The Food and Drug Administration as Gatekeeper and the Menthol Exemption

The core structure of the 2009 Tobacco Control Act’s¹ regulatory framework was straightforward: tobacco products available as of 2007 would be “grandfathered in” (although still subject to regulation), but any new tobacco product would require premarket authorization from the US Food and Drug Administration (FDA) before sale.² Beyond being a political compromise, this structure made sense. Pulling all existing products off the shelves was not a realistic option, but the FDA could act as a gatekeeper going forward (as it does for drugs and medical devices), ensuring that the mistakes of the past would not be repeated.

But once the act was passed, the FDA failed in its gatekeeping role. For e-cigarettes, which the FDA conceded were “tobacco products” for regulatory purposes in 2011, premarket review never happened. (After-the-fact “premarket” review might happen soon, but a decade too late, and only because of sustained legal pressure from public health groups.) This was not solely the fault of the FDA, but it laid bare the political and structural obstacles that make it difficult for the FDA to act promptly and effectively.²

Without premarket review, we witnessed the history of tobacco industry misconduct replaying itself. In the absence of oversight, some e-cigarette companies copied (and updated) the tobacco industry’s well-worn playbook by marketing to youths, using flavors that appeal to children, designing their products to be maximally addictive, and more.² Without regulation or product review, the irresponsible actors had an upper hand in the marketplace.

The FDA’s January 2020 guidance has to be viewed in light of this history. The FDA has now belatedly responded to the flavored e-cigarettes that have flooded the market and contributed to the surge in youths’ e-cigarette use, but the FDA’s guidance is no substitute for premarket review. Among other missed opportunities, the guidance does not address flavored cigars and only applies to a too-narrow subset of the e-cigarette market. But the missed opportunity that stands as a microcosm of FDA tobacco regulation is the exemption for menthol-flavored e-cigarettes.

In 2009, Congress exempted menthol from the Tobacco Control Act’s rule restricting flavored cigarettes, instead instructing the FDA to review the science and determine whether menthol cigarettes should be prohibited as well. Since that time, the agency has seemingly gone out of its way to avoid regulating menthol. The agency commissioned reviews from its advisory committee, its own scientists, and external peer reviewers, with all groups concluding that removing menthol from cigarettes would benefit public health.² The FDA has also requested additional information on menthol from the public twice. But after all of this research—and despite numerous commitments from FDA commissioners—the agency has yet to even propose removing menthol from cigarettes or any other tobacco product. Not only that, but the FDA continues to authorize new menthol tobacco products for sale, including combustible products.

In the January 2020 guidance, the FDA insists that menthol should be exempted because people who currently use menthol cigarettes “may be looking for an alternative product to seek to transition completely away from combusted products.”^3(p23) Whether menthol e-cigarettes actually make it easier for current menthol smokers to quit is still unknown,⁴ but regardless, a better way to reduce cigarette use would be for the agency to remove menthol from combustible products, rather than exempt it again in noncombustible ones. The FDA’s past missteps should not be the excuse preventing further progress. (The FDA also tries to establish that youths are not attracted to menthol e-cigarettes, a conclusion not supported by the evidence.⁵)

Premarket review was intended to allow the FDA to proactively protect the public from new products that pose population health risks. But with the January 2020 guidance, the FDA is still stuck looking backward.