The Food and Drug Administration is seeking data on the role that flavors, including menthol, in tobacco products play in the initiation, use, and cessation of tobacco products, with an emphasis on how flavoring impacts young people.

“In the spirit of our commitment to preventing kids from using tobacco, we are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation,” FDA Commissioner Scott Gottlieb, MD, said in statement . It is important “that we also explore how flavors, under a properly regulated framework that protects youth, may also be helping some currently addicted adult cigarette smokers switch to certain noncombustible forms of tobacco products.”

The agency issued an advance notice of proposed rule making March 20 that seeks information on flavoring in tobacco products to inform future policy making.

“Youth consistently report product flavoring as a leading reason for using tobacco products,” Dr. Gottlieb noted. “In fact, there is evidence indicating that youth tobacco users who reported their first tobacco was flavored had a higher prevalence of current tobacco product use, compared to youth whose product was not flavored.”

The advance notice calls for information across a number of areas, including the role of flavors other than tobacco in tobacco products; flavors and initiation and patterns of tobacco product use, particularly among youths and young adults; and flavors and cessation, dual-use, and relapse among current and former tobacco product users.

It also is seeking comment on whether standards should be set on tobacco flavoring, including whether there should a prohibition or restriction on flavors and to which types of products these standards should apply. The notice specifically asks about menthol and its role in cigarette initiation and whether limitations on menthol could lead to use of other tobacco products.

“Because almost 90% of adult smokers started smoking by the age of 18, it’s imperative we look at new ways we can ensure that kids don’t progress from experimentation to regular use,” Commissioner Gottlieb said.

The American Heart Association called the action “long overdue.”

“We encourage the FDA to quickly move beyond information gathering and develop a strong flavoring product standard,” CEO Nancy Brown said in a statement. “There is already clear evidence that flavored tobacco products, including menthol, harm the public health. To make it worse, fruit- and candy-flavored e-cigarettes, cigars, and other tobacco products are highly attractive to kids and make it more likely that they will take up this addiction.”

The action comes less than a week after FDA published an advance notice seeking information comments on reducing nicotine levels in cigarettes to help combat nicotine addiction.

The advance notice will be published March 21 in the Federal Register; comments will be accepted at www.regulations.gov for 90 days.

gtwachtman@mdedge.com

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