Brazil

Importers, Sellers

ANVISA RDC No. 90 of 2007 makes violation of content restrictions and prohibitions subject to penalties established in Act 6.437. The Act establishes a range of penalties, with exact penalties to be determined by ANVISA based on the seriousness of the violation. Potential penalties for violation of the disclosure requirement include: warning, seizure of product, rendering unviable and/or banning of product; suspension of sale and/or manufacture of product, cancellation of product registration; partial or total banning of the establishment, cancellation of company’s federal operating permit, cancellation of the establishment’s state operating license, prohibition of advertising and/or fine.

The law aligns with FCTC Art. 9 and the FCTC Arts. 9 & 10 Partial Guidelines in that it imposes sanctions for content regulation violations.

Manufacturer, importer

ANVISA RDC No. 90 of 2007 makes violation of the disclosure requirement subject to penalties established in Act 6.437. The Act establishes a range of penalties, with exact penalties to be determined by ANVISA based on the seriousness of the violation. Potential penalties for violation of the disclosure requirement include: warning, seizure of product, rendering unviable and/or banning of product; suspension of sale and/or manufacture of product, cancellation of product registration; partial or total banning of the establishment, cancellation of company’s federal operating permit, cancellation of the establishment’s state operating license, prohibition of advertising and/or fine.

The law aligns with FCTC Art. 10 and the FCTC Arts. 9 & 10 Partial Guidelines in that the law imposes sanctions for disclosure violations.