In a move that anti-tobacco groups say is long overdue, the FDA is asking for input on whether menthol and other flavorings in tobacco products should be restricted or banned.
On Tuesday, FDA Commissioner Scott Gottlieb, MD, announced that the agency (ANPRM) to gather research and other data on the potential pros and cons of banning or restricting menthol and other flavors from combustible and non-combustible tobacco products.
The move comes a week after Gottlieb announced that the FDA will consider lowering nicotine levels in combustible cigarettes to non-addictive levels.
With the exception of tobacco and menthol, flavorings have been banned from combustible cigarettes for almost a decade, but they are ubiquitous in little cigars, electronic cigarettes and other tobacco products widely used by younger users.
The JUUL brand e-cigarette, which has quickly become the most popular vaping product among teens and young adults, comes in flavors including fruit, creme brulee, mango, tobacco, and menthol.
Gottlieb said the input of all stakeholders is needed to "inform our process for examining the role that flavors -- including menthol -- play in initiation, use and cessation of tobacco products."
He noted that flavoring in vaping products clearly appeal to younger users. E-cigarettes are now the most commonly used tobacco product among middle- and high-school age youth.
"No child should use any tobacco products, including e-cigarettes," Gottlieb noted. "At the same time, we're aware that certain flavors may help currently addicted adult smokers switch to potentially less harmful forms of nicotine-containing tobacco products."
Robin Koval, who is president of the anti-tobacco group , applauded Gottlieb and other FDA officials for their recent actions regarding tobacco products.
"The FDA seems very focused and very serious about making real progress on tobacco," she told 鶹ý. "Last week's announcement and this one indicate that reducing tobacco use is a priority with this agency. That being said, if they talk the talk, they have to walk the walk."
Koval said action to remove menthol flavorings from combustible and non-combustible tobacco products is needed now, not years from now.
She noted that in 2013 the FDA also considered banning menthol from tobacco products in a ANPRM, but ended up doing nothing.
"Menthol is the number one priority. More than any other flavoring menthol is impeding progress on driving down smoking rates," she said. "There is already a wealth of information showing this. This is not a question of evidence, it is a question of will."
Campaign for Tobacco-Free Kids president Matthew L. Myers agreed.
"FDA has been down the menthol road many times, and the evidence is overwhelming that menthol is associated with increased use among youth and African Americans," he said.
In 2011, FDA concluding that the the flavor “is likely associated with increased smoking initiation by youth and young adults†and that smokers of menthol cigarettes may have a higher risk for becoming addicted.
Enid Neptune, MD, who is co-chair of the American Thoracic Society’s Tobacco Action Committee, said the move to issue a ANPRM could be viewed as a way to stall action on flavoring bans.
“The FDA may be sincere in this effort, but the more cynical view is that this could be a delaying tactic,†she said. “This has all been studied to death, and we’ve already had plenty of comment. They have all the data they need. So why is the commissioner moving forward in this way?â€
Myers told 鶹ý that while there is also overwhelming evidence that e-cigarette flavorings are associated with increased use among teens and young adults, there is little evidence that the flavoring help cigarette smokers quit.
American Heart Association CEO Nancy Brown called Tuesday's announcement by the FDA "welcome, but long overdue."
"We encourage the FDA to quickly move beyond information gathering and develop a strong flavoring product standard," Brown said in a statement. "There is already clear evidence that flavored tobacco products, including menthol, harm the public health."
If the agency moves forward and acts to restrict or ban some are all flavors from tobacco products, another comment period will be required.
Koval said even in the best-case scenario, it is likely to be several years before nicotine reductions or flavoring restrictions are a reality.
"The FDA is taking the right actions, so we are optimistic that they are serious about this," she said. "But time is of the essence. This has taken way too long."
The ANPRM gives the public and other stakeholders 90 days to provide comment. Specifically, the FDA wants input on the extent to which flavorings:
- Promote initiation and patterns of tobacco use, particularly among youth and young adults
- Help some adult cigarette smokers reduce cigarette use and/or switch to potentially less harmful tobacco products, or perhaps start to use more than one type of tobacco product
- Present potential adverse health effects in and of themselves to users or others
Additionally, the agency is seeking information on the impact of local, state, and international efforts to restrict flavored tobacco products, and on consumer perceptions of health risks and addictiveness of flavored tobacco products.