FDA WARNING_LETTER - Vape.com - November 03, 2025

The FDA issued a Warning Letter to smokespotvape.com on November 20, 2025, following a review of their website, which identified the online sale of unauthorized electronic nicotine delivery system (ENDS) products. The primary violation centers on the marketing of "new tobacco products" without the required premarket authorization. Specifically, products like Elf Bar 5000 Puffs Blueberry Tobacco and Lemon Lime Sparkling Lost Mary OS 5K were offered for sale without the necessary FDA marketing orders.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including amendments extending jurisdiction to products with nicotine from any source, new tobacco products must receive premarket authorization to be legally marketed in the U.S. Products lacking this authorization are considered adulterated and misbranded.

smokespotvape.com is required to take prompt action to address these violations. This includes discontinuing the sale and distribution of all unauthorized tobacco products. The company must submit a written response to the FDA within 15 working days from receipt of the letter, detailing the actions taken to achieve compliance, the dates on which violative sales ceased, and their plan for ongoing adherence to FDA regulations. Failure to comply could lead to further enforcement actions such as civil money penalties, seizure, or injunction.