The National Health Surveillance Agency (ANVISA in Portuguese) has published an amendment to Normative Instruction No. 28/2018, which establishes the lists of components, usage limits, claims, and supplementary labeling for food supplements.

 

The Ministry of Production, Foreign Trade, Investments and Fisheries (MPCEIP) has announced that it is extending the deadline (60 days) for submitting comments and contributions on the draft Partial Reform of the Sanitary Technical Regulations for Obtaining Sanitary Notification and Control of Food Supplements at Establishments Where They Are Manufactured, Stored, Distributed, Imported, and Marketed, Resolution ARCSA-DE-028-2016-YMIH, published in Official Registry Supplement No. 937 of February 3, 2017. The purpose of the regulatory project in question is to establish the Good Manufacturing Practices (GMP) conditions for food processing plants, as well as the requirements that must be met by the manufacturing, production, processing, preparation, packaging, contract manufacturing, transportation, storage, import, distribution, and marketing of processed foods for human consumption.

Without a specific regulatory category that clearly defines what a dietary supplement is, based on its nature, confusion arises in Peru about whether it should be treated as food or medicine (despite being distinct products). This impacts the regulatory treatment given to it, which constitutes a barrier to the development of this industry in the country.
Therefore, it is imperative that Peruvian legislation clearly differentiate dietary supplements from pharmaceutical products and from the food category. Having an autonomous classification would allow for the establishment of technical and health criteria appropriate to their nature, guarantee oversight of their characteristics, and provide greater legal certainty for all involved. This regulatory differentiation would not only strengthen the protection of public health but would also promote the development of a more dynamic, safe, and competitive supplement market. Currently, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID in Spanish) has the authority to regulate and establish the procedures applicable to dietary supplements, pursuant to Law 29459, the Law on Pharmaceutical Products, Medical Devices, and Health Products. This law defines pharmaceutical products as preparations intended to prevent, diagnose, treat, or cure diseases, a classification that includes the category of dietary products, even though the latter do not have a therapeutic purpose.
However, Article 17 of Decision No. 9 of the Free Trade Commission of the Additional Protocol to the Pacific Alliance Framework Agreement (the decision applicable to Peru) establishes that the competent authority to regulate the category of dietary supplements should be the General Directorate of Environmental Health and Food Safety (DIGESA in Spanish).

The National Health Surveillance Agency (ANVISA in Portuguese) has published Normative Instruction IN No. 361/2025, which amends Normative Instruction IN No. 28/2018, which establishes the lists of components, limits of use, declarations and supplementary labeling of food supplements.

Amendments:

I – “List of components authorized for use in food supplements, except for food supplements intended for infants (0 to 12 months) or young children (1 to 3 years)”, contained in Annex I;

II – “List of minimum limits for nutrients, bioactive substances, enzymes, and probiotics that food supplements must provide, in the recommended daily intake and by population group indicated by the manufacturer”, contained in Annex III;

III – “List of maximum limits for nutrients, bioactive substances, enzymes, and probiotics that food supplements cannot exceed, in the recommended daily intake and by population group indicated by the manufacturer”, contained in Annex IV;

IV – “List of claims authorized for use on the labeling of food supplements and their respective composition and labeling requirements”, contained in Annex V; and

V – “List of requirements for the supplementary labeling of food supplements”, included in Annex VI.

Art. 2 The “List of components authorized for use in food supplements, except for food supplements intended for infants (0 to 12 months) or young children (1 to 3 years)” in Annex I of Regulatory Instruction – EN No. 28 of 2018, enters into force with the addition of the components listed in Annex I of this Regulatory Instruction.

Art. 3 The “List of minimum limits of nutrients, bioactive substances, enzymes, and probiotics that food supplements must provide in the recommended daily consumption and by population group indicated by the manufacturer” in Annex III of Regulatory Instruction – IN No. 28 of 2018, will enter into force with the addition of the limits listed in Annex II of this Regulatory Instruction.

Sole paragraph. Footnote iii is changed to “As cholecalciferol. 1 μg of cholecalciferol = 40 IU of vitamin D = 0.3333 μg of calcidiol.”

Art. 4 The “List of maximum limits of nutrients, bioactive substances, enzymes, and probiotics that cannot be exceeded by food supplements in the recommended daily intake and by population group indicated by the manufacturer” of Annex IV of Regulatory Instruction – IN No. 28, of 2018, will enter into force with the addition of the limits listed in Annex III of this Regulatory Instruction.

Sole paragraph. Footnote ii is changed to “As cholecalciferol. 1 μg of cholecalciferol = 40 IU of vitamin D = 0.3333 μg of calcidiol.”

Art. 5. The “List of Authorized Declarations for Use in the Labeling of Dietary Supplements and the Respective Composition and Labeling Requirements” in Annex V of Regulatory Instruction – IN No. 28 of 2018 will enter into force with the addition of the declarations listed in Annex IV of this Regulatory Instruction.

Art. 6. The “List of Supplementary Labeling Requirements for Food Supplements” in Annex VI of Regulatory Instruction – IN No. 28 of 2018 will enter into force with the incorporation of the supplementary labeling requirements listed in Annex V of this Regulatory Instruction.

Art. 7. A period of 24 (twenty-four) months is established for the adaptation of the labeling of food supplements that contain any of the constituents provided for in this Regulatory Instruction and that have been regularized before the National Health Surveillance System by the date of publication of this Regulatory Instruction.

The Committee on Science, Technology, Innovation and Information Technology and the Committee on Transparency, Governance and Consumer Protection discussed in a public hearing the growth in the consumption of dietary supplements in Brazil without proper sanitary control.
The debate was proposed (REQ 6/2025 – CCT and REQ 3/2025 – CTFC) by Senator Astronauta Marcos Pontes (PL-SP), who highlighted the urgency of clearer regulation and investments in laboratory equipment, such as liquid chromatographs, essential for product analysis.
The experts warned about the risk of unauthorized substances and highlighted loopholes in the importation of products. Senators defended more investments in the National Health Surveillance Agency (ANVISA in Portuguese), such as the purchase of equipment to analyze the composition of supplements. Updates to legislation and mechanisms to improve oversight were also discussed.

For further information, consult the following sources in Portuguese: Link(1), Link(2)