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
Tobacco companies or front groups may challenge any legislative or regulatory measure that affects their business interests. Unlike public interest litigation, these cases seek to weaken health measures. These cases frequently involve the industry proceeding against the government. For example, a group of restaurant owners challenging a smoke free law as unconstitutional.
A violation of the right to the enjoyment of the highest attainable standard of health. Public health advocates may claim the public’s right to health is violated by weak tobacco control measures, industry tactics, or an organization’s or smokers’ actions.
Subsequent regulations exceed the scope of the originating law.
Type of Tobacco Product
None
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
"Art. 8º, heading and § 1º, X, of Law nº 9.782/1999 subjects smoking products, whether or not they are derived from tobacco, to a specific, differentiated regime of regulation, oversight and enforcement by ANVISA, since products are involved that entail a risk to public health. The specific competency of ANVISA to regulate products that pose a risk to health (Art. 8º, § 1º, X, of Law nº 9.782/1999) necessarily includes the competency to specify, on the basis of technical and safety criteria, the ingredients that may or may not be used in the manufacture of such products. Hence the legal support for RDC nº 14/2012, insofar as it prohibits the addition to smoking products derived from tobacco of compounds or substances intended to enhance their attractiveness. Eminently technical in nature, controlling the manner of presentation (composition, characteristics, etc.) of a product intended for consumption."
"Freedom of enterprise (Arts. 1º, IV, and 170, heading, of the Constitution) does not prevent the imposition by the State, of conditions and limitations on the conduct of private activities, keeping in view their being rendered compatible with other principles, guaranties, fundamental rights and constitutional, individual or social protections, emphasizing, in the case of tobacco control, the protection of health and the right to information. The risks associated with tobacco consumption justifies its market being subjected to intense sanitary regulation, keeping in view the public interest in the protection and promotion of health."
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
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.")