Are flavored tobacco products getting kids hooked or helping smokers quit?
That’s one of the central questions the U.S. Food and Drug Administration (FDA) is investigating as it makes a preliminary move to potentially limit flavorings allowed in tobacco products.
The FDA announced last week that it’s seeking comments from the public on an advance notice of proposed rulemaking (ANPRM) to gather information about the role flavorings play in “initiation, use and cessation” of tobacco products.
“The thought of any child starting down a path of a lifelong addiction to tobacco, which could ultimately lead to their death, is unacceptable. We need to take every effort to prevent kids from getting hooked on nicotine,” said Dr. Scott Gottlieb, the FDA commissioner, in a statement.
“We are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation,” he said.
The ANPRM marks the second action this month by the FDA on tobacco products.
Agency officials also announced they’d be investigating whether or not to limit the amount of nicotine that tobacco products could contain.
Flavored tobacco products have long been known to appeal to teens and encourage smoking at a young age.
Did e-cigarettes lead to latest action?
But, if that’s a known fact, as cited by the FDA and major health organizations such as the American Heart Association and the American Lung Association, why is there a need for any additional input?
It turns out the tobacco marketplace has actually changed quite rapidly over the past decade, as has the FDA’s regulatory power over tobacco products.
In particular, vaporizers and other noncombustible forms of tobacco consumption — sometimes referred to as electronic nicotine delivery systems, or ENDS — have had a polarizing effect on members of the healthcare community.
Some argue the products are less harmful than traditional cigarettes. Others say that vaping is just another form of tobacco initiation.
Gottlieb cites this dynamic as one of the reasons for the ANPRM published earlier this month.
“Here, it’s possible for flavors to do both harm and good,” he said.
“I’ve talked to ex-smokers, who’ve told me that they quit cigarettes altogether and that they now vape. And they’ve also told me it was the flavors that helped them make that transition off combustible cigarettes. Now I know anecdotes aren’t the same as data. And the ANPRM specifically seeks data on this issue,” said Gottlieb.
In a statement to Healthline, a spokesperson for the FDA explained that the purpose of the ANPRM is to look for information related to different age groups who use flavored tobacco products.
So, are the flavors that help a 60-year-old lifelong smoker kick the habit the same phenomenon that’s getting middle schoolers to take their first puff on a vape?
Consolidation of power
The FDA’s recent announcement on flavored tobacco is also indicative of the agency’s greater consolidation of regulatory power over tobacco products.
Beginning in 2009, the Tobacco Control Act gave the FDA authority to regulate tobacco products. It also limited the flavorings that cigarettes could use — fruit, clove, vanilla, and others were subsequently banned.
However, it did maintain that menthol cigarettes could still be sold, despite the fact that they tend to be more popular with teens.
Since then, the FDA was also granted the power to regulate other tobacco products on the market besides cigarettes through the so-called “deeming rule.”
The “deeming rule” allows the FDA to “deem” whether or not certain tobacco products are subject to regulation.
E-liquids, for example, aren’t explicitly tobacco products, although they may contain nicotine. But the FDA says they still meet the statutory definition for a tobacco product.
The deeming rule also extends to other tobacco products, including snuff, cigars, small cigars (cigarillos), pipe tobacco, and hookah.
Additionally, components and accessories used with these products are also regulated by the FDA, including vaporizers and other ENDS.
While the FDA hasn’t announced any action in particular related to flavoring yet (comments from the public on the ANPRM are open until June 19), there’s a sense that new regulations governing flavored tobacco products are likely on the horizon.
The FDA spokesperson reiterated to Healthline that they’re taking this opportunity to “look more broadly at the issue and consider all flavors, including menthol, as we comprehensively explore their public health impact and receive information to inform what regulatory action, if any, the FDA might take.”
While the organization is taking its time in a final decision, other organizations have voiced criticism.
The American Heart Association and American Lung Association have both issued statements urging the FDA to move forward with regulation on flavored tobacco products as soon as possible.
“Flavored tobacco products are on the market for one reason: to attract youth and get them hooked using tobacco products. The lung association believes the FDA is long overdue in requiring that all flavored tobacco products be removed from the marketplace,” Erika Sward, assistant vice president of national advocacy for the American Lung Association, told Healthline.
“Congress prohibited all flavored cigarettes except menthol cigarettes in 2009, and in 2011, the FDA’s own Scientific Advisory Committee urged that all menthol cigarettes be removed from the marketplace, which the American Lung Association strongly supported,” Sward said.