On Jan. 3, FDA announced the update of 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.
FDA 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. This has always been and continues to be FDA’s policy; however, the updates will help to provide further clarity to those impacted by the alert and those responsible for implementing it. More specifically, Import Alert 98-07 has been streamlined, including to add links to FDA’s Searchable Tobacco Products Database and a downloadable list of authorized e-cigarette products, which are generally eligible for legal importation into the United States. FDA’s website further describes the agency’s tobacco product enforcement priorities, including the limited number of instances for which FDA currently does not intend to take enforcement action on unauthorized e-cigarettes.
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. FDA has not adopted a broad policy of enforcement discretion regarding unauthorized e-cigarette products. Notably, a pending application does not create a legal safe harbor to distribute or sell an unauthorized product.
FDA also updated Import Alert 98-06 to focus on 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, with recent additions such as NOIS, LYFT, and SKRUF brand pouches. These tobacco products may also be detained by import officials, without the need to conduct physical examination, and refused admission by FDA.
In addition to import alerts, which involve accurately declared products, the agency continues to work with federal partners to address misdeclared products. For example, in October 2024, FDA and U.S. Customs and Border Protection announced the successful completion of a joint operation involving the administrative seizure of approximately three million units of misdeclared, unauthorized e-cigarettes products, with an estimated retail value of $76 million. Such actions reflect the increased collaboration and coordination facilitated by the federal multi-agency task force to curb the distribution and sale of illegal e-cigarettes.
source：https://www.fda.gov/tobacco-products/ctp-newsroom/fda-updates-import-alerts-reinforce-all-unauthorized-e-cigarettes-may-be-detained-without-physical
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