Brazil

I. FOOD SUPPLEMENTS

Food supplements are classified as foods in Brazil. With the aim of unifying and simplifying their former regulatory framework, the Brazilian health authority of ANVISA introduced new regulations in 2018.

In accordance with Resolution (Resolução) “RDC No. 243/2018”, food supplements (suplementos alimentares) are defined as “products for oral ingestion, presented in pharmaceutical forms, intended to supplement the diet of healthy individuals with nutrients, bioactive substances, enzymes or probiotics, isolated or combined.”

The permitted pharmaceutical forms can be solid, semi-solid or liquid, such as capsules, tablets, liquids, powders, bars, gels, lozenges, chewing gums, etc.

Resolution (Resolução) “RDC No. 843/2024” and Normative Instuction (Instrução Normativa) "IN 281/2024"regulates the registration of foods.

Food supplements must be notified to ANVISA prior to their supply by the manufacturer or the importer.

The holder of the notification is responsible for:

I - ensuring the correctness of the information presented in the regularization procedures;
II - ensuring the sanitary requirements of composition, quality, safety and labeling established for the regularized product;
III - requesting changes to the information provided in the regularization process whenever the product undergoes modification due to an update in legislation or by determination of the health authority;
IV - requesting revalidation of registration or maintenance of notification, whenever there is an interest in continuing to make the product available on the market; and
V - requesting cancellation of regularization, when there is no longer any interest in offering the product.

The data required for the notification are:
- Notification form duly completed;
- Copy of the valid health license of the manufacturer(s);
- Report of stability studies that guarantee the nutritional properties of the product throughout the declared shelf life, including post-reconstitution studies in the case of products for dilution;
- Analysis report/certificate or calculation report for the product that proves compliance with the composition requirements established by the specific technical regulation.

Notifications generally do not involve an assessment by ANVISA and the product can only be offered on the market after the notification has been filed.
The labeling of the notified food must contain the information statement "Food notified at Anvisa:", followed by the full number of the notification process.

However, ANVISA may request additional information to that included in the notification, in order to assess the adequacy of the notified product to the legislation.

Every 5 years from the entry into force of RDC 843/2024, it is necessary to submit a request to maintain the notification and avoid inactivation from the authority.

IV. COMPOSITION OF FOOD SUPPLEMENTS iN BRAZIL

Resolution (Resolução) “RDC No. 243/2018” and Normative Instruction (Instructiva Normativa) “IN No. 28/2018” regulate the composition of food supplements.

(i) Nutrients, bioactive substances and enzymes

• Annexes I and II of “IN No. 28/2018” establish the list of constituents authorised in food supplements for different population groups. These include the following:
  • Nutrients (proteins, carbohydrates, dietary fibres, fatty acids, vitamins and minerals);
  • Bioactive substances (such as caffeine, coenzyme Q10, lycopene, lutein…);
  • Enzymes (lactase and fitase);
  • Other substances (creatine, taurine, carnitine and adenosine).
• Annexes III and IV of “IN No. 28/2018” establish the minimum and maximum levels of nutrients, bioactive substances, enzymes and probiotics in food supplements for different population groups.
• Furthermore, “RDC No. 243/2018” provides for nutrients, bioactive substances and enzymes to fully comply with the specifications of identity, purity and composition established in at least one of the following references:
  • Brazilian Pharmacopoeia;
  • Foreign pharmacopoeias officially recognized (“RDC No. 37/2009”). These include the Argentine, British, European, French, German, Japanese, Mexican, Portuguese, U.S.  and International Pharmacopoeia (WHO);
  • Codex Alimentarius;
  • Joint FAO / WHO Expert Committee on Food Additives (JECFA);
  • Food Chemicals Code - FCC;
  • USP Dietary Supplement Compendium - DSC; or
  • European Food Safety Authority (EFSA).

(ii) Probiotics

• A list of probiotics authorised for use in food supplements has been introduced by “IN No. 76/2020” in the list of constituents set by IN 28/2028.
• The products containing probiotics must meet the minimum levels included in Annex III of “IN No. 28/2018” to be able to use the authorised claim.
• The use of probiotics in food (including food supplements) requires both proof of their safety and health benefits, that is, their effectiveness. The requirements for proving the safety and health benefits of probiotics are included in “RDC No. 241/2018”.
• The "Guide for procedural instructions for petitions to evaluate probiotics for use in food" ("Guia Para Instrução Processual De Petição De Avaliação De Probióticos Para Uso Em Alimentos), published in 2021 by ANVISA, is a guideline on how to structure technical-scientific dossiers to support requests for the evaluation of probiotics in food, including information on the identity, safety and benefits of the probiotic strain.

(iii) Herbal substances

• Concentrates and plant extracts may be used in supplements, provided that their purpose is to provide one of these constituents included the food supplement definition (nutrients, bioactive substances and enzymes). An example is garlic extract, which is permitted as a source of allicin (bioactive substance).
• Permitted plant extracts must have a history of safe use or evidence on their safety.

(iv) Other substances

• Additives and processing aids permitted for use in food supplements are regulated in “RDC No. 778/2023”.
• Ingredients that are traditionally used in food preparation can be used in food supplements if their aim is to provide flavour, colour or aroma or to dissolve, dilute, disperse or change their consistency or shape. These ingredients cannot have any claim associated to them that indicates they are a source of nutrients, bioactive substances or probiotics (RDC No. 243/2018).
• Some examples of traditional ingredients (with evidence of safe use) are fruit pulps, chocolate, spices, cereals or starch. However, this does not apply to all herbal extracts, even those obtained from vegetables or fruits with a tradition of consumption, since they may contain a concentration of substances that represent a risk to the health of the consumer. Therefore, plant extracts must have proven safety of use before their inclusion in the positive list.

(v) Substances not allowed

The following substances are not allowed in food supplements (RDC No. 243/2018):

• Substances considered as doping by the World Anti-Doping Agency;
• Substances and drugs subject to special control (Ordinance (Portaria) No. 344/1998);
• Substances obtained from species that cannot be used in the composition of traditional herbal products (Annex I of RDC No. 26/2014);
• Partially hydrogenated oils and fats.

V. LABELLING REQUIREMENTS OF FOOD SUPPLEMENTS IN BRAZIL

(i) The labeling of food supplements is regulated by "RDC No. 243/2018" and specific labelling provisions and warnings for certain nutrients are laid down in Annex VI of “IN No. 28/ 2018” (E.g., "This product should not be consumed by pregnant women, nursing mothers and children").

(ii) Name of the product:
- The descriptor name “Suplemento Alimentar” (food supplement), followed by its presentation form and voluntarily individual names or category names or source names of nutrients, bioactive substances or enzymes shall be included. E.g.: Vitamin C food supplement in tablets (“Suplemento Alimentar de vitamina C em cápsulas”).
- The designation must be declared close to the product brand and with legible characters. E.g.: in upper case, in bold, in a colour contrasting with the label background and with a minimum font size. 

(iii) Recommendation of use including the following information all grouped:
 

• The population groups for which the product is indicated, including the age group in the case of children (Annexes III and IV of “IN No. 28/2018”);
• The quantity and frequency of consumption for each of the population groups;
• The highlighted and bold warning "This product is not a medicine";
• The highlighted and bold warning "Do not exceed the recommended daily consumption indicated on the packaging"; and
• The highlighted and bold warning "Keep out of the reach of children".

(iv) The storage instructions, even after opening the packaging; and

(v) For food supplements containing probiotics, the identification of the species of each strain, according to the most current binomial nomenclature, in the list of ingredients.

vi) The nutritional labelling of food supplements must follow the provisions of “RDC No. 429/2020” and "IN No. 75/2020", with the following considerations:

• The portion declared must be the daily amount recommended by the manufacturer, for each of the population groups and specific age groups;
• The nutritional information table must contain a declaration of the amounts of energy value and all nutrients, bioactive substances and enzymes added to the product.
• The %VD must be determined based on the VDR defined in Annex VIII of Normative Instruction "IN No. 75, of 2020", for each of the specific population groups indicated on the label.

(vii) Specific warnings for certain nutrients are laid out in Annex VI of "IN No. 28/2018”, including: “This product should not be consumed by pregnant women, nursing mothers and children.”

VI. NUTRITION & HEALTH CLAIMS

Annex V of “IN No. 28/2018” provides the list of nutrition and health claims authorised in food supplements.

Textual variations of authorised claims are not allowed, except when:

• The claims for the same substance are combined in a single sentence; or
• Identical claims for different substances are brought together in a single sentence.

The use of claims is optional, except for food supplements with probiotics or enzymes.

In accordance with “RDC No. 243/2018”, the labelling of food supplements cannot present any other representation, including in other languages, that affirm, suggest or imply, expressly or implicitly, that:

• The product has medicinal or therapeutic purposes;
• The product contains unauthorized or prohibited substances;
• Food is not able to provide the necessary components for health; or
• The product is comparable or superior to conventional foods.