Under the nicotine-level ANPRM, the FDA will focus on several topics, including the following:
— Appropriate maximum nicotine levels.
— Measurement of nicotine levels.
— How the agency should implement the product standard (all at once or gradually).
— Unintended consequences, such as the effect on illicit trade, or whether users will smoke more to get the nicotine levels they want.
“The ANPRM provides a wide-ranging review of the current scientific understanding about the role nicotine plays in creating or sustaining addiction to cigarettes and seeks comments on key areas, as well as additional research and data for public review, as we continue our consideration of developing a nicotine-product standard,” Gottlieb said.
Also raising the “continuum of risk” theory, Gottlieb reiterated the agency’s hope to take advantage of product innovation such as electronic nicotine delivery devices (ENDS) to get current smokers to move away from traditional combustible cigarettes. “We’re in a unique time where we can combine … product innovation with regulatory tools to regulate cigarettes and pursue new product standards,” he said.
When asked if Gottlieb saw e-cigarettes as a bridge for helping smokers to quit, he said, “Those and other products need to be properly evaluated through the regulatory process … [and] science-based assessment. … The jury is still out.”