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New guide to the classification of dietary supplements in Mexico.

For the correct application of the legal framework for dietary supplements and their proper classification on June 12, 2026, COFEPRIS published the Non-Regulatory Guide for the Classification of Products as a Food Supplement,

The guide introduces for the first time a structured evaluation mechanism, based on a classification format that integrates four fundamental regulatory sections for the evaluation of a product as a possible food supplement, which are the following:

  1. The General Health Law, which states that supplements must be based on herbs, plant extracts or traditional foods, aimed at complementing the diet, and free of restricted ingredients.
  2. The Regulation on the Sanitary Control of Products and Services, which incorporates criteria on composition, exclusion of substances with pharmacological action and, especially, strict rules on labelling, prohibiting therapeutic indications or misleading information.
  3. and 4. The Decree determining additives and adjuvants in food, beverages and food supplements, their use and sanitary provisions, published in the Official Gazette of the Federation (DOF) on December 15, 1999, and its amendments published on September 5, 2013 and May 16, 2016, and the Decree determining the prohibited or permitted plants for teas, infusions and edible vegetable oils, published in the DOF on December 15, 1999, which delimit the substances that can be used and the specific conditions applicable, including labeling requirements in the case of certain ingredients.

This guide establishes the possibility of using the Herbal Pharmacopoeia of the United Mexican States as a reference in the development of food supplements, since it lists plants and their derivatives that can cause unwanted effects, have interactions with other plants and medications, and even be toxic due to their chemical constituents and the physiological conditions of the consumer because they can induce toxic effects and allergies.

Additionally, the same guide clarifies the following:

  • The prohibition of including substances with pharmacological action.
  • The restriction of pharmaceutical forms or presentations that may lead to confusion (e.g. confectionery).
  • The need to prevent labelling and marketing information from being misleading or targeting vulnerable populations, such as minors.

Another important aspect in this guide is that compliance must be strict and inclusive, i.e. that the product can only be classified as a food supplement if it satisfies the four sections evaluated; otherwise, it must be analyzed under another regulatory category.

The issuance of this guide represents a significant step towards the standardization of criteria and the reduction of regulatory uncertainty in the food supplement sector in Mexico.

In this context, it is essential that companies comprehensively review the formulation, labeling, intention to use and marketing information of their products, in order to ensure correct classification and avoid regulatory contingencies.

At OLIVARES, we will continue to keep our clients informed of regulatory updates, providing support and guidance on the implementation and interpretation of this guide.

FOR FURTHER INFORMATION ON THE CONTENT OF THIS NEWSLETTER, PLEASE CONTACT:

Alejandro Luna Fandiño

Alejandro Luna Fandiño

Partner

Alejandro Luna joined OLIVARES in 1996 and being made partner in 2005, he has been instrumental to the firm´s IP Litigation, Regulatory and Administrative Litigation practices. He co-chairs the Life Sciences & Pharmaceutical Law industry group and coordinates the Litigation Department.
Armando Arenas

Armando Arenas

Partner

Armando Arenas joined OLIVARES in 2000 and became a partner in January 2017. He has experience working on a range of IP matters, including consulting and litigation on trademark, patent, unfair competition, trade dress protection, and misleading advertising cases before the Mexican Institute of Industrial Property (IMPI), Federal Court of Tax and Administrative Affairs (FCTA), Federal Circuit Courts (FCC) and the Supreme Court of Justice (SCJ) Regulatory Affairs and Public Acquisitions.
Gustavo A. Alcocer

Gustavo A. Alcocer

Partner

Gustavo Alcocer manages the Corporate and Commercial Law Group at OLIVARES, advising domestic and foreign businesses and the owners of those businesses on Mexican and cross-border corporate and commercial transactions.

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