Proposed smoking machine adaptor could ease regulatory challenges
For decades, tobacco companies and researchers have used specialized smoking machines to test the physical and chemical properties of cigarette smoke — an important step in the U.S. Food and Drug Administration’s regulatory process. The machines work by essentially “puffing” a cigarette and capturing the smoke onto a filter, which can be analyzed to determine levels of various toxins in the smoke.
But most of these machines have no ability to test newer products like e-cigarettes and vapes, posing a challenge to the public health agencies evaluating whether or not a product is safe enough to enter the market, said Marielle Brinkman, senior research scientist in the Division of Epidemiology at The Ohio State University College of Public Health.
That’s why Brinkman, along with Theodore Wagener, associate professor at the College of Medicine and director of Ohio State’s Center for Tobacco Research, is leading a five-year, $5 million project to create a device that — when paired with existing smoking machines — will allow researchers to test emissions from e-cigarettes, cigars and heat-not-burn tobacco products.
“The FDA needs machine smoking emissions data for these newer products, but there are no machines that can accomplish that,” Brinkman said. “The idea is to create a universal adaptor kit that public health and tobacco industry researchers can use to couple these novel products to traditional smoking machines so that they can test them the way they test cigarettes.”
Currently, tobacco companies use single-use adaptors to test e-cigarettes and heated tobacco products, which the FDA didn’t start regulating until 2016, Brinkman said. But the absence of a widely available tool for researchers to use to assess the devices has been an obstacle.
“A large multinational tobacco company can generate data on heat-not-burn tobacco products using their own adaptor that they have created, and nobody else can validate those data because nobody else has that adaptor,” she said.
The device the researchers are developing would help reduce variability in emissions data reported around the world.
Brinkman said one of the biggest challenges for the team will be assessing the landscape of worldwide tobacco product emissions testing to ensure the team develops an adaptor that meets the biggest need. The big-picture goal, she said, is to enhance what is known about tobacco products in the global marketplace and help generate more reliable, more precise data to help policymakers and educate the public.
“This is an exciting opportunity for us to contribute to the field of tobacco research in a very practical way and, hopefully, for many years to come,” Wagener said.
The research is funded by the U.S. Food and Drug Administration Center for Tobacco Products. The team will also work closely with the Centers for Disease Control and Prevention Tobacco Products Laboratory, smoking machine industry partners and Ohio State’s Center for Design and Manufacturing Excellence and Particle and Aerosol Characterization Laboratory. Co-investigators and key personnel include Chad Bennett, Michael Camp, Brittney Keller-Hamilton, Andrew May, Mary Hoffman Pancake, and Jason Robinson of Ohio State; Linda Crumpler (Cerulean) and Jeremy Jones (Produced Better); and Clifford Watson of the CDC.