FDA WARNING_LETTER - spacepuffbar.com - October 01, 2025

The FDA issued a Warning Letter to spacepuffbar.com on October 24, 2025, after a website review identified the sale of unauthorized tobacco products. The main violation involved offering electronic nicotine delivery system (ENDS) products, specifically "Lost Mary MO5000 Disposable Vape [1-pack] – Ginger Beer" and "Lost Mary MO5000 Disposable Vape [1-pack] – Plum Rose Mint," which lacked the required premarket marketing authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these are considered "new tobacco products" that were not marketed before February 15, 2007, and did not receive necessary FDA clearance. As a result, these products are deemed adulterated and misbranded, rendering their marketing unlawful. spacepuffbar.com must provide a written response within 15 working days, detailing steps taken to cease the sale and distribution of these non-compliant products and outlining a plan for maintaining future adherence to the FD&C Act. Failure to comply could lead to further regulatory action.