In April 2024, the Public Health Law Center published a commentary entitled, “A Closer Look at the 23 FDA Authorized E-Cigarettes.” This was in response to a frequently asked question from commercial tobacco regulators across the country: what should we make of the 23 tobacco products that the U.S. Food and Drug Administration has authorized thus far, and can we identify any policy trends among them?

With an optimistic view of the FDA's intentions, we identified three commonalities among these authorized e-cigarettes: none were (1) flavored, (2) marketed as modified risk, or (3) single-use disposable vapes. We hoped this indicated that the FDA was committed to taking a firm stance against menthol and other flavors, recognized the health risks of e-cigarettes, and understood the environmental concerns associated with disposable vapes. Unfortunately, we were wrong.

The FDA has now authorized four new e-cigarettes, all of which are menthol flavored. On June 21, 2024, the FDA issued a press release, “FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific Review: Authorization Includes Restrictions to Mitigate Youth Risk.” Dr. Brian King, director of the FDA’s Center for Tobacco Products, perplexingly stated, “This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.” His statements in defense of the authorization are baffling, given the many previous statements he has made about the risks that menthol products pose to youth and other groups.

Until this announcement, only tobacco-flavored e-cigarettes were authorized for sale in the U.S. This marks the first time the FDA has authorized the marketing of an e-cigarette flavor other than tobacco.

Understanding FDA Authorization

It is important to differentiate between FDA “authorization” and “approval.” The FDA approves food, drugs, and devices but authorizes tobacco products. This only means that authorized tobacco products are marketable in the U.S., not that they are safe or present a reduced harm alternative to combustible tobacco products.  Nevertheless, there is often a disconnect between FDA terminology and consumer understanding. The authorization of menthol vapes may make many consumers mistakenly believe these products are safe, which is not the case.

Details on the Four Newly Authorized Menthol E-Cigarettes

The FDA issued marketing granted orders to NJOY LLC for four menthol-flavored e-cigarette products—NJOY Ace Pod Menthol 2.4%, NJOY Ace Pod Menthol 5%, NJOY Daily Menthol 4.5%, and NJOY Daily Extra Menthol 6%. Let’s take a closer look at these products.

Flavors: The four newly authorized e-cigarettes are all menthol-flavored even though in 2022, the FDA proposed a ban on menthol cigarettes due to their appeal to youth and the potential health benefits of banning them. Further, tobacco companies have aggressively marketed menthol cigarettes to Black communities, and research shows that non-tobacco e-liquid flavors are more appealing than tobacco flavors, especially to young people. Until now, the FDA has previously denied applications for menthol e-cigarettes, citing insufficient scientific evidence to show that the potential benefits to adult smokers outweigh the risks of youth initiation and use.

Modified Risk: None of the 27 authorized e-cigarettes have been designated as modified risk tobacco products, nor have their manufacturers applied for them to bear such a designation. There is a lack of evidence proving that e-cigarettes are safer alternatives to traditional cigarettes or effective tools for quitting smoking, especially outside a counseling setting. Culturally tailored cessation techniques remain the most effective method for helping addicted smokers quit. Switching to menthol vapes does not resolve the core problem and may delay actual treatment, not to mention initiate new smokers.

Environmental Impact: Of the four newly authorized products, two are sealed, prefilled pods with menthol-flavored nicotine liquid, and the other two are disposable e-cigarettes. Once the prefilled menthol e-liquid is used up, the disposable devices cannot be reused. By authorizing these products, the FDA overlooks the environmental concerns associated with vaping products. Disposable vapes, often containing lithium-ion batteries glued into the product, are nearly impossible to remove safely or to recycle, posing significant environmental challenges.

Looking Ahead

The timing of the FDA’s decision to authorize four menthol e-cigarette products certainly raises questions. Why now? It is difficult not to speculate that this might be connected to the recent lawsuit filed by the African American Tobacco Control Leadership Council against the U.S. Department of Health and Human Services and the FDA, coupled with the FDA’s previous commitment to ban menthol combustible cigarettes. Though speculative, it is plausible that the FDA might be preparing to ban menthol cigarettes and views the approval of menthol e-cigarettes as a harm reduction strategy. Essentially, the FDA may be authorizing menthol e-cigarettes to ease the transition ahead of an impending ban on combustible menthol cigarettes. After all, the ongoing case, AATCLC v. DHHS (2024), continues to exert pressure on the agency to fulfill its commitment to ban menthol cigarettes.

In conclusion, while the FDA should play a pivotal role in safeguarding public health, it cannot be relied upon as our only line of defense. Recent federal decisions, such as the authorization of menthol e-cigarettes and the delayed implementation of the menthol ban, are challenging to justify from a public health standpoint. A comprehensive approach, particularly at the local government level, continues to be essential to address these issues effectively and to protect all segments of society.

Willow Anderson, Staff Attorney
July 1, 2024