The growing demand for dietary supplements in Mexico presents a significant opportunity for companies in the sector. However, this highly competitive market demands a deep understanding of the health regulations established by COFEPRIS. Non-compliance with these regulations can lead to legal consequences that affect the brand. This document aims to provide manufacturers and marketers with the regulatory requirements that dietary supplements must meet in Mexico.
Dietary supplements have surged in popularity in Mexico, reflected in the wide variety of products on the market and the increasing number of companies entering the industry. However, their production and consumption are not without risks, and requiring specific regulations.
Understanding the regulations governing dietary supplements ensures product safety and quality, protecting consumer health and solidifying market positions.
What are Dietary Supplements?
According to Mexico's General Health Law (LGS), dietary supplements are products made from herbs, plant extracts, traditional foods, dehydrated or concentrated fruits, with or without added vitamins or minerals, that may be presented in pharmaceutical form. Their purpose is to increase total dietary intake, complement it, or supply specific components. However, to make these products more appealing to consumers, advertising often attributes to them the ability to solve health problems or improve physical conditions, which may violate existing regulations.
Regulation in Mexico
In Mexico, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) is responsible for regulating dietary supplements. This agency establishes standards to guarantee the safety and quality of these products.
Sanitary Registration: Dietary supplements do not require sanitary registration. However, a product classification consultation can be requested from COFEPRIS to verify compliance with applicable legal frameworks based on the product's formulation and labeling.
Labeling: The Sanitary Control Regulations for Products and Services (RCSPyS) require specific labeling for dietary supplements, including product name, ingredient list, nutritional information, manufacturer or distributor data, lot number, expiration date, precautionary statements, consumption and storage instructions, among other aspects. This ensures consumers have the information needed to make informed choices.
Advertising: Advertising for these products is strictly regulated by the Regulations of the General Health Law on Advertising (RLGSMP), which prohibits attributing characteristics to dietary supplements that do not correspond to their function, such as claiming that a product alone meets nutritional requirements, treats or prevents diseases, or alters body proportions. An advertising permit from COFEPRIS is required to avoid misleading claims.
Importation: Dietary supplements intended for import must have a prior Sanitary Import Permit (PSPI) issued by COFEPRIS. This document allows health authorities to verify compliance with current sanitary legislation.
Additionally, companies manufacturing dietary supplements must consult and comply with the following regulations:
Regulation on food, beverage, and dietary supplement additives and coadjuvants.
Regulation on permitted and prohibited plants for teas, infusions, and edible oils.
Mexican Herbal Pharmacopoeia.
The above regulations ensure that products contain only authorized ingredients in safe levels.
Finally, as part of regulatory compliance, companies must also comply with NOM-251-SSA1-2012, which establishes good hygiene practices in the manufacture of products.
Conclusion
Adherence to regulations is essential for the long-term sustainability of any company in the dietary supplement sector. Compliance prevents penalties and facilitates access to new markets, strengthening consumer trust.
Written By:
Mariel Antonio
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