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Healthwest Minerals, Inc. dba Mt. Capra Products was cited for marketing a Goat Milk Formula Recipe Kit as an infant formula without proper FDA authorization, violating the Federal Food, Drug, and Cosmetic Act. The company's website and social media representations claimed the product "mimics breast milk," followed infant formula guidelines, and served as a "DIY alternative to commercial infant formula," thereby meeting the legal definition of infant formula under section 201(z) of the Act. The FDA determined that by marketing the kit as a suitable substitute for human milk and complete infant food, the company failed to comply with infant formula regulations and safety requirements established under the 1980 Infant Formula Act.