FDA Issues Warning Letters to Nine Online Firms for Selling Unauthorized Flavored, Disposable Vapes

Targeted Products Include Brands Popular Among Youth, Such as Geek Bar and Lost Mary

On December 19, 2024, the U.S. Food and Drug Administration (FDA) announced that it had issued warning letters to eight online retailers and one manufacturer for selling and/or distributing unauthorized flavored, disposable vapes. The warning letters cited several popular youth-oriented brands, including Geek Bar and Lost Mary, as well as products featuring the names and/or images of celebrities.

The firms receiving these warning letters sold and/or distributed vapes in the United States without the required FDA authorization, violating the Federal Food, Drug, and Cosmetic Act. In addition to the specific violations mentioned in the warning letters, the FDA cautioned the firms to address any similar violations and take prompt action to comply with the law. Failure to do so may result in additional enforcement actions, such as injunctions, seizures, and/or civil money penalties.

The FDA remains committed to enforcing the law and collaborating with federal enforcement partners to address unauthorized tobacco products in the United States. This latest round of warning letters underscores the agency’s ongoing efforts to remove unauthorized vapes from the market, particularly those that appeal to youth.

To date, the FDA has issued more than 700 warning letters to firms for manufacturing, selling, and/or distributing unauthorized new tobacco products, over 800 warning letters to retailers for selling unauthorized tobacco products, and filed civil money penalty complaints against more than 83 manufacturers and more than 175 retailers for distribution and/or sale of unauthorized tobacco products.

Limited Number of Authorized Vapes

As of December 19, 2024, the FDA has authorized only 34 vape products and devices. The agency provides a printable one-page flyer listing all authorized vape products to help retailers determine which products may be lawfully marketed and sold in the United States. Entities manufacturing, importing, selling, or distributing vapes without the required premarket authorization risk enforcement action.

As a vaping industry professional, it is essential to stay informed about the regulatory landscape and ensure compliance with all applicable laws and regulations. Manufacturers and retailers should carefully review the list of authorized vape products and take immediate action to remove any unauthorized products from their inventory. By working collaboratively with the FDA and other regulatory agencies, the vaping industry can demonstrate its commitment to responsible marketing and sales practices, while helping to prevent youth access to these products.

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Matthew Ma

Marketing at Ecigator

With over a decade of experience in the e-cigarette industry, Matthew Ma is a seasoned expert in both the manufacturing and usage aspects of vaping products. His extensive background has provided him with a deep understanding of the intricacies and evolving dynamics of e-cigarettes.

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