April 4, 2019
"By deliberately making or selling e-liquid products that look like prescription cough syrups, these companies are putting adults and children at risk of nicotine poisoning. The products are being designed in ways that make them falsely appear to be ingestible. These actions are egregious. 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,” said FDA Commissioner Scott Gottlieb, M.D. “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. The FDA will continue to crack down on misleading labeling and advertising and illegal and dangerous e-liquids that may entice youth or put consumers at risk."
Today, the U.S. Food and Drug Administration issued warning letters to Undisputed Worldwide and EZ Fumes for manufacturing, selling and/or distributing nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause the products to misleadingly appear to be ingestible by imitating prescription cough syrups.
The action is part of the agency’s ongoing effort to protect kids from tobacco products, including the risk to both children and adults of poisoning by nicotine-containing e-liquid products that misleadingly appear to be ingestible. The FDA has previously issued warning letters, many in collaboration with the Federal Trade Commission, to makers and sellers of nicotine-containing e-liquids that looked like food products, such as juice boxes, candy and cereal.
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 cause them to appear to be ingestible by imitating 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-liquid products also cause them to appear to be ingestible as food.
Adults and children are at risk of poisoning by nicotine-containing e-liquid products that appear to be ingestible. An adult might unknowingly consume these products that appear to be ingestible, which could result in ingesting toxic amounts of liquid nicotine. Likewise, nicotine exposures of these sorts are extremely problematic and could be fatal for children. For both adults and children, exposure to the nicotine in the e-liquid product, even in relatively small amounts, could result in acute toxicity. Child poisonings due to the ingestion of liquid nicotine have recently increased substantially. 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.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.