Recently, Mitch Zeller, director of the Center for Tobacco Products (CTP) at the U.S. Food and Drug Administration (FDA), outlined CTP’s vision for the regulation of tobacco products in the United States. While Zeller’s remarks did not contain any significant new information, they did shed some light on his thinking regarding e-cigarettes.
Specifically, Zeller acknowledged that CTP does not yet know the extent to which e-cigarettes are harmful, and thus the agency needs to get a better handle of the product’s toxicity and its actual impact on public health. He added that he does not yet know if e-cigarettes are more likely to help current smokers transition away from tobacco use, or if they are more likely to encourage non-smokers to begin using tobacco.
The FDA and the CTP are responsible for implementing the Family Smoking Prevention and Tobacco Control Act, which was enacted in June 2009. The law gives the FDA broad authority to regulate the retail sale of tobacco products, as well as the manufacture and marketing of such products. The law initially granted FDA jurisdiction over cigarettes, roll-your-own tobacco and smokeless tobacco products; in April 2014, the FDA proposed extending its authority to cover additional products such as e-cigarettes, cigars and hookah tobacco.
In his remarks yesterday, Zeller noted that up to this point, much of his time has been devoted to issues concerning the April 2014 proposed rule and potential future regulations governing menthol cigarettes, as well as implementing restrictions on the retail sale of tobacco products (such as minimum age requirements). Moving forward, Zeller said the Center will continue developing foundational rules and guidance for these matters, while also building CTP to achieve programmatic goals, including improving its external communications and human resources, IT acquisitions and policy analysis efforts.
From a policy perspective, Zeller views CTP’s ability to develop product standards as one of its most powerful tools, and CTP plans on using this authority in the future. Zeller wants to advance a product strategy that will “yield strong standards to improve public health and that can withstand legal challenge,” he said, adding that CTP is exploring potential standards for addictiveness, toxicity and appeal. Regarding nicotine, CTP is working on an integrated, FDA-wide policy on nicotine-containing products that is public-health based. “The reality [is] that people smoke for the nicotine but die from the tar,” Zeller said.