US FDA updates import alert: All unauthorized e-cigarettes may be seized without physical inspection

US FDA updates import alert: All unauthorized e-cigarettes may be seized without physical inspection

The FDA stated that if a product or company is suspected of violating relevant FDA laws and regulations, it can be included in the import alert list, and then the subsequent shipments of the product can be seized without testing or physical inspection.

On January 3, the U.S. Food and Drug Administration (FDA) updated the import alert and issued a press release on its official website titled "FDA Updates Import Alerts to Reinforce that All Unauthorized E-Cigarettes May Be Detained Without Physical Examination".

FDA press release | Source: FDA official website

The press release pointed out that the U.S. Food and Drug Administration (FDA) announced the update of two import alerts, namely 98-07 and 98-06. These updates distinguish imported e-cigarette products from all other tobacco products, providing clearer instructions for FDA frontline staff, federal partners, and a wider trade group including importers, customs brokers, declarants, etc.

The FDA stated that if a product or company is suspected of violating FDA laws and regulations, the FDA may put the product or company on the import alert list and then seize the subsequent shipment of the product without testing or physical inspection.

The press release also mentioned that the FDA's update to Import Alert No. 98-07 emphasized that any unauthorized e-cigarette products imported into the United States may be seized without physical inspection and refused entry by the FDA.

The update to Import Alert No. 98-06 focuses on imported tobacco products other than e-cigarettes. The import alert covers unauthorized tobacco products in categories such as smokeless tobacco and nicotine pouches, and recently added nicotine pouch products such as NOIS, LYFT and SKRUF brands. These tobacco products may also be seized by import officials without physical inspection and refused entry by the FDA.

It is worth mentioning that the FDA also mentioned that an application under review does not create a legal safe haven for the distribution or sale of unauthorized products.

The following is the full text of the press release (the content is translated by 2Firsts using AI, and the original text of the FDA shall prevail):

On January 3, the U.S. Food and Drug Administration announced the update of two import alerts, No. 98-07 and No. 98-06. These updates distinguish imported e-cigarette products from all other tobacco products and provide clearer instructions for FDA front-line staff, federal partners, and the broader trade community (including importers, customs brokers, declarants, etc.).

If a product or business appears to be in violation of FDA laws and regulations, FDA may place that product or business on an Import Alert and subsequently seize subsequent shipments of that product without testing or physical inspection.

The updates to Import Alert 98-07 emphasize that any unauthorized e-cigarette products imported into the United States may be seized without physical inspection and refused entry by FDA. This has been and remains FDA policy; however, these updates will help provide additional clarity to those affected by the alert and those responsible for enforcing it. More specifically, Import Alert 98-07 has been streamlined, including the addition of a link to the FDA's searchable tobacco product database and a downloadable list of authorized e-cigarette products that are generally eligible for legal import into the United States. The FDA's website further elaborates on the agency's tobacco product enforcement priorities, including a few situations where FDA currently does not intend to take enforcement action against unauthorized e-cigarettes.

FDA has authorized a list of e-cigarette products | Source: FDA

The revised e-cigarette import alert also reinforces a basic legal requirement that all new tobacco products - including e-cigarettes - must be authorized by the FDA before they can be legally sold in the United States. The FDA does not adopt a broad enforcement discretion policy for unauthorized e-cigarette products. It is worth noting that an application under review does not create a legal safe haven for the distribution or sale of unauthorized products.

The FDA also updated Import Alert No. 98-06 to focus on imported tobacco products other than e-cigarettes. The import alert covers unauthorized tobacco products in categories such as smokeless tobacco and nicotine pouches, and recently added pouch products such as NOIS, LYFT and SKRUF brands. These tobacco products may also be seized by import officials without physical inspection and refused entry by the FDA.

In addition to import alerts involving truthfully declared products, the agency continues to work with federal partners to address falsely declared products. For example, in October 2024, the FDA and U.S. Customs and Border Protection announced the successful completion of a joint operation that resulted in the seizure of approximately 3 million falsely declared, unauthorized e-cigarette products with an estimated retail value of $76 million. Such actions reflect the increased collaboration and cooperation of the federal multi-agency task force to curb the distribution and sale of illegal e-cigarettes.

Next, 2Firsts will conduct an in-depth analysis and detailed interpretation of this policy, so stay tuned.