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Nutraceutical Regulations and Registration in Colombia (INVIMA)

The Colombian nutraceutical market is likely to continue growing as consumers increasingly prioritize their health and well-being. As the market evolves, there may be a greater emphasis on personalized nutrition and innovative product offerings that cater to specific health concerns. The global COVID-19 pandemic triggered a profound shift in lifestyle priorities. A report from Glanbia Nutritional highlights a significant finding: more than 50% of consumers expressed intentions to embrace a more active lifestyle post-pandemic. Colombia's health supplement Market is projected to grow at a rapid pace during the forecast period. The Market was valued at US$47.938 million in 2020 and is projected to grow at a CAGR of 8.99% to attain a value of US$87.661 million by 2027.

Nutraceutical Regulations Registration  Colombia INVIMA

This article outlines the nutraceutical regulations and registration in Colombia (INVIMA)

Nutraceutical regulatory framework in Colombia.

The primary regulatory authority responsible for regulations and registration overseeing nutraceuticals and dietary supplements in Colombia is the National Food and Drug Surveillance Institute (INVIMA). INVIMA operates under the Ministry of Health and Social Protection and is responsible for ensuring the safety, quality, and efficacy of food products, including nutraceuticals.

Health supplement diversity in Colombia.

The Colombian nutraceutical market encompasses a wide range of products, including dietary supplements, functional foods, vitamins, minerals, herbal products, and other wellness-enhancing products. These products are marketed for various health benefits, including immunity support, digestive health, weight management, cognitive function, and more.

INVIMA nutraceutical Registration process.

Legal Documentation:

  • Duly signed application by legal representative.

  • Company details: name, address, manufacturer's name, and product brand.

  • Proof of petitioner entity's constitution and legal representation.

  • Manufacturer's existence and legal representation certificate.

  • GMP (Good Manufacturing Practices) certificate.

  • Power of attorney for process management if applicable.

  • Payment receipt for sanitary registry issuance.

  • Technical Documentation:

Product technical sheet.

  • Container, packaging details.

  • Ingredient composition with scientific names for plants.

  • Label artwork with mandatory statements, ingredients, and nutrition.

  • Shelf life up to 2 years, extendable to 3 with stability studies.

  • Proof of BSE-free ingredients if applicable.

Health Claims and Scientific Evidence:

Nutraceutical products that make health claims must be supported by scientific evidence. This evidence could include clinical studies, research data, or other relevant scientific literature that substantiates the claimed benefits of the product. INVIMA evaluates the scientific evidence provided during the registration process to ensure that the claims are accurate and supported by reliable data.

Registration of Imported Products:

  • Health certificate from the exporting country's authority (within 1 year).

  • Importer's authorization from the product owner.

  • Documents authenticated by Colombian consul and Ministry of Foreign Affairs, with official translation.

Authorization of Advertising nutraceuticals in Colombia:

  • Prior authorization is needed for advertising.

  • Separate from product registration, Obtained from INVIMA following Ministry of Social Protection rules.

Nutraceutical Labelling requirements INVIMA:

  • Product Name: Clear and concise name describing the product.

  • Ingredients List: All ingredients used, along with their respective quantities.

  • Nutrition Information: Nutritional content per serving, including macronutrients and micronutrients.

  • Usage Instructions: Recommended dosage and instructions for use.

  • Warnings and Precautions: Any potential side effects, contraindications, or special instructions.

  • Manufacturer Information: Name, address, and contact details of the manufacturer or distributor.

  • Batch Number and Expiry Date: For traceability and consumer safety.

Compliance with Good Manufacturing Practices (GMP):

Manufacturers of nutraceutical products are generally expected to follow Good Manufacturing Practices (GMP) to ensure the quality, safety, and consistency of their products. Compliance with GMP standards helps ensure that the manufacturing process maintains product integrity and minimizes the risk of contamination or errors.

Timeline and fee associated with nutraceutical registration in Colombia:

Upon submission of the registration dossier to INVIMA, the procedure is expected to conclude within 15 business days, though practical durations can be longer. The registration expenses for dietary supplements amount to approximately USD 1,150.



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