FDA Strengthens Import Alerts to Address Unauthorized E-Cigarettes Detention

On January 3rd, the U.S. Food and Drug Administration (FDA) updated its import alerts and released 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.

The news release states that the U.S. Food and Drug Administration (FDA) has announced updates to two import alerts, namely 98-07 and 98-06. These updates will distinguish imported e-cigarette products from all other tobacco products, providing clearer guidance for FDA frontline staff, federal partners, and a broader trade community including importers, customs brokers, and declarants.

The FDA stated that if a product or company is suspected of violating FDA regulations, the FDA may place the product or company on an import alert list, and subsequently detain the products without the need for testing or physical examination.

The press release also mentioned that the FDA's update on Import Alert 98-07 emphasizes that any unauthorized e-cigarette products imported into the United States may be detained without physical examination and refused entry by the FDA.

The update to the import alert from 1998 to 2006 now focuses on imported tobacco products other than e-cigarettes. This import alert covers unauthorized tobacco products such as smokeless tobacco and nicotine pouches, and has recently added nicotine pouch products from brands like NOIS, LYFT, and SKRUF. These tobacco products may also be detained by import officials, without physical examination, and denied entry by the FDA.

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

Below is the full text of the press release (content translated by 2Firsts using AI, subject to FDA original text):

On January 3rd, the US FDA announced updates to two import alerts, numbered 98-07 and 98-06. These updates will distinguish imported e-cigarette products from all other tobacco products and provide clearer guidance for FDA frontline staff, federal partners, and a broader trade community including importers, customs brokers, declarants, and others.

If a product or company appears to violate FDA laws and regulations, the FDA can place the product or company on an Import Alert list, and subsequently detain future shipments of the product without the need for testing or physical inspection.

The update on Import Alert 98-07 emphasizes that any unauthorized e-cigarette products imported into the United States may be detained without physical examination and refused entry by the FDA. This has been and will continue to be the FDA's policy; however, these updates will help clarify the requirements for those affected by the alert and those responsible for enforcing it. Specifically, Import Alert 98-07 has been simplified to include a link to the FDA's searchable tobacco product database and a downloadable list of authorized e-cigarette products eligible for legal importation into the United States. The FDA's website further elaborates on the agency's enforcement priorities for tobacco products, including a few specific situations in which the FDA does not currently intend to take enforcement actions against unauthorized e-cigarette products.

The revised e-cigarette import warning also reinforces a basic legal requirement that all new tobacco products, including e-cigarettes, must be authorized by the FDA in order to be legally sold in the United States. The FDA does not have a broad enforcement discretion policy for unauthorized e-cigarette products. It is worth noting that an application that is currently under review does not create a legal safe harbor for distributing or selling unauthorized products.

The FDA has also updated Import Alert 98-06 to focus on imported tobacco products other than e-cigarettes. This import alert covers unauthorized tobacco products in categories such as smokeless tobacco and nicotine pouches, with recent additions including brands such as NOIS, LYFT, and SKRUF. These tobacco products may also be detained by import officials, denied entry by the FDA without physical inspection.

In addition to issuing import alerts for accurately declaring products, the agency continues to collaborate 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 legally seized approximately 3 million unauthorized e-cigarette products with an estimated retail value of $76 million. Such actions reflect the enhanced cooperation and coordination among federal agencies as part of a special 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. Stay tuned for updates.