12 May 2023
By Erica Werner, Washington Post
The 10 affected companies cannot market or distribute the merchandise in the U.S., and retailers who sell them risk an enforcement action
The Food and Drug Administration on Friday blocked 10 companies from marketing or distributing 6,500 flavored e-liquid and e-cigarette products, part of its campaign against tobacco products being marketed to youths.
The agency said the product applications covered a variety of flavored e-cigarettes, including some with flavors such as Citrus and Strawberry Cheesecake, as well as Cool Mint and Menthol. The FDA said the companies in question did not provide sufficient evidence that marketing the products would be appropriate for public health.
“Today’s decision to deny approximately 6,500 products was based on the lack of scientific evidence provided in the applications,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products. “We will continue to ensure all new tobacco products undergo robust, scientific premarket evaluation to determine whether they meet the appropriate public health standard to be legally marketed.”
The head of the industry group representing vape shops disputed the FDA’s characterization, saying the agency would not offer clear guidance and just wanted to reject every application it received.
“It doesn’t really matter to the FDA what your scientific evidence is or anything else, they’re pretty much handing anyone out there an MDO (market denial order),” said Char Owen, president of the American Vapor Manufacturers Association.
She said some of the companies targeted Friday had just one or two storefronts and were genuinely trying to help adults stop smoking through the use of flavored products.
“It’s tough out here because you’re dealing with lives and businesses,” Owen said.
The FDA has been on a campaign against cigarettes and tobacco products such as Juul that could appeal to kids, but has been inundated with more and more applications to sell such goods.
The FDA said it’s received applications for more than 26 million new tobacco products since spring 2020, most for e-cigarette products. The regulator has reviewed and taken action on more than 99 percent of them, it said.
The FDA named eight of the 10 companies it had taken action against Friday, saying it was declining to name two of them to protect potentially confidential consumer information.
The companies are: Imperial Vapors LLC, Savage Enterprises, Big Time Vapes, SWT Global Supply Inc., Great Lakes Vapor, DNA Enterprise LLC dba Mech Sauce, Absolute Vapor Inc., ECBlend LLC.
The FDA move not only blocks the companies from marketing or distributing the merchandise in the U.S., the agency said that retailers who sell them risk an enforcement action.
In most cases, representatives of the companies declined to comment or did not respond to requests for comment.