SILVER SPRING, Md., Nov. 29, 2018 /PRNewswire/ -- 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.
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.
This new warning letter is part of series of actions over the past several months to address an epidemic growth in the use of e-cigarettes by children and disturbing evidence of illegal sales of e-cigarettes to youth. These actions include steps to target the kid-friendly marketing and appeal of these products. This month, the FDA outlined a series of proposed new steps to directly confront and reverse rates of youth e-cigarette use, including: a plan to revise the FDA's compliance policy for premarket review requirements for most flavored e-cigarette products that would limit their sales to age-restricted, in-person locations and online with heightened age verification processes, and stop the sale of e-cigarette products marketed to youth. The FDA also intends to advance rules to ban the use of flavors in combustible tobacco products, including menthol in cigarettes.
The agency previously announced a series of critical and historic enforcement actions in September that included issuing more than 1,300 warning letters and fines to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores this summer – the largest coordinated enforcement effort in the FDA's history.
The FDA also launched "The Real Cost" Youth E-Cigarette Prevention Campaign in September. This is a new, comprehensive effort targeting nearly 10.7 million youth, aged 12-17, who have used e-cigarettes or are open to trying them. The new campaign features hard-hitting advertising on digital and social media sites popular among teens, as well as posters with e-cigarette prevention messages in high schools across the nation.
For more information:
E-Liquids Misleadingly Packaged as Food Products
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.
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SOURCE U.S. Food and Drug Administration