Editor’s Note: The following is a brief excerpt from a Medscape interview with Mitch Zeller, JD, Director of the FDA’s Center for Tobacco Products. The complete interview is available here.
Laurie Scudder, DNP, NP, Mitch Zeller, JD
Medscape: The AAP released a press statement praising the FDA for this effort but also urging increased federal regulation of all tobacco products, including electronic nicotine delivery devices (e-cigarettes). Can you discuss the current regulatory parameters under which the FDA operates? With the example of CVS, does the FDA have the authority to regulate tobacco at the point of sale?
Mr. Zeller: Let me start with the products that we do and don’t regulate, and then talk about enforcement. In 2009, Congress passed, and the President signed into law, the Family Smoking Prevention and Tobacco Control Act. It gave the FDA broad authorities to regulate the manufacture, sale, and distribution of tobacco products within the agency’s jurisdiction. The initial grant of authority by Congress in the Tobacco Control Act was limited to cigarettes, roll-your-own tobacco, and smokeless tobacco.
There is a provision in the law that we call the deeming clause. That means we can do a rulemaking to expand our authority and deem other products that meet the statutory definition of a tobacco product to be within our regulatory and jurisdictional reach. The FDA has been on record as saying that it intends to issue such a regulation.
Basically, all smokeless tobacco products were part of the original jurisdictional grant of authority from Congress in 2009. There are other tobacco products out there that we do not currently regulate, such as large cigars and small cigars. When we get this deeming regulation published, everybody will be able to see how we are proposing to expand our authority to cover all products that meet the statutory definition of a tobacco product. And specifically for e-cigarettes, the FDA intends to create a regulatory framework for e-cigarettes.