FDA WARNING_LETTER - Naturista Store LLC - April 15, 2025

The FDA issued a Warning Letter to Andy Garcia following a website review (Dec 2024 - Feb 2025) of naturistastore.com, identifying the product “ADVANCE KING” as an unapproved new drug and a misbranded drug. Laboratory analysis confirmed “ADVANCE KING” contains undeclared dexamethasone, diclofenac, and methocarbamol. These ingredients classify the product as a drug under section 201(g)(1) of the FD&C Act due to its intended use for disease treatment, and as a new drug under section 201(p) because it is not generally recognized as safe and effective. Furthermore, since diclofenac and dexamethasone were approved as drugs before being marketed as dietary supplements, “ADVANCE KING” is excluded from the dietary supplement definition under section 201(ff)(3)(B)(i). The product is misbranded under section 502(a) because its labeling is misleading by failing to declare these potent drug ingredients, which pose serious health risks. The FDA also expressed concern about other similarly named products sold on the website. The firm must respond within fifteen working days with specific corrective actions and documentation to prevent recurrence of violations, or face potential legal action including seizure and injunction.