11.07.19

All eyes on menthol

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As if the e-cigarette saga weren’t dramatic enough, Juul announced today that it will only sell its tobacco- and menthol-flavored products in the U.S. now. This comes before the current Administration’s announcement of a new flavored e-cigarette policy by the U.S. Food and Drug Administration (FDA), which is expected any day now, and is the last in a series of steps the company has taken to try and address the alarming increases in youth e-cigarette use in the last two years (none have seemed to actually work yet). 

The timing and circumstances of this announcement are like déjà vu. The company made a similar announcement about halting sales of its sweet flavors (fruit, mango, cucumber, and crème) in brick-and-mortar stores almost a year ago shortly before the FDA announced a new flavored tobacco products policy framework. Part of that framework was advanced in March when FDA issued a draft guidance modifying its compliance policy for certain flavored tobacco products (mostly non-tobacco, mint, or menthol e-cigarettes and non-tobacco flavored cigars), but that guidance has not yet been finalized, which means none of the policies outlined have gone into effect yet. The FDA’s much-anticipated finalization of its flavored e-cigarette policy is likely to be a modified version of the March draft guidance, and all eyes will be on menthol.

If menthol e-cigarettes continue to be excluded from efforts to restrict flavored e-cigarettes, evidence suggests youth will migrate to them because of a shift in the availability of e-cigarette flavors. A former Juul executive has said that the company knew this type of migration would happen when it halted sales of its other sweet flavors. There is also concern that a menthol exemption would allow Juul and others to simply rename their mint flavors and sell them as menthol since there are no standards for what actually constitutes a “mint” or “menthol” flavor.

Some argue that a menthol e-cigarette exemption is necessary to preserve a potential off-ramp for adults addicted to the most lethal of tobacco products: conventional combusted cigarettes. This relative-risk argument is especially poignant with the continued availability of menthol cigarettes (the only legal flavored cigarettes still available in the U.S.) and evidence suggesting an increase in the selection of regular cigarettes when no flavored e-cigarettes are available but menthol cigarettes are.

To fully mitigate these concerns, all eyes should be on menthol not just in the context of e-cigarettes, but for all tobacco products, including cigars and regular cigarettes. This was recognized in FDA’s November 2018 announcement of its new flavored tobacco products policy framework, but the parts of that framework focused on the most lethal tobacco products, which are arguably more important because of their greater potential for both larger net public health gains and advancing health equity, have largely been ignored. Failing to address the continued availability of menthol cigarettes and flavored cigars with a singular focus on e-cigarettes not only allows the very product e-cigarettes seek to make obsolete to thrive, but it also further entrenches systemic inequities.

While there is seemingly little appetite from this Administration to seriously consider the broader tobacco control context, Congressman Frank Pallone Jr., Chairman of the House Energy and Commerce Committee, introduced H.R. 2339 earlier this year. The bill–with 87 cosponsors–had a hearing last month and would prohibit menthol cigarettes and all other flavored tobacco products, including e-cigarettes. It would also preserve the option for flavored e-cigarettes that FDA determines are appropriate for the protection of public health to remain on the market. All eyes will be on menthol when this Administration finally releases its FDA flavored e-cigarette policy, including Chairman Pallone’s. As an eternal optimist, I choose to believe this means that the unthinkable progress on menthol cigarettes at the federal level may now be a reality more than ever. 

Posted in FDA, Food and Drug Law, Non-Communicable Diseases, Tobacco ; Tagged: , , , .

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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