FDA WARNING_LETTER - R&D On Del Prado Inc, d/b/a Purple Rain DP Vape & Smoke - October 01, 2025

On October 2, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to R&D On Del Prado Inc, operating as Purple Rain DP Vape & Smoke. Following a review of inspection records, the FDA determined the company was selling and distributing unauthorized e-liquid products in the United States.The primary violation involved marketing a "new tobacco product," specifically "Pod Juice Raz Eliquid Series Jolly Watermelon 6mg/100ml," without the required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), e-liquid products, including those containing nicotine from any source, are considered tobacco products. These products require premarket authorization if they were not commercially marketed in the U.S. before February 15, 2007, or are modified products introduced thereafter. The FDA found Purple Rain DP Vape & Smoke"s product lacked this essential marketing order, rendering its sale unlawful and deeming it both adulterated and misbranded.To address these violations, the FDA requires R&D On Del Prado Inc to take prompt action, including immediately ceasing the sale and distribution of all unauthorized tobacco products. The company must submit a detailed written response within 15 working days, outlining specific actions taken to discontinue the violative sales, the dates of these actions, and a comprehensive plan for maintaining ongoing compliance with the FD&C Act and its implementing regulations. Non-compliance could lead to further regulatory enforcement, such as civil money penalties or product seizure.