How to classify a product as a dietary supplement? (Case study)
The correct classification of a dietary supplement in Mexico is a step that can determine a product's commercial viability. Beyond the formulation, factors such as the method of consumption and intended use play a role, both of which are evaluated under the sanitary framework applied by the competent authority. This case study illustrates how a technical decision can become a key strategic point for a successful entry into the Mexican market.
Regulatory analysis for Dietary Supplements in Mexico
An international company with a presence in the United States and Europe decides to enter the Mexican market with a portfolio of products aimed at general well-being. Among them is a capsule-based product formulated with a combination of B-complex vitamins, botanical extracts, minerals, and amino acids.
In its home markets, the product is marketed as a dietary supplement and promoted as support for energy metabolism, fatigue reduction, and strengthening the immune system.
Before starting operations in Mexico, the company wishes to comply with the regulatory framework. To this end, the company has sought specialized support to identify risks and define a market entry strategy aligned with Mexican sanitary regulations.
Regulatory Challenge Statement
During the preliminary review of the product, the following elements are identified:
It contains vitamins and minerals within generally accepted ranges.
It incorporates botanical extracts that, in other countries, are associated with specific physiological effects.
It includes amino acids in concentrations close to those used in products for therapeutic purposes.
The original marketing material uses expressions such as:
"Improves immune system function"
"Reduces chronic fatigue"
"Optimizes metabolic functions"
These factors create uncertainty as to whether the product fully meets the definition of a dietary supplement in Mexico or if it could be considered a:
Herbal remedy
Medicine/Drug
Applicable Regulatory Framework in Mexico
In Mexico, the classification of dietary supplements is primarily governed by:
General Health Law (LGS)
Regulations for the Sanitary Control of Products and Services (RCSPyS)
Regulations of the General Health Law regarding Advertising (RLGSMP)
NOM-051-SCFI/SSA1-2010 (Labeling Standard)
According to the regulation, a dietary supplement is a product:
Intended to increase total dietary intake.
Containing vitamins, minerals, herbs, or other permitted ingredients.
That does not attribute therapeutic, preventive, or curative properties.
This last point is key to the case evaluation.
Regulatory Analysis of the Product
Formula Evaluation
A thorough review of the product's formula and labeling must ensure compliance with specific regulations:
Nutrients: The amounts of vitamins and minerals must comply with the established maximum and minimum limits.
Additives and Ingredients: Relevant Agreements (Acuerdos) must be consulted to confirm that all additives and excipients are permitted and within authorized quantities for dietary supplements.
Plants and Extracts: Herbs or botanical extracts used are checked to ensure they do not appear on current lists of prohibited or restricted plants.
Communication and Claims Evaluation
One of the main regulatory risks detected lies in advertising and labeling. COFEPRIS evaluates not only the product itself but also:
On-label claims.
Advertising material across all media.
Expressions related to the prevention, treatment, or improvement of health conditions may cause the product to be classified as a medicine or herbal remedy, regardless of its composition.
Identified Regulatory Risks
Based on the analysis of the product in question, the following risks are identified:
Reclassification of the product as a medicine or herbal remedy.
Additional regulatory requirements, such as a Sanitary Registration (Registro Sanitario).
Administrative sanctions for unauthorized advertising.
These risks can directly impact market entry timelines, costs, and commercial viability.
Proposed Regulatory Strategy
To mitigate these risks, a comprehensive strategy is proposed, including:
A full review of the product (labeling and advertising materials).
Formulation adjustments, if necessary, to align with dietary supplement criteria.
Adjustment of claims to ensure they do not attribute properties that do not correspond to a dietary supplement.
Obtaining a formal Classification Consultation (Consulta de clasificación).
Support during import processes and advertising authorization.
Conclusions
This case illustrates how the classification of a dietary supplement in Mexico does not depend solely on the formula, but on a comprehensive analysis that includes:
Ingredients
Recommended serving size
Intended use
Consumer communication
An adequate regulatory strategy allows for:
Reduced risks before COFEPRIS.
Optimized market entry timelines.
Protection of the product's commercial continuity.
In an increasingly scrutinized regulatory environment, anticipating the correct classification is a strategic decision, not just a regulatory one.
This case study is fictitious and for informational purposes only.
Written by:
Tania Ramirez
Mariel Antonio
About IPS
Mexico’s regulatory framework for cosmetics and dietary supplements requires more than just understanding the rules—it demands strategic application and proactive compliance. At IPS, we specialize in guiding companies through COFEPRIS requirements.
Let our team of regulatory experts help you avoid costly setbacks and ensure your products meet all labeling and safety requirements.
For tailored support, contact us at info@insumosparasalud.com