NIH–FDA Effort Focuses on Tobacco Research

Tobacco science is getting an assist from the federal government. The NIH and the U.S. Food and Drug Administration (FDA) announced in September a collaborative effort establishing 14 Tobacco Centers of Regulatory Science (TCORS), almost all of which are at large universities, to investigate tobacco's effects on human health.

The two agencies awarded $53 million to the centers to fund their first year of tobacco research, which will generate evidence to inform future regulations for the marketing, manufacturing, and distribution of products derived from tobacco.

Over the next 5 years, total funding for the program could exceed $273 million, according to the NIH.

The research targets seven core research areas: diversity of tobacco products, addiction, toxicity and carcinogenicity, adverse health consequences, communications, marketing, and economics and policy.

Each center is funded to pursue a specific goal relevant to at least one of the core areas. At Yale University's TCORS in New Haven, CT, investigators will study how flavors influence addiction.

“Most kids will tell you that they started using tobacco with flavored products,” says Suchitra Krishnan-Sarin, PhD, an associate professor of psychiatry who leads the Yale TCORS with Stephanie O'Malley, PhD. Flavors improve taste and ease the body's reaction, and studies connect early use of these products with later nicotine addiction and smoking.

Yale's center uses experts from many fields to understand the flavor–addiction connection. “We have projects ranging from basic molecular studies, to clinical studies on different populations, to epidemiologic studies, to studies based on the economics of tobacco use, to get at the broad question of how flavor influences addiction,” says Krishnan-Sarin.

Epidemiologist Pamela Clark, PhD, at the University of Maryland, College Park, directs a TCORS that focuses on the toxicity of new and “manipulated” tobacco products, like e-cigarettes, which are not currently regulated by the FDA and haven't been evaluated for safety or effectiveness.

“There's a chance some of those products may be beneficial in helping people quit smoking,” says Clark, “but most of these are marketed to get people through until they can have another cigarette.”

In order to help the FDA rapidly understand these products and make regulatory decisions, “we want to be very nimble,” Clark says. “As soon as a new product is put into place, we want to be able to find out what it's all about.” That includes identifying the array of chemicals in the product.

In a press statement, NIH Director Francis S. Collins, MD, PhD, notes that one in five deaths can still be blamed on smoking. Partnerships like TCORS, he says, “keep us focused on reducing the burden and devastation of preventable disease caused by tobacco use.”

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