Dietary supplements are defined as products intended to increase or complement the total dietary intake, or to supply one or more of their components. COFEPRIS is the authority in Mexico responsible for regulating these products and for establishing the labeling requirements they must meet to be marketed in the country.
COFEPRIS is the authority responsible for issuing the applicable regulations for dietary supplements; therefore, it establishes the requirements that must be met for their manufacturing, marketing, and labeling.
To guide the industry in complying with these provisions, the regulatory agency has developed the “Labeling Guide for Dietary Supplements.”
Information That Must Be Included on the Label.
Generic product name as a dietary supplement.
List of ingredients in descending order. If the product contains plants, both the common name and the scientific name (genus and species) must be included.
Nutrition facts per recommended serving and per 100 g of product (including energy content, proteins, fats, carbohydrates, sugars, and other relevant ingredients such as vitamins and minerals).
Disclaimers: “The consumption of this product is the responsibility of the person who recommends it and of the person who uses it” and “This product is not a medicine.”
Business name and address of the manufacturer, importer, contract manufacturer, or domestic or foreign distributor.
Identification code (lot number).
Expiration date.
If the product contains any ingredient that may pose a risk to the consumer (such as allergens or plant extracts that may affect a specific group), include the applicable warning statement. Example: “Do not consume during pregnancy or breastfeeding”; “Not to be used by individuals under 18 years of age.”
Directions for use and storage instructions. (Store the product in a cool, dry place.)
Net content, the quantity of product in the package, must be indicated, either in units of mass (grams, kilograms) or volume (milliliters).
Country of origin.
All information and disclaimers must be provided in Spanish.
Information That Must Not Be Included on the Label
Claims with preventive, rehabilitative, or therapeutic properties must not be made (e.g., "prevents," "cures," "strengthens," "relieves," among others).
Images referencing organs or body parts.
The product name must not include references to body parts or diseases.
Statements suggesting the replacement of meals.
It is important to consider the above points, as failure to comply may result in observations, sanctions, or fines imposed by the regulatory authority during inspection procedures.
Recommendations
For ingredients, it is recommended to review the official lists and decrees regarding permitted and prohibited plants and additives. If no information is found, it is possible to submit an inquiry to CEMAR to determine whether the ingredient may be used and in what proportion.
To ensure compliance with product labeling requirements, it is also advisable to submit a classification query, as this allows you to obtain a formal opinion from the regulatory authority regarding your product.
To learn more about classification queries, we invite you to read our article: “Classification query: A regulatory tool for marketing your cosmetics and dietary supplements.”
Written By:
Tania Ramírez
about ips
Mexico’s regulatory framework for 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