The Brazilian National Health Surveillance Agency (ANVISA) has published Regulatory Instruction IN No 336, which modifies Normative Instruction No. 28, dated July 26, 2018, which establishes the lists of constituents, limits of use, declarations and complementary labeling of dietary supplements.

On June 6, the national public consultation of the draft decree “Whereby the sanitary conditions and requirements regarding dietary supplements are established, and other provisions are issued” began. This draft decree corresponds to the comprehensive update of the legislation regarding dietary supplements in Colombia, which seeks to repeal Decree 3249 of 2006 and its amending or complementary rules, such as Decree 3863 of 2008, Decree 272 of 2009 and Resolution 3096 of 2007.
The project is published in the Ministry’s web page and the consultation is open until July 17 at 6:00 p.m.
Some of the aspects to be updated are related to:

• Reference values and maximum tolerable intake levels.
• Specific Good Supply Practices.
• Harmonization of regulatory requirements with the agreements made within the framework of the Pacific Alliance with Chile and Peru.
• Adjustment of the sanitary registration issuance process, making some requirements more flexible, such as the Certificate of Good Manufacturing Practices.
• Definition of a new subcategory of products, dietary supplements for athletes.
• Establishment of minimum conditions for the use of non-psychoactive cannabis in the manufacture of dietary supplements.

All those who are interested in participating in the national public consultation can refer to the following link: https://www.minsalud.gov.co/normatividad_nuevo/forms/allitems.aspx

Comments on the draft decree must be accompanied by the appropriate technical justification during the national public consultation process.

It should be noted that, since this is a technical regulation, this process is just beginning. Once the national public consultation is completed, the comments received will be answered, adjustments will be made to the draft decree, and the required process will continue, which includes several stages such as: international public consultation, proceedings before the Superintendence of Industry and Commerce (SIC in Spanish) and the Administrative Department of Public Administration (DAFP in Spanish) on the draft technical regulation, and proceedings before the Legal Department of the Ministry for the issuance of the final version of the technical regulation.

All of the above will allow making the required adjustments to the text, with due technical justification, prior to the implementation of the standard.

The National Administration of Medicines, Food and Medical Technology (ANMAT in Spanish) prohibited the manufacture and marketing of a number of products, through its publication in the Official Gazette (Provision 5884/2024).

The products that were restricted are: “Magnesium Citrate”; “Potassium Citrate”; “Natural Ginger”; “Analgesic Black Nettle”; “Yacon Diabetes”; “Memorex Cerebral”; “Maca Forte Multivitamin”; “Higazan Plus”; “Hydrolyzed Collagen”; “Biotin Hair and Nails”; “Magnesium Chloride”; “Chupa Panza Fat Burner”; “Stem Cells Premature Aging Hyaluronic Acid/Folic Acid”; “Zinc Magnesium Calcium +D Hydrolyzed Collagen Shark Cartilage” and “Biotin Hydrolyzed Collagen” all from the brand “Natural Medix”.

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.