The U.S. Food and Drug Administration today issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products, such as cereal, candy and peanut butter and jelly. The action is part of the agency’s ongoing effort to protect kids from tobacco products.
Electric Lotus ‒ a manufacturer, distributor and retailer, based in Redlands, California ‒ was also cited for illegally selling products to a minor, for failing to list its products with the FDA and for selling e-liquids without the required FDA premarket authorization. The warning letter follows actions taken this summer by the FDA—many in partnership with the Federal Trade Commission—against 17 other makers and sellers of nicotine-containing e-liquids that looked like juice boxes, candy, and cookies and had the potential to be confused with these ordinary products by a child.
“We’re seeing too many cases where companies are designing e-liquid products in packages that resemble children’s food items and this sort of egregious marketing can lead to accidental ingestion of potentially lethal doses of nicotine by young kids. There’s no excuse for this sort of packaging and we’ll continue to target these products and the companies that market them,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA will also continue to implement new steps to make sure children aren’t started down a path to nicotine addiction and tobacco use. Those include actions to target those who design products in ways that are clearly marketed to appeal to children. No child should be using any tobacco product. We’ll continue to hold industry accountable to ensure these products aren’t being marketed to, sold to or used by kids.”
The products outlined in the new warning letter, include, for example: “Cereal Treats Crunch,” which resembles Cinnamon Toast Crunch cereal products; “Cereal Treats Loopz,” which looks like Froot Loops cereal; “Cereal Treats Charms,” which resembles Lucky Charms cereal products; and “Cereal Treats Krispies,” which looks like Rice Krispies Treats cereal.
Many of these products have cartoon characters on their labeling and/or advertising. Additional products include those such as “Jammin Berries Peanut Jamz Raspberry,” which resembles Smucker’s Goober Strawberry PB&J Stripes and “Dripflavors Strawberry Lemonade Salt,” which looks like Life Savers candy products.
No premarket authorization
All of the products identified in the warning letter are adulterated and misbranded because they do not have required FDA premarket authorization. Additionally, the products are not subject to the FDA’s current compliance policy regarding enforcement of the premarket authorization requirements because they were introduced after Aug. 8, 2016 – the effective date of the final deeming rule.
The products are also misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because their labeling and/or advertising imitate kid-friendly foods, which is misleading. Some of the products are also misbranded because the company failed to include these products in a product list as required under the FD&C Act.
The FDA has requested that the company respond within 15 working days to describe how it intends to address the agency’s concerns. Failure to correct violations may result in further action such as seizure or injunction. In addition, misbranded or adulterated products imported into the United States are subject to detention and refusal of admission.
The continuing rise in popularity of electronic nicotine delivery systems such as e-cigarettes has coincided with an increase in calls to poison control centers and visits to emergency rooms related to e-liquid poisoning and other liquid nicotine exposure by children younger than six, according to a recent analysis of National Poison Data System data. Severe harm can occur in small children from exposure to or ingestion of nicotine contained in e-liquids, including death from cardiac arrest, as well as seizure, coma and respiratory arrest.