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Prime Vitality, Inc. operating as Prime Peptides was cited for selling unapproved new drugs—specifically Semaglutide and Retatrutide—in violation of the Federal Food, Drug, and Cosmetic Act. Despite labeling the products as "for research purposes only" and "not for human consumption," the company's website and social media made numerous claims establishing these products were intended for human therapeutic use, including reducing cardiovascular events and improving insulin resistance. The FDA determined these products met the legal definition of drugs because they were marketed to prevent, treat, or cure disease conditions and affect body structure or function, yet lacked required FDA approval before being introduced into interstate commerce.