eCig Distributors, Inc. d/b/a eJuices.com – FDA Warning Letter, Sep 2, 2025

The FDA issued a warning letter to ejuices.com, located at 5808 Spring Mountain Rd, Ste 107, Las Vegas, NV, concerning the sale of electronic nicotine delivery system (ENDS) products. The inspection revealed that products such as HQD Everest 25,000 Puffs Disposable in Blue Raspberry Grape and Black Dragonfruit flavors were being marketed without the necessary premarket authorization. These products are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially available in the U.S. before February 15, 2007, and lack FDA marketing authorization.

The regulatory framework requires that all tobacco products, including those containing nicotine from any source, comply with the FD&C Act and its implementing regulations. The recent legislative amendment to the FD&C Act expanded the definition of "tobacco product" to include products with nicotine from any source, not just tobacco-derived nicotine.

The FDA has determined that the products in question are adulterated and misbranded, as they lack the required marketing authorization and necessary notifications. The company is required to submit a written response within 15 working days detailing corrective actions, including cessation of unlawful sales and plans to ensure compliance with the FD&C Act. Failure to comply may result in enforcement actions such as civil penalties, seizure, or injunction. The company is advised to consult the FDA"s searchable tobacco products database for authorized products and ensure all marketing and sales activities comply with applicable regulations.