Food & Food Supplements registration in Mexico

Dietary Supplements and Foods – Overview

In Mexico, dietary supplements and foods are considered over-the-counter consumer products; however, they are subject to different regulatory frameworks.

Dietary supplements are regulated by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). Foods, in addition to sanitary regulation overseen by COFEPRIS, are also subject to the supervision and regulation of the Ministry of Economy, particularly with respect to labeling and commercial information.

The regulatory requirements applicable to foods and dietary supplements vary depending on the product classification, formulation, intended use, and the claims intended to be communicated.

In particular, dietary supplements are strictly regulated by COFEPRIS, which requires compliance with specific regulatory provisions and establishes clear restrictions on the attribution of therapeutic or preventive properties.

Freyr provides comprehensive regulatory support for foods and dietary supplements in Mexico, including:

• Product classification
• Definition of the regulatory strategy
• Ingredient and formulation assessment
• Labeling and claims review
• Preparation of technical documentation
• Regulatory process support and authority interactions

Our approach facilitates market access, minimizes regulatory risks, and ensures ongoing compliance.

Product Classification

Foods and Dietary Supplements in Mexico

In Mexico, the proper classification of foods and dietary supplements is a fundamental element, as it defines the applicable regulatory requirements, particularly with respect to labeling, composition, ingredients, and claims.

Although these products are not subject to prior authorization for commercialization, they must comply with the applicable Mexican sanitary regulations and must not include misleading information or attribute therapeutic, preventive, or curative properties. Non-compliance may result in regulatory oversight actions and sanctions by the health authority.

Foods

In Mexico, foods are regulated as conventional foods and are subject to sanitary oversight by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), as well as to the provisions issued by the Ministry of Economy regarding labeling and commercial information. These products must comply with the applicable requirements related to sanitary safety, composition, and labeling, in accordance with the current regulations.

Dietary Supplements

Dietary supplements are products made from herbs, plant extracts, traditional foods, as well as dehydrated or concentrated fruits, which may or may not be supplemented with vitamins or minerals. They are presented in dosage forms, such as capsules, tablets, powders, or liquids, and are intended to increase total dietary intake, supplement the regular diet, or replace a specific nutritional component.

Under Mexican sanitary regulations, dietary supplements may not attribute or declare therapeutic, preventive, or medicinal properties.

Their composition, labeling, and claims are subject to the criteria established by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), with the aim of ensuring regulatory compliance and preventing misleading interpretations by consumers.