FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
Today,
the U.S. Food and Drug Administration issued a proposed rule that, if finalized, would
make cigarettes and certain other combusted tobacco products minimally or
nonaddictive by limiting the level of nicotine in those products. If finalized,
the United States would be the first country globally to take such a bold,
life-saving action to prevent and reduce smoking-related disease and death.
The FDA first announced its
intent to propose such a ruleExternal Link Disclaimer in 2018, and
today’s announcement is an important next step in the rulemaking
processExternal Link Disclaimer. The agency intends to
seek input on the proposal, including through public comment and the FDA’s
Tobacco Products Scientific Advisory Committee.
Nicotine
is the primary addictive chemical in tobacco products that keeps people using
the products. In the case of combusted products, such as cigarettes, nicotine
addiction leads to users being repeatedly exposed to a toxic mix of chemicals
in the smoke that cause disease and death. Based on the scientific evidence
outlined in the proposed rule, the proposed nicotine level for cigarettes and
certain other combustible tobacco products would be low enough to no longer
create or sustain addiction. Importantly, a large body of research also shows
reduced nicotine content cigarettes do not lead smokers to compensate for lower
nicotine by smoking more.
Existing
evidence shows that cigarettes and other combusted tobacco products—products
that are smoked, such as cigars and pipe tobacco—are the most harmful types of
tobacco products. In fact, cigarette smoking is the leading cause of
preventable disease and death in the United States and is a major driver of
chronic disease nationally. Each year, cigarette smoking alone is estimated to
kill nearly half a million people in the United States and has been estimated
to cost the country more than $600 billion annually in healthcare costs and
lost productivity.

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