In May, we wrote about the Trump administration’s first major enforcement action involving the importation of unauthorized e-cigarettes, in which the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) seized products valued at nearly $34 million. FDA and CBP have once again seized unauthorized e-cigarettes in Chicago, but this time the estimated retail value was $86.5 million — the largest seizure of its kind. This enforcement action is consistent with a statement on FDA’s website: “[e]nforcing against unauthorized ENDS products, including unauthorized products popular with youth, are [sic] among our highest enforcement priorities.” FDA maintains that decisions about whether to take enforcement action will continue to be made on a case-by-case basis after considering youth use and other risk factors.
E-cigarettes may not be marketed in the U.S. unless they receive FDA authorization. FDA has a history of exercising discretion not to take enforcement action against e-cigarette sellers whose e-cigarettes are part of pending applications for marketing authorization, but FDA’s position has become less clear over the last couple years.
This coordinated operation targeted a network of e-cigarette importers and distributors after a joint investigative team identified potentially noncompliant, incoming shipments. FDA maintains that most of the seized e-cigarettes originated in China and that all of them lacked mandatory premarket authorization.
FDA also sent letters to 37 importers and import entry filers regarding their involvement in importing the seized products. These companies were advised that it is a federal crime to make false statements or entries to the U.S. government, and that it is their responsibility to confirm the products they import comply with U.S. requirements. FDA is awaiting responses to its letters, and it is unclear whether the agency will take further action against these companies.
Why It Matters
FDA has faced growing pressure over the last few years to find an effective solution for e-cigarettes lacking FDA authorization. To the extent FDA cannot control unauthorized products, it creates market conditions in which legitimate stakeholders are squeezed out by actors with no interest in compliance. The latest seizure of e-cigarettes underscores this administration’s efforts to remove unauthorized products from shelves, which has the secondary effect of “leveling the playing field” for those that play by the rules.