Washington, DC - The U.S. Food and Drug Administration today issued four new warning letters to manufacturers and retailers for selling e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products, such as cereal, soda and pancakes. One of the companies receiving a warning letter was also cited for illegally selling the product to a minor. The warning letters follow actions taken last week by the FDA and the Federal Trade Commission against 13 other makers and sellers of nicotine-containing e-liquids that look like juice boxes, candy or cookies.
“Companies putting children at risk or enticing youth use are on notice. If you target kids, then we’re going to target you,” said FDA Commissioner Scott Gottlieb, M.D. “These tactics also hurt the e-cigarette industry and those seeking to quit smoking. 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 youth at risk in this fashion. The actions we’ve taken over the last several weeks under our new Youth Tobacco Prevention Plan are just the opening salvo in what’s going to be a sustained campaign to address all aspects of youth access and appeal of tobacco products, and in particular, e-cigarettes.”
The products outlined in the new warning letters, and being sold through multiple online retailers, include: “Frank ‘N Vape,” which resembles Franken Berry cereal; “Chill Purple Grape,” which resembles a grape soda can; and “Unicorn Cakes,” which includes images and cartoons of pancakes, a strawberry beverage and unicorns eating pancakes, similar to graphics and images from the “My Little Pony” television and toy franchise.
The warning letters stem from investigations that began in late 2017 of tobacco product labeling and advertising that cause the tobacco products to imitate food products, particularly those that are marketed toward, and/or appealing to, children. The products are considered misbranded in violation of the Federal Food, Drug, and Cosmetic Act because their labeling and/or advertising imitating kid-friendly foods is misleading. The FDA has requested responses from each of the companies within 15 working days on how they intend 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 (ENDS) 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 e-liquids, including death from cardiac arrest, as well as seizure, coma and respiratory arrest.
Additionally, more than 2 million middle and high school students were current users of e-cigarettes and other ENDS in 2016, with flavor availability being one of the top reasons for use. This use by children and teens is especially concerning to the FDA because of evidence that youth exposure to nicotine affects the developing brain and may rewire it to be more susceptible to nicotine addiction in the future. That’s why combating youth use of nicotine-containing products is a core priority and the guiding principle behind the FDA’s Youth Tobacco Prevention Plan. In April, for example, the agency conducted a nationwide blitz of brick-and-mortar and online retailers, and issued warning letters to businesses that sold JUUL brand products to minors. The agency also sent a letter to JUUL Labs requiring the company to submit important documents to better understand the reportedly high rates of youth use and the particular youth appeal of these products.
As part of the FDA’s comprehensive plan on nicotine and tobacco regulation announced last summer, the agency is also exploring clear and meaningful measures to make tobacco products less toxic, appealing and addictive with an intense focus on youth. This could include measures on flavors/designs that appeal to youth, child-resistant packaging and product labeling to prevent accidental child exposure to liquid nicotine. Additionally, the agency plans to explore additional restrictions on the sale and promotion of ENDS to further reduce youth exposure and access to these products. The FDA has also expanded “The Real Cost” public education campaign with messages focused on preventing youth use of e-cigarettes and will launch a full-scale campaign this fall.