ANVISA Nutraceutical and Dietary Supplements Regulations in Brazil

In recent years, there has been a growing interest in nutraceuticals and dietary supplements as individuals seek to improve their overall health and well-being. In Brazil, like many other countries, the use of these products has surged, leading to increased attention from regulatory authorities to ensure their safety, efficacy, and quality. The current scenario of nutraceuticals and dietary supplements in Brazil shows a growing market driven by increased consumer awareness and demand for health and wellness products. Regulatory updates by ANVISA have enhanced product safety and quality, fostering competition and diversity in available supplements.

BRAZIL Health Authority and Legal Representation

Nutraceutical and dietary supplements regulations in Brazil falls under the purview of the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA). ANVISA is responsible for overseeing and enforcing health regulations related to food, medicines, and other health-related products, including dietary supplements.

ANVISA Nutraceutical and Dietary Supplements Product classification in Brazil

In Brazil, dietary supplements are considered a subcategory of food, which means they are not classified as drugs or medicines. This categorization implies that dietary supplements should not make therapeutic or medicinal claims. Instead, they should be marketed and promoted solely as products that support general well-being and health. Examples of dietary supplements include vitamins, minerals, amino acids, herbal extracts, probiotics, and other natural substances.

ANVISA Nutraceutical and Dietary Supplements Pre-Registration Requirements

Before initiating the formal registration process with ANVISA, manufacturers or importers of dietary supplements should gather essential documentation and information about the product. This includes details about the ingredients, product composition, safety data, and evidence supporting any health claims (non-therapeutic claims).

ANVISA Nutraceutical and Dietary Supplements Registration Process in Brazil

The steps involved in the registration process are:

1. Check the list of ingredients.

2. Check the compliance of the label.

3. Check the compliance of the claims.

4. Submit all necessary documents to ANVISA.

5. ANVISA reviews applications (~180 days).

6. Receive a sanitary license.

7. ANVISA inspection.

ANVISA Nutraceutical and Dietary Supplements Registration : Document Requirements in Brazil

Module	Document Requirements
Module I - Administrative Documents	Company registration and legal representation documentation Technical Responsibility documentation Proof of payment of applicable fees
Module II - Product Technical Documents	Product composition details Manufacturing process description Quality control documentation Brazil (GMP compliance) Stability study data Packaging and labeling details
Module III - Product Safety and Efficacy Documents	Toxicological and safety data Clinical studies (if applicable) Supporting evidence for non-therapeutic claims

ANVISA Nutraceutical and Dietary Supplements Labeling requirements in Brazil

The labeling of food supplements shall have the following information:

I. The recommendation for use according to population group and age range in the case of children.

II. The quantity and frequency of consumption for each of the population groups indicated on the label.

III. Highlight and bold warning:

• “This product is not a medicine”

• “Do not exceed the daily recommendation of consumption indicated on the packaging”

• “Keep out of the reach of children”

IV. the instructions for storage, including after opening the package.

ANVISA Nutraceutical and Dietary Supplements Import and distribution in Brazil

Once a nutraceutical or dietary supplement is approved for sale in Brazil, importers and distributors must also comply with Brazil’s health authority guidelines. They should have an operating license from ANVISA, follow good storage practices, and ensure proper transportation conditions to maintain product integrity.

ANVISA Nutraceutical and Dietary Supplements Timeline and Associated Fees

The timeline for the registration process is 12-18 months and the fee associated with registration of dietary supplements in BRAZIL ranges from $100 USD-$ 2060 USD.

ANVISA Nutraceutical and Dietary Supplements Post-Market Surveillance in Brazil

After obtaining product registration, manufacturers must comply with post-market surveillance requirements. This involves monitoring and reporting any adverse events associated with the use of their products. Failure to report adverse events can result in sanctions and withdrawal of the product from the market.

Brazil's strict regulation of ANVISA for nutraceuticals and dietary supplements is designed to protect consumers and ensure that these products are safe, effective, and properly labeled. Manufacturers, importers, and distributors must adhere to ANVISA's nutraceutical regulation guidelines to bring these products to the Brazilian market successfully. Consumers can feel confident that the nutraceuticals and dietary supplements they purchase in Brazil meet high standards of quality and safety.

Artixio is committed to assisting companies in achieving regulatory compliance and market success in the Brazil nutraceutical and dietary supplements industry. Contact us today to learn more about how Artixio can support your regulatory needs in the Brazil.