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Each obligation cites its official source (COFEPRIS / LGS / DOF). Informational content; does not constitute legal advice. EUM class: liquid dietary supplements (tinctures/oil-based solutions with CBD, full/broad spectrum/isolate). It is one of the highest-volume classes in the catalog.

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1. Classification

  • COFEPRIS category: dietary supplement.
  • SCIAN code (operating notice): 325412 — “Manufacture of pharmaceutical preparations” (used by COFEPRIS specifically for dietary supplements). *Source: gob.mx/cofepris.

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2. Sanitary procedure

  • No sanitary registration required. It operates under an Operating Notice (homoclave COFEPRIS-05-018), filed 30 days before starting operations; at no cost. A Sanitary Officer Notice also applies.
  • Legal basis: Art. 200 bis of the General Health Law. *Source: gob.mx/cofepris + LGS (LeyesBiblio).
  • Notice address: that of the manufacturing establishment (not offices/warehouses).

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3. Documentation that must be kept available

Name of each ingredient (and scientific name for plants) · monographs of uncommon substances · qualitative-quantitative formula · instructions for use · samples of the original label. Source: COFEPRIS.

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4. Labeling

  • Mandatory statement: “This product is not a medicine”. (Source: COFEPRIS.)
  • General labeling of prepackaged foods and seals: NOM-051-SCFI/SSA1-2010 (mod. 2020) applies — the seals/octagons system (“EXCESS…”) and precautionary statements according to nutritional profile. The exact cutoffs of each octagon (sugars, calories, sodium, fats per 100 g/100 ml) are in the Annex of NOM-051 (DOF 27/03/2020, Third Phase in force since 01/10/2025) — see NOM-051 Seals for the thresholds table.
  • General data: product name, ingredients, net content, batch, expiration date, responsible party’s data, country of origin.

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5. Advertising and PROHIBITED claims

A supplement may not claim that it: cures/prevents/relieves/treats diseases or physiological conditions · modifies proportions/physical or mental state · on its own covers nutritional requirements · has extraordinary properties · induces harmful eating habits. Advertising without a permit violates the sanitary law. *Legal basis: Art. 79 of the Regulation of the LGS on Advertising. Source: COFEPRIS.

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6. What of this the EUM system RESOLVES

  • Prohibited claims → the regulated-language guardrail (prohibitedClaims) blocks medicinal/therapeutic assertions in product content and in Ara (enforced in code, not at discretion).
  • Traceability and analysis → the Smart COA covers batch, analysis and verification (QR/CVV); it supports the technical documentation (formula/monographs are kept separately).
  • Label → Label Studio already generates barcode + QR + CVV (designer + templates); the automatic verification of NOM-051 seals and NOM fields is the compliance layer built on top (read this SoT).
  • “Not a medicine” statement → must be enforced as a mandatory label field for this class (pending in the engine).

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7. Sources

Last updated: 2026-08-01 · official sources cited above. Informational, does not constitute legal advice.