Informing Tobacco Regulation through Research
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This information describes how FDA’s Center for Tobacco Products (CTP) funds and uses scientific research to better understand tobacco products, how they cause death and disease, and how to best reduce the harm from these products.
“For the first time, under the Family Smoking Prevention and Tobacco Control Act, the federal government, through the FDA Center for Tobacco Products (CTP), is able to bring science-based regulation to the manufacturing, marketing, and distribution of tobacco products.”
FDA Commissioner Margaret A. Hamburg, M.D.
September 19, 2013
At CTP, we consider scientific findings in all our activities. Our unique position as a regulatory agency allows for a framework of decision-making based on – and within the limits of -- both the science and the law. Although a vast and sound science base already exists for many areas of the Tobacco Control Act, new research will build upon that robust base of scientific evidence. CTP has identified seven categories of research priorities:
- Product diversity – understanding the types of tobacco products and how their specific characteristics affect people's attitudes, beliefs, perceptions, and use of these products
- Addiction – understanding what effect different levels of nicotine and other factors have on addiction
- Toxicity and carcinogenicity – understanding how changes in tobacco products affect their potential for harm and ways to reduce that harm
- Health consequences – understanding the risks of different tobacco products
- Communication – finding ways to effectively convey information about the risks of using tobacco and about CTP's role in regulating tobacco products
- Marketing – understanding the impact of tobacco product marketing and public education on people's attitudes, beliefs, perceptions, and use
- Economics and policy – estimating the economic impact of CTP's regulations; also understanding how CTP's actions change tobacco use and illness and death from tobacco use
CTP relies on the most current science to make regulatory decisions on tobacco products. Scientific research is critical to our mission of reducing the death and disease resulting from tobacco use. Funding and supporting research will help us both write appropriate rules (regulations) and assess the impact of our rules and activities on public health.
In addition to conducting our own research to support regulatory science, CTP partners with other agencies such as National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC), as well as with FDA’s National Center for Toxicological Research. Currently, CTP is partnering with NIH to support important research efforts, including:
The Population Assessment of Tobacco and Health (PATH) Study
The PATH Study will help scientists learn how and why people start using tobacco, switch products, quit using tobacco, and start using it again after they’ve quit. By monitoring and assessing the behavioral and adverse health impacts of tobacco use in the United States, the PATH Study will add to the evidence base to inform regulatory decisions about the marketing, manufacture, and distribution of tobacco products.
Tobacco Centers of Regulatory Science (TCORS)
TCORS is a first-of-its-kind program designed to generate research to inform the regulation of tobacco products to protect public health. The program was initially funded in 2013 and will run up to five years. Essential elements of these centers include three or more theoretically grounded, strong research projects with an integrative theme, the ability to respond quickly to emerging research questions through pilot projects, and a program for career development to train future generations of researchers in tobacco regulatory science.
NIH and CTP have published funding opportunity announcements. To learn more about these collaborative efforts, please find the following links:
- Funding opportunities that are currently accepting applications
- The grant application process, from application planning and submission to awarding
- A list of current and ongoing grants and contracts in the NIH-FDA tobacco regulatory science program
In addition to supporting research through NIH’s programs, CTP will occasionally solicit proposals for research contracts administered by FDA. Those opportunities are published through the FedBizOpps website and posted on the CTP website.
Research supported by CTP will be used, in addition to other relevant research, as the foundation for our policies and as we develop guidance and regulations designed to reduce the public health impact of tobacco product use. For example, as CTP considers the development of tobacco product standards to reduce the harms of tobacco products, research will play a critical role in defining any proposed standards. Also, the research CTP supports helps to inform our review of new tobacco products seeking to enter or remain on the market. Research on the products themselves, how products are used and by whom, perceptions of the products, labeling, and advertisings, their adverse impact on an individual’s health, and potential impact on the population as a whole are some of the important areas to understand as we consider a potential new product’s impact on public health.
Results from these studies, including the PATH Study, will be important indicators of the impact that CTP’s activities are having on the nation’s public health.
Other Key Areas of Focus
Center for Tobacco Products Overview
CTP is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act. This law – commonly called the Tobacco Control Act – gives us broad authority to regulate the manufacturing, distribution, and marketing of tobacco products.
- Compliance and Enforcement
This information will help the public and those who work with CTP understand what FDA’s Center for Tobacco Products (CTP) is doing to ensure compliance with the Tobacco Control Act.
- Policy, Rulemaking, and Guidance
This information describes how FDA’s Center for Tobacco Products (CTP) sets policy and develops rules (regulations) and guidance under the Tobacco Control Act.
Public Education Campaigns
As part of this approach, FDA’s Center for Tobacco Products (CTP) is investing in a number of tobacco prevention public education campaigns that directly support our mission by educating the public about the dangers of regulated tobacco products.