FDA Updates Import Alerts on Unauthorized E-Cigarettes

The updates clarify that unauthorized e-cigarettes may be detained without physical examination.

January 07, 2025

Last week, the U.S. Food and Drug Administration (FDA) updated two import alerts, 98-07 and 98-06. These updates “separate imported e-cigarette products from all other tobacco products and provide clearer instructions to FDA staff in the field, as well as our federal partners and the wider trade community—including importers, customs brokers, filers and others,” according to a press release.

FDA said it can place a product or firm on an import alert if they appear to be in violation of FDA laws and regulations, and then detain future shipments of the product without having to test or otherwise physically examine it.

The updates to Import Alert 98-07 reinforce that any unauthorized e-cigarette product imported into the United States may be subject to detention without physical examination and refused admission by FDA. FDA said the updates will help provide further clarity to those impacted by the alert and those responsible for implementing it. More specifically, Import Alert 98-07 has been streamlined, adding links to FDA’s Searchable Tobacco Products Database and providing a downloadable list of authorized e-cigarette products, which are “generally eligible for legal importation into the United States.”

“The revised e-cigarette import alert also reinforces the basic legal requirement that all new tobacco products—including e-cigarettes—must have FDA authorization to be marketed legally in the United States. … Notably, a pending application does not create a legal safe harbor to distribute or sell an unauthorized product,” FDA said in the release.

“The illicit market for e-cigarettes is out of control. A critical step in cleaning up the marketplace is for the Center for Tobacco Products to finally provide a list of which specific products can be on the market and a list of products that cannot,” stated Anna Blom, director of government relations at NACS. “Without these lists from the agency, retailers are left in the dark and lacking the full picture of compliance.”

FDA also updated Import Alert 98-06 for imported tobacco products other than e-cigarettes. This import alert includes unauthorized tobacco products in categories such as smokeless tobacco and nicotine pouches, among others.