In Mexico, the labeling requirements for food supplements (known as “suplementos alimenticios”) are primarily governed by a combination of NOM-051-SCFI/SSA1-2010 (as amended in 2020) and specific sanitary regulations under the oversight of the Secretaría de Salud (SSA) and COFEPRIS (Federal Commission for Protection Against Sanitary Risks).
These products are defined as items intended to complement a diet with nutrients or bioactive substances (e.g., vitamins, minerals, herbs, amino acids). The requirements ensure consumer safety, prevent misleading claims, and align with Mexico’s broader food and health regulatory framework.
A Few Key Labeling Requirements:
- Classification and Product Name. Labels must clearly identify the product as a “suplemento alimenticio” (food supplement) to distinguish it from medicines, cosmetics, or conventional foods.
- List of Ingredients.
- Net Content. The quantity must be expressed in metric units (e.g., grams, milligrams, milliliters, or number of capsules/tablets), excluding packaging weight.
- Nutritional Information.
- Mandatory Statements.
- Disclaimer: Labels must include the statement: “Este producto no es un medicamento y no tiene como propósito diagnosticar, tratar, curar o prevenir ninguna enfermedad” (This product is not a medicine and is not intended to diagnose, treat, cure, or prevent any disease). This prevents therapeutic claims.
- Instructions for Use.
ARTICLE 169.
Food supplements shall not contain substances such as procaine, ephedrine, yohimbine, germanium, animal or human hormones, plants that are not permitted for infusions or tea, or any other recognized pharmacological substance or substance that poses a health risk.
In the event that they contain little-known substances that may pose a risk or harm to health, the processing and importation of the products referred to in this title shall be subject to scientific proof of their safety being provided to the Secretariat.
ARTICLE 170.
The raw materials of food supplements, particularly dehydrated plants, must undergo treatments, controls, or procedures that eliminate the accompanying microbial flora and physical or chemical residues that may be harmful to health.
ARTICLE 171.
Products that incorporate substances with recognized pharmacological action or those that, based on their composition, are attributed therapeutic, preventive, or rehabilitative properties may not be marketed in the national territory unless they comply with the provisions applicable to health supplies.
ARTICLE 172.
The Secretariat may request the following information: I. Description of the product, indicating: a. Name of each ingredient, scientific name in the case of plants, and monograph for uncommon substances; and b. Quantitative formula; II. Instructions for use; and III. Sample of the original label and information with which it is marketed.