lowkeydis.com – FDA Warning Letter, Nov 3, 2025

The FDA issued a Warning Letter to lowkeydis.com on November 14, 2025, after reviewing their website and determining they were unlawfully marketing electronic nicotine delivery system (ENDS) products. The primary violation centers on the sale of "new tobacco products," specifically "Fog Off 50,000 Puff - Grape Slush" and "Fog Off 50,000 Puff - Blue Razz Ice," without the required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including recent amendments extending jurisdiction to all nicotine sources, these ENDS products are considered "new tobacco products" because they were not commercially marketed in the U.S. before February 15, 2007, and lack FDA marketing orders. Consequently, the products are deemed adulterated and misbranded under the FD&C Act. lowkeydis.com is required to submit a written response within 15 working days, detailing actions taken to cease the violative sales, achieve compliance, and outline a plan for sustained adherence to the FD&C Act and FDA regulations. Failure to comply could result in enforcement actions such as civil money penalties, seizure, or injunction.