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Mexico COFEPRIS Labeling Requirements for Food Supplements under NOM-051-SCFI/SSA1-2010


Mexico COFERPIS Labeling Food Supplements NOM-051-SCFI/2010
Mexico COFERPIS Labeling Food Supplements NOM-051-SCFI/SSA1-2010

In Mexico, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) plays a crucial role in ensuring the safety and quality of food supplements through stringent regulations and labeling requirements. Among these regulations, NOM-051-SCFI/SSA1-2010 stands out as a comprehensive guideline governing the labeling of prepackaged food and non-alcoholic beverages, including food supplements. 

In March 2020, COFEPRIS introduced significant amendments to NOM-051-SCFI/SSA1-2010, marking a pivotal moment in the regulation of food supplements labeling in the country. These amendments, aimed at addressing public health concerns and promoting informed consumer choices, bring about notable changes to the labeling requirements.

The Official Mexican Standard, NOM-051-SCFI/SSA1-2010, applies to all prepackaged non-alcoholic foods and beverages, both domestically produced and imported, intended for consumers within Mexico. However, there are exemptions from this standard, including food supplements covered by specific Mexican official standards or federal regulations that explicitly exclude compliance with NOM-051-SCFI/SSA1-2010. Additionally, bulk products, foods and beverages packaged at the point of sale, and other products determined by the competent authority are also exempt from this standard.

The Official Mexican Standard requires that food supplements display mandatory information in Spanish, while allowing for the inclusion of other languages. However, if other languages are used, the information must also appear in Spanish with equal prominence. Additional information or graphics on the label beyond the standard requirements can be presented in other languages, but must not replace the mandatory labeling in Spanish. This additional information should only be included if necessary to avoid misleading or deceiving consumers.

Key Labeling Requirements for Food Supplements under NOM-051-SCFI/SSA1 :

  • Product Name and Brand Identity: Food supplements must be labeled with their accurate product names and brand identities, enabling consumers to easily identify and differentiate them from other products. The name should accurately reflect the nature of the supplement and its intended use.

  • List of Ingredients: Manufacturers are required to provide a complete list of ingredients used in the food supplement, listed in descending order of predominance by weight. This allows consumers to make informed decisions, especially those with allergies or dietary restrictions.

  • Nutritional Information: The labeling must include comprehensive nutritional information, including serving size, servings per container, and the amount of key nutrients such as vitamins, minerals, and macronutrients (e.g., protein, carbohydrates, fats). This information helps consumers understand the nutritional value of the supplement and its contribution to their diet. The information must be in compliance with NOM-086-SSA1, an official Mexican Standard (NOM) that sets forth specific guidelines and requirements for labeling aspects such as nutrient content, serving sizes, daily reference intakes, and the inclusion of warning labels for products high in certain nutrients such as added sugars, saturated fats, trans fats, and sodium.

  • Guidelines for Use: Clear and concise instructions for the proper use of the food supplement should be provided on the label. This includes dosage recommendations, frequency of intake, and any specific instructions or precautions for use.

  • Warnings and Precautions: Manufacturers must include any relevant warnings, precautions, or contraindications associated with the use of the food supplement. This ensures consumer safety and helps mitigate potential risks or adverse effects.

  • Expiration Date and Lot Number: Each package of food supplement should display the expiration date and lot number, allowing for traceability and quality control. Consumers can verify the product's freshness and authenticity, while authorities can track and recall products if necessary.

  • Contact Information: The label should include the name and address of the manufacturer, importer, or distributor responsible for the food supplement. This facilitates communication and accountability, enabling consumers to seek assistance or provide feedback if needed. 

The amendments, introduced in March 2020, came into effect from October 2020. Evolving dietary patterns, rising obesity rates, and increased awareness of nutritional content, the need for revisions to the standard became evident. For food supplements and nutraceuticals, compliance with the amended NOM-051-SCFI/SSA1-2010 is essential to avoid penalties, ensure regulatory compliance, and maintain consumer trust. Companies must review and update their product labeling and marketing strategies to align with the new requirements, including implementing Front-of-Pack labeling, incorporating graphic warning labels where necessary, and adjusting promotional tactics targeting children. 

For consumers, the amended standard represents a step forward in promoting healthier dietary choices and increasing transparency in food labeling. The introduction of Front-of-Pack labeling and graphic warning labels empowers consumers to make more informed decisions about the products they purchase, enabling them to prioritize their health and well-being.

  • Front-of-Pack Labeling (FOP): One of the most significant changes introduced by the amendment is the requirement for front-of-pack labeling of certain nutritional elements, including added sugars, saturated fats, trans fats, and calories. This "high in" warning label aims to alert consumers to products that exceed recommended thresholds for these nutrients, enabling them to make healthier choices.

  • Graphic Warning Labels: In addition to FOP labeling, the amendment mandates the inclusion of graphic warning labels on products high in added sugars, saturated fats, trans fats, or sodium. These labels feature eye-catching symbols and messages intended to raise awareness of the health risks associated with excessive consumption of these nutrients, such as obesity, diabetes, and cardiovascular disease.

  • Restrictions on Marketing to Children: Recognizing the impact of marketing on children's dietary choices, the amendment prohibits the use of certain promotional tactics, such as cartoon characters, celebrities, or toys, on packaging or advertising of foods high in added sugars, saturated fats, trans fats, or sodium. This measure aims to reduce children's exposure to unhealthy food marketing and promote healthier eating habits from a young age.

  • Guidelines for Nutritional Claims: The amendment introduces stricter guidelines for making nutritional claims on food and beverage packaging, requiring such claims to align with specified nutritional criteria. This ensures that claims such as "low fat," "high fiber," or "reduced sugar" accurately reflect the nutritional content of the product, preventing misleading marketing practices.

Navigating COFEPRIS labeling requirements for food supplements under NOM-051-SCFI/SSA1-2010 is essential for ensuring regulatory compliance and consumer safety in Mexico's dynamic market. By understanding and adhering to these requirements, stakeholders can uphold the highest standards of transparency, integrity, and quality in the food supplement industry.

For tailored solutions and expert guidance on navigating NOM-051-SCFI/SSA1-2010 and other regulatory challenges for food supplements, contact Artixio. Our team of specialists is dedicated to helping businesses achieve compliance, uphold consumer trust, and thrive in a changing regulatory environment. Visit our website or reach out to us directly to learn more.

Contact Artixio: info@artixio.com 

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