FDA Starts Formal Debate on Nicotine Levels

Agency officially opens discussion to develop potential new product standards

WASHINGTON -- The potentially game-changing discussion about government regulation of nicotine levels in cigarettes has officially begun, with the commissioner of the U.S. Food and Drug Administration (FDA) formally announcing in a March 15 press conference the start of a 90-day exploratory public-comment period that is expected to lead to a tangible new product standard.

During the webcast, FDA Commissioner Dr. Scott Gottlieb announced that the Silver Spring, Md.-based agency is issuing an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower nicotine in cigarettes to minimally or nonaddictive levels.

When CSP Daily News asked how long it would to take to determine a new nicotine standard, Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that beyond the 90-day comment period, he could not estimate how much time the agency would need. He said the process would include a review of comments and research, the development of a proposed standard, a review of that proposed standard and then a time frame in which to enact the final standard if the agency determines it to be a viable option.

In the meantime, all tobacco products now on the market and new-product innovations are not affected by this ANPRM for nicotine levels in cigarettes, but they do fall under all requirements outlined in the FDA’s deeming rules and revised deadlines, Zeller said.

Under the nicotine ANPRM, Zeller said the FDA will focus on several topics, including:

  • 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 how smokers may smoke more to get the nicotine levels they want.

“The ANPRM being issued today 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.

He reiterated the agency’s hope to take advantage of product innovation such as electronic nicotine delivery devices to get current smokers to stop using 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 he saw e-cigarettes as a bridge for smokers to quit, Gottlieb said, “Those and other products need to be properly evaluated through the regulatory process … [and] science-based assessment. … The jury is still out.”

FDA officials said they will announce two additional ANPRMs soon, one regarding flavored tobacco products and another on cigars.

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