The Federal Commission for Protection against Sanitary Risks (COFEPRIS) is entrusted with the crucial task of overseeing and regulating products and services intended for human consumption, such as food supplements, to ensure their quality and safety. This article explores the surveillance actions undertaken by COFEPRIS and the key aspects companies should consider.
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is entrusted by the General Health Law (LGS) to exercise sanitary control and surveillance over specific products and services intended for human use and consumption. This ensures their safety and quality.
Dietary supplements, an industry experiencing significant growth in consumer habits, fall under these products subject to sanitary surveillance. It's crucial to understand COFEPRIS's surveillance actions and the key aspects companies must address to comply with current regulations.
According to the LGS, dietary supplements are products based on herbs, plant extracts, traditional foods, or dehydrated/concentrated fruits, with or without added vitamins or minerals. They can be presented in pharmaceutical form and aim to increase, complement, or replace components of the total dietary intake.
These products have a specific regulatory framework outlining the fundamental aspects that manufacturers, marketers, distributors, and importers must adhere to. It also specifies the mechanisms COFEPRIS will use to conduct sanitary surveillance, ensuring compliance with these regulations.
Sanitary surveillance is carried out through verification visits and, in the case of advertising, verification reports.
Verification visits, conducted by COFEPRIS specialists, occur directly at the establishment where dietary supplements are manufactured or marketed. Inspectors must have a Verification Order specifying the company name, address (matching the Operation Notice), and the visit's purpose (aspects to be reviewed).
For establishments manufacturing and packaging dietary supplements, visits primarily focus on compliance with NOM-251-SSA1-2009, Good Hygiene Practices for processing food, beverages, or dietary supplements. This standard covers aspects like facility and equipment maintenance, raw material traceability, and waste management.
Verification also includes reviewing aspects directly observable in the finished product, mainly related to labeling and ingredients:
Product name inclusion
Nutritional information
Absence of therapeutic, preventive, or rehabilitative claims
Ingredient list
Regarding advertising, besides visits, COFEPRIS can issue Verification Reports, analyzing advertising material for compliance with the Regulation of the General Health Law on Advertising. For dietary supplements, this includes:
Having the necessary advertising permit
Attributing only characteristics corresponding to dietary supplements
Including precautionary statements
If non-compliance is found during visits or reports, COFEPRIS can impose security measures like product seizure, activity suspension, or advertising suspension.
COFEPRIS's surveillance actions are crucial for ensuring the safety and quality of dietary supplements in Mexico. Through a specific regulatory framework and constant verification, COFEPRIS protects consumer health and fosters trust in the industry.
Companies must proactively comply with regulations. Prioritizing quality and safety is not only an obligation but also an opportunity to differentiate themselves in the market and build a strong, reliable brand.
Written By:
Mariel Antonio
about ips
If your company requires assistance in meeting COFEPRIS regulatory requirements, IPS has a team of experts in sanitary regulation ready to assist you. Contact us at info@insumosparasalud.com for more information about our services.