FDA Seeks Input on Flavored-Tobacco Restrictions

Agency initiates public-comment period on menthol, role of flavored products

SILVER SPRING, Md. -- Less than a week after opening a public-comment period on possible restrictions on nicotine levels in cigarettes, the U.S. Food and Drug Administration (FDA) is launching a similar process for considering further regulation of flavored tobacco products.

The FDA on March 20 issued an advanced notice of proposed rulemaking (ANPRM) for flavored tobacco products—including menthol—calling on all stakeholders to share data, research and information surrounding the role flavors play “in initiation, use and cessation of tobacco product [use].”

In a statement, FDA Commissioner Dr. Scott Gottlieb said flavors in tobacco products and vaping devices can help initiate youth on the use of nicotine, but at the same time, he recognized that flavors can help adult smokers switch to alternatives such as vaping.

While there is “no acceptable number of kids using tobacco,” he said, he has spoken to vaping adults who have since quit smoking. “Now I know anecdotes aren’t the same as data. And the ANPRM specifically seeks data on this issue,” Gottlieb said in the statement. “But these personal stories are important to me as we shape our overall approach to smoking cessation. And it’s important to me that we uphold the FDA’s responsibility to consider all sides and take into account, among other things, the risks and benefits to the population as a whole.”

The ANPRM seeks comments, data, research results or other information on topics including but not limited to:

  • The role that flavors play in initiation and patterns of tobacco use, particularly among youth and young adults.
  • The role that flavors may play in helping some adult cigarette smokers reduce cigarette use and/or switch to potentially less harmful tobacco products.
  • The role that flavors in noncombusted tobacco products may play in quitting combusted-tobacco products use, quitting all tobacco use or starting to use more than one type of tobacco product.
  • Consumer perceptions of health risks and addictiveness of flavored tobacco products.
  • Whether certain flavors used in tobacco products present potential adverse health effects to users or others.
  • The impact of local, state and international efforts to restrict the sale or marketing of flavored tobacco products.

The 90-day comment period will begin March 21. The FDA said it will review all submitted information and potentially develop new rules surrounding flavors in tobacco products and nicotine delivery systems, but it did not say how long that process would take.

The FDA on March 15 initiated the same process to address nicotine levels in cigarettes.

Click here for more information on how to provide input.

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