FDA WARNING_LETTER - evapekings.com - October 09, 2025
Discuss this record with AI
On October 9, 2025, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products issued a Warning Letter to evapekings.com following a review of their website. The FDA determined that evapekings.com offers for sale several electronic nicotine delivery system (ENDS) products, specifically "Fume WeFume Disposable Vape Device [30K Puffs] – Dragon Fruit" and "Fume WeFume Disposable Vape Device [30K Puffs] – Lychee Soda," which are considered tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The primary violation is that these ENDS products are "new tobacco products" that lack the required premarket authorization order. Under the FD&C Act, new tobacco products must have FDA marketing authorization to be legally sold in the U.S. Without this, the products are deemed adulterated and misbranded. The FDA also expressed particular concern that the products" labeling and advertising may appeal to youth due to their design imitating smartphones and other smart technology, potentially concealing their nature as tobacco products. Evapekings.com is required to take prompt action to address these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and its implementing regulations. A written response detailing actions taken must be submitted to the FDA within 15 working days of receiving the letter. Failure to comply may lead to further regulatory actions.
ID · c2c72e81-1911-4844-82d3-766da5e72e93
Full citation text and observation details available on the Dashboard.