Amid the whirlwind of federal government layoffs over the last few weeks, convenience-store operators, manufacturers, suppliers and associations in the tobacco industry paid particular attention to one department—the emptying of the Food and Drug Administration’s Center for Tobacco Products (CTP) workforce.
On April 21, a group of Democratic senators, led by Jeff Merkley (D-Oregon), Richard Blumenthal (D-Connecticut), Dick Durbin (D-Illinois) and Edward J. Markey (D-Massachusetts) sent a letter to the Department of Health and Human Services (HHS) also expressing concern over the FDA’s CTP cuts.
“Dozens of staffers at the Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) have been placed on administrative leave, including the Center’s director, and the Center for Disease Control and Prevention’s (CDC) Office on Smoking and Health (OSH) has been gutted. These actions risk undermining progress that has been made in reducing the death, disease and addiction caused by tobacco use,” the senators wrote. “Without these critical staff, we are concerned that more youth will start using tobacco products, fewer people will quit and more people will become ill and die from tobacco-caused disease.”
In the letter, the senators warned “the firing of thousands of staff at HHS also effectively eliminates CDC’s OSH, which plays a critical role in preventing youth tobacco use and helping adult tobacco users to quit. Eliminating this office will deprive states of the only dedicated source of federal funding for state tobacco prevention and cessation programs.”
The CTP is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act that Congress passed in 2009 that places tobacco under the authority of the federal FDA.
The recent layoffs at the CTP have been met with both positive and negative criticism, prompting many to voice their opinions of what is essential to move the CTP forward.
Missed Opportunities
When former CTP Director Brian King was removed from his position, skeptics of his leadership told CSP there were missed opportunities. CSP reached out to King, but he declined to comment.
“Rather than concentrating on his core mission—to keep tobacco and vape products away from American youth—King devoted an inordinate amount of time to high‑profile speaking engagements and political maneuvering that, in practice, obstructed meaningful progress,” said Lonnie McQuirter, owner of the 36 Lyn convenience store in Minneapolis.
McQuirter said that under King’s watch, illicit vaping devices have inundated schools and playgrounds, which he said is clear evidence that enforcement against black‑market operators was deprioritized.
“At the same time, King and CTP repeatedly cast the convenience‑store industry—the sector with the longest track record in responsibly retailing age‑restricted products—as the primary culprit for youth access, rather than a partner in public‑health enforcement,” he said.
McQuirter, among CSP's 2023 Power 20 and 2018 Indie Influencers, told CSP that decision makers need to give c-store operators a bigger seat at the table.
“If the recent layoffs force the FDA to refocus its priorities, it should begin by rebuilding a collaborative framework with convenience retailers—harnessing our proven compliance tools and decades of partnership—to finally deliver on CTP’s mandate: making our children safer,” he said.
The Vapor Technology Association (VTA) in a statement said the “removal of Brian King from a position of leadership impacting millions of Americans is the first step in correcting the broken mindset that has crippled the FDA and the Center for Tobacco Products over the past four years.”
The VTA said the next step needed is “fixing the broken regulation that allowed CTP, under King’s leadership, to make politically motivated decisions that have done nothing to save the 480,000 Americans who die from smoking every year.”
VTA Executive Director Tony Abboud told CSP that the PMTA regulation process itself is broken.
The Trump administration is “clearly an administration that is looking very skeptically at regulations that have had adverse and negative consequences for business,” Abboud said.
He said part of the CTP’s reset needs to include concrete changes.
“They need to be looking at how do they dramatically alter what has been put in place as opposed to simply trying to tinker with and muddle through a broken, burdensome, onerous regulation that has not served the public’s interests or the industry’s interests,” he said.
Battered with criticism for its lack of efficiency and clarity from tobacco insiders, when it comes to missteps from the CTP, U.S. Policy Analyst Elizabeth Hicks, of the Consumer Choice Center, an independent, nonpartisan consumer advocacy group based in Washington, D.C., told CSP that there are two key problems the agency’s CTP needs to address.
Hicks said that firstly, there is still a backlog of premarket tobacco product applications (PMTAs) for e-cigarettes and other nicotine alternatives.
“We recently saw a PMTA approved for all strength levels and flavors of Zyn, however, it took five years for CTP to decide when they said it would be determined within only 180 days. This highlights the need for a streamlined PMTA process that gets e-cigarette and nicotine alternative products on the market more quickly for consumers.”
The second problem Hicks listed is the growing illicit market.
“Unfortunately, due to the missteps in setting up the legal market through the PMTA process, CTP unintentionally emboldened the illicit market to step in and meet consumer demand for nicotine products,” she said.
Instead of correcting the mistakes made and fixing the PMTA process, Hicks said CTP has created a task force alongside the Department of Justice (DOJ), Drug Enforcement Administration (DEA), the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), and other agencies to “waste user fees while attempting to put a band-aid on a situation they created in the first place.”
Return to Work
Within weeks of the CTP layoffs, Politico reported that some FDA staffers in the agency’s CTP were asked to return.
A spokesperson for the HHS told CSP in an email on April 16 that “all employees affected by the reduction in force may be asked to temporarily work until their government service ends on June 2. This decision is focused on ensuring that the transition is as seamless as possible, minimizing any disruption to the agency’s mission and operations. HHS fully supports this approach, which aims to maintain public health services while managing the reorganization process effectively.”
Former FDA Commissioner Robert Califf on April 15 shared his thoughts regarding federal workers being asked to return to the agency with CSP.
“If the reports are true, it shows either a competence problem or a complete disregard for the dignity and well-being of this vital workforce which has a difficult job to do to reduce our leading cause of remediable death against a very wealthy and aggressive industry,” Califf told CSP on April 15.
With the Trump administration’s sweeping changes at the CTP, tobacco manufacturers and suppliers see this as an opportunity for a reset.
“This transition presents an excellent opportunity to step back and critically think about what is working and what is not,” said Kellsi Booth, chief legal officer for smokeless tobacco company Black Buffalo, Chicago. “While the agency may struggle to move key initiatives forward until a new structure is finalized, I am optimistic that in the long run the agency can operate more efficiently, fairly, and transparently with updated priorities that better promote public health.”
Zeroing in on what is needed to improve operations, including the PMTA process, Booth said a review of the Reagan-Udall Foundation report is critical.
The Reagan-Udall Foundation report has validated many criticisms of the agency from those in the tobacco industry, including the agency’s priorities, PMTA review process and transparency.
“That report contains a number of recommendations, which have the potential to significantly improve operations if implemented,” she said. “This report should be revisited and carefully considered by the new CTP leadership.”
When it comes to the Trump administration’s steps going forward, Sam Dashiell, regulatory communications senior specialist for Philip Morris International (PMI), Stamford, Connecticut, said that “President [Donald] Trump and [HHS] Secretary Robert F. Kennedy have emphasized a commonsense policy approach, and this presents an important opportunity to refocus CTP on one of its core functions: to efficiently and effectively review and authorize scientifically-substantiated smoke-free products to take the place of cigarettes—the most harmful form of tobacco use— and provide better choices for legal-age American adults who smoke.”
As for the role c-store operators can play, Dashiell said the agency needs to acknowledge their involvement.
“Retailers across the U.S. work tirelessly to provide for their adult customers and comply with the law, and the FDA should work with them to ensure they have clear, timely, and accurate information about and access to FDA-authorized products to meet consumer demand,” he said.
Illicit Market
With the illicit market a juggernaut, FDA Commissioner Marty Makary inherits CTP’s looming issues of reviewing PMTAs the illicit vape market and other tobacco-related issues.
“The FDA must stop the proliferation of illicit products,” Booth said.
During the previous administration, the FDA struggled to enforce against these products, which are saturating the U.S. market, a Reynolds spokesperson told CSP.
“These illicit vapor products target youth and undermine the legitimacy of potentially reduced risk products, which help adult smokers progress towards harm reduction,” the spokesperson for the Winston-Salem, North Carolina-based company said.
Rebuilding trust is one of the steps the CTP also needs to implement, said Chris Howard, executive vice president, external affairs and new product compliance for Jacksonville, Florida-based Swisher.
“CTP’s credibility has recently been challenged—by courts, Congress, public health groups, and the tobacco industry,” he said. “A reboot could help rebuild trust through better engagement with stakeholders and demonstrate a willingness by the agency to evolve and improve.”
Howard said now is a chance for the CTP to better align regulatory decisions with broader harm reduction strategies, which he said have been neglected for some time.
“This would be significant in particular for adult smokers seeking to alternatives to combustible cigarettes,” he said.
To combat the illicit e-vapor market, a spokesperson for e-cigarette maker Juul Labs, Washington, D.C. said the U.S. can and should make cigarettes obsolete.
“Doing so requires that adults who smoke have access to a variety of scientifically-validated smokefree nicotine products, including in a variety of responsibly-marketed flavors,” said Juul Labs. “Today, that demand is being met almost entirely by illegal products, which comprise at least 60% of the U.S. vapor market.”
As for how the FDA’s CTP can clean up the marketplace and get illicit products off the market, Dashiell said several steps need to be established.
“By focusing on improving one of its key functions—product application review—CTP can help establish a robust market of authorized products while promoting American innovation and competition to crowd out bad actors,” he said.
At the same time, Dashiell noted that the CTP must work with other agencies, law enforcement, and public-private partnerships to make full use of existing expertise, information sharing, innovative solutions and evolving technologies to tackle illicit trade.
Going a step further, Howard listed four ways the agency’s CTP can clean up the market.
“The CTP should speed up product authorizations to provide legal alternatives, target major distributors and importers of illicit products, work with [Customs and Border Protection] CBP and law enforcement to block illegal imports and publish a clear, real-time list of authorized products and products with pending PMTAs for retailers and regulators,” he said.
Following the news of the layoffs, critics against the mass layoffs at the FDA’s CTP said the cuts will benefit the tobacco industry at the expense of kids and lives.
“The gutting of these agencies conflicts with the repeatedly stated commitments of President Trump and Secretary Kennedy to reduce chronic disease and protect children’s health,” Yolonda C. Richardson, president and CEO, Campaign for Tobacco-Free Kids, said in a statement. “It is inexplicable and especially harmful that these cuts are coming at a time when the FDA should be redoubling its enforcement efforts against the many illegal, flavored e-cigarette products that have entered our country from overseas and put kids at risk.”
Richardson in her statement said the cuts will not save taxpayers money as the center is funded with user fees paid by the tobacco industry.
She said the fight against tobacco “must remain a national priority in order to protect children, save live, fight chronic disease and keep America healthy.”
Critics on all sides can agree on one thing—they are watching the FDA's next move with tobacco.
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