FDA WARNING_LETTER - EZ Fumes - April 04, 2019

The FDA Center for Tobacco Products issued a Warning Letter to Mike Makhani of ezfumes.com after reviewing their website and determining that Double Cup Liquids Spritech Lemon Lime E-Juice Syrup and Double Cup Liquids Pineapple Phantom Flavor E-Juice Syrup e-liquid products are offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The FDA determined these e-liquid products are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because their labeling and/or advertising are false or misleading. The investigation revealed the products' labeling and advertising cause them to appear ingestible, imitating cough syrups like Actavis Prometh with Codeine and Hi-Tech Promethazine Hydrochloride and Codeine Phosphate Syrup, and also resembling beverages. Examples include similar bottle features, ingredient lists, "Syrup" terminology, and packaging shaped like Styrofoam beverage cups with "Double Cup" and "Who Got The Juice" terms. The e-liquids also have strong, sweet scents.

The FDA states that adults and children are at risk from ingesting liquid nicotine, which can cause severe harms including death, seizure, coma, and respiratory arrest. Given the products' nicotine content (up to 6mg/mL with 60mL volume), even small ingestions could be