> ## Documentation Index
> Fetch the complete documentation index at: https://docs.extractoseum.com/llms.txt
> Use this file to discover all available pages before exploring further.

# Dietary supplement

> Compliance for dietary supplements with cannabinoids in Mexico: SCIAN 325412, COFEPRIS-05-018 notice, 'not a medicine' statement, NOM-051, prohibited claims.

> 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.

***

## 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.

## 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).

## 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.*

## 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](sellos-nom051.md) for the thresholds table.
* General data: product name, ingredients, net content, batch, expiration date, responsible party's data,
  country of origin.

## 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.

## 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](../smart-coa.md)** 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).

## 7. Sources

* COFEPRIS — Dietary supplements: [https://www.gob.mx/cofepris/acciones-y-programas/suplementos-alimenticios](https://www.gob.mx/cofepris/acciones-y-programas/suplementos-alimenticios)
* LGS (Art. 200 bis, Art. 245 fracc. V): [https://www.diputados.gob.mx/LeyesBiblio/pdf/LGS.pdf](https://www.diputados.gob.mx/LeyesBiblio/pdf/LGS.pdf)
* NOM-051-SCFI/SSA1-2010 (labeling/seals): DOF 27/03/2020 (amendment: seals system).
* Regulation of the LGS on Advertising (Art. 79): DOF/LeyesBiblio —

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