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Innovative Formulations, LLC dba Insane Labz distributed "Wake the Dead Smelling Salts," an unapproved over-the-counter stimulant drug product sold through their website and Amazon marketplace, in violation of Federal Food, Drug & Cosmetic Act sections 505(a) and 502(ee). The product was determined to be a drug based on labeling claims indicating its intended use as a stimulant and its effects on body function, yet it lacked FDA approval as a new drug and was misbranded. The company introduced and delivered the product for introduction into interstate commerce without obtaining the required new drug approval, making its distribution illegal under the FD&C Act.