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COFEPRIS Product Classification Consultation for Food Supplements in Mexico

Updated: Feb 16

Navigating the regulatory landscape when introducing food supplements into the Mexican market requires careful consideration of various factors. One critical aspect is ensuring compliance with the classification guidelines set forth by the Federal Commission for Protection against Health Risks (COFEPRIS). In case of any uncertainty about product qualifying as a food supplement under Mexican regulations, the Federal Commission for Protection against Health Risks (COFEPRIS) offers a free consultation service to help the manufacturer determine the classification of the product. 

The product classification consultation is a crucial step in ensuring compliance with the legal framework for food supplements. This free procedure allows the health authority to assess your product's formulation and labeling to determine if it meets the criteria for classification as a food supplement. It's important to note that the consultation provides a technical opinion and does not constitute a health authorization. In case of imported products, the Product Classification Consultation shall be carried out before applying for an advertising permit for the food supplement.

Requirements for Classification Consultation request

To request a product classification consultation, an application on the company's letterhead, signed by the owner, legal representative, or health responsible individual must be submitted. The application should be addressed to the Sanitary Operation Commission of COFEPRIS. The request must include the information about the food supplement -

  • Detailed information about the product, including the name of each ingredient, quantitative formula per serving and per 100g, and the intended use.

  • Description of the recommended usage of the product.

  • An original label or graphic arts printing, readable in Spanish. In case of imported products, the food supplement labels used in the Country of Origin should also be included.

Response Time and Possible Outcomes from the consultation - 

Upon submission of the consultation request, COFEPRIS will provide a response within a maximum of 90 days. The possible outcomes may include:

  • It's a Food Supplement: Your product meets the criteria for classification as a food supplement.

  • Request for Information: COFEPRIS may require additional information or clarification regarding your product.

  • It's Not a Food Supplement: Your product does not meet the requirements for classification as a food supplement.

COFEPRIS Food supplements Mexico
COFEPRIS Product Classification Food Supplements Mexico

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Reference: COFEPRIS Website.

COFEPRIS product classification consultation serves as a valuable resource for manufacturers and distributors seeking to navigate the regulatory requirements for food supplements in Mexico. By obtaining a clear classification for their products, stakeholders can ensure compliance with applicable regulations, thereby facilitating their entry into the Mexican market. For further guidance on product classification consultation or assistance with regulatory compliance, manufacturers and distributors are encouraged to engage with COFEPRIS and leverage their expertise in this domain.

For expert assistance in navigating COFEPRIS regulations and ensuring compliance for your food supplement products, contact Artixio today! Our team of regulatory experts is here to help you streamline the process and ensure your products meet all necessary requirements.

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