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Food Supplements Regulations in Mexico COFEPRIS

Updated: Mar 18

Food Supplements Regulations in Mexico COFEPRIS
Food Supplements Regulations in Mexico COFEPRIS

Latin America plays a pivotal role in the global food supplements market, constituting 7 percent of the industry. Mexico, as the second-largest market in the region after Brazil, is at proximity to the United States, the world's leading consumer of food supplements. Mexico food supplements market is set to expand significantly, projecting a growth from $9.2 million in 2022 to $14.96 million by 2030, at a CAGR of 7.4%.

The regulatory landscape for food supplements in Mexico is governed by Federal Commission for the Protection Against Sanitary Risks (COFEPRIS). COFEPRIS oversees the production, sale, distribution, imports and exports, advertising, commercialization, and compliance of food supplement regulations.

Under Article 215, Section V of the Mexico’s COFERIS General Health Law, a food supplement is defined as a herbal products, plant extracts, traditional foods, dehydrated or fruit concentrates, with or without added vitamins or minerals, which can be presented in pharmaceutical form and whose purpose of use is to increase the total dietary intake, complement it or replace any component”.

The food supplements must be taken through oral route alone and the product presented as confectionery (candy, lollipops, chewing gum), patches, injectable solution, among others, are not allowed are not categorized as Food Supplements. The food supplements can be presented as oral dosage forms such as capsule, emulsion, suspension, syrup, powder, solutions and tablets. 

What can be included in the Food Supplements?

The food supplements may include vitamins, minerals or herbal substances. COFEPRIS do not consider products containing plants not allowed for infusions or tea as food supplements. The food supplements containing vitamins and minerals shall met the maximum daily limits established in Appendix XVII.1 of the Regulation. In case of food supplements containing the little known substances that may represent a risk or damage to health, scientific evidence to prove their safety should be submitted to the COFEPRIS. Food supplements containing substances such as procaine, ephedrine, yohimbine, germanium, animal or human hormones; or other pharmacological substance recognized or substances posing a health risk are also not considered as food supplements. 

COFEPRIS Food Supplements Regulations and Standards – 

The Food supplements are regulated under General Health Law. In addition to the Law, food supplements are also regulated under the Mexican Standards, Norma Oficial Mexicana.

  • NOM-251-SSAI-2009: Hygienic practices for the processing foods, beverages, or food supplements 

  • NOM-051-SCFI/SSA1-2010 and its subsequent amendments : General labelling specifications for pre- packaged foods and non-alcoholic beverages-Commercial and sanitary information.

Claims Assessment –

Claims assessment is the critical step in determining the product classification and the registration requirements. Claims are regulated under Articles 6.2 and 6.3 of NOM-051-SCFI/SSA1-2010. Disease reduction claims are not allowed. The claims made by the food supplements could be 

  • Conditional Claims

  • Nutrition claims

  • Health Claims

Type of Claims

Claims made by the Food supplement

Conditional Claims

  • Enhanced nutritional value attributed to added nutrients; 

  • Specific nutritional attributes resulting from the reduction or exclusion of certain nutrients; 

  • Use of terms such as "natural," "pure," "fresh," "home-made," and "organically grown" is permissible when aligned with the applicable legal framework; 

  • Religious preparations (e.g., Halal, Kosher) are acceptable if they adhere to the specified requirements; 

  • Indicating that a food product possesses unique characteristics is allowed when it is evident in the declaration of properties and applies to all similar foods with such characteristics.

Nutrition Claims

Nutrition claims are permitted for caloric content, protein, carbohydrate, fat, fiber, sodium, and vitamins and minerals based on Daily Reference Values (DRV). Examples include nutrient content claims such as "Calcium source," "high fiber content," and "low fat." Additionally, nutrition comparison claims like "reduced," "less than," "less," "increased," and "more than" are also allowed.

Health Claims

A health claim refers to any representation that indicates, suggests, or implies a connection between a food or its components and health. Health claims encompass two categories:

  • Nutrient Function Claims: These statements highlight the nutritional properties of a nutrient, elucidating its physiological role in growth, development, and normal body functions. For instance, a claim might state, "Nutrient A promotes health and growth in the body. Food X is a rich source of/high in Nutrient A."

  • Other Function Claims: These claims focus on specific positive effects resulting from the consumption of food or its constituents within the context of a complete diet. These effects contribute to the normal biological functions or activities of the body, aiming to enhance, modify, or preserve health. For example, a claim might say, "Substance A positively influences a physiological function or biological activity associated with health. Food Y contains X grams of Substance A."

Registration requirements for Food supplements in Mexico

Retailers dealing in food supplements in Mexico enjoy a streamlined process as they do not require prior approval or sanitary registration.

For domestically manufactured food supplements, regulatory requirements are comparatively lenient. Domestic manufacturers are obligated to notify COFEPRIS about their product facilities. A "Notice of Operation" must be submitted 30 days before commencing operations. This notification serves as a proactive measure to inform COFEPRIS about the intended manufacturing activities.

Importation of Overseas Products: In contrast, overseas products face a more intricate process for market entry. The importer must submit a Notice of Operation to COFEPRIS as a pe-requisite. The food supplement must have a COFEPRIS Classification Consultation and Prior Sanitary Import Permit (PSPI) issued by COFEPRIS to import and market the food supplements in Mexico. Manufacturers of overseas products must thoroughly check ingredients, labels, and claims, before submitting to COFEPRIS for correct classification. The submission of an application to COFEPRIS includes essential documentation such as a health certificate or certificate of free sales from the country of origin, original and translated labels, chemical and microbiological analyses for each batch, and proof of fee payment.

Advertising Permit and Entry Approval: Upon obtaining Prior Sanitary Import Permit (PSPI) or submitting Notice of Operations, an advertising permit from COFEPRIS, under NoM 251 NUMERAL 6.7, is mandatory for marketing food supplements. This is required for food supplements manufactured domestically or overseas. Failure to obtain this advertising permit exposes products to sanctions outlined in the General Health Law. Obtaining a food supplement advertising permit typically takes an estimated two months.

Labeling requirements

Mexico implemented amendments to its food labeling regulations, NOM-51-SCFI/SSA1-2010, with the finalization of changes on March 27, 2020 and the amendments were enforced from November 30, 2020. The regulations were phased in over three periods: 

  • Phase 1 (Oct. 1, 2020, to Sept. 30, 2023), 

  • Phase 2 (Oct. 1, 2023, to Sept. 30, 2025), and 

  • Phase 3 (on and after Oct. 1, 2025). 

The amended regulations introduce a front-of-pack labeling model using warning labels. The system involves octagonal stamps for products exceeding critical nutrient thresholds, posing health risks with excessive consumption. The warnings include “EXCESO CALORÍAS”, “EXCESO AZÚCARES”, “EXCESO GRASAS SATURADAS”, “EXCESO GRASAS TRANS”, and “EXCESO SODIO”.

Navigating through regulatory changes and ensuring compliance can be a complex task. At Artixio, we specialize in providing comprehensive regulatory support and consultancy services. If you are a business looking to understand and adhere to Mexico's evolving food regulations, contact Artixio today. Our experienced team can guide you through the process, ensuring your products meet the latest standards while maintaining a smooth market entry.

Contact Artixio for expert regulatory support in Mexico's dynamic food industry.

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