Tag: center for tobacco products

U.S. Urged to Bolster Post-Employment Rules

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Public policy experts are calling for stronger federal post-employment regulations as U.S. regulators, including those overseeing the tobacco business, are increasingly losing talent to the private sector.
A recent article in The Examination details how, over the past 15 years, nearly two dozen lawyers have left the U.S. Food and Drug Administration and its Center for Tobacco Products to advise, litigate for or work with the tobacco and vaping industry.
“It seems like every time we get sued in the tobacco industry, a former FDA lawyer is leading the lawsuit,” Commissioner Robert Califf told an FDA oversight organization last year.
After gaining FDA experience, lawyers can significantly increase their salaries by moving to a major law firm or corporation. While a lawyer’s salary in the FDA’s chief counsel’s office, for example, starts at around $83,000, a first-year lawyer at a firm made on average $200,000 a year in 2023, according to the National Association for Law Placement.
Daniel Aaron, a former FDA attorney, says lawyers who’ve left the agency to work on behalf of the tobacco industry not only increase their renumeration but can also have a powerful impact on what lands on store shelves.
“It’s a huge advantage to getting your product to market.” said Aaron, now a University of Utah law professor. “Ex-FDA lawyers know what the agency is worried about, and how a client can maximize its options. They know not just what the law is, but they know how the FDA will enforce the law.”
Federal post-employment rules also bar former employees from communicating with or lobbying a federal employee for two years on behalf of a client or employer under certain circumstances. That said, employees are allowed to work “behind the scenes” advising clients, according to the FDA’s post-employment guidelines.
Genevieve Kanter, a professor at the University of Southern California who co-published a study in 2023 on the revolving door in health care regulation, believes the rules should be strengthened if society is truly interested in preserving independent government.
Kanter’s study focused specifically on conflicts of interest of employees at the highest level of the U.S. Department of Health and Human Services; It found that 38 percent percent of the political appointees from the FDA went into private industry, the fourth highest out of roughly two dozen offices and divisions.
Eric Lindblom, director of the Center for Tobacco Products’ Office of Policy from 2011 to 2016, proposed blocking former staff from working for the tobacco industry for at least one or two years, in all cases, after leaving the policy office. “I thought it was really important that we had that independence,” said Lindblom, now a senior scholar at Georgetown University’s O’Neill Institute.
The proposal went nowhere.
The Examination is a publication supported by Bloomberg Philanthropies.
October 31, 2024
CTP Office of Management Gets Brandt as Director
Credit: Otseira
The U.S. Food and Drug Administration’s Center For Tobacco Products (CTP) is pleased to announce that Erin Brandt will serve as director of CTP’s Office of Management.
Brandt currently holds the position of deputy director in CTP’s Office of Management.
“Brandt has more than a decade of experience working in leadership positions in administrative management,” the CTP stated in a release. “She has extensive experience overseeing a wide range of administrative services, including human capital, information technology, financial management, administrative management, acquisitions and grants, ethics, facilities, and risk management and analysis.”
Brandt joined CTP in 2013 as the Office of Management’s Management analysis officer, and became the deputy director in 2014, a position she held until assuming her current role as acting director.
Before joining FDA, Brandt was a management analyst at the National Institutes of Health (NIH) and worked for several non-profit organizations, including Global Philanthropy Alliance, World Resources Institute, and Habitat for Humanity as an AmeriCorps VISTA.
She earned a master’s of Public Policy from the University of Minnesota Humphrey School of Public Affairs and holds a bachelor’s of Science in Political Science from the University of Wisconsin-Eau Claire.
Brandt was selected after an extensive nationwide search, multiple interview panels that evaluated a substantial and well-qualified applicant pool, and clearance through important FDA ethics and security processes. CTP is excited for Ms. Brandt to continue her service with CTP, with an effective date of June 16th.
June 5, 2024
John Verbeten to lead CTP Compliance Office

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John Verbeten is the new director of the U.S. Food and Drug Administration Center for Tobacco Products’ Office of Compliance and Enforcement.
Verbeten has more than 20 years of experience leading field operations, compliance and enforcement, and national-level program management. In his latest role within Office of Import Operations, Verbeten served as the principal advisor to the Office of Regulatory Affairs’ (ORA) leadership on import operations and enforcement activities, and oversaw the FDA’s field import operations, which includes a staff of more than 700 people.
He also provided leadership in the development, implementation and evaluation of new laws, regulations and policies related to ORA’s global and national programs and activities.
Most recently, he led the agency’s development of a memorandum of understanding between the FDA and U.S. Postal Service (USPS), which established a framework that provides a basis for the development of bilateral data exchange and provides the FDA access to the USPS advanced electronic data for imported mail shipments.
May 13, 2024
FDA: New 5-Year Strategic Plan Announced for CTP

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On Dec. 18, Brian King, director of the U.S. Food and Drug Administration Center for Tobacco Products, published a statement about the release of the center’s comprehensive strategic plan. The new strategic plan outlines CTP’s programmatic and workforce initiatives for the next five years.
The CTP’s strategic plan defines five goals, 10 outcomes and several corresponding objectives. As outlined in the goals and outcomes in the plan, the center is collectively committed to issuing impactful regulations, using robust science to inform application reviews, pursuing timely and impactful compliance and enforcement strategies, and educating the public about the risks of tobacco products.
King said the CTP will also continue to invest in its staff by advancing operational enhancements and supporting the further development of its workforce.
In conjunction with the strategic plan, the CTP also published the center’s policy agenda of rules and guidance documents that are in development or planned for development. According to the agency, this policy agenda will create a more efficient approach to meeting the CTP’s strategic plan. The agenda will be updated annually.
December 18, 2023
King: Progress Implementing Reagan-Udall Suggestions

Photo: GTNF
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has made significant progress in addressing the recommendations made by an expert panel facilitated by the Reagan-Udall Foundation, CTP Director Brian King said in a recent update.
Key areas of focus include cross-cutting initiatives, science and application review, regulations and guidance, compliance and enforcement, public education campaigns, and resource development.
According to King, the CTP is working on a new strategic plan set to be released by December 2023, which includes cross-cutting themes like science, transparency, stakeholder engagement and health equity. The center has solicited extensive feedback from both internal and external stakeholders, aiming to create a robust and inclusive plan.
Regarding science and application review, the CTP has processed more than 26 million deemed products’ applications and is committed to addressing the remaining applications efficiently while ensuring scientific accuracy and legal compliance. It has also developed resources and engaged with stakeholders to enhance the premarket application review process.
In the realm of compliance and enforcement, the CTP has taken various actions to curb the sale of illegal tobacco products, particularly those appealing to youth. They have issued warning letters and complaints for civil money penalties, demonstrating their commitment to enforcing the law.
Public education campaigns continue to play a crucial role in preventing youth tobacco product use. The CTP is actively seeking input and aims to share updated campaign information soon.
The CTP recognizes the importance of their staff and is working on enhancing their workforce development. They are also exploring options for securing user fees to support regulation efforts and requesting additional funding in the president’s fiscal year 2024 budget.
October 29, 2023
CTP Announces new Director of Office of Science

Matthew Farrelly (Credit: RTI International)
The new director of the U.S. Food and Drug Administration’s tobacco science division is Matthew Farrelly, former chief scientist and director of the Center for Health Analytics, Media, and Policy for RTI International.
In an announcement, The FDA’s Center of Tobacco Products (CTP) stated that Farrelly’s extensive work in the field of tobacco and nicotine science for more than 25 years, and being recognized internationally as an expert with proven leadership and organizational management skills will help him succeed as the director of the CTP’s Office of Science.
“He has led or been involved with numerous scientific endeavors related to tobacco control policies and regulatory approaches, including those related to graphic health warning labels, excise taxes, smoke-free policies, quitlines, state tobacco control programs, retail advertising, and flavored tobacco products,” the release states. “He has also extensively researched the influence of mass reach health campaigns, including FDA’s The Real Cost.”
Farrelly also has authored or co-authored over 120 articles in peer-reviewed scientific literature, which have been cited over 10,000 times. He earned his Ph.D. in Economics from the University of Maryland at College Park.
Farrelly will replace Matt Holman, who left the position last year to Philip Morris International. Holman was hired in 2017 and took over for David Ashley.
February 17, 2023
CTP to Release Reagan-Udall Response in February

The Head of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) said in a perspective released today that the Center recently received the findings from the Reagan-Udall Foundation’s independent evaluation of its program and is in the process of closely reviewing the feedback. In February, the Center will provide an update on its planned actions in response to the evaluation.
When the Reagan-Udall Foundation submitted its recommendations to Robert Califf, commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the PMTA process.
CTP Director Brian King also announced the Center has accepted for review more than 8,600 marketing applications for synthetic products. In a recently released perspective, King said the center received more than 1 million premarket tobacco product applications (PMTAs) from 200 companies by May 14, 2022.
“FDA has also issued refuse-to-accept (RTA) letters for more than 925,000 products in applications submitted by May 14 that do not meet the criteria for acceptance,” King wrote. “The RTA letters state that it is illegal to sell or distribute the product in the U.S. marketplace without a premarket authorization.”
Brian King / Credit: FDA
He also stated that in 2022, CTP participated in 52 meetings with stakeholders – averaging one per week – including 25 meetings since King became director. King also stated that starting when the FDA was given the authority by Congress to regulate non-tobacco nicotine products in April 2022, the CTP has issued more than 75 warning letters to manufacturers through Jan. 20, 2023, including manufacturers of brands popular among youth, such as Puff Bar.
“We have also issued over 585 warning letters to retailers for the sale of non-tobacco nicotine products to underage purchasers as of December 2022. In October 2022, the U.S. Department of Justice (DOJ), on behalf of the FDA,” filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers that failed to submit PMTAs and continued to sell products,” wrote King.
In a court filing last week, the FDA stated it will take until possibly December 31, 2023, before it completes the PMTA review process for some of the most popular vapes on the market.
Much like an earlier op-ed this year, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers.
King also failed to address the conclusion of a recent investigation conducted by the U.S. Office of Special Counsel that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.
January 31, 2023
CTP Terms: ‘Grandfathered’ Becomes ‘Pre-existing’

Photo: Olivier Le Moal
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has updated the term “grandfathered tobacco product” to “pre-existing tobacco product” to describe these products more appropriately.
Additionally, the term “grandfathered,” when used to describe someone or something exempt from a new law or regulation has its roots in 19th century racist voting laws, according to the FDA.
Like the grandfathered products before it, a pre-existing tobacco product is any tobacco product (including those products in test markets) that was commercially marketed in the United States as of Feb. 15, 2007.
As was the case with submitting a grandfathered determination request, submitting a request to determine the pre-existing status of a tobacco product is voluntary and not required under the Federal Food, Drug and Cosmetic Act.
According to the CTP, the terminology update requires no additional action by companies with pending grandfathered determination request.
August 24, 2022
Zeller to Retire from Center for Tobacco Products in April
Mitch Zeller, the director of the Food and Drug Administration’s Center for Tobacco Products, plans to retire in April 2022 after serving in the post since 2013, reports The Washington Post. In a letter to staff, acting FDA Commissioner Janet Woodcock praised his work as “invaluable and instrumental” to advancing “numerous historic public health milestones in tobacco regulation.”
A graduate of Dartmouth College and the American University Washington College of Law, Zeller has been working on FDA issues for more than 30 years. He began his career as a public interest attorney in 1982 at the Center for Science in the Public Interest (CSPI). In 1988, Zeller left CSPI to become counsel to the human resources and intergovernmental relations subcommittee of the House of Representatives’ government operations committee, where he conducted oversight of enforcement of federal health and safety laws.
In 1993, Zeller joined the staff of then FDA Commissioner David Kessler. What began as a two-week assignment by Kessler to examine the practices of the tobacco industry led to his serving as associate commissioner and director of the FDA’s first Office of Tobacco Programs. Instrumental in crafting the agency’s 1996 tobacco regulations, Zeller also represented the FDA before Congress, federal and state agencies. Zeller also served as an official U.S. delegate to the World Health Organization working group for the Framework Convention on Tobacco Control.
In 2000, Zeller became executive vice president of the American Legacy Foundation. His responsibilities there included marketing, communications, strategic partnerships and, in 2002, creating the foundation’s first Office of Policy and Government Relations. That year, Zeller joined PinneyAssociates, where, as senior vice president, he provided strategic planning and communications advice.
He left PinneyAssociates in 2013 to begin his second stint at the FDA.
December 9, 2021