The game-changing discussion of government regulation of nicotine levels in cigarettes has officially begun, with FDA Commissioner Dr. Scott Gottlieb formally announcing in a March 15 press conference the start of a 90-day exploratory public-comment period that could ultimately lead to a tangible new-product standard.

During the live webcast, Gottlieb announced that the agency is issuing an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower nicotine in cigarettes to minimal or nonaddictive levels.

When 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 formal 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 products now on the market and new-product innovations are not affected by this ANPRM, but they do fall under all requirements outlined in the FDA’s “deeming” rules and revised deadlines, Zeller said.

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