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Spirochaete Research Labs distributed four unapproved OTC stimulant drug products under the "Atomic Rhino" brand (including "Red Line" and "Megaton" variants) in violation of the Federal Food, Drug & Cosmetic Act. The products were deemed unapproved new drugs and misbranded because they made drug claims on labeling, websites, and social media indicating intended use as stimulants affecting body structure or function, yet lacked the required FDA approval. The company marketed these smelling salts products through their website (atomicrhino.com) and Instagram with claims targeting professional athletes, establishing intent to use them as drugs without obtaining a New Drug Application approval.