FDA recently announced the issuance of warnings letters to 189 retailers found to be selling unauthorized tobacco products, specifically Elf Bars and Esco Bars.

As a result of the passage of the Family Smoking Prevention and Tobacco Control Act (TCA), new tobacco products may only be sold in the U.S. if they have received marketing authorization from FDA. Products with pending premarket applications are currently subject to FDA’s enforcement discretion. According to FDA, Elf Bars and Esco Bars have neither received marketing authorization, nor have applications pending with the agency, and therefore cannot be lawfully sold.

FDA indicates that it targeted retailers of these two brands after reviewing data showing that these are the most popular brands in the United States, with high youth appeal.  These electronic nicotine delivery systems (ENDS) are sold in a variety of fruit and candy flavors. In contrast, FDA has only authorized a few tobacco-flavored ENDS through the premarket authorization pathway.

As we previously reported, FDA is ramping up its efforts to enforce against unauthorized vapor products. This latest batch of letters has been issued to retailers in dozens of U.S. states and were the result of a “retailer inspection blitz.” It appears from at least some of the letters that the agency inspected retailers’ websites, rather than making in-person visits. The letters warn retailers that it is their responsibility to ensure that the tobacco products they offer, plus all related labeling and advertising on their websites or other media, are in compliance with the TCA. Failure to address the violations could lead to civil money penalties, seizure, and/or injunction. Retailers have 15 days to respond to the agency with a plan of correction.

The press release also notes that the agency issued import alerts for Elf Bar and Esco Bar. Import alerts allow FDA agents at the borders to detain a product without physically examining it at the time of entry. Such detainment places the burden on the importer to prove that the products may be lawfully sold in the U.S. Given the thousands of retailers across the country that are knowingly or unknowingly selling unauthorized products, import controls may be the best way to impact this segment of the market meaningfully.

It will be interesting to see if this enforcement “blitz” gathers momentum. It is notable that FDA’s efforts are now supported by a newly-funded Center for Rapid Surveillance of Tobacco (CRST). If it functions as intended, the CRST will provide the agency time-sensitive data collection, analysis, and reporting to help inform enforcement efforts.