Most e-cigarettes sold in the United States are imported (mostly from China). FDA has allowed these products to be imported and sold despite them lacking FDA authorization. Any and all e-cigarettes sold in the US without premarket authorization are illegal, although FDA has used its “enforcement discretion” to allow many to remain on the market. FDA allowed some that were on the market before 2016, when FDA issued its “deeming” rule taking jurisdiction over e-cigarettes, and others to be sold while FDA considers their premarket tobacco product application submitted before September 2020 (July 2022 for synthetic nicotine). But many others, including kid-popular brands like Elf Bar, Myle, Stik, Smok and Fume, don’t qualify for any of these exemptions.
Elf Bar has become one of the most popular products among kids, and provides walloping doses of nicotine salts. At 50 mg/mL nicotine and 5000 puffs per device, one Elf Bar BC5000 really packs a punch.
Last week (May 17, 2023), FDA finally acted to clamp down on some of these products, by asking Customs and Border Enforcement to block them at ports of entry, in its Import Alert 98-06, “Detention Without Physical Examination of New Tobacco Products Without Required Marketing Authorization.” FDA did this through the Commercial Targeting and Analysis Center, which facilitates information sharing among participating government agencies to prevent, deter, interdict and investigate violations of U.S. import and export laws. FDA issued a “red list” including these and other products from China and South Korea that will be blocked at the border.
Parents Against Vaping e-cigarettes (PAVe) deserves credit for pressing Customs and Border Protection, FDA and Congress to block these illegal products. The red list needs to keep growing as FDA clears the backlog of pending applications for other e-cigarettes by the end of the year, as it has promised to do.
Stanton Glantz blog 