The first of the three ANPRM deadlines looks at whether the FDA should limit nicotine levels in cigarettes. The agency is seeking input on several issues, including:

—Appropriate maximum nicotine levels.
—Measurement of nicotine levels.
—If the agency should implement potential product standards all at once or gradually.
—Potential unintended consequences.

“We see opportunity to use product standards to more rapidly migrate … from combustible [forms of tobacco] and onto modified-risk access to nicotine,” Gottlieb said at a March press conference. “It’s a unique time … to combine product innovation with regulatory tools to regulate cigarettes and pursue product standards.”

When asked about the timing of a nicotine regulation, CTP Director Mitch Zeller told CSP he could not estimate how much time the agency would need beyond the period of public comment. According to Zeller, the process will 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).

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