More warning letters sent to e-cigarette manufacturers

April 4, 2019

On the heels of yesterday’s emergency announcement from the Food and Drug Administration regarding a possible connection between e-cigarettes and serious adverse reactions, including seizures, the FDA is now warning e-cigarette manufacturers to stop selling specific products that resemble prescription cough syrup. “Child poisonings due to the ingestion of liquid nicotine have recently increased substantially,” said FDA. “Severe harms can occur in small children from ingestion of liquid nicotine, including death from cardiac arrest, as well as seizure, coma and respiratory arrest.”

Two e-cigarette vendors have been issued warnings not to sell or distribute vaping products that are marketed to mimic cough syrup. The advertisements, warns FDA, are misleading and could lead to ingestion of the chemicals contained in e-cigarettes – an issue the FDA and others are looking at very closely, after an increase in seizures among e-cigarette users, although they have not been deemed the actual cause. More research and information are needed to determine the exact cause.

Warning letters were delivered to Undisputed Worldwide and EZ Fumes for making and distributing the following products:

· Double Cup Liquids Spritech Lemon Lime E-Juice Syrup, marketed to resemble Actavis Prometh with Codeine

· Double Cup Liquids Pineapple Phantom E-Juice Syrup, market to resemble Hi-Tech Promethazine Hydrochloride and

"These actions are egregious,” said FDA Commissioner Scott Gottlieb. “The products not only use labeling with statements, representations and graphical elements that imitate legitimate cough medications, but they also have a list of ingredients that mimics a drug facts label. Efforts to encourage the innovation of novel and potentially less harmful products such as e-cigarettes for currently addicted adult smokers will be severely undermined if bad actors put the public, and kids in particular, at risk in this outrageous fashion.” 

About the Author

Valerie J. Dimond | Managing Editor

Valerie J. Dimond was previously Managing Editor of Healthcare Purchasing News.