SAN ANTONIO -- Travel troubles didn’t stop Mitch Zeller, director of the Food and Drug Administration’s (FDA’s) Center for Tobacco Products, from addressing attendees at the Convenience Distribution Association’s Marketplace event Feb. 11 in San Antonio.
Instead of appearing in person, Zeller appeared via video from Washington, D.C., providing an update on the agency’s Comprehensive Plan for Tobacco and Nicotine.
Here are five takeaways from his speech ...
The FDA’s vision for tobacco
Zeller emphasized that the FDA’s vision for the future of tobacco is still the same as when the agency introduced its Comprehensive Plan for Tobacco and Nicotine in July 2017.
“We envision a world where cigarettes as we know them would no longer create or sustain addiction and where adults who are still looking for nicotine—still seeking it—can get it from alternative and less harmful sources,” he said.
At a crossroads
Zeller mentioned several times that the FDA is at a crossroads when it comes to efforts to reduce tobacco use.
“There has been tremendous progress … in reducing both consumption and prevalence of tobacco products compared to the year of the first surgeon general’s report back in 1964, when there was an adult smoking rate of 44%,” he said. “We’ve achieved a two-thirds reduction of that in prevalence and an even greater reduction in the number of cigarettes that smokers smoke per day, per week or per month.
“Despite that progress, tobacco use remains the leading cause of preventable disease and death in the country and, for that matter, the world.”
The FDA estimates that the annual death toll from tobacco use is 480,000.
Preventing youth use
Recent proposals by the FDA to ban or restrict flavored tobacco products have been driven by increased tobacco use among youth. Zeller cited previously reported results from the 2018 National Youth Tobacco Survey, which found that e-cigarette use among high schoolers has increased 78% from 2017 to 2018, and 48% among middle school students.
“One of the real problems of concern here are products that closely resemble USB flash drives," he said. “The product Juul has gotten most of the attention, but there are other products like Juul.”
Last September, the FDA issued 1,300 warning letters and fines to an undisclosed number of retailers for selling tobacco products to minors as a result of a summerlong undercover operation at the store level. While Zeller admitted that most retailers do comply, "what concerns us are the ones that repeatedly break the law."
“The overall compliance record is something that the industry can point to, but collectively what can we do about the retailers that repeatedly, illegally sell tobacco products to minors and break the law? That’s what we are concerned about the most," he said.
The PMTA process
Since its inception, the premarket tobacco application (PMTA) process for the approval of new tobacco products has come under fire for being onerous and expensive.
“We’ve heard a lot from the industry and from other sectors about the product review process, and we’re committed to improving the efficiency and transparency of that process,” Zeller said.
The FDA announced in August that it will take another look at the process.
Zeller said the FDA is “committed to improving the efficiency and transparency of that process.”
“That starts with issuing with what we call foundational rules and guidances to clarify the rules of the road for application submissions,” he said. “The first of those foundation rules is now under review at the White House and that’s the rule for SE (substantial equivalence). But we are also hard at work on rules for the PMTA review process and the modified-risk tobacco product application review process.”
Many PMTA applications that have been submitted over the past few years were rejected at the front end, Zeller said, because they were “simply incomplete.”