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Native Salts LLC distributed "N, Native Salts," an unapproved OTC stimulant drug product in violation of federal law. The FDA identified two primary violations: the product was an unapproved new drug introduced into interstate commerce under section 505(a) of the FD&C Act, and it was misbranded under section 502(ee) of the FD&C Act. The company's website and social media marketing made claims demonstrating intended use as a stimulant, including statements that the product provides "instant alertness," improves focus and energy, and produces an "energizing and alert sensation"—all of which positioned the product as a drug requiring FDA approval before distribution.