FDA WARNING_LETTER - dummyvapes.com - July 29, 2025

The FDA"s Center for Tobacco Products issued a warning letter on July 25, 2025, to High Quality Distribution LLC, operating as Dummy Vapes, following an inspection of their website, https://dummyvapes.com. The inspection revealed that the company was selling electronic nicotine delivery system (ENDS) products, specifically Dummy Vapes - Alien Invasion and Dummy Vapes - Gangsta Punch, without the required FDA marketing authorization. These products are considered "new tobacco products" as they were not commercially available in the U.S. before February 15, 2007, and lack the necessary premarket authorization, making them adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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 FDA"s jurisdiction over these products was expanded by the Consolidated Appropriations Act, 2022, which amended the definition of "tobacco product" to include products with nicotine from any source.

The FDA has requested that Dummy Vapes take immediate action to address these violations by discontinuing the sale and distribution of the non-compliant products and ensuring future compliance with the FD&C Act. The company must submit a written response within 15 working days detailing corrective measures and plans to maintain compliance. Failure to comply may result in enforcement actions, including civil penalties or product seizure. The letter serves as a formal notification of the violations and an opportunity for the company to rectify them.