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Mexico is Latin America's second-largest economy and a rapidly growing supplement market, driven by urbanisation, rising health awareness, and a large middle class. Supplements (Suplementos Alimenticios) are regulated by COFEPRIS (the Federal Commission for Protection against Health Risks) and require notification or registration before sale.
COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) regulates food supplements under the Mexican Official Standard NOM-086-SSA1-1994 (health claims) and general food law. Most dietary supplements are classified as 'Suplementos Alimenticios' and require notification to COFEPRIS rather than full registration. However, products with specific health claims or ingredients approaching medicinal claims may trigger the full registration pathway, which is significantly more complex and expensive.
Mexico's NOM-051-SCFI/SSA1-2010 is one of the world's strictest front-of-pack labelling standards, requiring black octagon warning labels for products that exceed threshold levels for: calories, added sugars, saturated fat, trans fat, and sodium. Many supplement products (especially protein powders, meal replacements, and gummies) trigger one or more octagon warnings. Labels without required octagon warnings cannot be legally sold in Mexico and will be detained at customs.
Importing supplements into Mexico requires: (1) A Mexican importer (Importador) registered with COFEPRIS. (2) A health permit (Aviso/Permiso de Importación) for each product. (3) Labels in Spanish with all NOM-051 requirements met. (4) A Mexican-address FBO on all labels. (5) Customs clearance via a Mexican customs broker (Agente Aduanal). Import tariffs for food supplements vary but USMCA (successor to NAFTA) provides preferential tariffs for US-origin products.
Labels must be in Spanish — Latin American Spanish with Mexican-appropriate terminology. The label must include: product name, ingredient list, NOM-051-compliant nutrition facts panel in the Mexican format (different from US or EU format), net quantity, best before date, lot number, country of origin, and the name and address of a Mexican-established responsible party. COFEPRIS notification number should appear if applicable.
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