The composition of dietary supplements is regulated in “Decree (Decreto) No. 3863/2008”.
Dietary supplements should not meet the definitions for food, medicine, herbal products, or pharmaceutical preparations from natural sources and alcoholic beverages. For instance, products with vitamins as a single active compound are considered “vitamin supplements”, regulated under the pharmacological regulation.
I. VITAMINS AND MINERALS
Annex I of the Decree establish the Recommended Daily Values and Upper Levels for vitamins and minerals. There are no minimum levels established.
II. HERBAL SUBSTANCES
The use of plants with proven nutritional contribution and permitted by the U.S. FDA (botanical GRAS), the Codex Alimentarius, European Commission, as well as the Colombian Institute of Family Welfare (Instituto Colombiano de Bienestar Familiar - ICBF), are allowed in dietary supplements.
Additionally, those plants permitted in the “List of authorised plants with therapeutic effects” (Pharmacological Norms, 2006), are permitted. These contain conditions of use and additional statements or warnings. It is also indicated whether they are allowed for free sale or require prescription.
There is also a list of prohibited plants, these are plants with a known toxicological effect. They are prohibited even if they are classified as GRAS.
III. OTHER SUBSTANCES
Annex 3 of the Decree allows the use of other substances if permitted by any of following references: U.S. FDA, the Codex Alimentarius, European Directives for "foods for particular nutritional uses", "dietetic foods" or " dietary foods", as well as the Colombian Institute of Family Welfare - ICBF.
These can include substances “Generally Recognized as Safe (GRAS)”, enzymes or additives. Common foods included in the Colombian food composition table from ICBF are also permitted.
New ingredients not included in the above-mentioned lists can be evaluated and authorised by a Review Committee from INVIMA (Sala Especializada de Productos Fitoterapéuticos y Suplementos Dietarios de la Comisión Revisora).
IV. SUBSTANCES NOT ALLOWED
Substances with an inherent health risk are prohibited. These include hormones and residues of antibiotics, veterinary medicines, heavy metals, etc.