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FDA warns companies marketing drug-imitating e-liquids

The Food and Drug Administration issued warning letters Thursday to Undisputed Worldwide and EZ Fumes for manufacturing, selling and/or distributing nicotine-containing e-liquids with misleading labeling and/or advertising that imitate prescription cough syrup.

Federal regulators said these products put both children and adults at risk of e-liquid poisoning because they appear to be ingestible when they are not.

For both adults and children, exposure to the nicotine in an e-liquid product, even in relatively small amounts, could result in acute toxicity, according to the FDA. Even more severe harm can occur in small children from ingestion of liquid nicotine, including death from cardiac arrest, as well as seizure, coma, and respiratory arrest.

The products identified in the warning letters include: “Double Cup Liquids Spritech Lemon Lime E-Juice Syrup” and “Double Cup Liquids Pineapple Phantom E-Juice Syrup” e-liquid products with labeling and/or advertising that imitate the prescription cough syrup products Actavis Prometh with Codeine and Hi-Tech Promethazine Hydrochloride and Codeine, respectively. The labeling and/or advertising of these “Double Cup” e-liquids also cause them to falsely appear to be ingestible as food.

FDA has requested that each company respond within 15 working days to inform the agency of the specific actions taken to address its concerns. The warning letters also state that failure to correct violations may result in further action such as seizure or injunction.

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