FDA Issues Warning Letters to Unlicensed E-cigarette Sellers and Retailers

According to a report on the official website of the US Food and Drug Administration (FDA) on September 13th, the agency has issued 11 warning letters to multiple manufacturers and retailers for selling or distributing unauthorized e-cigarette products at industry trade shows.

The FDA's Center for Tobacco Products (CTP) conducted an investigation after attending a trade show and found that six retailers and manufacturers were suspected of selling or distributing unauthorized e-cigarette products, violating regulations under the Federal Food, Drug, and Cosmetic Act. John Verbeten, Director of CTP's Office of Compliance and Enforcement, emphasized that the FDA will gather leads and conduct investigations through various channels, including trade shows, to crack down on illegal activities.

In addition, the FDA has issued warning letters to five online retailers accusing them of selling unauthorized e-cigarette products popular among teenagers, such as brands like Breeze, Mr. Fog, and Raz. These brands of e-cigarette products have high usage rates among teenagers and are favored for their wide variety of flavors.

Source: FDA official website.

Companies that have received a warning letter must respond within 15 business days, detailing the actions taken to address the violations and prevent future non-compliance. Companies that fail to address the issues in a timely manner may face further action by the FDA, including injunctions, seizures, or civil penalties.

The FDA's actions are part of its ongoing efforts to combat the unauthorized sale of e-cigarette products in the supply chain. Over the past year, the FDA has conducted multiple retailer inspections, exposing numerous cases of unauthorized e-cigarette sales, issuing over 690 warning letters, and imposing more than 140 civil penalties on retailers.

It is worth noting that the percentage of American teenagers using e-cigarettes decreased by nearly 25% between 2023 and 2024, dropping from 2.13 million to 1.63 million. The FDA has authorized 34 types of e-cigarette products and devices that are legally sold in the United States. The public can access further information about legally marketed tobacco products in the FDA's searchable tobacco product database. With increasing global regulations on e-cigarettes, governments around the world are taking unprecedented measures to combat illegal e-cigarette activities. From the seizure of over a thousand untaxed e-cigarettes by German customs, to the sales bans imposed by the Department of Trade and Industry in the Philippines on brands such as Relx, Flare, Team X, and Funky Monkey, these actions not only demonstrate the government's commitment to protecting public health and upholding tax regulations but also reflect the international community's collective efforts in combating illegal e-cigarette trade.