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Gorilla Healing was cited for unlawfully selling unapproved and misbranded semaglutide and tirzepatide drugs through its website in violation of the Federal Food, Drug, and Cosmetic Act (sections 301(a), 301(d), and 505(a)). The company failed to obtain FDA approval before introducing these new drugs into interstate commerce and did not ensure proper drug labeling and regulatory compliance. These unapproved products posed inherent safety risks to consumers, as they may have been contaminated, counterfeit, contained inconsistent active ingredients, or included entirely different ingredients than represented.