National Confederation of Industry (Confederação Nacional da Indústria) v. ANVISA

In 2012, Brazil banned tobacco additives and flavors. The National Confederation of Industry (Confederação Nacional da Indústria) challenged the ban. The Supreme Federal Tribunal, Brazil’s highest court, upheld the 2012 regulation and affirmed the Brazilian Health Regulatory Agency’s (ANVISA) right to regulate tobacco products. The court held that freedom of enterprise does not prevent Brazil from imposing conditions and limitations on private activities. The court found that while businesses have rights, they must be compatible with other fundamental and constitutional rights. In the case of tobacco control, these fundamental and constitutional rights include the right to health and the right to information. The court further held that the risks associated with tobacco consumption justify the tobacco market being subjected to intense health regulations.

Because the court failed to reach a majority (5-5 tie), the decision is not binding on other tribunals, and, by not reaching a majority, the court rejected the constitutionality claim against the ANVISA regulation (“Resolução da Diretoria Colegiada da ANVISA 14/2012”). Although the decision is not binding because of a lack of quorum, it is unlikely that subsequent challenges to the regulation would be decided differently.  (Note that the decision is in Portuguese with five pages translated into English. The English translation is located in "Related Documents.")


Direct Action of Unconstitutionality (ADI) 4874, Unique Number: 9984745-20.2012.1.00.0000

  • Brazil
  • Feb 1, 2018
  • Supreme Federal Court of Brazil


Plaintiff National Confederation of Industry (Confederação Nacional da Indústria)

Defendant ANVISA (Agência Nacional de Vigilância Sanitária)

Legislation Cited

International/Regional Instruments Cited

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product