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Regulatory Science

legislation photoResearch that will expand the scientific basis to inform the regulation of nicotine and tobacco products at the local, state and national levels

As a result of the Family Smoking Prevention and Tobacco Control Act of 2009, the U.S. Food and Drug Administration (FDA) now has authority to oversee and regulate tobacco products. At the same time and in response to regulatory and market pressures, the tobacco industry has intensified the development and marketing of a host of new products. Harm reduction claims, often made by health professionals, are increasingly associated with some of these. 

Yet little research has been done to determine the long-term health effects and addiction potential of inhaled vaporized nicotine or the ingestion of orally delivered nicotine. The FDA’s responsibility to protect the health of the public provides an unprecedented role for the government and multiple research opportunities for the scientific community.

The FDA’s scientific framework for regulation of tobacco products includes studies on:

  • Toxicity: constituents, formulation and product design including in vitro, in vivo and human laboratory and clinical trial analyses

  • Pharmacological addiction potential

  • Abuse liability, i.e., use intensity and factors affecting use intensity in humans including product appeal, consumer perception, marketing and social influences;

  • After-market prevalence of use and health outcomes

  • Price and availability

cigarette warningsRead about recent research estimating the impact of FDA mandated cigarette packaging pictorial health warnings.

Read more on how tobacco products can be evaluated by Dr. Kenneth Warner at the University of Michigan.

Read the most recent Surgeon General’s report on how tobacco smoke causes disease and research questions that remain.




E-cigarettes have emerged as a highly controversial new product.

e-cigaretteThere is a lack of information on e-cigarettes regarding safety, abuse liability, and efficacy as aids to smoking cessation. Read more
TRDRP has begun to support research with the potential to advance science in this critical new area:

Read more: Electronic Cigarettes: Are They Safe?
Principal Investigator Prudence Talbot. Ph.D. (Grant #20XT-0118)