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Botanical Be was warned for selling three unapproved new drug products—"Kuka Flex Forte," "Reumo Flex," and "Artri King Reforzado con Ortiga y Omega 3"—in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. FDA laboratory analysis confirmed that all three products contained undeclared diclofenac, a non-steroidal anti-inflammatory drug (NSAID) that poses serious health risks including cardiovascular events, gastrointestinal bleeding, and potentially fatal perforation, as well as dangerous drug interactions. The products were marketed as dietary supplements on the company's website despite containing a prescription-level active pharmaceutical ingredient, making them misbranded drugs under section 502 of the FD&C Act.