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Pico IV Inc. was cited for marketing and selling "Pico IV," an unapproved intravenous CBD drug product in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company falsely claimed the injectable product qualified as a dietary supplement despite the FD&C Act definition limiting dietary supplements to products intended for ingestion, when in fact the intravenous product met the definition of a drug due to its intended therapeutic use. The FDA emphasized that injectable drug products pose particular public health risks because they bypass the body's natural defenses against toxins and microorganisms, potentially causing serious and life-threatening conditions.