The Food and Drug Administration on Jan. 3 updated two import alerts, 98-07 and 98-06. These updates separate imported electronic-cigarette products from all other tobacco products, the agency said. 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, the agency said.
“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,” the agency said.
The updates also provide “clearer instructions to the FDA staff in the field, as well as the FDA’s federal partners and the wider trade community—including importers, customs brokers, filers, and others,” the FDA said in a statement.
The FDA said Import Alert 98-07 has been streamlined, including the addition of links to the FDA’s Searchable Tobacco Products Database and a downloadable list of authorized e-cigarette products.
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,” the agency said.
The FDA said it has not adopted a broad policy of enforcement discretion regarding unauthorized e-cigarette products.
“A pending application does not create a legal safe harbor to distribute or sell an unauthorized product,” the agency said.
Updates to Import Alert 98-06 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 and more including NOIS, LYFT and SKRUF brand pouches.
The FDA said these tobacco products may also be detained by import officials, without the need to conduct physical examination and refused admission by FDA.
Import alerts involve accurately declared products; however, the agency also continues to work with federal partners to address mis-declared products.
In October, the FDA in collaboration with the U.S. Customs and Border Protection (CBP), seized about three million units of unauthorized e-cigarette products, with an estimated retail value of $76 million.
The products included various brands of illegal e-cigarettes, including Geek Bar.
The seizures were part of a July joint operation, which examined incoming shipments and prevention of illegal e-cigarettes from entering the country.
Most of these unauthorized e-cigarettes were intentionally mis-declared as items with no connection to vaping products and with incorrect values, the agency said.
To date, the FDA has authorized 34 e-cigarette products and devices.
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