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On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the...more
In 2016, the U.S. Food and Drug Administration (FDA) began regulating all manufacturers, retailers, and distributors of electronic nicotine delivery systems (ENDS) with following the agency’s promulgation of the Final Deeming...more
In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more
In September, the U.S. Food and Drug Administration (FDA) issued two new rounds of warning letters to online retailers, manufacturers, and distributors for reportedly selling or distributing unauthorized e-cigarette products....more
On July 10, 2019 Ned Sharpless, M.D., the Acting Commissioner of the Food and Drug Administration (FDA) issued a statement reaffirming FDA’s commitment to overseeing the manufacturing, marketing, and sale of e-cigarettes. The...more
High-profile cases of exploding e-cigarettes and vaping devices have made front-page news in recent months. In January 2019, a Texas man died after a vape pen he was using exploded in his face. This followed a similar death...more
The FDA and FTC jointly issued thirteen (13) warning letters to companies involved in the manufacture, distribution and retail of certain e-liquid products to be used in connection with e-cigarettes which feature packaging...more