Dietary Supplements, Herbal Remedies, and Medicines: Key differences in their regulation.

In the Mexican regulatory landscape, the classification of products intended for health or well-being is fundamental. In the market, we can find options such as dietary supplements, herbal remedies, and medicines, all of which possess specific characteristics, a defined purpose of use, and, most importantly, a clearly differentiated regulatory framework.

For any individual or company seeking to market any of these products in Mexico, understanding these distinctions is essential.

• Sources

  • General Health Law

  • Regulation on the Sanitary Control of Products and Services

  • Regulation on Health Supplies

  • Agreement Establishing the Prohibited or Permitted Plants for Teas, Infusions, and Edible Vegetable Oils

  • Agreement Establishing Additives and Processing Aids in Foods, Beverages, and Dietary Supplements, their Use and Sanitary Provisions, and their Amendments

General Definitions

According to the General Health Law (LGS) and the Regulations for Health Supplies (RIS), these products are defined as follows:

• Medicine (Art. 221 LGS): Any substance or mixture of substances of natural or synthetic origin that has a therapeutic, preventive, or rehabilitative effect, presented in a pharmaceutical form and identified as such by its pharmacological activity, physical, chemical, and biological characteristics.

• Dietary Supplement (Art. 215 LGS): Products based on herbs, vegetable extracts, traditional foods, dehydrated or concentrated fruits, with or without added vitamins or minerals, that may be presented in a pharmaceutical form and whose purpose is to increase total dietary intake, complement, or substitute any of its components.

• Herbal Remedy (Art. 88 RIS): Preparation of medicinal plants, or their individual or combined parts and their derivatives, presented in a pharmaceutical form, to which the relief of certain isolated or participating symptoms of a disease is attributed by popular or traditional knowledge.

The fundamental distinction between these categories lies in their main purpose and the required evidence. The Medicine is the only one intended for a therapeutic, preventive, or rehabilitative action, demanding the highest scientific rigor to demonstrate its pharmacological activity. The Dietary Supplement focuses solely on the nutritional function, seeking to complement the diet without curative properties. Finally, the Herbal Remedy is situated at a point where symptom relief is attributed, but it is not subject to the exhaustive scientific proof required for a medicine.

Considering the scope of each classification, the regulatory requirements change, and therefore, their type of authorization. While medicines must have a sanitary registration, herbal remedies must have an alphanumeric key. Finally, dietary supplements may have a classification query, through which the health authority evaluates product characteristics such as ingredients and labeling, confirming that it is indeed a product of this category.

Each procedure must cover certain requirements such as: labeling compliance, good manufacturing practices, stability studies, clinical studies, among others.

Ingredients

Another major characteristic that differentiates these three products is the ingredients and their concentrations in the product.

It is important to review the various Agreements published by the health authority and the Herbal Pharmacopoeia of the United Mexican States (Farmacopea Herbolaria de los Estados Unidos Mexicanos), which establish the ingredients that can be used, their proportions, whether they have proven pharmacological action, and if there is any prohibition for their use in dietary supplements.

Advertising

When advertising any of these products, it is important to consider the claims that will be used, since attributing properties that do not correspond to the actual function of the product can generate confusion about its classification and lead to the suspension of the advertisement.

In the case of dietary supplements, advertising must not be related to therapeutic, preventive, or rehabilitative properties, which it lacks. Furthermore, it must have an advertising permit.

Herbal remedies and medicines may use claims that relate solely to the properties established in their Permit or Sanitary Registration. Their advertising will also require an advertising permit to be directed to the general public or an advertising notice, if it is exclusively for health professionals.

Conclusion

In summary, the correct classification of products, is the cornerstone of health regulation in Mexico. Understanding that their difference lies in the purpose of use (nutritional vs. therapeutic) and the required scientific evidence is vital, as this defines the type of authorization needed: from the classification consultation for supplements, to the sanitary registration for medicines. For any industry player, detailed knowledge of these distinctions not only ensures legal compliance with COFEPRIS but also guarantees transparency and safety for the final consumer.

For more specific information on the regulation of dietary supplements, we invite you to read our article Dietary Supplements: Regulatory Framework in Mexico. For claims topics, you will find more information in the article Key Considerations for Cosmetic and Dietary Supplement Claims in Mexico.

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Written by:

Mariel Antonio

Tania Ramírez

About IPS

The regulatory framework in Mexico demands a deep understanding and precise execution for the commercialization of products. At IPS, we have a specialized team in Dietary Supplement regulations, ensuring that your product strategy aligns with COFEPRIS guidelines.

Contact us at info@insumosparasalud.com to learn more about how we can help you.