The majority of the violations described in the warning letters were for the illegal sale of five e-cigarette products: Vuse, Blu, Juul, MarkTen XL and Logic, the agency said. These five brands currently make up more than 97% of the U.S. market for e-cigarettes, according to the FDA.
The agency gave each of the five e-cigarette companies 60 days to submit plans describing how they will address youth access and use of their products. If they fail to do so, or if the plans do not appropriately address this issue, the FDA said it will consider whether it would be appropriate to revisit the current policy on making these products available without a marketing order from the agency. That could mean requiring these brands to remove some or all of their flavored products from the market until they receive premarket authorization and otherwise meet all of their obligations required by law.
Similarly this past spring, the FDA along with the Federal Trade Commission (FTC) issued warning letters to several manufacturers, distributors and retailers for selling e-liquids with labeling that they said could resemble kid-friendly food products.
Some of these e-liquids (used in electronic cigarettes for vaping) resemble juice boxes, candy or cookie packages or use cartoon imagery, FDA officials said in a statement released May 1. Several of the companies that received warning letters, some for selling their products via the internet, were also cited for illegally selling the products to minors, the agencies said.
In August, the FDA said 17 of the manufacturers, distributors and retailers that had received warning letters from the agency in May had stopped selling e-liquids with labeling or advertising that evoked kid-friendly foods.