FDA Commissioner: new efforts to improve the tobacco product application review process

Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

Our comprehensive plan on tobacco and nicotine regulation, unveiled in July 2017, aims to tackle the leading cause of preventable death in the U.S. by focusing on two key areas: reducing the nicotine levels in combustible cigarettes to render them minimally or nonaddictive; and harnessing new forms of nicotine delivery that could allow currently addicted adult smokers to get access to nicotine without all the risks associated with using combustible tobacco products.

In order to secure these goals, and to advance our efforts to protect kids from the harms of tobacco products, we’re committed to issuing foundational rules to make the science-based regulatory review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission. In particular, it’s critical we have a strong, science-based application review process that ensures new products meet public health standards by evaluating important factors such as ingredients, product design and health risks.

CONTINUE READING ON www.fda.gov