Advancing tobacco regulation to protect children and families

In the past year, FDA has taken several key steps forward in its tobacco regulation efforts, including issuing three important advance notices of proposed rulemaking, write FDA Commissioner Scott Gottlieb, MD, and Mitch Zeller, JD, director of FDA's Center for Tobacco Products.

In the past year, FDA has taken several key steps forward in its tobacco regulation efforts, including issuing three important advance notices of proposed rulemaking, write FDA Commissioner Scott Gottlieb, MD, and Mitch Zeller, JD, director of FDA's Center for Tobacco Products. Noting the importance of the premarket review of tobacco products, Gottlieb and Zeller note the agency is also committing to a number of efforts "to respond to stakeholders and to make the regulatory process more efficient, predictable, and transparent for industry, while also advancing the agency's public health mission. Establishing a rigorous, predictable, science-based framework for the premarket review of tobacco products is a key element of our program." These steps include proposing foundational rules, holding a public meeting on premarket review, and exploring opportunities for premarket review efficiencies through rulemaking and guidance and new administrative steps to modernize and improve the review process. To prevent tobacco use by children, FDA is moving quickly to advance three initiatives: expediting action on flavors, developing an e-cigarette product standard, and exploring ways to accelerate enforcement. "We remain on track to meet our ambitious goals," write Gottlieb and Zeller. "But there is still much work to be done."