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Distinctive USA LLC was found to be offering electronic nicotine delivery system (ENDS) products for sale through their website without obtaining required premarket authorization from the FDA. The company's tobacco products, which contain nicotine from any source, were determined to be in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. The FDA's enforcement action reflected expanded regulatory jurisdiction that took effect in 2022, which extended FDA authority over all nicotine-containing products regardless of whether the nicotine was derived from tobacco or other sources.