SILVER SPRING, Md. – In a sweeping move to reinforce its public statements on preventing underage sales of electronic cigarettes—and a move that may potentially affect product flavors—the U.S. Food and Drug Administration (FDA) has issued 1,300 warning letters and fines to an undisclosed number of retailers as a result of a summerlong undercover operation at the store level, the agency announced.
The majority of the violations 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. FDA officials said it 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 under the law.
Flavor has been one of the central concerns of the FDA, which has publicly expressed concerns about both flavors and packaging that resemble products such as candy or desserts.
“I believe certain flavors are one of the principal drivers of the youth appeal of these products,” said Scott Gottlieb, commissioner of the Silver Spring, Md.-based agency, in a statement released Sept. 12. “While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids.”
In addition to the 1,300 letters and fines, the FDA this past spring issued 12 warning letters to other online retailers that are selling what the agency called misleadingly labeled or advertised e-liquids “resembling kid-friendly food products such as candy and cookies.”
Those products were the subject of agency action in May and, for the most part, are no longer being sold with the labeling and advertising by the companies that received the May warning letters. Agency officials, however, said the retailers receiving warning letters Sept. 12 are still advertising and selling the products in question. Several of these retailers were also cited for illegally selling the products to minors, the agency said.
In addition to these new actions, the FDA had previously issued more than 60 warning letters and fines to businesses that allegedly sold Juul-branded products to minors stemming from another enforcement blitz this past spring. The agency also recently sent letters to Juul Labs, San Francisco, and several other companies requiring them to submit documents to better understand the reportedly high rates of youth use and the particular youth appeal of their products. The FDA is also investigating whether manufacturers introduced certain e-cigarette products to the market after Aug. 8, 2016, and may be subject to enforcement for marketing those products without premarket authorization, the agency said.