Regulating Tobacco: Q&A with Lawrence Deyton, M.S.P.H., M.D.

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Lawrence Deyton, M.S.P.H., M.D., joined the U.S. Food and Drug Administration (FDA) on Sept. 14, 2009, as director of the agency’s new Center for Tobacco Products. A graduate of the University of Kansas, the Harvard School of Public Health and the George Washington University School of Medicine, Dr. Deyton is an expert on public health, tobacco use, and veterans’ health issues. He is also a clinical professor of medicine and health policy at George Washington University School of Medicine and Health Sciences.

Q: On June 22, 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act, which gives FDA the authority to regulate tobacco products. What are your key goals for this legislation?

A: Our objective is to use the best available science to develop and put into action effective public health strategies to reduce the enormous toll of illness and death caused by tobacco products.

According to the Centers for Disease Control and Prevention, tobacco use causes more than 400,000 deaths each year in the United States—about 1 out of every 5 deaths. On average, adults who smoke cigarettes die 14 years earlier than nonsmokers. And more than 8.5 million Americans have chronic illnesses related to smoking. Despite those facts, 1 in 4 high school students report current tobacco use. About 3,600 kids start smoking and 1,100 kids become regular smokers every day.

Our priorities are to

• prevent youth from using tobacco;
• help adults who use tobacco to quit;
• provide accurate information on the contents of tobacco and consequences of tobacco use to the public; and
• use regulatory tools, including tobacco product standards, to reduce the public health burden of tobacco in the United States.

Q: Is FDA going to ban tobacco?

A: No. The law specifically states that FDA cannot ban an entire category of tobacco products, such as cigarettes. While FDA will implement the law, we do so knowing the long, complex role tobacco has played in American culture. That said, FDA must execute its responsibilities in full recognition of the indisputable facts about tobacco use: it is an addictive product and has profound health effects on users and on the public health of our nation.

People who choose to use tobacco have the right to hear the facts, including detailed information on what is in these products. FDA is now in a position to provide this information.

Q: How does the regulation of tobacco products differ from FDA’s regulation of drugs or medical devices?

A: FDA’s regulatory role for drugs and medical devices is usually based on a safety and effectiveness standard. The tobacco act establishes a new standard: to regulate tobacco products based on a public health and population health standard.

When FDA gets an application for a new drug to treat a disease, we normally consider studies of patients who have the disease. But when we get an application for a new tobacco product, the law tells us we have to consider whether permitting the product’s marketing protects the public health and we have to evaluate the effects of the product on the population as a whole. We’re directed to consider both users and nonusers, and whether our action might encourage people who don’t use tobacco products to begin using them, or encourage people who might otherwise quit to continue using them.

Q: What can FDA do to help ensure that children are no longer targeted to become the next generation of smokers?

A: Research has proven that children begin using tobacco products very early because of all kinds of pressures and motivations. We have a goal, under this law, to keep youth tobacco-free.

The law specifically recognizes that there are certain tobacco products designed to appeal particularly to children. Some cigarettes have been sold with candy-like characterizing flavors, such as mint, chocolate, cinnamon, coconut, and strawberry. After Sept. 22nd of this year, cigarettes are prohibited from having candy, fruit, herbs, or spices as their characterizing flavors. It is possible that FDA could develop other product standards to make tobacco less attractive to youth.

Studies have found that children are more influenced by tobacco marketing than adults. Here, our job is to understand how messages are delivered to children and teenagers through advertising, marketing, and labeling of tobacco products. Then, we can design regulatory efforts to interrupt these messages.

Among my own adult patients, I often hear the story that they started smoking in their youth and became addicted before they fully recognized the serious health risks.

Q: What do you think will be the biggest challenge facing FDA in regulating tobacco products?

A: The biggest challenge is communication. FDA will be sharing a lot of information and recommendations with the public in the ensuing years. And to succeed, we need help from moms and dads, uncles and aunts and grandparents, as well as from the public—whether they use tobacco products or not.

Q: You’ve said you want the public to work with us in our efforts to regulate tobacco products. How can they do that?

A: We really need to hear from the public on how best to carry out our mission because the law asks us to address the population as a whole. The more we hear from the public, the better we’ll be able to target what we do to have the greatest positive health effect.

We have invited public comments through www.regulations.gov. I’ve read a lot of the input and there are some really wonderful suggestions there.

We get so much out of public input—both positive and negative. Please feel free to contribute your thoughts today.

Q: FDA is a science-based and science-led agency. How will science be used to regulate tobacco products?

A: Science will guide all of our actions to reduce the public health toll from tobacco products in the United States. For example, science will help us understand tobacco and its ingredients and constituents, tobacco addiction, tobacco marketing and labeling, and childhood tobacco use.

We have established a scientific advisory committee to make recommendations on our efforts and responsibilities under the law. The committee will have 12 members: 7 will represent various science and medical disciplines; 1 will be from the local, state, or federal government; 1 from the general public; and 3 (non-voting) from industry and tobacco growers.

Q: What appealed to you about the position of director of FDA’s Center for Tobacco Products? What brought you to FDA from your previous position at the U.S. Department of Veterans Affairs?

A: It’s been a very hard choice for me emotionally because of my commitment to care for the men and women who have served our nation in war and peacetime. The choice was not as hard professionally. There is no more important public health issue in the nation today than tobacco use. Its impact on the nation, on our communities, on our families, and on individuals attracted me to this job both as a practicing physician and as someone who’s dedicated my career to public health.

My public health career actually started out in tobacco control. I was the first full-time staff member assigned to help set up the federal Office on Smoking and Health in 1978. And my public health career has taken me into fascinating areas spanning broad public health policy issues facing Congress, HIV/AIDS research and treatment, and then into veteran’s health and environmental exposure issues as well as bioterrorism, emergency preparedness, influenza, and pandemic flu. The honor of being asked to help set up FDA’s new Center for Tobacco Products feels like coming home to an issue that galvanized my interest in public health. I am thrilled to join my colleagues at FDA to address the public health consequences of tobacco use.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: September 28, 2009