On June 22, 2023, FDA announced it had issued warning letters to 189 retailers for selling unauthorized flavored tobacco products manufactured by Elf Bar and Esco Bar brands. This enforcement action comes on the heels of earlier aggressive action by FDA in its issuance of more than 570 warning letters to firms for the manufacture, sale, or distribution of unauthorized tobacco products from January 2021 through May 2023.

In its press release, FDA highlighted two studies recently published in the CDC’s Morbidity and Mortality Weekly Report.  The first study found that Elf Bar branded disposable e-cigarettes were the most popular disposable e-cigarette sold in the U.S. in 2022, and the second study showed thousands of e-cigarette exposure cases reported to the U.S. poison control centers in the past year, most of which were among kids younger than five years old.

For context, according to the most recent published annual report from the National Poison Data System (NPDS) in 2021, there were 2,527,332 exposures reported to poison centers. The five products most frequently reported were analgesics (11.2%), household cleaning substances (7.49%), cosmetics/personal care products (5.88%), antidepressants (5.61%) and sedatives/hypnotics/antipsychotics (4.73%). Tobacco products (all categories) were identified in 0.51% of exposure cases, with nicotine-containing e-cigarettes representing 0.21% of all exposures.  For children five years and younger, tobacco products accounted for 1.17% of exposures, with e-cigarettes representing 0.47% of all exposures.    

To date, FDA has authorized only twenty-three tobacco-flavored e-cigarette products and devices and has either refused or denied Premarket Tobacco Product Applications (PMTAs) for over 26 million products, the vast majority of which are non-tobacco flavored. Only e-cigarettes subject to PMTA Marketing Granted Orders are authorized to be sold in the United States.  Sales of unauthorized tobacco products are prohibited by the Food, Drug and Cosmetic Act and are subject to penalties, including warning letters, injunctions, product seizures, and/or civil monetary penalties.