The Ministry of Health and Social Protection has announced the publication of the new draft Decree that establishes the sanitary conditions and requirements for dietary supplements, and other provisions. This new draft Decree will update the provisions on dietary supplements established in Decree No 3249 of 2006, Decree No 3863 of 2008, Decree No 272 of 2009 and Resolution No 3096 of 2007, in accordance with the policy of regulatory improvement adopted by the national government.

The objective of this initiative is to protect human health and prevent practices that may mislead consumers due to the inappropriate use of dietary supplements.

According to the health authority, from the evaluation it was concluded that it is necessary to update the regulations concerning dietary supplements in Colombia based on some recommendations such as: update the technical requirements that correspond based on the agreements of the Annex on Dietary Supplements within the framework of the Pacific Alliance; carry out a review and update of the daily reference values and maximum intake levels of vitamins, minerals and trace elements, using as main input the Recommendations for Energy and Nutrient Intake (RIEN in Spanish) adopted for the Colombian population; define specific good supply practices for dietary supplements or consider whether those in force for medicines are applicable; and strengthen post-marketing control activities for dietary supplements based on health risk management, among other regulatory and non-regulatory measures.

It should be noted that the draft Decree incorporates the following changes:

• It describes in more detail those related to the purpose and scope of application, with emphasis on activities related to “manufacturing, primary and secondary packaging, storage, marketing, quality control, supply, labeling, nutritional or health claims, sanitary registration, advertising and inspection, surveillance and control of dietary supplements”.
• Dietary supplements are confirmed as a special category, different from foods, medicines, phytotherapeutic products, cosmetics, alcoholic beverages or energy drinks.
• It incorporates a number of new definitions: Conditioner; Physical Activity, Cannabidiol or CBD; Formulation Aid or Excipient; Athlete; Exercise; Principal Ingredients; Maximum Tolerable Intake Level; Physically Active Person; Daily Serving or Daily Serving Size; High Biological Value Protein; Dietary Supplement for Athletes; and Daily Reference Value.
• Excludes from the definition of dietary supplements, the condition of “physiological or Nutritional effect” for substances other than conventional nutrients. It is replaced by “other authorized ingredients”.
• Describes how the generic name of the dietary supplement should be indicated.
• Allows new forms of presentation/pharmaceutical forms for dietary supplements, complying with a series of specific requirements.
• Expansion of the international reference list for the acceptance of nutrients and other substances.
• It incorporates the description of the procedure for the recognition of ingredients not included in the accepted references, by the Specialized Room of Phytotherapeutic Products and Dietary Supplements of the Review Commission of the National Institute of Drugs and Food Surveillance – INVIMA.
• In relation to commercialization, the commercialization of dietary supplements in the form of kits is prohibited.
• Incorporate the following legends or sentence of mandatory warnings: “ESTE PRODUCTO NO ES UN MEDICAMENTO Y NO SUPLE UNA ALIMENTACIÓN SALUDABLE” (THIS PRODUCT IS NOT A MEDICATION AND DOES NOT SUPPLEMENT A HEALTHY FOOD)”,
  Dietary supplements containing chromium should include the legend: “DIABÉTICOS: CONTIENE CROMO. CONSULTE A SU MÉDICO O NUTRICIONISTA” (DIABETICS: CONTAINS CHROMIUM. CONSULT YOUR PHYSICIAN OR NUTRITIONIST).
• Incorporates the description of the General conditions for nutrient declaration; Nutrients for mandatory declaration; General conditions of the table of nutritional information, Specific conditions of the table of nutritional information and Formats of the table of nutritional information.
• Incorporates descriptors for nutrient content claims; Requirements for comparative nutrient claims: General Requirements for Health Claims; Requirements for Nutrient Function Claims; List of 65 Accepted Nutrient Function Claims; List of 8 Risk Reduction Claims and List of 2 Other Function Claims.
• Incorporates the description of General conditions for nutrient declaration; Nutrients for mandatory declaration; General conditions of the table of nutritional information, Specific conditions of the table of nutritional information and Formats of the table of nutritional information.
• Incorporates descriptors for nutrient content claims; Requirements for comparative nutrient claims: General Requirements for Health Claims; Requirements for Nutrient Function Claims; List of 65 Accepted Nutrient Function Claims; List of 8 Risk Reduction Claims and List of 2 Other Function Claims.
• Incorporates the Daily Reference Values for amino acids.
• Incorporates for nutrition labeling compliance the following nutrient daily reference values (DRVs) for: Calories, Protein, Total Fat, Saturated Fat, Trans Fatty Acids, Omega-3 Fatty Acids, Cholesterol, Total Carbohydrates, Sugars, Dietary Fiber.
• Incorporated changes to the Tolerable Upper Level Intake (UL) for:
• Vitamins
• Vitamin D (+), Vitamin E (-), Vitamin C (+).
• Minerals
• Calcium (-), Phosphorus (+), Silicon (Not established), Vanadium (Not established).
• Amino acid
• Maximum tolerable intake levels for Arginine, Glycine, Histidine, Leucine, Lysine, Methionine, Phenylalanine, Serine, Taurine and Tryptophan.