“E-liquids,” as they are called, are typically a mix of nicotine, flavors and other ingredients. Ingesting them can cause nicotine poisoning — and even death — for small children, experts say. The government cited a recent analysis that found between January 2012 and 2017 there were more than 8,200 e-cigarette and liquid nicotine exposures among children younger than 6.
The products being targeted include: “One Mad Hit Juice Box,” which resembles children’s apple juice boxes, such as Tree Top-brand juice boxes; “Vape Heads Sour Smurf Sauce,” which looks like WarHeads candy; “V'Nilla Cookies & Milk,” which resembles Nilla Wafer and Golden Oreo cookies; “Whip’d Strawberry,” which resembles Reddi-wip dairy whipped topping, and “Twirly Pop” -- which the FDA said, “not only resembles a Unicorn Pop lollipop but is shipped with one.”
The warning letters cover eight different products. Not all e-liquids contain nicotine; the government action Tuesday targeted only items that have nicotine.
The agencies told the companies that the products are “misbranded” under the Federal Food, Drug, and Cosmetic Act “because their labeling and/or advertising imitating kid-friendly foods is false or misleading.” In joining the FDA, the FTC cited its authority under the Federal Trade Commission Act, which prohibits unfair or deceptive advertising.
The companies have 15 days to respond on how they will change the labels and packaging of the products. Failure to make changes “may result in further action such as seizure or injunction,” the agencies warned.
FDA commissioner Scott Gottlieb, in a telephone briefing with reporters, said that it would be hard for “any reasonable person” to examine the products and not conclude that “they are deliberately being packaged and marketed in a way that is designed to not only be appealing to kids” but also to confuse them by mimicking items they frequently consume.
He added that he planned to take more action against entities selling tobacco products to youth or marketing them in “this egregious fashion.”
Acting FTC chairman Maureen K. Ohlhausen warned, “Nicotine is highly toxic, and these letters make clear that marketing methods that put kids at risk of nicotine poisoning are unacceptable.”
Several of the businesses that got the letters also were cited for illegally selling the products to minors, the officials said.
Mitch Zeller, director of the FDA's Center for Tobacco Products, said that the agency has not seen any deaths associated with these specific products, though the agency has been told of one death of a youth exposed to a different e-liquid product.
“Frankly, we are trying to nip this in the bud,” he said, adding that just a very small amount of liquid nicotine can kill or sicken a young child.
Nicholas Warrender, owner of Lifted Liquids, a Wisconsin manufacturer of e-liquids, got one of the warning letters — about the company's Vape Heads Sour Smurf Sauce e-liquid, which had packaging that resembled WarHeads candy. But Warrender said that he recognized the problem last year and changed the design in November to feature a man in a beard, which he said signaled adult use of the product.
Warrender said he has been trying to contact the FDA but that reaching the agency was like “trying to pull teeth out of a chicken.” He said he was only trying to help adults stop smoking regular cigarettes.
Cosmic Fog Vapors, a California manufacturer, said in an email that in response to FDA concerns, it stopped selling Whip’d Strawberry liquid.
FDA's Zeller was asked on the call whether the agency was sure the products were still being marketed with the offending packaging. He said, without mentioning any specific company, that the government had evidence of such marketing within the last six months.
Greg Conley, president of the consumer group American Vaping Association, said he didn't have a lot of sympathy for companies that “rip off the trademark of an existing product,” referring to packaging that resembled children's drinks and snacks. “That's not responsible marketing,” he added.
Gottlieb said the 13 warning letters were part of the FDA's new Youth Tobacco Prevention Plan. Last week, the agency announced a nationwide undercover “blitz” to crack down on the sale of e-cigarettes — particularly the hugely popular Juul products — to children and teenagers by regular and online retailers. The agency said it had uncovered dozens of violations of the law and issued 40 warning letters related to Juul e-cigarettes.
Juul e-cigarettes resemble a USB flash drive but contain high levels of nicotine. They come in such flavors as mango, creme brulee and cool mint, and their emissions can be virtually invisible, making it difficult for teachers to spot and stop use of the product.
Gottlieb, as part of a comprehensive tobacco policy announced last summer, pledged to reduce the level of nicotine in conventional cigarettes to minimally addictive levels and said he believes e-cigarettes could be an important tool in helping adult smokers switch to less harmful nicotine-delivery products. The policy also delayed for several years a requirement that e-cigarette makers get agency approval for their products. Health groups have sued the agency over the delay.
Gottlieb said last week that while e-cigarettes could be helpful for addicted adults, the viability of the products “is severely undermined if those products entice youth to start using tobacco and nicotine.”