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HomeGlossaryCOFEPRIS suplemento alimenticio (Mexico)
Compliance

COFEPRIS suplemento alimenticio (Mexico)

Mexico COFEPRIS Supplement Classification and NOM-051 Discipline · Suplemento Alimenticio · NOM-051 · Remedio Herbolario · Medicamento Herbolario

In short

Term — Mexican suplemento alimenticio classification under COFEPRIS: mexico COFEPRIS framework — Suplemento Alimenticio (notification, structure/function claims), Remedio Herbolario (light registration with traditional-use claims), Medicamento Herbolario (full pharmaceutical authorisation), with NOM-051-SCFI/SSA1-2010 octagonal warning seal system (EXCESO AZÚCARES/SODIO/CALORÍAS/GRASAS SATURADAS/GRASAS TRANS) and mandatory Mexican Spanish labelling.

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.

Regulatory anchors
  • NOM-051-SCFI/SSA1-2010
  • Reglamento de Control Sanitario de Productos y Servicios
  • Ley General de Salud
Where this term comes up
Dietary Supplements
How V5 handles it
Score your compliance gap — then download the validation pack.
A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.
Labels — designed, approved, checked and printed in one place.
Many plants run a separate label tool beside their production records, so label versions drift and reprints go unrecorded. In V5 the label designer, approval, printing and the recipe's label details sit with the production record: the barcode scheme set on a recipe is checked when the operator packs, and the approved artwork revision is printed on the batch record. Printer connections are configured per workspace.
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
Related terms
Claims Substantiation
Software that covers COFEPRIS suplemento alimenticio (Mexico)
V5 Ultimate Dietary Supplements
Written for supplement contract manufacturers and brand owners tired of surviving FDA 483s on paper.
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