Dietary Supplement labeling: COFEPRIS compliance guide
This article details the technical and legal requirements that must be met by labels for dietary supplements marketed in Mexico. Its objective is to provide manufacturers, importers, and distributors with a clear roadmap to ensure their products present truthful information, avoiding omissions that compromise transparency toward the consumer. The correct implementation of these elements ensures that the product remains within the current sanitary legal framework before COFEPRIS.
In Mexico's dynamic health and wellness industry, dietary supplements occupy a strategic position. However, their commercial success and market permanence strictly depend on regulatory compliance in their visual communication. Labeling is not merely a marketing tool; it is the legal vehicle of information that defines the product's identity and its sanitary classification. Understanding the rigor of current official provisions allows companies to mitigate operational risks and consolidate the trust of an increasingly informed consumer.
Conceptual framework: definition and legal scope
To address labeling, it is imperative to recall the definition established in Article 215 of the General Health Law: supplements are products whose purpose is to increase total dietary intake, complement it, or supply a component. They consist of concentrated sources of nutrients or other substances with a physiological or nutritional effect. Under this premise, their labeling must be extremely precise to avoid confusion with medications or other health supplies.
Mandatory technical requirements on the label
According to the Regulations for the Sanitary Control of Products and Services (RCSPyS), the label must be clear, legible, and in the Spanish language. The elements it must contain are detailed below:
A. Product Identification and Denomination
Generic Denomination: It must indicate that it is a "Suplemento Alimenticio" (Dietary Supplement). This denomination is what grants the product its legal identity.
Specific Denomination: Describes the product by indicating the pharmaceutical form (powder, tablet, capsule, etc.), the characterizing ingredients, and flavor.
Net Content: Declared numerically followed by the corresponding unit of measurement (g, mg, ml, etc.).
Lot Number: A code to track the production history.
Expiration Date: Indicated clearly (day/month/year). Overprinting is not permitted.
B. Legal Responsibility Information
Name or Corporate Name: Identification of the manufacturer, importer, or responsible distributor in Mexico.
Tax Address: Full physical address.
Country of Origin: A clear legend indicating where the product was manufactured (e.g., "Hecho en México", "Producto de EE. UU.").
Responsibility: In the case of imports, this phrase is usually accompanied by the importer's details: "Hecho en [Country] por [Manufacturer's Name] para [Importer/Distributor Name in Mexico]".
C. Ingredient List and Allergen Declaration
Descending Order: Ingredients must be listed from highest to lowest weight in the formula.
Component Identification: Include vitamins, minerals, herbal extracts, and additives used. In the case of herbs and vegetables, the common name and botanical name (genus and species) must be included, as well as the part used.
Allergen Declaration: It is essential to declare the presence of ingredients that may cause sensitivity or allergic reactions (gluten, dairy derivatives, soy, etc.), allowing the consumer to make an informed decision.
D. Nutritional Information
It must include a detailed table per 100 g or ml and per serving, specifying energy content, proteins, lipids (fats), carbohydrates, and sodium.
Mandatory Legends and Communication Restrictions The Mexican regulatory framework establishes two precautionary legends that are pillars in the labeling of these products to avoid diagnostic or therapeutic confusion:
"Este producto no es un medicamento" (This product is not a medication): This phrase must be presented with clear, visible characters in contrast with the background.
"El consumo de este producto es responsabilidad de quien lo recomienda y de quien lo usa" (The consumption of this product is the responsibility of those who recommend it and those who use it): This complements the warning regarding the use of the supplement as a dietary aid rather than a clinical treatment.
Important: The use of images or texts suggesting that the product can cure, relieve, treat, or prevent diseases, syndromes, or specific symptoms is prohibited.
Conclusion
Compliance in the labeling of dietary supplements in Mexico should be viewed as a pillar of commercial ethics and consumer safety. A label that strictly follows the Regulations for the Sanitary Control of Products and Services projects professionalism and protects the company's investment against sanitary surveillance processes.
Practical Recommendations:
Technical Text Review: Before printing, validate that all denominations and ingredients correspond to what is permitted by the General Health Law, the RCSPyS, and applicable regulations in general.
Linguistic Adaptation: Ensure that all technical information is correctly presented in Spanish and is understandable.
Regulatory Monitoring: Keep your ingredient catalog updated, as the authority may update the lists of permitted substances.
Informative Focus: Center your communication on nutritional benefits and dietary contribution, avoiding any claims related to the treatment of ailments.
FAQ
-
No, according to the current legal framework, dietary supplements have specific regulation under the Regulations for the Sanitary Control of Products and Services and do not fall into the category of processed foods subject to the front-of-pack labeling system.
-
The use of terms such as "natural" must be fully justified and should not be used to imply that the product is harmless or possesses superior health properties due to its origin.
Written by:
Mariel Antonio
Regulatory affairs specialist with extensive technical expertise in the sanitary authorization and surveillance of advertising in digital platforms and traditional media. She provides strategic guidance to dietary supplement, cosmetic, and medical device companies to ensure strict compliance with current regulations.
About IPS
At IPS, we have an expert team in regulatory compliance for the labeling of dietary supplements in Mexico, ensuring that every label avoids omissions and complies with sanitary regulations before COFEPRIS. If you seek to commercialize your products in Mexico and/or mitigate risks related to sanitary surveillance processes, contact us today to discuss your needs at info@insumosparasalud.com
