Overview
The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), under the Ministry of Health (MoH), regulates food, beverages, and food supplements (Suplementos Alimenticios). The regulatory framework is mainly based on the General Health Law (Ley General de Salud), the Regulation for Sanitary Control of Products and Services (Reglamento de Control Sanitario de Productos y Servicios – RCSPyS), and applicable Normas Oficiales Mexicanas (NOMs):
- NOM‑051: Labeling requirements for pre‑packaged food and non‑alcoholic -ICONS beverages.
- NOM‑251: Hygiene practices for food processing. -ICONS
Food supplements are defined in Article 215, Section V of the General Health Law as products intended to supplement dietary intake and must not include therapeutic or medicinal claims. Companies must comply with applicable COFEPRIS requirements for food supplements, food products, and beverages, including labeling, hygiene, ingredient, and commercialization provisions under Mexican regulations and NOM standards.
Understanding the Regulatory Landscape in Mexico
Regulation of food, beverages, and food supplements involves multiple authorities:
COFEPRIS - Primary Regulatory body under the Ministry of Health, responsible for product classification, registration, labeling review, and enforcement.
Ministry of Economy - Accredits Verification Units that issue Certificates of Conformity to confirm NOM compliance.
Normas Oficiales Mexicanas (NOMs) - Technical standards that define labeling, hygiene, and additive requirements across categories.
With COFEPRIS as the central authority and the Ministry of Economy accrediting verification units, the regulatory framework in Mexico is structured and layered. Freyr’s experts streamline this complexity, guiding your products through classification and compliance so you can move confidently toward registration and market entry.
Food Supplement Registration Process in Mexico
The Cosmetic Product Registration process in Sri Lanka involves multiple Regulatory and technical review stages. Manufacturers must ensure that all submitted documents, labels, formulations, and claims comply with NMRA Requirements before filing the application.
STEP 01
Classification Request
Regulatory assessment to determine whether the product may be classified as a food supplement under COFEPRIS regulations.
STEP 02
Dossier Submission
Submit formula composition, manufacturing details, and Spanish label artwork.
STEP 03
Notice of Operation (Aviso de Funcionamiento)
File with COFEPRIS for facilities manufacturing or importing.
STEP 04
Import Documentation
Provide a free sale certificate, GMP evidence, and a health certificate for foreign products.
STEP 05
COFEPRIS Approval
Once applicable regulatory, labeling, and import requirements are met, food supplements may proceed to commercialization in Mexico, subject to COFEPRIS oversight and post-market surveillance.
Documents Required
Formula composition
Manufacturing details
Spanish label artwork in accordance with applicable COFEPRIS labeling requirements for supplements
Free sale certificate
GMP evidence
Ingredient specifications
Selecting an experienced local agent is essential for ensuring smooth Regulatory communication and faster Cosmetic product approval timelines.
Freyr provides reliable Legal Representation services along with End-to-end Cosmetic Regulatory support to help manufacturers efficiently navigate Sri Lankan Cosmetic Regulations.
Mexico Labeling Requirements
- Spanish labeling is mandatory for all food, beverages, and food supplements.
- Warning statements and allergen declarations must be included across categories.
- Nutritional and labeling information for food supplements must comply with applicable Mexican labeling requirements, including relevant NOM standards where applicable. For food supplements, labels must avoid medicinal positioning and present dosage form clearly.
- Applicable compliance requirements may include NOM-051 (labeling), NOM-251 (hygiene), and other Mexican regulatory provisions depending on the product classification and composition
Claims Under COFEPRIS
Japan classifies cosmetics into two main categories, each with its distinct requirements:
Food & Beverages
- May use nutritional or functional claims if compliant with NOM standards (e.g., “source of fiber”).
Food Supplements → Stricter restrictions
- No therapeutic claims (e.g., “treats arthritis”).
- No disease prevention claims (e.g., “prevents flu”).
- No medicinal positioning — supplements cannot be marketed as medicines.
- Only nutritional support claims are permitted (e.g., “supports daily vitamin intake”). Claims, ingredient profile, dosage, and product presentation may influence whether COFEPRIS classifies a product as a food supplement or as a medicinal product.
Ingredient & Classification Assessment
Certain ingredients, dosage levels, botanical substances, claims, or dosage forms may trigger additional regulatory scrutiny in Mexico and could potentially lead COFEPRIS to classify a product as a medicinal product rather than a food supplement.
Therefore, early regulatory assessment is strongly recommended prior to commercialization or import activities.
How Can Freyr Help?
Support in the classification of foods and food supplements in accordance with Mexican regulations.
Ingredient and formulation review in line with applicable Mexican requirements.
COFEPRIS compliance assessment and labeling review including sanitary and commercial information and claims alignment.
Regulatory gap analysis against applicable regulatory expectations.
Support in obtaining Certificates of Conformity issued by Verification Units accredited by the Ministry of Economy.
Need Guidance on COFEPRIS Requirements for Food and Food Supplements?
Why Choose Freyr?
End-to-end regulatory consulting.
Market-specific regulatory consulting and support.
Structured and cost-effective approach to ensure speed to market.
Extensive global network of strategic partners.
Strong relationships with multiple health authorities (HAs).
Step confidently into Mexico’s expanding food and food supplement market.
Frequently Asked Questions (FAQs)
Clear answers to common queries on Mexico’s food supplement and food product registration process, designed to help you navigate compliance with confidence.
1. What is the difference between food and Suplementos Alimenticios under COFEPRIS?
Food is regulated for general consumption, while Suplementos Alimenticios are dosage form products intended to supplement diet. COFEPRIS classification determines which pathway applies.
2. Which NOM standards apply to beverages in Mexico?
Non alcoholic beverages must comply with NOM 051 for labeling and NOM 251 for hygiene. Additional NOMs may apply depending on additives or sweeteners.
3. How does COFEPRIS evaluate supplement ingredients?
Ingredients are reviewed against approved lists. Restricted substances, novel ingredients, or additives require additional justification and may trigger rejection.
4. What is the Notice of Operation (Aviso de Funcionamiento)?
It is a mandatory filing for facilities manufacturing, importing, or distributing food, beverages, or supplements in Mexico. Without it, commercialization is not permitted.
5. Do imported supplements need Certificates of Conformity?
Yes. Verification Units accredited by the Ministry of Economy issue Certificates of Conformity to confirm NOM compliance for imported products.
6. Can supplements in Mexico include health claims like “supports immunity”?
Only if phrased as nutritional support. Direct disease prevention or therapeutic claims are prohibited under COFEPRIS regulations.
7. What labeling elements are mandatory under NOM 051?
Spanish language, allergen declarations, warning statements, nutritional information, and commercial name are all required.
8. Can foreign companies register supplements without a local representative?
No. Foreign companies generally require a locally established importer, distributor, or legal entity in Mexico to support applicable regulatory and commercialization activities.
9. What penalties apply for non compliance with COFEPRIS?
Penalties range from product seizure and fines to suspension of commercialization. Repeat violations can lead to facility closure.