FDA WARNING_LETTER - Undisputed Worldwide - April 04, 2019

The FDA issued a Warning Letter to Double Cup Liquids for misbranded e-liquid products, specifically "Spritech Lemon Lime E-Juice Syrup" and "Pineapple Phantom Flavor E-Juice Syrup," sold on their website, https://doublecupliquids.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act.

The products are deemed 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 e-liquids imitate ingestible products, such as cough syrups (Actavis Prometh with Codeine and Hi-Tech Promethazine Hydrochloride and Codeine Phosphate Syrup) and beverages. Examples include similar bottle labeling, ingredient lists, graphic elements, and the use of "Syrup" in the product names. The outer packaging also resembles Styrofoam beverage cups with images of ice and dripping syrup, and the products have strong, sweet scents.

This misleading presentation poses a significant risk of accidental ingestion by adults and children, leading to severe harms like cardiac arrest, seizure, coma, and respiratory arrest, potentially fatal due to nicotine toxicity. For instance, ingesting less than half a teaspoon of a 6mg/mL, 60mL e-liquid could be fatal for an average two-year-old.

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