ORBIS Compliance

Brazil strengthens health security: Total ban on unregistered products

Published /Effective /Brazil

On July 18, 2025, the National Health Surveillance Agency (ANVISA) announced strict measures to remove several irregular products from the Brazilian market that pose health risks.

The action covers both medicines and foods that do not comply with safety, quality, and mandatory registration regulations.

Among the banned medicines is a syrup, whose manufacture, distribution, sale, importation, advertising, and use were prohibited due to the lack of any type of registration or notification to the authorities.

Similarly, ANVISA banned three manufactured supplements, such as Collagen + Vitamin C, Magnesium L-Threonate, and Espinheira Santa, all of which are unregistered and whose companies lack the necessary Operating Authorization to produce medicines.

In the food sector, ANVISA ordered the immediate recall of all batches of the product Curcumyn Long (95% curcuma longa extract) produced by a specific company, after determining that its production method did not comply with current legal specifications. As a result, its marketing, distribution, manufacture, advertising and use were prohibited.

WHOM DOES IT IMPACT?

The direct impact is felt by consumers, the pharmaceutical and food sectors, the companies involved, and distributors.

CONCLUSION:

The pharmaceutical and food sectors are forced to strengthen their registration and regulatory compliance processes, as ANVISA demonstrates strict oversight to ensure the safety and quality of products entering the Brazilian market.

Regulatory Authority

ANVISA

Regulatory Impact

Impact TypeStatus
Top Priority
Type Certificate
Spectrum Bands
Import Changes (HS Codes)
Standard Changes
Product Changes
Label Changes

Brazil Quick Facts

Regulatory AgencyANATEL (Agência Nacional de Telecomunicações)
Certification TypeMandatory
License ValidityTechnical compliance certificate: 2 to 3 years
Application LanguagePortuguese
Legal License HolderRequired
In-country Testing RequirementRequires testing

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