The US’ Food and Drug Administration has issued an advance notice of proposed rulemaking (ANPRM) in respect of tobacco-product flavors.
In a ‘Special Announcement’ issued through its Center for Tobacco Products, the FDA said it was seeking ‘comments, data, research results, or other information related to the role that flavors, including menthol, play in tobacco product use and potential regulatory options the agency could take, such as tobacco product standards and measures related to the sale and distribution of flavored tobacco products’.
‘This notice, along with another ANPRM issued last week related to reducing nicotine in cigarettes to minimally addictive or non-addictive levels, is part of the FDA’s comprehensive plan on tobacco and nicotine regulation, as announced in July 2017.
‘FDA values the public’s input through the comment process and will consider all submissions as it considers possible regulatory actions on these topics. If FDA decides to issue a rule, the first step would be to issue a notice of proposed rulemaking in the Federal Register, which would give the public another opportunity to comment on the proposal.’
The ANPRM on the role of flavors in tobacco products was made available for comment for 90 days from yesterday.
Meanwhile, the FDA Commissioner Scott Gottlieb, MD, issued a 1,400-word statement on the flavors ANPRM in which he said, in part, that, ultimately, the FDA was working to ensure its policies achieved the greatest public health benefit.
‘As such, we’re proceeding with the utmost caution by securing more information about both the potential positives and negatives of flavors in youth initiation and getting adult smokers to quit or transition to potentially less harmful products. ‘Through this lens, the ANPRM we’re issuing today 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 non-combusted 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; and
- The impact of local, state and international efforts to restrict the sale or marketing of flavored tobacco products.
Gottlieb’s piece is at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601690.htm