Erin Warren, Head of Regulatory and Public Policy at Philip Morris International (PMI US), delivered a powerful keynote at GTNF Brussels, urging urgent reform to accelerate tobacco harm reduction, opening with stark numbers.
“Cigarette smoking remains the leading cause of preventable death in the United States, taking more than 480,000 lives every year,” she said. “That’s 1,300 people every single day. Globally, the toll exceeds 8 million deaths annually.” She emphasized that behind these statistics are real people: “A mother, a father, a friend, a colleague—each hoping for better options but often finding barriers instead.”
Central to her message was the “continuum of risk.” Praising the FDA’s pilot program to expedite nicotine pouch applications, she said: “For the first time in a long time, the FDA explicitly acknowledged the continuum of risk. This is the difference between paralysis and progress. While nicotine is addictive, it is not the primary cause of smoking-related disease. Smoke is. Combustion is.
“Sweden’s long-standing availability of snus has driven smoking rates down to 5.3%, near the smoke-free benchmark. In contrast, Belgium’s ban on nicotine pouches removed regulated, safer alternatives but left the most dangerous products on the market. Smoking rates rose from 19% in 2017 to 21% in 2023.”
She also addressed widespread misconceptions among healthcare providers: “A recent survey found that 47% of U.S. doctors mistakenly believe nicotine is carcinogenic, and another 19% are unsure. This misinformation traps millions in a cycle of smoking.”
To move from paralysis to progress, Warren outlined five reforms: elevate public education, increase regulatory transparency, embrace innovation and harm reduction, clear the FDA backlog of nearly half a million stalled applications, and ensure independent oversight. “Regulatory delays create a vacuum filled by illicit products—undermining public health and consumer safety,” she said.
“Every delay, every unclear decision, every piece of misinformation prolongs the moment when someone might finally step away from cigarettes. When that mother switches, she not only improves her own health—she shows her children that positive change is possible.”
Closing with a call for partnership and action, Warren urged stakeholders to act decisively.
“We are not asking regulators to lower standards,” Warren said. “We are asking for standards that are clear, consistent, and anchored in science. The FDA pilot is a promising sign—but it’s just a signpost, not a destination. Let’s build a future where adults have better choices, doctors have better information, and public health has better outcomes.”