Food & Dietary Supplements Registration in Colombia

End-to-end support from experienced regulatory experts.

Food & Dietary Supplements Registration in Colombia – Overview

In Colombia, food products and dietary supplements are regulated by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), which oversees sanitary compliance and market surveillance.

Regulatory requirements depend on product classification, composition, labeling, and intended use. Dietary supplements are prohibited from making therapeutic or preventive claims.

Freyr supports manufacturers with comprehensive regulatory consulting services, including product classification, regulatory pathway assessment, formulation and ingredient review, labeling and claims compliance, technical documentation preparation, and support throughout registration or notification processes before INVIMA.

Product Classification – Food and Dietary Supplements in Colombia

In Colombia, the classification of food products and dietary supplements is governed by the national sanitary framework and supervised by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA). Product classification directly determines the applicable regulatory pathway, including requirements related to labeling, composition, claims, and sanitary authorization or notification.

All products must comply with Colombian sanitary regulations and must not include misleading information or imply therapeutic, preventive, or curative properties, unless expressly authorized under the applicable regulatory category.

Foods

Foods include any natural or processed substance intended for human consumption that provides nutrients necessary for growth, maintenance, and normal physiological functions. These products are regulated as conventional foods and are subject to sanitary control requirements related to safety, labeling, and quality, as established by INVIMA.

Dietary Supplements

Dietary supplements are products formulated with vitamins, minerals, herbs, plant extracts, or other ingredients of nutritional origin, presented in pharmaceutical or similar dosage forms such as capsules, tablets, powders, or liquids. Their purpose is to supplement the normal diet.

Under Colombian regulation, dietary supplements are strictly prohibited from claiming therapeutic, preventive, or medicinal effects. Labeling, composition, and claims are subject to regulatory review to ensure compliance with INVIMA requirements and to prevent consumer misinterpretation.

Freyr Expertise

  • Support in the classification of food products and dietary supplements under Colombian regulations
  • Regulatory pathway assessment for food and dietary supplements in Colombia
  • Ingredient and formulation review against applicable Colombian sanitary requirements
  • Labeling review and compliance assessment (mandatory information and alignment of claims)
  • Claims review to ensure non-therapeutic positioning in line with INVIMA requirements
  • Gap analysis against applicable regulatory expectations
  • Technical documentation support for registration or notification processes, as applicable

Freyr Advantages

  • End-to-end regulatory consultation
  • Market-specific regulatory consulting and advice
  • A structured and cost-effective approach, supporting timely market access
  • An extensive global partnership network
  • Solid experience interacting with health authorities.