FDA To Reduce Nicotine Levels In Cigarettes

Tuesday, the Biden Administration announced plans to issue a proposed product standard by May 2023 that would establish a maximum nicotine level in cigarettes and certain other combusted tobacco products.

A product standard is a power granted to the FDA under the Family Smoking Prevention and Tobacco Control Act to reduce or eliminate an ingredient in a tobacco product or a constituent in tobacco smoke.

The Administration has not identified which other products other than cigarettes will be subject to a maximum nicotine level in the proposed rule.

Tuesday’s announcement by the U.S. Food and Drug Administration (FDA) was part of the Spring 2022 Unified Agenda of Regulatory and Deregulatory actions report on the actions administrative agencies are considering issuing in the near and long term.

To propose a new regulation, a federal agency is required to follow a nine-step process which involves proposing a new regulation, drafting the regulation, having the White House Office of Management and Budget (OMB) review the regulation if it is economically significant, publish the proposed regulation for public comment, review all public comments, make any changes deemed necessary to the regulation, obtain final White House OMB approval, and publish the final regulation with an effective date.

The FDA is currently on the first step of this nine-step process.

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