The U.S. Food and Drug Administration recently announced the award of a five-year cooperative agreement with the University of Kentucky College of Agriculture, Food and Environment’s Kentucky Tobacco Research and Development Center. KTRDC will work alongside the FDA in establishing programs that are relevant for scientific research on tobacco products and evolving standards for regulating those products.

In June 2009, Congress enacted the Family Smoking, Prevention and Tobacco Control Act, which handed regulatory control of the manufacture, distribution and marketing of tobacco products to the FDA. The law’s intent is to protect the public health by, among other things, assuring that tobacco products be reviewed and are in compliance with federal regulations for the manufacture, storage and design. It also prohibits the addition of flavors other than menthol to cigarettes and false and misleading labeling and advertising with the goal of preventing and reducing tobacco use in young people.

KTRDC scientists will cooperate with the FDA to develop and provide certified reference cigarettes to tobacco researchers around the world. Certified reference tobacco products are vital tools for scientific analysis used for instrument calibration, method validation and laboratory proficiency testing, as well as for non-clinical investigational purposes. Orlando Chambers, KTRDC managing director, said the development of validated methods and the science behind them is important to be able to establish regulations.

“We currently have the only reference cigarette program in the U.S. and about the only one like it in the world,” Chambers said. “We’ve provided reference products that are the foundation for a great deal of scientific research, including method validation, and we look forward to partnering with the FDA to develop new certified reference products that will be needed for future tobacco product research.”

The partnership provides more than $5 million in the first year to hire new personnel, establish analytical capability and purchase equipment. KTRDC will also be working with statisticians from UK’s Markey Cancer Center to establish a laboratory proficiency testing program as part of the project.

“From my perspective, it allows us to build on our current expertise to create an extensive academic program for tobacco product research,” Chambers said.

College of Agriculture, Food and Environment Dean Nancy Cox believes that turning to research institutions is one of the best ways to achieve the goals set by the act.

“I think it’s important that universities like the University of Kentucky, who have excellent tobacco research programs, are part of that science of setting up a regulatory environment,” she said. “The decision to undertake this project was made through careful consultation with a wide variety of stakeholders, who encouraged our scientists in this new direction.”

 “Tobacco regulation needs to be based on science,” Chambers said, “so as an academic institution, we are happy to be part of that.”

Funding for this project was made possible, in part, by the Food and Drug Administration through grant RFA-FD-14-001. The views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices organization imply endorsement by the United States Government.