FDA takes frequent actions, and US e-cigarettes face more frequent market supervision

On June 12 this year, at a hearing on combating the rise of illegal electronic cigarettes in the US Senate, the US Food and Drug Administration (FDA) and the US Department of Justice (DOJ) were criticized by many senators for not effectively combating illegal e-cigarettes.

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Since then, the FDA has taken frequent actions. At the end of July (July 25 and July 31), the FDA issued two "work summaries" in a row, showing that it had issued warnings to retailers who sold unauthorized e-cigarettes offline and online.

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On July 25, the FDA announced that it had sent warning letters to 80 physical retailers in 15 different states because they sold unauthorized e-cigarette products that are popular among young people. In addition, the FDA also announced the filing of civil penalties (filing of complaints for civil money penalties, CMPs) against eight other retailers because these retailers had failed to take action after being warned about the sale of unauthorized e-cigarettes.

On July 31, the FDA issued warning letters to five online retailers that sold unauthorized disposable e-cigarette products, involving several popular brands and well-known retailers.

These warning letters are the result of the FDA's ongoing monitoring of multiple monitoring systems, including a review of various data to identify emerging products that are popular among youth or attractive to youth and are of particular concern.

To date, the FDA has issued more than 680 warning letters to companies that manufacture, sell and/or distribute unauthorized new tobacco products, more than 690 warning letters to retailers that sell unauthorized tobacco products, and has filed civil penalty lawsuits against 64 manufacturers and more than 140 retailers.

Note 1: The FDA typically issues warning letters when violations are first discovered during an investigation or inspection. The recipient of the warning letter has 15 business days to respond with the measures they will take to correct the current violations and prevent future violations. However, failure to correct the violations in a timely manner may result in additional FDA actions, including CMPs.

Note 2: To date, the FDA has approved 34 e-cigarette products and devices. The list refers to the printable flyer of authorized e-cigarettes maintained by the FDA https://digitalmedia.hhs.gov/tobacco/hosted/E-Cigarettes-Authorized-FDA-JULY2024.pdf