The Food and Drug Administration (FDA) Center for Tobacco Products (CTP) recently issued draft guidance clarifying its approach on flavored e-cigarettes. The guidance outlines a “graduated risk-proportionate evaluation” establishing a lower evidentiary burden to authorize tobacco-flavored e-cigarettes, a greater burden for menthol and mint-flavored products, and the greatest burden for sweet-flavored products. To date, the CTP has authorized 45 e-cigarette products in primarily tobacco and menthol flavors—and these are the only e-cigarettes legally sold in the United States.
At the same time, there is strong consumer demand for e-cigarettes not authorized by the FDA. Multiple organizations, including the FDA and the Truth Initiative, estimate that most e-cigarettes currently sold in the US are illegal products that lack FDA authorization, and there is growing concern across government, public health, and industry that an illicit market for unauthorized e-cigarettes is posing increased public health and public safety concerns. Much of the discussion to date has focused on the need for greater enforcement actions to address the illegal import, distribution, and sale of illegal e-cigarette products.
To be sure, law enforcement actions against the import and distribution of illegal products are necessary. But the US can and should avoid a drug war approach to e-cigarettes.
