Dr. Lawrence Deyton of the FDA Center for Tobacco Products: NewPublicHealth Q&A
Last month at the Association of State and Territorial Health Officials Annual Meeting (ASTHO), attendees focused during one session on the progress made in reducing tobacco death and disease—and the significant room for improvement, as tobacco remains the leading cause of preventable death in the United States.
We caught up with Lawrence Deyton, MSPH, MD, director of the Food and Drug Administration’s (FDA) Center for Tobacco Products at the ASTHO meeting to get his take on the value of tobacco control as a prevention strategy, as well as the role of state and local public health officials.
NewPublicHealth: What did you go to ASTHO to learn, and what did you share?
Dr. Deyton: State health officers are on the front lines of tobacco control. They see the impact in their communities. I went to the ASTHO meeting to both hear from them, and to explain where we are in tobacco regulation at the FDA and to invite the public health community to get more involved in the regulatory process by commenting.
The depth and breadth of my respect for the work state health officers do—and the budgets they have to do it with—is great. We’ll want to see comments from all stakeholders, including folks from ASTHO, on our proposed regulations, because public health officials all have a very important view we’ll want to hear about. They may have the data that could be important to support their recommendations.
NPH: What is the FDA Center for Tobacco Products doing to help prevent tobacco-related death in the U.S., and what do you want public health leaders to know about this work?
Dr. Deyton: Our vision is to make tobacco-related disease and death part of America’s past, not its future.
The Family Smoking Prevention and Tobacco Control Act was signed into law June 22, 2009. This was the culmination of decades of work—but it’s really just the beginning.
This law grants FDA the direct authority to regulate tobacco products including cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, and we are working on a regulatory proposal to assert FDA authority over additional products such as new, novel tobacco products.
We also now require tobacco product manufacturers to report to FDA levels of harmful and potentially harmful constituents [ingredients and chemicals] in their products. FDA can propose restrictions on advertising and promotion of tobacco products, and establish new product standards all to protect the public health.
NPH: What's the value of tobacco control as a prevention strategy?
Dr. Deyton: That’s a good question. Tobacco use is the leading preventable cause of disease and death in this country. These deaths can be prevented.
It’s important to distinguish between tobacco control and tobacco product regulation. Tobacco product regulation is a new arrow in the prevention quiver. Tobacco use cessation represents the gold standard when it comes to cost-effectiveness of public health interventions. But that’s not what the FDA Center for Tobacco Products does. The drugs used to treat nicotine addiction are regulated by a different part of the FDA. The part I’m talking about is new and involves FDA regulation of the manufacture, distribution and sale of regulated tobacco products in the U.S. At FDA we have now developed the regulatory framework to do that.
FDA’s traditional standard is for products to be “safe and effective,” but we know tobacco products are different. So the Tobacco Control Act allows us to use a new standard that takes a population health approach. As tobacco product manufacturers want to change products or introduce new products they have to submit data to FDA to prove that their product does not do more harm or in fact improves public health.
NPH: What state actions are critical for helping to reduce tobacco use in the U.S.?
Dr. Deyton: State and territorial governments have a huge frontline role in tobacco control. That includes education, prevention, use of effective quit lines and making cessation devices and therapies available. State governments frequently conduct epidemiology and surveillance to understand tobacco use at the state level. That data is critical. States and territories are also helping FDA with compliance with new FDA tobacco regulations. One new important development is that FDA now has a relationship with every tobacco merchant in the country that didn’t exist before this law. Those store owners are now responsible for complying with new national sales regulations that FDA has put in place to reduce youth access and attraction to regulated tobacco products, including standards for minimum age at purchase. FDA is enforcing these regulations and sending contracts to states and territories to help with inspections. We’ve done over 100,000 inspections of tobacco product retailers with state-hired employees. They’re hired, trained and supervised through the state. Where the inspector wants to check compliance, they can bring a kid along to try and buy a regulated product. The good news is I see most retailers trying to follow the regulations. 4,398 stores didn’t pass and were issued warning letters. Each one of those stores is selling to kids. It’s unacceptable and a violation of law.
The results of all those inspections are all public information. That’s cool because you can look in your neighborhood to see what the results are. The Boston Globe picked up the story on their front page, and published the names and locations of those stores that violated the law. That’s why we do it—parents, community groups and others would want to know that the store down the street is doing its job or not.
NPH: What's next for the Center in its mission to keep young people from starting to use tobacco products?
Dr. Deyton: What’s next is what we call the deeming regulation. We’ve announced our intent to assert jurisdiction over all tobacco products. We recognize tobacco use is diverse, and people use many different products. We’ve seen the advent of novel tobacco products such as e-cigarettes, hookahs and sweetened little cigars that look just like cigarettes. CDC recently released new data demonstrating a dramatic and disturbing increase in use of flavored little cigars by kids. We hope to get a regulatory proposal about FDA jurisdiction over other tobacco products out for comment in the near future—and we hope state health officers and other public health stakeholders voices will offer comment through the regulatory process. Also, it will be important for state and territorial health officers to know what FDA is doing and where we’re going, and as we put out regulatory proposals for comment—comment.