NATO Sends Comments to FDA on Nicotine Levels

The FDA is looking at reducing nicotine levels in cigarettes by up to 90% from current nicotine levels.

The National Association of Tobacco Outlets (NATo) NATO submitted the accompanying comments to the U.S. Food and Drug Administration (FDA) in response to the agency’s Advanced Notice of Proposed Rulemaking (ANPRM) regarding a potential regulation that would set a maximum level of nicotine in cigarettes and possibly other combustible tobacco products.

In the ANPRM, the FDA requested comments from the public and the industry about setting nicotine levels in an attempt to make cigarettes and other tobacco products “minimally addictive or non-addictive.” This ANPRM indicates that the agency is looking at reducing nicotine levels in cigarettes by up to 90% from current nicotine levels.

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In NATO’s comments, the association focuses on many different issues and concerns raised by this ANPRM which include the following:

  1. The need to allow a market for alternative non-combustible and heat-not-burn products to be regulated and approved before maximum nicotine levels in combustible tobacco products would be required.
  2. The need for the FDA to conduct an educational campaign so that adults do not serve as a source of tobacco products for underage youth. In the ANPRM, the FDA specifically notes that most underage individuals obtain tobacco products from non-retail sources and NATO has been recommending to the FDA for several years to conduct a media campaign to dissuade adults from providing tobacco to minors.
  3. The level of nicotine being considered by the FDA is close to zero, which could potentially violate the restriction imposed on the FDA by Congress that the agency cannot require the level of nicotine in any tobacco product to be zero.
  4. The likelihood of a significant illicit market for cigarettes and tobacco products with current levels of nicotine if the FDA mandates a lower nicotine level in these products.
  5. The decline in the legal sale of cigarettes and tobacco products and the need for a fiscal impact analysis so that state and federal lawmakers are aware of the potential for reduced cigarette and tobacco product excise tax revenue and sales tax collections.
  6. The public misperception that very low nicotine content cigarettes are less harmful than current cigarettes.
  7. The impact of a lower nicotine level on the public health.

The FDA will review all the comments submitted in response to this ANPRM and then decide whether to propose a maximum level of nicotine in cigarettes and possibly other tobacco products.