There is a dual regime for the categorisation of food supplements in Peru. These are classified both as foods and pharmaceutical products (dietary products) depending on the product presentation and health properties declaration:
Those in pharmaceutical form (e.g. capsules, tablets, etc.) and/or with health claims fall under the administration of the “General Directorate of Medicines, Supplies and Drugs – DIGEMID” (Dirección General de Medicamentos, Insumos y Drogas). These are regulated as dietary products in accordance with “Law No. 29459 of Pharmaceutical Products, Medical Devices and Sanitary Products (Ley n° 29459 - Ley de los productos farmacéuticos, dispositivos médicos y productos sanitarios).”
Those in food form (e.g. shakes, bars, etc.) with no health claims fall under the administration of the “General Directorate of Environmental Health and Food Safety – DIGESA (Dirección General de Salud Ambiental e Inocuidad Alimentaria)” and are regarded as foods.
Dietary products (productos dietéticos) are defined as those products whose purpose is to complement the normal diet with concentrated sources of nutrients or other substances that have a nutritional or physiological effect, alone or combined, and in dose form. They are only used orally.
Dietary products must be registered in Peru for their manufacture, import, store, distribution, market, promotion, sell or use. The General Health Law (Ley General de Salud) - Law/Ley n° 26842, which is the overarching regulation for pharmaceutical products, establishes the requirements for sanitary registration.
The sanitary registration of dietary products is granted by name, pharmaceutical form, quantity of active ingredient (expressed in unit of dose or concentration), manufacturer and country.
The application for registration is made electronically, which is available on the website of the Ministry of Foreign Trade - MINCETUR:
Applications are evaluated by the Functional Unit of Biological, Natural, Dietary Products and other Pharmaceutical Products within 60 days.
For its evaluation, the requirements from the following regulations/lists should be met:
Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products (Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos) approved by “Supreme Decree No. 016-2011-SA” and amendments;
List of documents considered equivalent to the Certificate of Good Manufacturing Practices;
List of warnings for the use of pharmaceutical and related products;
List of competent authorities for the issuance of the Pharmaceutical Product Certificate or Certificate of Free Marketing of Products or Devices;
List of vitamins, minerals and other nutrients allowed in the manufacture of dietary products;
List of colours;
List of excipients.
Dietary products are regulated under a separate section together with sweeteners, making that required documentation is different from what is required for pharmaceutical products. In accordance with “DS No. 016-2011-SA”, the required documentation is the following:
Conditions for sale
Label and leaflet (in Spanish)
Information from producer and local applicant
Specifications and analysis of active ingredients, excipients and finished product
Specifications from packaging (direct and indirect)
Certificate of free sale
According to the result of the evaluation, the dietary product is either registered under a unique identification number called the “Sanitary Registration” (Registro Sanitario) or the application for product registration is denied.
The sanitary registration of dietary products is valid for 5 years, counted from the date of authorization of the sanitary registration, and may be renewed for equal and successive periods.
The fee for product registration is about USD 1000.
Products manufactured in the country for exclusive export purposes are exempt from this requirement.
The list of vitamins, minerals and other nutrients (amino acids) that can be added to dietary products is regulated under the “RD No. 177-2013 (RD 177-2013 - Listado de vitaminas, minerales y otros nutrientes permitidos en la fabricación de productos dietéticos.)”
However, other nutrients and other sources are allowed when supportive evidence on safety and adequate use is included.
In accordance with “DS No. 016-2011-SA”, either Dietary Reference Intakes (DRI) or maximum limits considered in countries of high sanitary surveillance for this type of products can be used.
The list of countries of high sanitary surveillance (‘Países de alta vigilancia sanitaria’) are: Austria, Australia, Belgium, Canada, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Korea, Netherlands, Norway, UK, United States, Portugal, Spain, Sweden and Switzerland (as regulated by “Supreme Decree No. 016-2011-SA” and its amendments).
In accordance with “DS No. 016-2011-SA”, other substances from natural sources of plant, animal and/or mineral origin which have nutritional properties may be used. No other limitations apply.
However, when levels are too high or there are claimed therapeutic effects, the products may be classified as medicines.
In accordance with “DS No. 016-2011-SA”, dietary products do not have a specific terminology and can be referred to with any of the following terms: ´complemento dietético’, ‘suplemento dietético’ or ‘suplemento nutricional’.
The following are mandatory labelling information in dietary products:
Labelling of active ingredients and amounts
Indications for use
Name and address of manufacturer, importer/applicant