advocacy groups” regarding CTP policies; all documents that describe the specific analytic process the FDA uses to apply the “appropriate for the protection of public health” standard; and all documents and communications related to the FDA’s enforcement efforts to remove illegally marketed tobacco or nicotine products from retail locations.
March 29, 2023