Dietary Supplement classification: Scope of the new Non-Regulatory Guide.
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has published the "Non-Regulatory Guide for the Classification of Products as Dietary Supplements." This technical document compiles the requirements of national legislation through a self-assessment format and a decision-making diagram to determine whether a product belongs in this category. It is a tool designed for manufacturers, importers, marketers, and legal advisors that mitigates the risks of sanctions, rejection of goods at customs, and formulation errors.
UPDATE
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) issued the "Non-Regulatory Guide for the Classification of Products as Dietary Supplements." This technical update is presented in the context of current modifications to the General Health Law (LGS) and seeks to standardize the interpretation of the current legal framework. The relevance of this document lies in the fact that it centralizes the applicable regulations for this type of product. Traditionally, the dietary supplement industry has faced challenges due to the dispersion of the norms regulating its components. By providing a unified review format, the guide reduces technical uncertainty in formula creation and label design. Although COFEPRIS specifies that this instrument is for guidance purposes, lacks legal validity, and does not replace current legal obligations, it constitutes the regulatory body's official stance for identifying products that attempt to evade regulatory compliance.
REGULATORY FRAMEWORK
The regulatory framework governing dietary supplements is evaluated in the guide through a sequential matrix divided into four mandatory blocks. For a product to receive an approval ruling, it must meet all criteria established in each section:
1. General Health Law (LGS) Requirements
This initial block evaluates the nature of the product according to the law's basic definitions:
Composition base: Products must be based on herbs, plant extracts, traditional foods, dehydrated products, or fruit concentrates. If the mixture contains ingredients foreign to this nature, the product loses its classification as a supplement.
Purpose of use: The product's exclusive objective must be to increase total dietary intake, complement it, or supply any of its components in the body.
Exclusion of regulated substances: The formula must be completely free of ingredients classified as narcotics (Art. 234) or psychotropics (Art. 245).
2. Sanitary Control Regulation (RCSPS) Parameters
This section delimits nutritional restrictions, the use of chemical substances, and rules for commercial communication:
Integrating components: The use of proteins, carbohydrates, amino acids, fatty acids, metabolites, plants, algae, and dehydrated traditional foods is permitted.
Restriction on pure micronutrients: A product composed solely of vitamins or minerals, individually or combined, does not meet the definition of a dietary supplement. The regulation indicates that these micronutrients can add to the product base but never replace it entirely.
Maximum limits per portion: Concentrations of vitamins and minerals must not exceed the daily doses allowed in the regulation's technical tables.
Absence of medical properties: The inclusion of drugs or compounds with recognized pharmacological action is prohibited (Art. 169). Labeling and advertising must not include information attributing therapeutic, preventive, curative, or rehabilitative properties, nor employ images of symptoms, anatomical data, or legends suggesting the replacement of complete meals.
3. Provisions of the Additives and Adjuvants Agreement
Explicit authorization: Any additive used (preservatives, thickeners, sweeteners) must appear in the annexes of the Additives Agreement under the specific category of use for dietary supplements.
Concentration limits: Maximum levels permitted by the authority must be respected. If a product is formulated without additives, the guide determines it complies with this section, given that the use of these substances is not mandatory.
4. Evaluation of the Plant Agreement and Pharmacopoeial References
Prohibited species: No plant ingredient may coincide with the species cataloged as prohibited in the first article of the Plant Agreement.
Warning labels: If plants authorized in the second article of said agreement are incorporated, the packaging must bear the corresponding precautionary legend exactly.
Safety validation: Consultation of the Herbal Pharmacopoeia of the United Mexican States (FHEUM) is established as a reference to identify possible botanical interactions, toxicity, side effects, or risks according to the consumer's physiological condition.
EFFECTS FROM RAUPDATE
The adoption of the criteria contained in this technical guide, together with the strategic use of the classification consultation process, redefines the operational dynamics of companies in the Mexican market as follows:
Implementation of automatic rejection for incomplete data: The evaluation system dictates that if a single requirement is answered as "NO" or with "INSUFFICIENT INFORMATION," the process is suspended and the result is considered negative.
Forced modification for confectionery products: The guide prohibits the use of the word "gummies" and restricts presentations that imitate candy if used to promote consumption among minors. Companies with portfolios oriented toward sweet chewable formats must reformulate their graphic identity strategies, name their products under forms authorized by the Pharmacopoeia (chewable gums), and ensure their marketing is not directed at the child public.
Monitoring of Sanitary Alerts in Foreign Trade: In alignment with article 237 of the regulation, any ingredient with a national or international sanitary alert will be sufficient reason to prevent its entry into the country. Organizations must integrate risk matrices that permanently cross-reference their current formulas against international food safety bulletins.
Mandatory reclassification of products with pharmacological activity: Those formulations that include concentrated extracts with demonstrated therapeutic effects are excluded from the supplement category. Companies face the scenario of withdrawing the product from the market or initiating the regulatory transition toward obtaining a sanitary registration as an herbal remedy or medication, extending market introduction times and increasing operating costs.
Written by:
Mariel Antonio
Regulatory affairs specialist with extensive technical expertise in the sanitary authorization and surveillance of advertising in digital platforms and traditional media. She provides strategic guidance to dietary supplement, cosmetic, and medical device companies to ensure strict compliance with current regulations.
About IPS
At IPS, we have a team of regulatory compliance experts for the dietary supplement industry in Mexico. We support companies through formula and labeling reviews, advertising compliance, and logistical support for their expansion into the national market, helping to prevent sanctions and ensure the commercial viability of their products. Contact us to learn more about our services and guarantee your business's regulatory compliance. info@insumosparasalud.com
