Dive Brief:

• The U.S. Food and Drug Administration has issued warning letters to Shenzen Innokin Technology Co. and Breeze Smoke, makers of Esco Bars and Breeze vape products, respectively, saying they are illegally importing and/or distributing unapproved products in the U.S., according to a Thursday press release. 
• The companies have 15 days to stop distributing and selling these products, unless they get authorization orders from the FDA before that. If they don’t address the issues, then further steps may be taken, including an injunction, seizures or civil and monetary penalties. 
• This comes about a week after the FDA placed a number of disposable e-cigarette products, including Esco Bar products and Elf Bars among others, on an import red list. This allows the FDA to detain such products when they’re being brought into the country.

Dive Insight:

Sales of flavored e-cigarettes have actually boomed in the wake of the FDA banning flavoring in vaping devices due to a loophole. Companies like Breeze and Esco tend to use either no nicotine or synthetic nicotine, which they believed exempted them from FDA oversight, according to New York Times reporting. 

With Esco Bar and Breeze products among the more popular brands of disposable vapes, according to the FDA, the agency is turning its attention toward this area of the market.

As the FDA continues working through its backlog of applications, a majority of which are for e-cigarette products, more vaping products will either receive authorization or denial orders. Currently, the FDA has approved 23 e-cigarette products for sale in the U.S., mostly for Njoy and Vuse products.

Former market leader Juul is still awaiting the FDA’s decision on its appeal of marketing denial orders issued for its products in June 2022.