Mexico’s nutraceutical and dietary supplements market is rapidly expanding as consumers prioritize preventive health, anti-aging, and overall wellness. With increasing awareness of lifestyle-related diseases, the Mexican nutraceutical industry is projected to reach USD 14.9 million by 2030.

To ensure product safety, efficacy, and quality, nutraceuticals and dietary supplements in Mexico are strictly regulated under the authority of COFEPRIS (Federal Committee for Protection from Sanitary Risks) a regulatory body that oversees foods, beverages, health supplements, and functional foods.

The COFEPRIS Nutraceutical Regulations mandate that all dietary supplements and functional foods comply with specific safety, quality, and labeling standards before being marketed in Mexico. The framework ensures that all nutraceuticals contribute to consumer health while maintaining scientific credibility and compliance with Official Mexican Standards (NOMs).

Key Regulatory Authorities

Definition of Nutraceuticals & Supplements (COFEPRIS Classification)

According to COFEPRIS, dietary supplements are:

“Products based on herbs, plant extracts, traditional food concentrates, dehydrated fruits, vitamins, and minerals intended to increase or supplement dietary intake.”

Permitted Ingredients

• Vitamins and minerals within approved limits
• Botanical extracts, amino acids, enzymes, probiotics, and prebiotics
• Dietary fibers, plant and algae-based ingredients

Prohibited Ingredients

• Pharmaceutical substances (e.g., procaine, ephedrine)
• Hormones, steroids, or controlled substances
• Germanium, yohimbine, or caffeine exceeding limits
• Cannabis-derived compounds (CBD, THC)

Pre-Registration Requirements

Before initiating registration, manufacturers must:

• Verify product classification (nutraceutical vs. pharmaceutical).
• Ensure ingredient compliance with COFEPRIS and NOM-051.
• Prepare documentation for product safety, efficacy, and labeling.
• Establish Good Manufacturing Practices (GMP) certification.

COFEPRIS Nutraceutical Registration Process

Required Documentation

• Product Information – Name, composition, intended use, dosage form.
• Safety Data – Toxicology and clinical safety evidence.
• Quality Control – Analytical methods and GMP compliance.
• Labeling Details – Draft label artwork per NOM-051.
• Efficacy Evidence – Published literature or clinical data if claims are made.

Labeling Requirements (NOM-051-SCFI/SSA1-2010)

All nutraceutical labels in Mexico must be:

• In Spanish language only.
• Clear, accurate, and not misleading.
• Displaying:
  • Product name
  • Ingredient list and quantities
  • Recommended dosage
  • Storage instructions
  • Manufacturer and country of origin
  • Scientific references supporting claims

Importation & Distribution

• Only COFEPRIS-registered nutraceuticals can be imported or distributed.
• Importers must retain compliance with documentation and maintain product traceability.
• Local representation in Mexico is mandatory for foreign manufacturers.

Timeline & Fees

Post-Marketing Compliance

Once approved, companies must:

• Monitor and report adverse effects.
• Renew registration on schedule.
• Notify COFEPRIS of manufacturing or label changes.
• Ensure continuous GMP compliance and periodic audits.

Allowed vs. Prohibited Ingredient Summary

Popular Nutraceutical Products in Mexico

• Omega-3 and essential fatty acid supplements
• Calcium and iron-fortified products
• Multivitamins and Vitamin C immune boosters
• Herbal extracts and functional beverages

Global Comparison: Mexico vs. Other Markets

Outlook

The Mexican nutraceutical industry continues to evolve with innovation in plant-based, probiotic, and functional formulations. Regulatory modernization by COFEPRIS is expected to streamline product registration, improve consumer trust, and attract global manufacturers to invest in the region.

Maven Regulatory Solutions assists manufacturers and distributors with COFEPRIS registration, compliance audits, labeling guidance, and post-marketing surveillance — ensuring smooth market access and full regulatory compliance in Mexico’s competitive nutraceutical market.