Dietary Supplement Regulations & Registration Process in Colombia

In Colombia, INVIMA issued 2025 alerts about dietary supplements that were being sold through websites and other channels. They didn’t have the required registration. So, the authorities warned consumers against purchasing or using them. Such cases enhance the significance of following the regulations properly.

This guide covers the regulatory framework, procedure to register, documentation, and adherence requirements for successful dietary supplements registration and compliance in Colombia.

Regulatory Authority for Dietary Supplements in Colombia

INVIMA is the regulatory authority for Colombian dietary supplements. Its English name is the National Drug and Food Surveillance Institute. In Spanish, it is Instituto Nacional de Vigilancia de Medicamentos y Alimentos.

It takes care of the sanitary registration, manufacturing and quality requirements, GMP certification and inspection, sanitary surveillance and control, advertising control, and review of changes to registered products.

The Ministry of Health and Social Protection provides the wider framework for these products.

Regulations Governing Dietary Supplements

The following regulations govern dietary supplements in Colombia:

Decree 3249 of 2006

Covers sanitary registration, manufacture, packaging, labelling, quality control, advertising, GMP, and sanitary surveillance and control of dietary supplements.

Decree 3863 of 2008

This decree amended Decree 3249. It discusses revised requirements for ingredients, maximum levels to add to vitamins, minerals, and trace elements, GMP certification, registration procedure, labelling, and advertising.

Decree 272 of 2009

It amended the advertising/label provision of Decree 3249. It bans misleading, exaggerated, or deceptive information on the product. Companies are also prohibited from adding preventive, rehabilitative, or therapeutic indications to labels and advertising.

What Are Dietary Supplements Under Colombian Regulations?

Decree 3249 defines them as products that can supplement the normal diet. They have concentrated sources of nutrients and other substances with nutritional or physiological effects in their serving. Vitamins, minerals, proteins, amino acids, other nutrients and derivatives, plants, and plant concentrates and extracts, individually or in combination, are a part of these products.

The permitted presentations include non-sterile oral pharmaceutical forms. This means solid, semisolid, and liquid forms. There are other physical forms as well that are allowed by the regulation.

To qualify as a dietary supplement, these products should not fall within the legal definition of a food, medicine, phytotherapeutic product, or other regulated pharmaceutical category. They also cannot be presented as diagnoses, treatments, prevention, or cures of illnesses.

Adulterated and Fraudulent Dietary Supplements

Colombian regulations differentiate between adulterated and fraudulent dietary supplements. It’s under Decree 3249 of 2006.

An adulterated dietary supplement may include a product that:

• Has had its authorised ingredients substituted, removed or replaced.
• Contains unauthorised substances that may change its properties or characteristics.
• Has undergone physical, chemical, biological or organoleptic changes.
• Is past its expiry date.
• Contains a quantity that does not correspond to what was authorised.
• Has not been stored or conserved under the required conditions.

A fraudulent dietary supplement may include a product that:

• Was manufactured by an unauthorised establishment.
• Does not originate from the authorised registration holder, manufacturer, distributor or seller.
• Uses packaging, containers or labels different from those authorised.
• Was imported without meeting the required technical and legal conditions.
• Has the appearance or general characteristics of a legitimate product but is not genuine.
• Does not have a valid sanitary registration.
• Is sold under a name or designation different from the one authorised in its sanitary registration.

Its Importance:

INVIMA actively issues sanitary alerts for fraudulent and illegally marketed dietary supplements. It’s particular about products sold without sanitary registration. So, manufacturers and importers must handle registration status, authorised formulation, packaging, labelling, supply chain, and storage controls as important parts of continuous adherence.

Dietary Supplements Registration Process in Colombia

Here are the outlined steps mentioned in detail:

Step 1: Determine the Registration Modality

According to Decree 3249, three registration modalities exist. These include (1) Manufacture and Sell, (2) Import and Sell, and (3) Import, Package, and Sell. The third one applies where the imported product undergoes permitted packaging operations in Colombia, such as packaging bulk product or packaging a product that has already been filled.

Choosing the correct modality is important for imported products because the registration must correspond to the actual manufacturing, importing, and packaging activities.

Step 2: Check the Classification and Formulation of the Product

Verify that the product is a dietary supplement according to the definition. It should not fall into another regulated product category. The ingredients used should be acceptable and comply with the applicable maximum levels. There should be no hazardous substances.

Decree 3863 establishes maximum daily levels for vitamins, minerals and trace elements based on the tolerable upper intake levels (ULs) in its applicable annex. It also prohibits substances that pose health risks, including hormones, pesticide residues, antibiotics, veterinary medicines, heavy metals and substances that are narcotic, psychotropic or dependency-producing.

It also identifies recognised reference sources for ingredients, including FDA, Codex Alimentarius, EFSA and ICBF, together with their updates. Ingredients or substances for which there are quality or safety alerts are not accepted.

Step 3: Prepare the Registration Dossier

Colombian dietary supplements require the following dossier:

Legal Documentation:

• Signed application from the applicant’s legal representative or attorney.
• Applicant’s legal constitution/existence and representation documents, where applicable.
• Manufacturer’s legal existence and representation certificate, where applicable.
• GMP certificate.
• Power of attorney, where applicable.
• Proof of payment of the applicable sanitary-registration fee.

Technical Documentation:

• Product presentation/form
• Packaging and container material
• Qualitative and quantitative composition of all components
• Scientific name and plant part used for botanical ingredients
• Proposed label artwork
• Mandatory statements
• Ingredient information
• Nutritional composition
• Stability information supporting shelf life

About Shelf Life Reports:

The regulation states that dietary supplements will not be granted a shelf life of more than two years unless the applicant provides stability studies supporting a longer shelf life. A shelf life exceeding two years can be supported by natural-ageing studies but cannot exceed three years.

Step 4: Apply and Pay the Appropriate Fee

Send the application to INVIMA with the corresponding documentation and payment of the fee. In case it’s incomplete, it can be rejected, and the missing documentation identified.

Step 5: Application Review by INVIMA

INVIMA validates formulation, labelling, claims, and supporting documents. When deficiencies are detected, more information will be required. In such cases, INVIMA may request it once, and the applicant has two months to respond. Failure to provide the requested information within this period can result in abandonment of the application.

Once the applicant has provided the complete information, INVIMA has 15 working days to approve or deny the registration under the procedure set out in Decree 3863. INVIMA may also visit the manufacturing plant or take samples for testing and quality control where considered necessary.

Step 6: Get the Sanitary Registration

INVIMA grants the Registro Sanitario after approval, allowing the product to be manufactured, imported, and commercialised within the approved registration modality. The registration number uses the “SD” nomenclature for dietary supplements under the decree.

Step 7: Maintain the Sanitary Registration

A Colombian dietary-supplement sanitary registration is valid for 10 years. It may be renewed for equal periods. Companies should submit the renewal application to INVIMA at least three months before the registration expires. Changes made during the validity period must also be handled through the applicable INVIMA modification process.

The decree specifically addresses changes involving excipients, manufacturing process, labels/packaging, manufacturer, registration holder, product name/brand, and commercial presentations. Other changes must also be reported to INVIMA where required.

Documents Required for Imported Dietary Supplements in Colombia

Imported products must meet the applicable national documentation requirements in addition to the documents required for domestic products. The official Decree 3249 framework requires, among other documents:

1. Certificate from the competent authority in the exporting country

The certificate must state that the product is authorised for human consumption in the country of export. This is better described as a sanitary-authority certificate of authorisation for human consumption rather than automatically calling it a “Certificate of Free Sale”.

2. Authorisation from the product owner

The applicant must have an express authorisation from the registration holder/product owner allowing the importer to apply for sanitary registration in its name and, where applicable, to use the brand and/or commercialise the product.

3. Foreign-document formalities

Foreign documents must meet the applicable authentication requirements, including apostille where applicable, and documents not in Spanish require an official translation. The decree also states that foreign documents should generally have an issuance date of less than one year or remain valid according to their terms in the country of origin.

Dietary Supplement Registration Timelines in Colombia

The applicable procedure provides for 15 working days for INVIMA to review the submitted information and approve, deny, or request additional information. Where further information is requested, the applicant has up to two months to respond, followed by a further 15-working-day period once the information is complete. Plant inspections or product testing may also affect the practical timeline.

Dietary Supplement Registration Costs in Colombia

Official fees imposed by INVIMA for registration, renewal and variation of a product depend on the dosage form, as described in its Manual Tarifario.

Applicants are required to have some additional funds available for the following:

• Translation and legalisation of foreign documents.
• Registration holder/representative fees.
• Label adaptation.
• Fees for renewal and variation post-approval.

Compliance Checklist for Dietary Supplement Approval in Colombia

When applying to INVIMA, make sure you:

• Correctly classify the product as a Dietary supplement.
• Check all ingredients for acceptability.
• Verify maximum acceptable levels of vitamins, trace elements, and minerals
• Get a valid GMP certificate for the manufacturing facility.
• Create an extensive technical report.
• Make sure the label meets INVIMA specifications and is in Spanish.
• Only use approved health claims.
• Designate a Colombian registration holder or legal representative as necessary.
• Get Sanitary Registration when importing or marketing the product.
• Confirm the INVIMA tariff before filing.

Ingredient Requirements for Dietary Supplements in Colombia

Colombia applies specific restrictions to ingredients used in dietary supplements.

Decree 3863 also states that products containing certain active ingredients alone that correspond to substances classified as vitamin supplements under pharmacological standards are not accepted as dietary supplements.

For an ingredient not covered by the accepted reference lists, the regulation provides a route through which the new substance may be evaluated and accepted by the competent INVIMA review mechanism before it can support registration.

INVIMA Labelling Requirements for Dietary Supplements in Colombia

Labels should be compliant with Decree 3249 of 2006 as amended by Decree 3863 and Decree 272. They should be included in the registration dossier and should be in the Spanish language. They must include:

• Product/Brand name.
• The designation “Suplemento Dietario”
• Ingredient list.
• Net contents.
• Recommended daily serving and directions for use.
• Nutritional information (where applicable).
• Details of manufacturer and/or importer.
• Country of origin (when the product is imported).
• Batch/lot number.
• Manufacturing and expiry dates.
• Storage conditions.
• Sanitary Registration
• Applicable declarations and warnings

Mandatory Statements:

• “This product is a dietary supplement. It is not a medicine and does not replace a balanced diet.”
• “Keep out of children’s reach.”

Other warnings may cover specific substances prohibited in sport, allergens/hypersensitivity, tartrazine, aspartame, pregnancy and breastfeeding. Labels cannot contain a statement that suggests the product is a diagnosis, treatment, cure, or prevention of disease.

GMP Requirements for Dietary Supplements in Colombia

Decree 3863 of 2008 establishes rules for obtaining Certificado de Buenas Prácticas de Manufactura (BPM)—Good Manufacturing Practices Certificate for plants manufacturing dietary supplements. The requirements vary according to the type of manufacturing establishment.

Colombian plants

Plants dedicated exclusively to dietary supplements must meet the applicable GMP requirements in the decree and its technical annex. Plants that also manufacture medicines or phytotherapeutic products are subject to specific requirements, including the applicable GMP certification. In some circumstances, prior manufacturing authorisation and cleaning-validation documentation.

Imported dietary supplements

For supplements manufactured exclusively in foreign plants dedicated to these products, INVIMA may accept a GMP certificate or equivalent document issued by the competent sanitary authority of the country of origin. If the required equivalent documentation is not available, the regulation provides for INVIMA inspection/certification mechanisms.

INVIMA also maintains an official list of national establishments with valid dietary-supplement GMP certification.

Health Claims and Advertising Regulations in Colombia

The advertising and health claims for dietary supplements fall under the scope of Decree 3249 of 2006, Decree 3863 of 2008, and Decree 272 of 2009. It is subject to prior INVIMA authorisation.

Dietary-supplement advertising requires prior approval and control. It must correspond to the benefits attributed to the characteristic ingredients of the composition. This means the interested party must request prior authorisation for advertising pieces presented to consumers through media including print, digital, television, radio, and other media.

Advertising must:

• Be complete and truthful.
• Not mislead or confuse consumers.
• Not contradicting healthy-diet and healthy-lifestyle policies.
• Not encourage harmful eating habits.
• Not claim that the supplement alone fulfils human nutritional requirements.
• Not claim that the product replaces a meal.
• Not attribute properties that cannot be demonstrated.
• Not claim that the product can prevent, relieve, treat or cure a disease, disorder or physiological condition.

Import Regulations for Dietary Supplements in Colombia

Imported dietary supplements must have the applicable INVIMA Sanitary Registration before commercial importation and sale. The registration modality must correspond to the intended import activity.

Along with import documents, INVIMA’s VUCE guidance confirms that the sanitary registration must be described in the import documentation. The Ventanilla Única de Comercio Exterior (VUCE) — Single Window for Foreign Trade is used for applicable import authorisation procedures.

Conclusion

To market a dietary supplement in Colombia, compliance with INVIMA is required for its classification, sanitary registration, labelling, GMP, and importation. A full and compliant submission streamlines the regulatory process and provides a faster pathway to market.

Artixio offers end-to-end regulatory support in Colombia, from classification and dossier preparation to INVIMA registration, labelling review, and lifecycle compliance. To know more, get in touch with us today at info@artixio.com.

FAQs

1. How long is dietary supplement registration valid?

There’s a 10-year sanitary registration, which is usually renewable.

2. Is it possible for a foreign manufacturer to apply to INVIMA?

Yes. Foreign manufacturers normally use a Colombian registration holder or a local representative to take care of their regulatory obligations.

3. Is a Free Sale Certificate required for imported dietary supplements in Colombia?

The requirement should be assessed against the documentation applicable to the sanitary-registration modality for imported dietary supplements. INVIMA’s Decreto 3249 of 2006 establishes specific documentation requirements for imported dietary supplements, and the article should not state a universal Free Sale Certificate requirement unless the applicable current INVIMA procedure specifically calls for one.