The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) awarded a five year $18.1 million grant to VCU, the third largest grant in the university’s history.
Thomas Eissenberg, Ph.D., professor of psychology and director of VCU’s Clinical Behavioral Pharmacology Laboratory, and Robert Balster, Ph.D., professor of pharmacology and toxicology in the VCU School of Medicine, are the co-principal investigators for the grant. VCU is one of 14 institutions nationwide to receive the grant and the only recipient in Virginia.
In 2009, the FDA gained authority to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act. Part of that act gives the FDA money to pay for its regulatory activities over the tobacco industry. The money comes from “user fees” in the tobacco industry itself.
“The FDA is taking in a lot of money from the tobacco industry in order to regulate the tobacco industry,” Eissenberg said. “Wisely, I think, the FDA decided that they needed some scientific advice on how best to carry out their regulatory activities.”
To carry out that goal, the FDA gave money to NIH to put out a request for applications to form tobacco centers of regulatory science (TCORS) that will inform the FDA of how to regulate tobacco.
With the money awarded to them, VCU will create the Center for the Study of Tobacco Products. Its goal is to inform the FDA of how to evaluate novel tobacco products like electronic cigarettes, specifically ones that are marketed as a way of reducing the risks of cigarette smoking called Modified Risk Tobacco Products, or MRTPs. The research will be in the form of four projects.
After initially taking up smoking cigarettes socially, biochemistry major Herzon Flores now smokes electronic cigarettes because regular cigarettes caused him to have wheezing fits.
Data gathered through the grant will ultimately inform users of electronic cigarettes, like Flores, whether or not MRTPs really are healthier than traditional cigarettes.
“The hope is that by the end of the grant period, not only will we be able to tell the FDA a lot about electronic cigarettes, but we’ll also be able to say this method of evaluating MRTPs works really well,” Eissenberg said.
The findings from these studies will be instrumental in aiding the FDA on its regulatory policy regarding electronic cigarettes. The center is looking for experienced electronic cigarette users to be paid participants in the study.