COFEPRIS suplemento alimenticio (Mexico)

Mexico COFEPRIS classification gates every downstream supplement decision — Suplemento Alimenticio (food framework, notification-based with Aviso de Funcionamiento and Aviso de Importación, structure/function claims only), Remedio Herbolario (herbal remedies with traditional-use claims, light registration), Medicamento Herbolario (herbal medicines with therapeutic claims, full pharmaceutical authorisation), Medicamento (pharmaceuticals). Misclassification is the dominant failure mode — Suplemento positioning with therapeutic claims triggers COFEPRIS enforcement and importer penalty. NOM-051-SCFI/SSA1-2010 (amended 2020) introduced the front-of-pack octagonal warning seal system — EXCESO CALORÍAS, EXCESO AZÚCARES, EXCESO GRASAS SATURADAS, EXCESO GRASAS TRANS, EXCESO SODIO plus precautionary legends for sweeteners and caffeine — applicable to supplements meeting per-100g/100ml thresholds (gummy supplements above sugar threshold, electrolyte products above sodium threshold). Mexican Spanish labelling is Mexico-specific — US Hispanic, Spain or other LATAM Spanish-language artwork is not Mexico-compliant. Mexican importer-of-record (Aviso de Funcionamiento holder) is mandatory for import clearance and is the legal responsible party for compliance and recall execution.