Industry News
FDA Tobacco Center Resets Playbook: New Enforcement Chief and 'Common Sense' Agenda
Three moves in three weeks show where the Food and Drug Administration's Center for Tobacco Products (CTP) is heading under its new permanent director, Bret Koplow. On September 30, he used a keynote at the National Association of Tobacco Outlets (NATO) legislative conference in Washington to describe a harm-reduction-based, "common sense" approach to regulation.
On October 14, the agency seated four new voting members on its Tobacco Products Scientific Advisory Committee. By October 19, it named Jessica Zeller, a former deputy in the center's enforcement office, to run compliance and enforcement starting November 1. These developments signal a significant shift in the agency's operational tone and leadership structure.
The Speech: Harm Reduction Moves to the Center
NATO marked its 25th anniversary with its first-ever legislative conference, drawing more than 150 retail, wholesale, and manufacturer members. Koplow, serving as the keynote speaker, addressed faster reviews of premarket tobacco product applications (PMTAs), regulation that reflects tobacco harm reduction, clearer rules, and the FDA resources available to retailers.
CSP columnist Mitch Morrison, who attended, described the address as a break from the agency's past tone. By his account, Koplow told retailers that while no tobacco product is safe and quitting entirely is the healthiest option, completely switching from cigarettes to FDA-authorized non-combusted products significantly cuts exposure to toxic chemicals.
"Making such products available is part of a common sense, evidence-based approach."
Morrison also reported Koplow's claim that illicit products make up roughly 85 percent of the e-cigarette market, a problem the director framed as a public-health threat rather than a paperwork issue. This stance aligns with recent efforts to curb counterfeit goods, similar to how Republic Brands has assisted in seizures of illicit smoking accessories.
The Enforcer: Zeller Returns November 1
The agency announced that Jessica Zeller will rejoin CTP from Edwards Lifesciences, where she served as vice president and corporate counsel. She was the Office of Compliance and Enforcement's inaugural deputy director from 2011 to 2013. The office she will lead handles the inspections, warning letters, civil money penalties, and import actions that reach retailers and importers directly.
The Advisers: Four New Voting Members
The FDA has named Holger Behrsing, Kim "Skip" Murray, Margaret Nolan, and Andrew A. Strasser as voting members of the Tobacco Products Scientific Advisory Committee. This committee evaluates product risks, dependence, and health effects for the commissioner. Murray, a long-time harm-reduction advocate, fills the committee's voting seat for the general public. The agency is currently seeking nominations for two more scientific or clinical seats, with a December 14 deadline for first consideration.
What It Means for Retailers and Shoppers
- Combustible categories stay regulated as before: Koplow's agenda is built around non-combusted products. Hookah tobacco, pipe tobacco, and cigarillos remain covered by the 2016 deeming rule.
- Expect more enforcement, not less: Rising import refusals and a returning enforcement veteran point to continued pressure on unauthorized products. Retailers stocking authorized products, such as Swisher Sweets or Captain Black, must remain vigilant regarding age verification.
- The direction is contested: The shift has drawn lawsuits from public-health groups, while industry leaders press for more authorizations and transparency.
The Bottom Line
The FDA's tobacco center is signaling a clearer, faster, and more harm-reduction-oriented approach while rebuilding its enforcement and scientific-advisory benches. For the industry, the practical takeaways remain steady: focus on authorized tobacco products, maintain strict age verification, and monitor the PMTA rewrite expected in the coming months.