Colombia

Classification

Suplementos dietarios are regulated by Decreto 3249 de 2006 as amended by Decreto 3863 de 2008.

Suplementos dietarios are not foods or pharmaceuticals but a separate category.

They are an addition to the normal diet.

Concentrated sources of nutrients and other substances with a physiological or nutritional effect.

Contain vitamins, minerals, proteins, amino acids, plant extracts and concentrates or other substances.

Distribution in pharmaceutical forms for oral use or other forms is permitted.

 

Registration

·        Sanitary registration required with Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA).

·         The submission must be made in person and include the following:

  • Administrative data

  • GMP certificate

  • Packaging, full quantitative and qualitative description of all compounds, labelling, plants (species and parts used)

. For imported products, the following requirements apply:

  • A certification by the authority of the exporting country, 1 year old at most

  • Authentication by Colombian consul and foreign affairs + official translation

  • Delegation to the importer

. The procedure should take 15 days, although in practice it may take longer.

. The registration is valid for a period of 10 years.

·         The costs are $ 1400.

Composition

·        Composition is regulated in Decree 3863 of 2008.

·     The decree establishes that products which as a single active compound have a vitamin, are considered vitamin supplements regulated under pharmacological regulation.

·       The decree also establishes maximum levels for vitamins which are relatively high but no minimum levels.

·     Substances with an inherent health risk are prohibited. These include hormones and residues of antibiotics, veterinary medicines, heavy metals etc.

. For other substances permitted in food supplements, the decree refers to the rules established by the FDA, the Codex Alimentarius, EFSA as well as the Colombian Institute of Family Wellbeing. Other substances include substances generally recognized as safe (GRAS) and additives.

. For foods for particular nutritional purposes and dietary foods, the decree refers to the corresponding EU frameworks.

. There is a list of authorized plants with therapeutic effects, containing conditions of use and additional statements or warnings. It is also indicated whether they are allowed for free sale or require prescription. These plants can consequently be used as ingredients in food supplements.

. There is also a list of prohibited plants. These are plants with a known toxic effect. They are prohibited even if they are included in the GRAS index.

. For common foods, also the list of the Colombian Institute of Family Wellbeing is relevant.

. New ingredients not included in the above-mentioned lists can still be authorized as novel foods.

 

Labelling

Claims

·       The general food labelling legislation does not apply.

·       The relevant rules for the labelling of food supplements are also included in Decree 3863 of 2008.

·     On the label, the following must be declared:

  • Dietary supplement

  • The name of the importer

  • The manufacturer

  • The nutritional composition

  • The statement “THIS PRODUCT IS A DIETARY SUPPLEMENT, NOT A MEDICINE AND DOES NOT PROVIDE A BALANCED DIET”

  • Keep out of the reach of children

  • Do not consume in pregnancy and lactation

. For imported products, the following is not required in Spanish:

  • List of ingredients

  • Registration number

  • Storage conditions

. The following ingredient specific warnings are mandatory:

  • Pregnant women must not consume dietary supplements containing Vitamin A, except on medical prescription.

  • Maximum intake level for people with a diet high in retinol, with calcium metabolism problems or diseases of the bones.

  • People with high alcohol intake, exposed to asbestos or smokers must not consume dietary supplements containing Beta Carotene.

  • For dietary supplements with Vitamin K: People taking anticoagulants must not consume dietary supplements with Vitamin K.

  • Although the adverse effects of high thiamine intake are unknown, these may still be present and therefore the intake must be done carefully.

  • The absorption of Vitamin B12 is limited, therefore high intakes do not present any benefit.

  • Consumption higher than 1600 mg of calcium can cause kidney stones, hypercalcemia, milk-alkali syndrome and renal failure.

  • Dietary Supplements with 3700 mg/day of Potassium of can produce erosions at the gastrointestinal level. Children, elderly and patients with conditions such as pre-existing hyperkalemia, renal disease, acidosis, insulin or digitalis intoxication should not take dietary supplements with Potassium without a prescription.

  • Allergens: "May Cause Hypersensitivity".

  • Tartrazine or FD&C yellow no 5 “Contains […]. May cause hypersensitivity“.

  • Aspartame: "Consuming this product is not suitable for people with Phenylketonuria“.

  • Substances prohibited in sport, according to the current list of World Anti-Doping Agency: "THIS PRODUCT CONTAINS SUBSTANCES PROHIBITED IN SPORT".

. Nutrient declarations for dietary supplements are regulated in Resolution 3096 of 2007.

. Calories and macronutrients may also be declared. If they are declared, the order must be the following:

  • Total calories and calories from fat

  • Fats, saturates, trans fats, cholesterol, sodium, carbohydrate, dietary fiber, sugar protein

  • Vitamins, minerals

  • Other substances (e.g. plants)

. The declaration of macronutrients is optional except when claims are used.

. Trans fats must be declared when there are claims on saturates, cholesterol or heart disease.

. The nutrition declaration must be in one of the formats indicated in the Resolution.

. A linear format is also allowed.

. Nutrients must be declared per daily portion. The portion size must be indicated as well as the reference values.

·  Statements on health properties are regulated in Resolution 3096 of 2007.

·       There are three different types of statements:

  • Declarations on properties related to the function of nutrients, for instance “Vitamin B 12 is necessary for the production of erythrocytes”.

  • Declarations on the reduction of disease risks, e.g. “A diet low in saturates may reduce the risk to cardiovascular disease”.

  • Declarations related to other functions such as probiotics and the normalization of digestive functions.

·      There are 12 authorized nutrient function claims:

  • CALCIUM helps in the development of strong bones and teeth.

  • PROTEINS help build and repair body tissues.

  • IRON is a factor in the formation of red blood cells.

  • VITAMIN D helps the body use calcium and phosphorus.

  • MAGNESIUM promotes absorption and retention of calcium.

  • (indicate source) provides FIBER to promote digestion.

  • VITAMIN B1 / THIAMIN is needed for energy from carbohydrates.

  • VITAMIN B2 / RIBOFLAVIN is needed for energy from proteins, fats and carbohydrates.

  • NIACIN is needed for energy from proteins, fats and carbohydrates.

  • VITAMIN B12 / CYANOCOBALAMIN is required for the production of red blood cells.

  • FOLIC ACID is essential for the growth and division of cells.

·  The followed disease risk reduction claims are authorized:

  • Calcium and the reduction of osteoporosis risk

  • Low saturates and the reduction of heart disease risk

  • Folic acid and the reduction of neural tube risk

  • Low sodium and the reduction of high blood pressure risk

  • Potassium and the reduction of high blood pressure risk

  • Soluble fiber and the reduction of heart disease risk

  • Stanol esters (including isoflavones) and the reduction of heart disease risk

  • Soy protein and the reduction of heart disease risk

  • Omega 3 and the reduction of heart disease risk

·  Other allowed function claims relate to probiotics and the digestive system, the intestinal flora and the immune system.

· The publicity of food supplements requires prior authorization.

. The authorization is a procedure separate from the product registration.

. The costs are 85 USD for <100 pages.

. The procedure takes 15 days.

. Authorization is to be obtained from the National Institute for Medicine and Food Surveillance (INVIMA) in accordance with the rules established by the Ministry of Social Protection.